DISSERTATION o Attribution - UJ IR

COPYRIGHT AND CITATION CONSIDERATIONS FOR THIS THESIS/ DISSERTATION

o Attribution — You must give appropriate credit, provide a link to the license, and indicate ifchanges were made. You may do so in any reasonable manner, but not in any way thatsuggests the licensor endorses you or your use.

o NonCommercial — You may not use the material for commercial purposes.

o ShareAlike — If you remix, transform, or build upon the material, you must distribute yourcontributions under the same license as the original.

How to cite this thesis

Surname, Initial(s). (2012) Title of the thesis or dissertation. PhD. (Chemistry)/ M.Sc. (Physics)/ M.A. (Philosophy)/M.Com. (Finance) etc. [Unpublished]: University of Johannesburg. Retrieved from: https://ujcontent.uj.ac.za/vital/access/manager/Index?site_name=Research%20Output (Accessed: Date).

http://www.uj.ac.za/

https://ujdigispace.uj.ac.za/

The Effect of Sodium Shale Oil Sulphonate 1% Shampoo on Dandruff

A Research Dissertation presented to the

Faculty of Health Sciences, University of Johannesburg,

as partial fulfilment for the

Masters Degree in Technology: Homoeopathy

By:

Zeenat Mia

(Student Number: 201001496)

Supervisor: __________________ Date: _________________

Dr Neil Gower MTechHom (UJ) CML (UNISA)

Co-supervisor: ________________ Date: _________________

Dr Marelize Caminsky MTechHom (UJ)

ii

DECLARATION

I declare that this dissertation is my own, unaided work. It is being submitted for the Degree of

Master of Technology at the University of Johannesburg, Johannesburg. It has not been submitted

before for any degree or examination in any other Technikon or University.

(Signature of Candidate)

day of

iv

ABSTRACT

Dandruff, also known as seborrhea sicca, pityriasis capitis or sicca capitis, can be defined as

chronic non-inflammatory scaling of the scalp, or an abnormality in the desquamation process

which occurs on the scalp (Willet, 2010). It is said that dandruff affects at least 50% of the world’s

adult population and about 15 – 20% of the world’s total population (Prambhamanju et al., 2009).

Dandruff is usually marked by flaking as well as itching and irritation of the scalp which can also

lead to greasiness. Dandruff can lead to physiological and psychological issues and can be very

distressing and embarrassing for sufferers, causing low self-esteem and social problems (Nowicki,

2006).

According to the literature, pale sulphonated shale oil has widespread dermatological uses as it is

believed to have anti-inflammatory, anti-microbial and anti-seborrheic properties (Lunar

Pharmaceutics, 2014).

The aim of the study was to ascertain the effect of sodium shale oil sulphonate 1% shampoo on

the appearance of dandruff. Forty participants completed the study and participants were of both

genders between the ages of 18 and 45. The study compromised of 16 days with 3 visits each 8

days apart.

The study design consisted of double-blind, placebo-controlled study where participants were

grouped into matching pairs based on the severity of the condition. Participants were then

randomly assigned to the treatment or placebo group. At each visit, participants were assessed

using the following assessment measures: a Visual Analogue Scale for the participant comprising

of scaling, irritation, itching, greasiness and global impression; a Visual Analogue Scale for the

researcher comprising of scaling, irritation, greasiness and global impression as well as an

Adherent Scalp Flake Score grading completed by the researcher.

Parametric and non-parametric analyses were used and the results of the study demonstrated

overall statistically significant improvement in all parameters for the treatment and placebo groups

but the extent of improvement was greater in the treatment group. However, at individual visits,

only certain parameters expressed statistically significant changes when compared to the placebo

group.

It was found that both Sodium Shale Oil Sulphonate 1% shampoo and the control shampoo may

contribute significantly to the improvement of the appearance of dandruff with respect to all of the

v

aforementioned parameters. No significant difference was found between the sodium shale oil

sulphonate 1% shampoo and the control shampoo relevant to irritation, itching, greasiness or

researcher global impression.

The Sodium Shale Oil Sulphonate 1% shampoo was shown to yield a higher percentage

improvement for each measured parameter than the control substance and showed a significant

improvement over and above the control shampoo with respect to only the following parameters:

scaling (participant rated p=0.012; researcher rated p=0.020) and the global impression

(participant rated p=0.048). Higher numbers of participants and longer study periods are however

required to verify these results.

The conclusion or results of this study may not be quoted for use or proof of efficacy nor

substantiation of any effect in any context without the express permission of the Department of

Homoeopathy, University of Johannesburg.

vi

DEDICATION

I dedicate this research dissertation to the following people:

My mother, Zuleikha Munshi. Thank you for your endless support, love and encouragement

throughout the tears and smiles during my studies.

My husband, Mohammed Adam, for forcing me to work on my research almost every single day

and for your continuous concern about my progress. For giving up our weekends for me to study.

My sister, Yumna Mia, for sharing a study with me.

My In Laws, for your concern and prayers.

My father, Abdul Mia, for the financial support.

vii

ACKNOWLEDGEMENTS

I would like to extend my utmost gratitude to the following people:

Dr N. Gower (Supervisor): For the expert advice, guidance, time and patience throughout

the entire process and for never getting mad at me for continuously hassling.

Dr M. Caminsky (Co-Supervisor): For your time, guidance and constructive input

especially with grammar.

Ms Juliana Van Staden (STATKON)

Mr Trevor Baillie (Medicine manufacturer)

All the participants who volunteered to take part in the study.

viii

TABLE OF CONTENTS

Page

DECLARATION ii

AFFIDAVIT iii

ABSTRACT iv

DEDICATION vi

ACKNOWLEDGEMENTS vii

TABLE OF CONTENTS viii

LIST OF FIGURES xiii

LIST OF TABLES xiv

LIST OF APPENDICES xv

CHAPTER 1: INTRODUCTION 1

1.1 Problem Statement 1

1.2 Aim 1

1.3 Hypothesis 1

1.4 Null Hypothesis 2

1.5 Importance of the Study 2

CHAPTER 2: LITERATURE REVIEW 3

2.1 Anatomy and Physiology of the Skin 3

2.1.1 Structure of the Skin 3

2.1.1.1 The Epidermis 3

2.1.1.2 The Dermis 5

2.1.1.3 Subcutaneous Layer 5

2.1.1.4 Vascular Supply 6

2.1.1.5 Nerve Supply 6

2.1.1.6 Accessory Structures (Epidermal Appendages) 7

2.2 Functions of the Skin 8

2.3 Dandruff 9

2.3.1 Epidemiology 9

ix

2.3.2 Aetiology and Pathogenesis 10

2.3.2.1 Malassezia 10

2.3.2.2 Lipase activity 11

2.3.2.3 Sebum 12

2.3.2.4 Lipid levels 13

2.3.2.5 Other Factors 13

2.3.3 Pathophysiology 13

2.3.4 Signs and Symptoms 14

2.3.5 Differential Diagnosis 14

2.4 Dandruff Severity Measures 16

2.4.1 Visual Analogue Scale (VAS) 16

2.4.2 Adherent Scalp Flake Score Grading (ASFS) 17

2.5 Treatment of Dandruff 17

2.5.1 Conventional Treatment 18

2.5.1.1 Fungicidal Substances 19

2.5.1.2 Cytostatic Substances 19

2.5.1.3 Keratolytic Substances 20

2.5.1.4 Anti Inflammatory Substances 20

2.5.2 Complementary and Alternative Treatments 21

2.6 Sodium Shale Oil Sulphonate/Pale Sulfonated Shale Oil Shampoo 22

2.6.1 Shale Oil 23

2.7 Related Research 24

CHAPTER 3: METHODOLOGY 25

3.1 Research Sample 25

3.1.1 Inclusion Criteria 25

3.1.2 Exclusion Criteria 25

3.2 Research Procedure and Design 25

x

3.3 Medication administration 26

3.4 Sodium Shale Oil Sulphonate 1% 26

3.5 Data Collection and Analysis 27

3.6 Reliability and validity measures 27

3.7 Ethics 27

CHAPTER 4: RESULTS 29

4.1 Introduction 29

4.2 Participant Recruitment 30

4.3 Demographic Data 32

4.3.1 Gender Distribution 32

4.3.2 Age Distribution 33

4.3.3 Race Distribution 33

4.3.4. ASFS Scores at Primary Visit 34

4.4 Outcomes and Estimations 34

4.4.1 Scaling 35

4.4.1.1 Participant VAS Evaluation 35

Comparable Scaling 35

Intragroup Analysis 35

Intergroup Analysis 37

4.4.1.2 Researcher VAS Evaluation 38

Comparable Scaling 38



4.4.2 Irritation 40


Comparable Irritation 40

xi




Comparable Irritation 43



4.4.3 Itching 46


Comparable Itching 46



4.4.4 Greasiness 48


Comparable Greasiness 48




Comparable Greasiness 51



4.4.5 Global Impression 54


Comparable Global Impression 54




Comparable Global Impression 57



4.4.6 Adherent Scalp Flake Score Grading (ASFS) 60

Comparable ASFS 60



xii

CHAPTER 5: DISCUSSION 63

5.1 Introduction 63

5.2 Demographic Data 63

5.2.1 Gender Distribution 63

5.2.2 Age Distribution 63

5.2.3 Race Distribution 63

5.3 Primary Visit Scores 64

5.4 Scaling 64

5.5 Irritation of the scalp 65

5.6 Itching 66

5.7 Greasiness 67

5.8 Global Impression 68

5.9 ASFS 69

CHAPTER SIX: CONCLUSION AND RECOMMENDATIONS 70

6.1 Conclusion 70

6.2 Recommendations 71

REFERENCES 72

xiii

LIST OF FIGURES

Page

Figure 1.1 The Layers of the Epidermis 5

Figure 2.2 Anatomy of the Skin 7

Figure 2.3 Anatomy of the Hair Follicle 8

Figure 2.4 Metabolic Pathways Involved in Dandruff 12

Figure 2.5 Examples of Products Used in the Treatment of Dandruff 18

Figure 4.1 CONSORT Flow Chart of Participants 32

Figure 4.2 Race Distribution 34

Figure 4.3 Estimated Marginal Means for Scaling – Participant Evaluations 36

Figure 4.4 Estimated Marginal Means for Scaling – Researcher Evaluations 39

Figure 4.5 Estimated Marginal Means for Irritation – Participant Evaluations 42

Figure 4.6 Estimated Marginal Means for Irritation – Researcher Evaluations 44

Figure 4.7 Estimated Marginal Means for Itching 47

Figure 4.8 Estimated Marginal Means for Greasiness – Participant Evaluations 49

Figure 4.9 Estimated Marginal Means for Greasiness – Researcher Evaluation 52

Figure 4.10 Estimated Marginal means for Global Impression – Participant Evaluations 55

Figure 4.11 Estimated Marginal Means for Global Impression – Researcher Evaluation 58

Figure 4.12 Estimated Marginal Means for the ASFS 61

xiv

LIST OF TABLES

Page

Table 4.1 Gender Distribution 33

Table 4.2 Group Statistics ASFS Visit 1 34

Table 4.3 Group Statistics Scaling – Participant Evaluations 35

Table 4.4 Friedman Test for Scaling – Participant Evaluations 37

Table 4.5 Wilcoxin Signed Ranks Test for Scaling Participant Evaluations 37

Table 4.6 Group Statistics Scaling – Researcher Evaluations 38

Table 4.7 Friedman Test for Scaling – Researcher Evaluations 39

Table 4.8 Wilcoxin Signed Ranks Test for Scaling – Researcher Evaluations 40

Table 4.9 Group Statistics for Irritation – Participant Evaluations 41

Table 4.10 Friedman Test for Irritation – Participant Evaluations 42

Table 4.11 Wilcoxin Signed Ranks Test for Irritation – Participant Evaluations 43

Table 4.12 Group Statistics for Irritation – Researcher Evaluations 44

Table 4.13 Friedman Test for Irritation – Researcher Evaluations 45

Table 4.14 Wilcoxin Signed Ranks Test for Irritation – Researcher Evaluations 45

Table 4.15 Group Statistics for Itching 46

Table 4.16 Friedman Test for Itching 47

Table 4.17 Wilcoxin Signed Ranks Test for Itching 48

Table 4.18 Group Statistics for Greasiness – Participant Evaluations 49

Table 4.19 Friedman Test for Greasiness – Participant Evaluations 50

Table 4.20 Wilcoxin Signed Ranks Test for Greasiness – Participant Evaluations 50

Table 4.21 Group Statistics for Greasiness – Researcher Evaluations 51

Table 4.22 Friedman Test for Greasiness – Researcher Evaluations 53

Table 4.23 Wilcoxin Signed Ranks Test for Greasiness – Researcher Evaluations 53

Table 4.24 Group statistics for Global Impression – Participant Evaluations 54

Table 4.25 Friedman Test for Global Impression – Participant Evaluations 56

Table 4.26 Wilcoxin Signed Ranks Test for Global Impression – Participant Evaluations 56

Table 4.27 Group Statistics for Global Impression – Researcher Evaluation 57

Table 4.28 Friedman Test for Global Impression – Researcher Evaluation 59

Table 4.29 Wilcoxin Signed Ranks Test for Global Impression – Researcher Evaluation 59

Table 4.30 Friedman Test for the ASFS 61

Table 4.31 Wilcoxin Signed Ranks Test for the ASFS 62

xv

LIST OF APPENDICES

Page

APPENDIX A: Advertisement 81

APPENDIX B: Participant Information Form 82

APPENDIX C: Participant Consent Form 85

APPENDIX D: Physical Examination 86

APPENDIX E: Modified Visual Analogue Scale for Participant 87

APPENDIX F: Modified Visual Analogue Scale for Researcher 88

APPENDIX G: Adherent Scalp Flaking Score Grading 89

APPENDIX H: Matching Procedure 90

APPENDIX I: Collected Data for Statistical Analysis 91

APPENDIX J: Statistical Analysis 93

1

CHAPTER 1: INTRODUCTION

1.1 Problem Statement

Dandruff, also known as Pityriasis capitis, is a common condition affecting the scalp. It is

estimated that dandruff affects at least 50% of the world’s adult population and about 15 – 20% of

the world’s total population (Nowicki, 2006). Dandruff is caused by increased desquamation and

cell growth leading to irritation, marked by flaking and itching of the scalp with associated

greasiness (Roger, 2010). Although dandruff is not a cause of major morbidity, as it only affects

the scalp, it may be embarrassing and distressing to sufferers leading to low self-esteem and social

problems (Nowicki, 2006). The psychological effects of dandruff warrants research into ways in

which the problem can be addressed.

Current treatment options for dandruff include many over-the-counter preparations, anti-dandruff

shampoos and topical steroid medications. These treatments may be accompanied by side effects

and possible aggravation of the condition. Some commonly used ingredients have carcinogenic

properties, while others cause increased irritability, dryness and itching of the scalp, allergic

reactions (contact dermatitis), endocrine and epithelial cell disruptions, and headaches (Pierard–

Franchimont et al., 2001).

Ichthyol® Pale shampoo is a sodium salt of pale sulphonated shale oil in aqueous solution. It has

anti-microbial, anti-inflammatory, anti-seborrheic and anti-fungal properties. It combats dandruff

by means of slowing down the desquamation process and regulating cell growth, thus addressing

both the cause and symptoms of dandruff (Lunar Pharmaceuticals, 2014). Research on Ichthyol®

Pale needs to be conducted in order to evaluate its effect on the treatment of dandruff, as no

external research has been done to date.

1.2 Aim

The aim of the study was to determine the effect of Sodium Shale Oil Sulphonate 1% shampoo in

the treatment of dandruff (Pityriasis capitis). This was evaluated by means of the Adherent Scalp

Flaking Score (ASFS) grading and a Visual Analogue Scale (VAS).

1.3 Hypothesis

It is hypothesized that Sodium Shale Oil Sulphonate 1% shampoo would decrease and ameliorate

the signs and symptoms of dandruff measured using a VAS and ASFS grading when compared to

the placebo over a 16 day period.

2

1.4 Null Hypothesis

The null hypothesis states that Sodium Shale Oil Sulphonate 1% shampoo would not decrease and

ameliorate the signs and symptoms of dandruff measured using a VAS and ASFS grading when

compared to the placebo over a 16 day period.

1.5 Importance of the Study

Current treatment options available for the treatment of dandruff are not always effective and can

pose the risk of higher recurrence rates. Some only provide symptomatic relief for the condition

and include numerous harmful side effects. The use of Sodium Shale Oil Sulphonate 1% shampoo

may provide a long term, safer and more effective treatment option for dandruff. Should the study

produce positive results, further research on the treatment of dandruff, and other similar conditions,

using Shale Oil Sulphonate 1% shampoo can be conducted.

3

CHAPTER 2: LITERATURE REVIEW

2.1 Anatomy and Physiology of the Skin

2.1.1 Structure of the Skin

The skin is the largest organ of the entire human body. Tissues that make up the skin constantly

grow, differentiate and renew themselves. The skin acts as a major protection barrier between the

internal and external environment (Hull, 2011).

The skin is made up of 3 layers – the epidermis (external layer), the dermis (internal layer), and

the subcutaneous tissue – together with blood vessels, nerves and accessory structures (hair, nails

and sweat glands) (Hall and Hall, 2010). The skin itself, together with accessory structures, makes

up the integumentary system. As with other systems of the body, the integumentary system does

not function in isolation. It depends largely on an extensive network of blood vessels as well as

sensory receptors in order to complete its functions (Martini and Nath, 2009).

2.1.1.1 The Epidermis

The epidermis consists of stratified squamous epithelial cells that offer mechanical protection as

well as protection from external microorganisms. It is the most superficial layer of the skin and

has an average thickness of less than 1mm. It contains many different cells including keratinocytes,

melanocytes, Langerhans cells and Merkel cells. It is also important to note that the epidermis is

free from blood vessels and lacks any nerves. The keratinocytes are the most abundant cells found

in the epidermis. The keratinocytes are arranged in 4 layers. From the deepest to the most

superficial these layers are as follows:

1. Stratum germinativum

2. Stratum spinosum

3. Stratum granulosum

4. Stratum corneum (Martini and Nath, 2009).

The stratum germinativum, stratum basale or the basal layer (Hall and Hall, 2010) is the innermost

stem cell layer whose divisions restore the keratinocytes that are shed and lost on the surface of

the epithelium (Martini and Nath, 2009). Cells present in this layer include melanocytes

(responsible for skin and hair colour), Merkel cells (acting as slowly adapting sensory receptors)

and Langerhans cells (responsible for delayed hypersensitivity reactions) (Hall and Hall, 2010).

4

The stratum spinosum or the spinous layer consists mainly of keratin filaments (Martini and Nath,

2009). Cells entering this layer from the stratum germinativum further divide to increase the

thickness of the epithelium (Hall and Hall, 2010).

The stratum granulosum or the grainy layer (Hall and Hall, 2010) consists of three to five

keratinocyte layers. By the time the dividing cells reach this grainy layer they begin producing

keratin, which forms the essential structure of hair and nails, and keratohyalin, responsible for

dehydration of cells (Martini and Nath, 2009). As keratin develops, the cells become thinner and

flatter with less permeable membranes. Nuclei of the cells also disintegrate in this layer causing

cell death (Hull, 2011).

The stratum corneum or the keratin layer is the most superficial layer. It acts as a major protective

barrier for the body as it is water resistant, but not water proof as it absorbs considerable amounts

of water (Martini and Nath, 2009). Keratinization occurs in this layer - it consists of layers of

keratinized cells that continuously shed (Hall and Hall, 2010).

Its takes about 15-30 days for cells to migrate from the innermost to the outermost layer of the

epidermis. The dead cells then remain on the stratum corneum for a further two weeks, after which

they are shed or washed away. By remaining on the stratum corneum, the cells act as a protective

barrier to the underlying epidermal layers. By keeping the surface of the stratum corneum dry, the

growth of microorganisms is discouraged (Martini and Nath, 2009). Figure 1.1 below illustrates

the various layers on the epidermis together with their components and functions.

5

Figure 1.1: The layers of the epidermis (Marieb and Hoehn, 2013)

2.1.1.2 The Dermis

The dermis is the layer lying between the epidermis and the subcutaneous layer. It contains a rich

lymphatic, vascular and nerve supply accompanied by eccrine and apocrine sweat glands and

pilosebaceous structures (Martini and Nath, 2009). Two major components make up the dermis:

the superficial adventitial layer and the deep reticular layer (Hall and Hall, 2010). The superficial

adventitial layer contains delicate elastic fibres, thin collagen fibres, and an abundance of

capillaries and ground substances (extrafibrillar matrix). The deeper reticular layer is primarily

made up of thick dense collagen bundles intertwined with elastic fibres making it bulky. It contains

less ground, vascular and cellular elements in comparison to the thin adventitial layer (Martini and

Nath, 2009).

2.1.1.3 Subcutaneous Layer

The subcutaneous or hypodermis layer of the skin consists of areolar tissue and of adipose tissue.

This layer consists mainly of fat tissue with blood vessels and nerve tissue. The hypodermis,

through the action of the areolar tissue, stabilizes the position of the skin in relation to the other

6

underlying structures, such as muscles, and provides nutrition and thermoinsulation to the skin

(Hull, 2011).

2.1.1.4 Vascular Supply

The skin contains a rather rich vascular supply providing the skin with blood volumes that far

exceed the necessary requirements. Due to the extensive blood supply, it had been suggested that

the primary function of the skin may in fact be heat regulation and blood pressure control instead

of nutrition to the skin (Hall and Hall, 2010). Cutaneous blood supply or the vascular plexus of the

skin arises from thick arteries residing in the subcutaneous layer. Two major vascular plexuses

running parallel to the epidermis exist: one in the deeper reticular dermis and the other in the

superficial dermis with vertical perforating divisions supplying blood to the skin appendages

(Martini and Nath, 2009).

2.1.1.5 Nerve Supply

The skin is regarded as a major sensory organ, as it contains thousands of nerve endings, constantly

receiving stimulation from the surroundings (Martini and Nath, 2009). Anything that comes into

contact with the skin causes a nerve impulse. The cutaneous blood vessels and skin appendages

receive efferent nerve supply from the sympathetic branch of the autonomic nervous system,

whereas the afferent nerve supply consists of a variety of different types of sensory receptors (Hull,

2011).

Figure 2.2 below illustrates the anatomy of the skin including the epidermis, dermis, hypodermis

and appendages.

7

Figure 2.2: Anatomy of the skin (Matthews, 2012)

2.1.1.6 Accessory Structures (Epidermal Appendages)

The appendages of the skin are made up of two types: cornified appendages, which are hair and

nails; and glandular appendages, including sebaceous glands and sweat glands (Martini and Nath,

2009).

Hair develops from almost every part of the human body covered by skin except the palms and the

soles. It is produced by a structure called the hair follicle. Hair is a keratin-containing filament that

is made up of a root and a shaft, and it is found in the hair follicle of the epidermis. Attached to

each hair follicle is a sebaceous gland which produces sebum into the follicle through the

sebaceous duct. The sebum is then discharged onto the skin’s surface where it inhibits bacterial

growth, and lubricates and protects the surrounding skin and the keratin in the hair shaft (Colledge

et al., 2010). Figure 2.3 below provides a detailed illustration of the hair follicle and sebaceous

glands with surrounding structures. The functions of hair are vast including ultraviolet protection

for the scalp, insulation and cushioning for light impact injuries (Hull, 2011).

8

Just like hair, the sebaceous glands are present on every part of the skin, except the palms and the

soles. They are a type of holocrine gland that secretes an oily lipid discharge into the hair follicles.

As the glands mature they produce large amounts of lipids called sebum (Hall and Hall, 2010).

Figure 2.3: Anatomy of the hair follicle (Dermweb, 2008)

2.2 Functions of the Skin

The following is a list of general functions of the skin (Martini and Nath, 2009):

1. Protection of the internal organs and tissues against impact and abrasion;

2. Water, salt and organic waste excretion;

3. Thermoregulation and insulation;

4. Ultraviolet radiation protection through the production of melanin;

5. Vitamin D synthesis which is important in calcium metabolism;

6. Lipid storage;

7. Detection of stimuli and the ability to relay information to the nervous system; and

8. Prevents the loss of essential fluids.

9

2.3 Dandruff

The word pityriasis capitis (dandruff), introduced to the world of dermatology by Galen, originates

from the Greek word ‘pityriasis’ which means bran-like (Rastegar, 2009). Dandruff, also known

as seborrhea sicca, pityriasis capitis or sicca capitis, can be defined as chronic non-inflammatory

scaling of the scalp, or an abnormality in the desquamation process which occurs on the scalp.

Scaling often occurs on the epidermal layer of the skin and can affect individuals to varying

degrees (Willet, 2010). The presenting white flakes of dandruff can be constant, recurrent or

sporadic and can vary in severity (Pierard–Franchimont et al., 2001). Two types of dandruff are

thought to exist: Common or dry dandruff and oily dandruff (Adamski, 2006).

Common or dry dandruff is characterized by the formation of tiny grey-white or pale coloured

flakes which accumulate on the scalp. Such flakes begin in the centre of the scalp and then move

towards the occipital and parietal regions of the scalp. The quality of the hair remains unchanged

and no excessive hair loss is present (Adamski, 2006).

Oily dandruff occurs in individuals who have varying degrees of sebum production on the scalp.

This type often occurs in individuals aged 18 to 24 years. Oily dandruff flakes appear more yellow

in colour and are accompanied by pruritis and hair loss in the affected areas (Adamski, 2006).

2.3.1 Epidemiology

Dandruff is an age-related condition. It is rarely seen prior to puberty, increases in occurrence in

post pubertal individuals, peaks in the early twenties, and declines in frequency in individuals over

50 years. According to American market research, at least 80-90% of people suffer from some

type of scaling disorder. Of that, 30-35% of those suffer from dandruff (Robbins, 2012). In terms

of the world adult population, at least 50% suffer from dandruff contributing to approximately 15-

25% of the total population (Prambhamanju et al., 2009). According to extrapolated statistics of

the United States, approximately 8 million South Africans suffer from dandruff (Pray, 2006).

Based on statistics from Proctor and Gamble Company (2002), 50% of Caucasians and 80% of

individuals with African lineage have suffered from dandruff at some time in their lives making it

one of the most common conditions apart from the common cold (Proctor and Gamble Company,

2002).

Some literature suggests that the greatest severity and prevalence occurs in young men of post

pubertal age due to androgenic influences (Pierard–Franchimont et al., 2001), and that the

10

condition worsens during the winter time, but this information seems to vary from source to source

(Ravichandran et al., 2004).

2.3.2 Aetiology and Pathogenesis

Since dandruff is a common problem, it has been subjected to considerable amounts of research.

Despite its common occurrence, very little is understood about the aetiology of the condition and

little progress has been made towards trying to understand dandruff (Harding et al., 2002).

Since the 19th century, many different causes for dandruff have been proposed. Through the years,

these propositions have been further studied in order to pin point a single cause of dandruff. The

aetiologic factors involved in causing dandruff can be described as multi-factorial, and includes

any combination of the Malassezia fungus, lipase activity, presence of sebum, lipid levels as well

as other factors such as stress, immune function, genetic susceptibility and humidity (Schwarts,

2003).

2.3.2.1 Malassezia

The most extensively studied cause of dandruff is the fungus Malassezia, previously called

Pityrosporum. The theory of the scalp peeling was already stated in 1874 by Malassez (Malassez,

1874).

The Malassezia genus can be divided into nine known species of lipophilic yeasts of which seven

are postulated to be the cause of dandruff (Arndt and Hsu, 2007).

The human scalp is home to many extensive colonies of microorganisms including Malassezia.

Malassezia is one of the normal scalp flora and usually comprises 46% of the total flora of a

healthy scalp. In a recent study, participants with dandruff presented with an excess of Malassezia

with amounts of up to 74%. Therefore, it is thought that a scalp flora imbalance and an overgrowth

of Malassezia plays a significant role in the condition and is considered as the most probable cause

of dandruff (Proctor and Gamble Company, 2002).

Malassezia species tend to accumulate in sebum rich areas such as the scalp. Malassezia are highly

dependent on lipids, and utilize the fatty acids present in regular sebum in order to thrive and

survive. The metabolites of Malassezia initiate many immune responses in the body resulting in

inflammation, thus contributing to dandruff (Ashbee and Bignell, 2010).

11

According to Percival and Cutting (2010), in a scalp affected by dandruff, the proportion of

Malassezia may proliferate by a factor of between 1 and 2 resulting in a total 75% occupation of

Malassezia on the scalp whereas in a healthy unaffected scalp, the total population of Malassezia

is 46%. Although Malassezia as the primary cause of dandruff is still under constant dispute, in

many reports it has been shown that patients with dandruff do in fact have increased proliferation

of Malassezia as well as an increased antibody titre of Malassezia.

A single species, Malassezia furfur, was previously seen as the primary causative factor of

dandruff. Recently, it has been discovered that these fungal species have the ability to

spontaneously change into a different fungal specie within the Malassezia genus. Thus, recent

studies have shown that the entire genus of Malassezia, together or individually, can cause

dandruff to accumulate on the scalp when they are found in excess (Arndt and Hsu, 2007).

Despite this increasing evidence to support and the strengthen the argument of Malassezia as the

single causative agent of dandruff, scientists still differ and insist on looking at the other factors as

stated previously.

2.3.2.2 Lipase activity

Lipase activity is another postulated aetiology for dandruff. As discussed above, Malassezia are

lipophilic yeasts that need lipids to survive. As the yeast absorbs the lipids or fats on the skin, they

release a specific fatty acid known as oleic acid that stays behind on the skin and in turn, due to

exposure, aggravates the skin. The oleic acid further penetrates the skin, specifically the layer

called the stratum corneum, disabling its primary function as a barrier. The skin attempts to rebuild

the destroyed barrier, but instead, it results in hyperproliferation as well as excessive sebum

production (Schwanke, 2002).

According to DeAngelis et al. (2005) a detailed model (illustrated below in Figure 2.4) describing

the metabolic pathways involved in the origination of dandruff can be proposed as follows. The

Malassezia yeast inhabits the surface of the scalp in an area called the follicular infundibulum or

the upper segment of the hair follicle. Hydrolytic enzymes such as lipase are secreted from the hair

cells into the extracellular environment. The lipase enzymes transform sebaceous triglycerides into

glycerol and fatty acids. The yeasts then consume the necessary fatty acids in order to proliferate,

leaving behind a large amount of unsaturated free fatty acids. These leftover fatty acids infiltrate

the epidermis stimulating a breach in the skins barrier and causing either direct or indirect irritation

of the skin which subsequently leads to flaking and hyperproliferation (DeAngelis et al., 2005).

12

Figure 2.4: Metabolic pathways involved in dandruff (DeAngelis et al., 2005)

2.3.2.3 Sebum

The sebum on the scalp seems to play a vital role in the formation of dandruff. Sebum is a substance

produced by the sebaceous glands. Although the function of sebum is still under dispute, recent

research and technology has supported that the functions of sebum are as follows: epidermal

development, barrier maintenance, antioxidant transport, protection, body odour, pheromone

generation, ultraviolet protection, epidermal regeneration and hormone signalling (Loden and

Maibach, 2000).

Normal sebum consists of many elements including triglycerides, wax esters, fatty acids,

cholesterol, sterol esters and squalene. When secreted, the esters and triglycerides are broken down

into free fatty acids, monoglycerides and diglycerides by certain microbes on the skin and scalp.

The fatty acids play a major role in irritant response initiation which is part of hyperproliferation

as seen in dandruff. The function of the sebum as a hormone signal supports the link between

dandruff severity and factors such as stress and hormones (Schwarts et al., 2010).

Dandruff occurs primarily in sebum rich areas. Sebaceous gland activity is closely related to the

appearance of dandruff. This correlation can be supported by the increase in incidence of scaling

13

in infants as seen with ‘cradle cap’, the decrease from infancy to adolescence, the rise during

adolescence and then the further decrease later in life (Gerson, 2004).

2.3.2.4 Lipid levels

In another research study conducted, researchers found that patients who suffer from dandruff may

have a reduced number of lipids in the scalp as well as in the body cells. The amount of lipids in

the cell is a fundamental element of the water barrier found in the epidermis (Loden and Maibach,

2000). The decreased lipid levels disturbs the capacity of the epidermis to hold water resulting in

increased attachment between the corneocytes and their respective desmasomes leading to the

typical scaling seen with dandruff (Harding et al., 2002).

2.3.2.5 Other Factors

Other contributing or exacerbating factors include high atmospheric humidity or climate. Dandruff

is usually more severe in winter and milder in summer as ultraviolet light counteracts the condition.

Genetic susceptibility, diet (poor nutrition and alcoholism), hormones (especially androgens),

physical and emotional stress, infrequent shampooing or poor hygiene and certain illnesses such

as Parkinsons disease or immune system diseases have also been implicated. Other less common

factors include excessive perspiration, inadequate rinsing of shampoo, tight head coverings and

excessive use of hair products such as hair spray and hair gel (Ravichandran et al., 2004). Although

these factors are not able to produce dandruff by themselves, they seem to contribute to the

exacerbation of the condition (Sage, 2005).

2.3.3 Pathophysiology

The shedding of the scalp is a normal physiological process and occurs in all human beings. The

skin of the scalp regenerates every 25-30 days as the basal cells mature and move to the stratum

corneum, the outermost layer of the skin, where they flatten, lose their nucleus and get shed. The

flaking on the scalp seen in dandruff is thought to be due to abnormal epidermal anatomy and

physiology. Hyperproliferation or rapid maturation of cells occurs in the stratum corneum of the

epidermis leading to flaking (Schwarts et al., 2010).

Migration takes place in 13-15 days, resulting in a disarray of cells and deregulation of

keratinization and corneocyte clumping which causes noticeable flaking (Pray, 2006). The stratum

corneum of a healthy scalp consists of 25-35 strong and closely adherent fully keratinized cell

layers. In the case of dandruff, that number of cell layers decreases to 10 irregularly arranged cells

together with hyperproliferation (Baran and Maibach, 1998). This results in shedding of dead skin

14

cells in clumps, leading to dry white-grey scaling appearing in areas of the scalp, particularly the

top of the head (Sage, 2005)

Irregularities in the stratum corneum occur throughout the scalp of individuals suffering from

dandruff (Schwarts et al., 2010).

2.3.4 Signs and Symptoms

Dandruff is characterized by loosely adherent small white-grey flakes. The flakes are generally

noticeable to the sufferer when brushing or combing the hair or on the shoulder area when dark

colour clothing is worn (Sage, 2005).

Scaling may be accompanied by itching of the scalp, irritation and also possible hair loss. In rare

cases, the skin can also become reddened with greasy patches and minute openings on the scalp

that may ooze a yellow liquid which later forms crusts (Jacoby and Moungson, 2005). Dandruff is

often referred to as a mild form of seborrheic dermatitis, but does not involve inflammation of the

skin. Dandruff also does not have an allergic origin and does not affect bald regions on the scalp

(Johnson and Nunley, 2000).

Although dandruff is not a serious or life threatening condition, even when left untreated,

occasional rare complications may arise when the cracks in the skin open. This may result in

infections or contagious skin diseases such as impetigo (Jacoby and Moungson, 2005).

The appearance of dandruff hardly ever suggests an underlying pathology and its effects are almost

completely cosmetic. It can be very distressing and embarrassing for the sufferer resulting in a

negative psychological impact. People may become very concerned and troubled by the

appearance and visibility of their dandruff, making dandruff a condition with a strong societal

stigma (Nowicki, 2006).

2.3.5 Differential Diagnosis

Many different conditions are commonly confused with dandruff as they share similar symptoms

as the condition. Conditions that are often wrongly diagnosed include psoriasis, Tinea capitis,

atopic eczema, allergic contact dermatitis, head lice and dry scalp (Thomas et al., 2001; Sage,

2005; Hall and Hall, 2010)

15

Psoriasis is typically a chronic recurring disease with characteristic scaling on well

demarcated salmon pink plaques. The plaques are thick with silvery scales and often bleed

when picked (Hall and Hall, 2010). Psoriasis lesions commonly affect the knees and

elbows, and nail involvement may lead to pitting and onycholysis. It can affect other areas

such as the scalp as well. The lesions of psoriasis are better demarcated and more easily

visible compared to the flakes found in dandruff (Thomas et al., 2001).

Tinea capitis or ringworm of the scalp is a fungal infection characterised by grey, scaly,

circular patches with broken off hair and balding (Hall and Hall, 2010). This differentiates

it from dandruff in two ways: dandruff does not involve balding or inflammation, and the

lesions found in Tinea capitis and all fungal infections leave vesicular borders with clear

margins (Sage, 2005). Two types of Tinea capitis exist: inflammatory and non-

inflammatory (Hall and Hall, 2010).

Atopic eczema also known as atopic dermatitis is a common, chronic, pruritic condition of

the skin that usually occurs in infants or adults. Infantile eczema consists of blistering,

crusting and oozing of lesions together with excoriation. Adult eczema is marked by

dryness, lichenification and scarring of the skin (Hall and Hall, 2010). Such lesions differ

significantly from the grey white flakes found in dandruff. In addition, unlike dandruff,

eczema has a strong familial link and more greasy scales (Thomas et al., 2001).

Contact dermatitis is an allergic reaction cause by exposure of the skin to an irritant

substance. This causes inflammation of the skin with lesions that appear red, edematous or

vesicular, with oozing of fluid not commonly seem in dandruff (Thomas et al., 2001, Hall

and Hall, 2010). Contact dermatitis may also cause pruritis (Sage, 2005).

Head lice, also known as Pediculus humanus capitis, affects people of all ages, particularly

those with lower socio-economic status due to lack of hygiene. It also commonly affects

kids in school. The nits of head lice are hard to remove, while the flakes of dandruff can

be easily detached from the scalp, thus differentiating the two conditions (Hall and Hall,

2010).

16

Dry scalp may also develop as a result of infrequent washing. This condition increases in

severity during the winter months. The flakes apparent on a dry scalp are smaller and less

oily than the flakes of dandruff (Thomas et al., 2001).

2.4 Dandruff Severity Measures

Many different measures can be used to measure the severity of dandruff.

One method involves brushing the hair vigorously for a certain amount of time and allowing the

scales to settle on a piece of paper. The paper is then measured in an analytical balance each time

the severity is measured. This method is not the best measure as it can be tedious and may be rather

inaccurate as scales on the paper can be from the dandruff and other scalp scaling disorders (Laden

and Finkelstein, 2000).

Another method involves brushing the hair with a particular brush in a particular direction. The

amount of strokes are also standardised. The flakes are collected on acetate plastic and weighed

once foreign materials are removed (Laden and Finkelstein, 2000).

The scales can also be measured by shampooing the hair and collecting the water in a plastic

bucket. Once the water is collected the scales remain suspended on the top or bottom of the water.

The scales are then filtered and collected for measuring (Saint-Ledger et al., 2000).

The Visual Analogue Scale (VAS) and Adherent Scalp Flake Score (ASFS) grading has also been

employed more recently for the measurement of dandruff scale as well as the accompanied

symptoms such as itching, greasiness, irritation and the social implications of the condition

perceived by the sufferer (Stubbs, 2000; Schwarts, 2012).

2.4.1 Visual Analogue Scale (VAS)

The visual analogue scale (VAS) is a measurement tool used to measure a characteristic that ranges

across a continuum of various values that cannot be measured directly with accuracy. The VAS is

used to give a subjective interpretation or self-report of a particular symptom. It was initially

formulated for the measure of pain, but has over the years been modified in order to suit individual

research requirements (Hauser and Walsh, 2008). According to Kelly (2001), the VAS is easy to

use and provides results that can be reproduced. It can also be applied to various practical

scenarios.

17

The VAS takes the form of a 10cm long line with descriptors that indicate the extremes on either

side of the line. Thus the 10cm long line is divided into 1cm units, each representing a number

from one to ten. Participants are requested to circle the unit which they feel matches the severity

of their condition at present: 10 being severe symptoms and 0 being no symptoms (Gift, 1989).

The modified VAS is a subjective measure which can be used to evaluate the symptoms of

dandruff including: scaling, irritation, greasiness and itching, as well the psychological effect of

dandruff on the participant, termed ‘global impression’ (Stubbs et al., 2000).

The VAS is the most commonly used scale of measure in terms of healthcare research (Johnson,

1997). Both self-perception and clinical assessment using VAS is regarded as a valid subjective

measure for participant’s evaluation of dandruff, as it exhibits a rational degree of reliability

(Stubbs et al., 2000)

2.4.2 Adherent Scalp Flake Score Grading (ASFS)

According to Baran and Maibach (1998), the Adherent Scalp Flake Score (ASFS) grading is the

primary measure used in many anti-dandruff trials. It is based on an 11 point scale of flaking,

ranging from 0 to 10 where 0 reveals no scaling and 10 reveals very heavy scaling. The scalp can

be divided into either 6 or 8 sections or anatomic sites on the scalp. The hair in each section is

parted in order to visualize the severity of the flaking in that particular atomic site on the scalp.

Each section is scored from 0 to 10. The scores are then added to give a total score out of 60 or 80

depending on the amount of sections examined. This evaluation method can be used effectively to

observe the condition over time (Schwarts, 2012).

The ASFS grading is one of the best methods for the assessment of seborrheic dermatitis and

dandruff as validated by various research trials and practice (Bacon, 2012). It is also used in private

practice by dermatologists to evaluate the extent of such conditions (Schwarts, 2012).

2.5 Treatment of Dandruff

The conventional approach for the treatment of dandruff does not provide a complete or a

permanent solution. Many different over-the-counter and prescription products are available, but

none with which complete cure is achieved. Symptoms generally recur as soon as the treatment is

stopped. According to Pierard (2008), treatment options available for dandruff may help, but do

not ultimately cure the condition as the recurrence rate of the condition is high. Some literature

18

describes dandruff as a lifelong condition (Reiman, 2003). Adverse effects are also commonly

found in numerous different treatment approaches making it unsafe for users (Nowicki, 2006).

There are also many alternative and complementary treatments available, including pale

suphonated shale oil.

2.5.1 Conventional Treatment

Treatment options for dandruff may be topical in the form of creams, ointment or shampoos, or

they can be taken orally (Gupta et al., 2004). The Consensus of the Expert Group of Polish

Dermatological Society Mycological Section has summarized and codified the pharmacological

treatment of dandruff. Based on the mechanism of action, anti-dandruff formulas can be classified

into three groups - fungicidal substances, cytostatic substances and keratolytic substances - each

with specific common active ingredients (Adamski, 2006). The table below illustrates the three

categories of anti-dandruff treatments as well as individual active ingredients which are

categorized into such groups. Product names are also stated together with their active anti dandruff

ingredients.

Figure 2.5: Examples of products used in the treatment of dandruff (Adamski, 2006)

2.5.1.1 Fungicidal Substances

This modern treatment approach is geared toward targeting the Malassezia yeast and decreasing

colonization of the yeast (Johnson and Nunley, 2000). Specific fungicidal substances include zinc

pyrithione and imidazole formulas (Gupta et al., 2004).

Fungicidal

substances

19

Zinc pyrithione acts by inhibiting cell wall transport in the fungal cell which leads to lysis of the

cell. It also manipulates the epidermal cells by enabling normalization of the cell layer. Zinc

pyrithione has a high lipid solubility rate and thus dissolves into the sebum allowing longer

maintenance of the substance in the epidermal layer, and subsequently increased fungicidal

activity (Pierard–Franchimont et al., 2001). Based on a study compiled by Sample et al. (2000),

zinc pyrithione was effective in treating moderate to severe dandruff with a 90% reduction in

pruritus and associated erythema of the scalp.

Unlike zinc pyrithione, imidizole formulas are hydrophilic and do not accumulate in lipid

environments making the required administration time for such formulas longer (Warner et al.,

2001). The most popular of all imidazole formulas is ketoconazole. It interferes with the synthesis

of ergosterol which is a fundamental element of the fungal cell wall structure (Nathan, 2010).

Ketoconazole can be used both topically and orally and is the most successful fungicidal agent in

the treatment of dandruff (Pierard, 2008). New formulas such as rilopirox, climbazole and lithium

succinate are at the stage of medical research as they hold promise to be successful agents for the

treatment of dandruff (Adamski, 2006).

Although fungicidal agents are effective in treating the symptoms of dandruff, side effects such as

local irritation, burning, stinging, erythema, and textural or colour changes of the hair have been

reported when used topically. Oral intake may cause side effects such as nausea, vomiting and

hepatotoxicity (Preedy, 2012).

2.5.1.2 Cytostatic Substances

Cytostatic substances act by regulating the accelerated speed of epidermal cell proliferation seen

in dandruff. This inhibits the peeling of the scalp and eliminates scaling or flaking, the signature

symptom of dandruff. The action of cytostatic substance is limited to the time of use of the

substance making it common for flakes to return after treatment cessation. Cytostatic substances

include selenium sulphide, coal tars and piroctolamine or Octopirox (Adamski, 2006).

Selenium sulphide preparations have proven efficacy in several studies as it has an antimitotic

effect on cells. Some studies suggest that selenium sulphide has an inhibitory effect on Malassezia

yeasts by changing the sulphydryl groups found in the yeast to firm polysulphide bonds, disabling

cell division (Nathan, 2010). Adverse effects of selenium sulphide include scalp irritation, dryness

20

of the scalp and hair, and possible hair loss (Preedy, 2012). Regular use of selenium sulphide can

cause excessive sebum production resulting in oily hair (Blenkinsopp et al., 2014).

Coal tars and derivatives thereof are the least effective anti-dandruff agents (Blenkinsopp et al.,

2014). The exact mechanism of action is disputable as coal tars do not appear to reduce cell

division. Instead, they prevent the appearance of flakes by hindering intracellular cement

formation. Coal tars also interfere with sebum formation, and have anti-pruritic actions (Nathan,

2010).

Side effects of coal tars car include skin sensitivity, such as allergic dermatitis or irritant dermatitis,

as well as photosensitivity. The appearance and odour of coal tars is rather unpleasant, making

suffers reluctant to use it. Coal tars can also cause an orange discolouration of the hair and scalp,

especially in far skinned individuals (Nathan, 2010). Other studies have also suggested coal tars

to have carcinogenic properties (Pierard–Franchimont et al., 2001), but this theory is still under

evaluation.

Piroctolamine is a water soluble pyrydinone derivative used in the treatment of dandruff (Adamski,

2006). Although the pharmacology of piroctolamine is not clearly understood, it has been

suggested that it disrupts the DNA repair of Malassezia yeasts (Boarder et al., 2010).

Numerous studies have also shown the efficacy of its use in dandruff but side effects such as

irritation of the skin can occur (Adamski, 2006).

2.5.1.3 Keratolytic Substances

Keratolytic agents are the oldest forms of anti-dandruff treatments and include coal tars (already

previously discussed), salicylic acid and sulphur-containing compounds (Gupta et al., 2004). Such

compounds aim to break up and loosen corneocyte bonds, resulting in the release of adherent scales

on the scalp in order to be washed away (Nathan, 2010)

Salicylic acid and other keratolytic substances may be accompanied by side effects, such as

erythema, further scaling and salicylate intoxication (Bolognia et al., 2003).

2.5.1.4 Anti-inflammatory Substances

Anti-inflammatory agents appear quite frequently in the literature regarding dandruff treatment.

Commonly topical corticosteroids are used when other topical treatments are ineffective.

Corticosteroids are employed as they hold anti-inflammatory and anti-pruritic properties. The use

21

of corticosteroids is not always advised unless the condition worsens and progresses into the more

severe form of dandruff, known as seborrheic dermatitis, where inflammation is involved (Pierard,

2008). It is also important to note that corticosteroid use can have adverse effects such as

folliculitis, acneform disorders, skin atrophy and an increased susceptibility to fungal infections

(Goodheart, 2009).

2.5.2 Complementary and Alternative Treatments

Alternative treatments are available for dandruff. Although most dermatologists do not agree with

such treatments, deeming them inadequate, many people place a lot of trust in them. These include

honey, lemon juice, apple cider vinegar, baking soda, tea tree oil, coconut oil and even mouthwash.

Supplements such as vitamin B, omega oils and zinc are recommended to help eradicate dandruff

(Colon, 2014). With regards to life style, reducing sugar, a healthy balanced diet, good hygiene

and frequent washing (to remove excess oil) are all believed to help control dandruff (Johnson and

Nunley, 2000). Many professionals in the hair care industry may also suggest reducing the use of

complementary hair products such as hair spray, gel and mousse (Sage, 2005).

According to Jacknin (2001), herbal therapies have been employed in the treatment of dandruff.

Herbs such as chamomile, calendula, thyme, rosemary and burdock root are all listed for the

treatment of dandruff as they may have astringent, anti-septic and anti-microbial properties which

can assist in the treatment of dandruff.

Other complementary therapies include probiotics such as Lactobacillus acidophilus and

Bifidobacterium bifidum which help to create a healthy internal microbial environment and assist

in fighting off the yeast infection (Jacknin, 2001)

Homeopathy can also be used to treat dandruff. Homeopathic remedies such as Arsenicum album,

Fluoric acid, Graphites, Sepia officinalis, Sulphur and Oleander are often used to treat dandruff.

However, with homeopathy, the remedy is chosen to match each individual patient respectively

(Jadhav, 2004).

According to Chhavi et al. (2011), conventional treatment options available for dandruff may have

many limitations due to either poor compliance or poor efficacy of the treatment. Conventional

treatments also have high recurrence rate making them unreliable. This warrants the need for

complementary and alternative treatment options. Chhavi et al. (2011) continues to state that the

best approach for the treatment of dandruff is to employ the use of herbal anti-dandruff shampoos,

22

in addition to a well-balanced diet. Nutritional and herbal treatments can potentially cause an

improvement in the condition within 6-8 weeks.

2.6 Sodium Shale Oil Sulphonate/Pale Sulfonated Shale Oil Shampoo

Sodium shale oil sulphonate 1% shampoo, trading as Ichthyol® Pale, is manufactured in Germany,

and distributed in South Africa by Lunar Pharmaceuticals. Ichthyol® Pale is a sodium shale oil

sulphonate which originates from keragon-containing sedimentary rock. Through the process of

distillation, the keragon rock produces a sulphur-rich shale oil which is purified, refined and

neutralized before use (Lunar Pharmaceuticals, 2014). Sodium shale oil sulphonate may be used

for the treatment of dandruff, as well as for skin complaints such as acne and blemishes (Sanders,

2008).

The following ingredients make up the base of the shampoo:

Aqua (Water)

Sodium laureth sulphate: Sodium laureth sulphate is one of the most common ingredients

used in numerous cosmetic products. It acts as a surfactant, detergent and emulsifier and

is found in many shampoos. Sodium laureth sulphate originates from coconuts and

provides foaming abilities to cosmetic products (Mercola, 2010). It aids in removing dirt

and oil from the hair but long term daily use of sodium laureth sulphate has been suggested

to cause excessive dryness of the hair and scalp as it interferes with the protective layer of

the skin and hair (SLS free, 2015).

Cocamidopropyl betaine: Cocamidopropyl betaine is also a coconut derived surfactant

which acts as a cleansing and foaming agent in many cosmetic products especially

shampoos and skin cleansing products. Although cocamidopropyl betaine is proposed as

safe by most governments, it can cause an allergic reaction in certain individuals (Case,

2013). According to Special chem (2013), cocamidopropyl betaine acts as a viscosity

controlling surfactant with conditioning, foaming, cleansing and antistatic properties.

Barel et al. (2010) claim that cocamidopropyl betaine may assist in decreasing irritation

on the scalp when added to shampoos.

Sweet almond-amphoacetate: Sweet almond is derived from the ripe seeds of the almond

tree. Sweet almond is most commonly used dermatologically as a moisturiser, anti-pruritic

agent and an anti-inflammatory agent. Sweet almond is generally used for conditions

accompanied by dryness and scaling. Topically, there are no adverse reactions to sweet

almond except if allergic tendencies are present (Wiles et al., 2011).

Sodium chloride: According to Leigh (2015), sodium chloride or table salt is used as a

thickener in many hair products. The use of sodium chloride in shampoos may cause

23

irritation to the eyes only if high salt contents are present. Excessive amounts of sodium

chloride many lead to irritation and dryness of the skin, but according to Born (2015), most

shampoos have a low sodium chloride content resulting in minimal concern.

According to Korting and Schmid (1998), sulphonated sodium shale oil, although classified as a

tar derivative, contains a different chemical composition when compared to other tar derivatives.

Sodium oil shale gives no indication of toxic or phototoxic effects, and it has good tolerance. It

also has strong anti-inflammatory effects as it blocks the formation of inflammatory mediators,

thus blocking any inflammatory reactions from taking place (Kandarova et al., 2005).

2.6.1 Shale Oil

Sodium shale oil sulphonate or pale sulfonated shale oil has a rather interesting development

history. In geological terms, the origin of sodium shale oil sulphonate goes back to the depositions

of microscopically minute phytoplankton or algae residing in a particular inlet environment found

in the Alpine region about 200-600 million years ago. Under certain climatic conditions, due to

biological degradation of the algae by sulphur rich bacteria, large amounts of naturally combined

sulphur were formed. The solid form of the biological material or biomass was formulated by the

development of the sulphur into a schist-like sedimentary rock or oil shale. In order to extract the

material from the earth, complex technical procedures are employed as the sulphuric deposits are

only found deep inside the mountains in which they develop (Lunar Pharmaceutics, 2014).

Once the mining of the rock is complete, a dry distillation process, lacking air, is performed as the

rock is gently heated. This allows the biomass to decompose only up to the extent where the rock

is converted from its solid form to a liquid form. This results in a sulphur-rich shale oil, unavailable

anywhere else worldwide (American Shale Oil Corp, 2015).

The shale oil undergoes another purification process in order to eliminate any excess solid particles

as well as high molecular elements. This allows a special low boiling shale oil fraction to be

produced. This then undergoes a gentle sulphonation reaction where the oil shale fraction reacts

with concentrated sulphuric acid and is neutralized with sodium hydroxide. The oil is then

converted into a water soluble substance that is able to act on the surface of the skin (Acton, 2013).

According to the literature, pale sulphonated shale oil has widespread dermatological uses as it is

believed to have anti-inflammatory, anti-microbial and anti-seborrheic properties (Lunar

24

Pharmaceutics, 2014). Based on its actions, pale sulphonated shale oil can be used for the

following:

1. Conditions with overproduction of the oil glands such as acne;

2. Bacterial and fungal infections;

3. Inflammatory conditions such as seborrheic dermatitis, atopic dermatitis and psoriasis;

4. Conditions of excess desquamation such as dandruff;

5. Venous leg ulcers; and

6. Wound healing (Willet, 2010).

Some of these applications will be discussed briefly in the related research section below.

2.7 Related Research

As mentioned above, pale sulphonated shale oil can be employed in many different dermatological

conditions.

According to a study performed by Gayko (2004), a 20% pale sulphonated shale oil hydrogel

formulation demonstrated tissue repairing and antimicrobial effects in wound healing. The formula

exhibited anti-bacterial effects against all the bacteria associated with impaired wound healing and

was well tolerated for long term topical use.

In a randomized, controlled multicentre study of 119 participants performed by Beckert et al

(2005), topical pale sulphonated shale oil was seen to be efficient in the treatment of leg ulcers.

The size of the ulcers in the experimental group participants was significantly smaller than the

ulcers of participants in the placebo group.

Korting et al (2010) conducted a study on 99 children suffering from mild to moderate atopic

eczema. Results of this trial showed that a topical preparation of 4% pale sulphonated shale oil

proved effective when comparing placebo and treatment groups. The formula also produced no

side effects, making it well tolerated for the treatment.

The safety of sodium shale oil sulphonate has been researched by Colcha et al. (2004). The studies

were conducted in order to deduce any acute or chronic toxicity of the substance as well as the

presence of carcinogenic, teratogenic and mutagenic properties. Sodium shale oil sulphonate was

administered both topically and internally in order to infer all the possible effects of this treatment.

It was found to be well tolerated for long or short term use, both locally and systemically, and had

no carcinogenic, teratogenic or mutagenic properties.

25

CHAPTER 3: METHODOLOGY

3.1 Research Sample

A representative sample of 40 participants, suffering from mild to moderate dandruff, were

recruited for the study via advertisements (Appendix A). The sample included both males and

females between the ages of 18 and 45 years. Advertisements were placed at the University of

Johannesburg Health Training Centre notice boards and restrooms, as well as in gyms and hair

salons in and around the South of Johannesburg. Relevant permission was given.

3.1.1 Inclusion Criteria

Participants were included if they were:

Males and females between the ages of 18 to 45 years;

Suffering from mild to moderate dandruff with itching, flaking, greasiness, irritation of the

scalp and possible hair loss (Kent, 2005);

Had a baseline Adherent Scalp Flaking Score grading ASFS score of ≥ 24; and

Had good general health.

3.1.2 Exclusion Criteria

Participants were excluded if they were:

Suffering from other conditions such as psoriasis, atopic dermatitis, contact dermatitis or tinea

capitis;

Diagnosed with systemic or chronic diseases (Appendix B);

Pregnant or lactating;

Currently on any chronic medication; and/or

Currently on treatment for dandruff.

Participants were requested to refrain from using any conventional, herbal or homeopathic

treatment for dandruff for the duration of the study. Only Sodium Shale Oil Sulfonate 1% shampoo

was used as treatment.

3.2 Research Procedure and Design

The research study was performed as a 16-day double-blind, placebo-controlled study design. The

research was conducted at the University of Johannesburg, Doornfontein Campus. The initial

consult (day zero) consisted of a full description and discussion of the research method with the

26

participant. Thereafter, the participant was requested to read a participant information form

(Appendix B) and sign a consent form (Appendix C). An evaluation based on the inclusion and

exclusion criteria, to determine whether the participant met the criteria for the research study, was

performed. A physical and general assessment was conducted to determine vital signs and health

status respectively (Appendix D). Thereafter, the participant’s dandruff was evaluated using the

Adherent Scalp Flaking Score (ASFS) grading (Appendix E), completed by the researcher, and

the Visual Analogue Scale (VAS), completed by both the participant (Appendix F) and the

researcher (Appendix G). The participants were divided into two groups by means of matched

pairing, according to the severity of dandruff of their dandruff (Appendix H). Based on the

determined group, the participants were given either the experimental (with active anti-dandruff

agents) or control (without active anti-dandruff agents) shampoo together with the directions for

the use of the shampoo. At the second consultation, which occurred on day 8, the participant’s

scalp was evaluated using the ASFS grading, completed by the researcher, and the VAS,

completed by the participant and the researcher. On day 16 (final consult), a final evaluation of the

participant’s dandruff was performed, using the same method described as with the second consult.

At each consult, all results were recorded. Participants were requested to wash the scalp once every

second day, starting from day one till day 16. Reminders to wash the scalp were sent to each

participant via SMS the night before they were due to wash their hair.

3.3 Medication administration

Each participant was given 200 ml of either Sodium Shale Oil Sulphonate 1% shampoo or placebo

shampoo for use over 16 days. Participants were requested to wash the scalp once every second

day (day 1, 3, 5, 7, 9, 11, 13, 15). Each time the scalp was washed, the participant was instructed

to use only 25ml of the shampoo which was measured out using a standard 25ml measuring cup

supplied. No other shampoo was used for the duration of the research.

3.4 Sodium Shale Oil Sulphonate 1%

Each bottle of the shampoo using the trade name Ichthyol Pale® contained 1% of Sodium Shale

Oil Sulphonate as the active anti-dandruff ingredient. The shampoo was produced by Lunar

Pharmaceutics which is a registered pharmaceutical company that maintains good manufacturing

procedures and is registered with the Pharmacy Council of South Africa. The shampoo was

produced, packaged and labelled by Lunar Pharmaceutics. The labels consisted of the numbers ‘1’

and ‘2’ to ensure that neither the participant nor the researcher was aware of which batch contained

the active ingredient and which batch contained the placebo. This was only determined at the end

of the study. The control shampoo was manufactured to look and feel the same as the experimental

27

shampoo but without the active anti-dandruff ingredient, sodium shale oil sulphonate. The

participants were given a particular bottle using matched pairing according to the severity of the

dandruff, to ensure a parametric distribution of the participants across the two groups.

3.5 Data Collection and Analysis

On completion of the study, Lunar Pharmaceutics disclosed the ingredients in the bottles labelled

‘1’ and ‘2’ for the purpose of the researcher to determine which participants were in the control

and experimental groups. All data was collated and an Exploratory Data Analysis (EDA) was

performed to determine group normality and comparability of the data. Parametric intergroup

analysis included the independent sample T- test, followed by intragroup analysis using the

repeated measures ANOVA test. Non-parametric intergroup analysis included the Mann-Whitney

U test, while intragroup analysis involved the Friedman or the Wilcoxon Signed-Ranks test (Van

Staden, 2014).

3.6 Reliability and validity measures

The Adherent Scalp Flake Score (ASFS) grading is one of the best methods for the assessment of

seborrheic dermatitis and dandruff as validated by various research trials and practice (Bacon,

2012). It is also used in private practice by dermatologists to evaluate the extent of such conditions

(Schwarts, 2012). The Visual Analogue Scale (VAS) is the most commonly used scale of measure

in terms of healthcare research (Johnson, 1997). Both self-perception and clinical assessment

using VAS is regarded as a valid subjective measure for participant’s evaluation of dandruff, as it

exhibits a rational degree of reliability (Stubbs et al., 2000)

3.7 Ethics

All information regarding procedures, duration and requirements of the study was provided and

explained to the participants as per the participant information form. In order to participate in the

study all participants were requested to sign the participant consent form. All participation in the

study was voluntary and withdrawal from the study could take place at any time. There were no

anticipated risk factors to the use of the shampoo. However, participants were advised to

discontinue the shampoo if any adverse reactions occurred and to contact the researcher. Privacy

and confidentiality of the participant was guaranteed by providing private consultations with the

researcher, and all information will be kept in a secure storage facility for five years to which only

the researcher and supervisor has access to. Anonymity was upheld by replacing the use of

participant names in the research with case numbers. Researcher and supervisor contact details

were made available to the participants should any further questions arise. In the event that results

28

were requested by the participant, they were made available. In case of any unforeseen

circumstances or outcomes, participants were referred to the relevant healthcare practitioner. In

the case of favourable data in the experimental Group as compared to the control Group, the

participants in the control Group were provided access to the shampoo at the end of the study. This

study was approved by the University of Johannesburg, Faculty of Health Sciences Higher Degrees

and Research Ethics committees (HDC01-65-2014) (AEC01-66-2014).

29

CHAPTER 4: RESULTS

4.1 Introduction

This chapter presents the results obtained from the study. The sample groups consisted of a

treatment group (Group 1) treated with Sodium Shale Oil Sulphonate 1% shampoo and a placebo

group (Group 2) treated with the shampoo without the active ingredient. Forty two participants,

suffering from mild to moderate dandruff were recruited for the study. Forty participants

completed the study and 2 participants did not complete the study due to poor compliance.

In order to statistically analyse the effect of sodium shale oil sulphonate 1% shampoo in the

treatment of dandruff, the independent and dependent variables were identified. The shampoo was

identified as the independent variable. The dependent variable was identified as the dandruff – as

a whole and represented by scaling, itching, irritation, greasiness and global impression – based

on the Visual Analogue Scale and the Adherent Scalp Flake Score grading. The interval/ratio scale

of measure was used as the scales used to measure the severity of the dandruff represent quantity

as well as equality of units. The value of zero is also absolute as no number exists below zero on

the measurement scales.

The statistical analysis includes the following:

Demographic data comprising of age and gender; and

Subjective and objective measurements collected from the Visual Analogue Scales and the

Adherent Scalp Flake Score grading discussed under intragroup and intergroup analysis.

The independent sample T-test (intergroup analysis) is a parametric statistical test used to

determine the presence or absence of statistical significance between the means of 2 different

groups. A significant difference in the means scores of the variables in the groups occurs when the

p sig (2-tailed) value is less than or equal to 0.05 (Lyman Ott and Longnecker, 2015).

The ANOVA – mixed between within subjects measures ANOVA (intragroup analysis) is a

parametric test used to compare the means of 2 groups based on 2 factors, the ‘within subject’

factor and the ‘between subject’ factor. A significant difference in the means scores of the variables

in the Groups occurs when the p (Wilks Lambda) value is less than or equal to 0.05 (Lyman Ott

and Longnecker, 2015).

30

The Friedman test (intragroup analysis) is a non-parametric statistical test used to measure

difference between sample groups. The Mann Whitney U test (intergroup analysis) is a non-

parametric test which compares the means of 2 populations and determines whether the population

means are equal or not. Both the Friedman and Mann Whitney U tests require p values of less than

0.05 for statistical significance to occur (Lyman Ott and Longnecker, 2015).

With regards to the Wilcoxin Signed Ranks test (intragroup analysis) test is a non-parametric

statistical test used to compare 2 related samples and to determine whether the means of the 2

samples differ. With respect to the Wilcoxin Signed Ranks test, the Bonferroni adjustment is

applied and statistical significance occurs if the p value is less than 0.016 (Lyman Ott and

Longnecker, 2015).

The Shapiro – Wilk test was performed for each variable in order to assess the normality of the

data. In the case of normally distributed data, parametric tests such as the independent samples T

test for intergroup analysis and the mixed between within subject ANOVA for intragroup analysis

were performed. With respect to abnormally distributed data, non-parametric tests such as the

Mann Whitney U test for intergroup analysis and the Friedman and Wilcoxin Signed Ranks tests

for intragroup analysis were used.

4.2 Participant Recruitment

As demonstrated in Figure 4.1, a total of 42 participants were assessed for eligibility from which

none were excluded as they all met the participation requirements and were included to participate

in the study. Of the 42 participants, 18 were given the active shampoo and 24 were given the

placebo shampoo randomly based on matched pairing on the basis of the severity of their dandruff.

As the result of the severity of dandruff being divided into 3 groups, unequal numbers were present

between the 2 groups.

One participant was lost from group 1 (treatment group) as the participant received a hair treatment

which did not allow the participant wash their hair every second day while using the shampoo.

One participant was also lost from group 2 (control group) due to failure to respond to contact

attempts. Therefore, 17 participants were analysed in group 1 and 23 participants were analysed

in group 2.

All the participants recruited met the participation criteria as they were all between the ages of 18

and 45 years old. All 42 participants suffered from mild to moderate dandruff with accompanied

31

symptoms such as itching, irritation, greasiness, flaking and possible hair fall and had a baseline

ASFS score of at least 24. None of the participants showed or reported any abnormalities in their

vital signs and no evidence of chronic disease was found or reported. None of the participants

suffered from any other scalp conditions and none of the female participants were pregnant or

lactating. None of the participants were on any current treatment for dandruff.

Recruitment for participants started in October 2014 and was completed in February 2015. All

participants commenced and completed the 16 day study by February 2015. Each participant was

requested to wash their hair every second day after the first wash with follow ups on days 8 and

16 of the 16 day study.

No adverse events or side effects were reported for any participants in both intervention groups.

32

Figure 4.1 CONSORT Flow Chart of Participants

4.3 Demographic Data

All data was extracted from statistical analysis (Appendix J).

4.3.1 Gender Distribution

A total of 40 participants completed the study. Of the 40 participants, 33 (82.5%) were females

and 7 (17.5%) were males. As indicated in Table 4.1, of the 40 participants 17 participants were

randomised to Group 1 and 23 participants were randomised to Group 2. In Group 1, 14 (82.4%)

participants were females and 3 (17.6%) participants were males. In Group 2, 19 (82.6%)

participants were females and 4 (17.4%) participants were males. Group 1 contributed 42.4% to

the total number of females whereas Group 2 contributed 57.6%. 42.9% of males were from Group

1 and 57.1% of males were from Group 2.

Assessed for

eligibility (n=42)

Excluded (n=0)

Randomized

(n=42)

Allocated to active

intervention (n=18)

Allocated to placebo

intervention (n=24)

Lost to follow up (n=1)

Could not wash

shampoo every 2nd day

due to hair treatment

Lost to follow up (n=1)

Lack of response to

contact attempts

Analysed (n=17) Analysed (n=23)

33

Table 4.1 Gender Distribution

Group

Total Active

shampoo

Placebo

shampoo

Gender

Female Count 14 19 33

% within

gender

42.4%

57.6%

100%

Male Count 3 4 7

% within

gender

42.9%

57.1%

100%

Total

Count 17 23 40

% within

gender

42.5%

57.5%

100%

4.3.2 Age Distribution

All participants were aged between 18 and 45 years. The mean age for the participants in Group 1

was 24.82 years with a minimum age of 18 and a maximum age of 38. The mean age of participants

in Group 2 was 27.78 with a minimum age of 18 and a maximum age of 45. The ages between the

participants were comparable as the p value was 0.161 and there is no statistical significance in

the age between the two groups.

4.3.3 Race Distribution

As illustrated in Figure 4.2, in Group 1, two of the 17 participants were black, 14 were Indian, one

was white and there were no coloured participants.

In Group 2, one of the 23 participants was black, 20 were Indian, one was white and one was

coloured.

34

Figure 4.2 Race Distribution

4.3.4. ASFS Scores at Primary Visit

The mean ASFS grading score for Group 1 at visit 1 was 34 when compared to Group 2 of 35.48.

The mean scaling of the two groups at visit 1 was found not to be statistically significant (p =

0.484). Therefore, the mean scaling in the two groups at visit 1 was comparable.

Table 4.2 illustrates the number of participants, the mean, the standard deviation and the p value

for scaling of Groups 1 and 2 at visit 1.

Table 4.2 Group Statistics

Adherent Scalp Flake Score Grading (Visit 1)

Group 1 N = 17

Mean = 34

Std Deviation = 11.597

Asymp. Sig (2-tailed) = 0.484

Group 2 N = 23

Mean = 35.48



4.4 Outcomes and Estimations

Each participant evaluated their condition using a modified Visual Analogue Scale (VAS) based

on the symptoms of dandruff such as scaling, irritation, itchiness, greasiness and global impression

at each of the three visits. The researcher also evaluated the condition using a modified visual

analogue scale (VAS) based on scaling, irritation, greasiness and global impression at each visit.

1; 5%

20; 87%

1; 4%

1; 4%

Black Indian White Coloured

2; 12%

14; 82%

1; 6%

0; 0%

Black Indian White Coloured

Group 1 Group 2

35

The scalp was also analysed and evaluated by the researcher using the ASFS grading. The

outcomes of each symptom evaluated by the participant and the researcher will be discussed

individually below followed by the ASFS grading scores.

4.4.1 Scaling

4.4.1.1 Participant VAS Evaluation

Comparable Scaling

The mean scaling for Group 1 at visit 1 was 6.35 when compared to Group 2 of 5.39. The mean

scaling of the two groups at visit 1 was found not to be statistically significant (p = 0.212).

Therefore, the mean scaling in the two groups at visit 1 was comparable.


for scaling of Groups 1 and 2 at visit 1.

Table 4.3 Group statistics

Visual Analogue Scale – Scaling (Visit 1)

Group 1 N = 17

Mean = 6.35


Sig (2-tailed) = 0.212

Group 2 N = 23

Mean = 5.39



Intragroup Analysis

Figure 4.3 demonstrates the changes in the means of scaling in the two groups between visits one

and two, visits two and three and visits one and three.

For Group 1 the mean of 6.35 for scaling at visit 1 dropped to 3.53 at visit 2. The mean then

dropped to 1.47 by visit 3. This indicates a total mean score improvement of 4.88 (76.9%).

For Group 2 the mean of 5.39 for scaling at visit 1 dropped to 3.91 at visit 2. The mean then

dropped to 2.96 by visit 3. Indicating a total mean score improvement of 2.43 (45.1%).

36

The mixed between within subject measure ANOVA was performed and as shown in Figure 4.3,

an interaction effect has taken place due to the lines on the graph running parallel to each other

then suddenly crossing over each other. This illustrates that both the groups behaved differently

over time. To determine whether or not the behaviour of the two groups over time was statistically

different the Wilks Lambda test was performed. The Wilks Lambda tests for the visits by group

yielded a p value of <0.001 concluding that there was a statistically significant effect over time

and a change in the mean scores across the three different time periods.

The effect size (Partial Eta Squared) demonstrates the magnitude of the difference in the means

between the two groups over time. The guidelines for the partial Eta squared are as follows: 0.01

= small effect, 0.06 = moderate effect, and 0.14 = large effect.

The value obtained for the partial Eta squared = 0.770 concluding a large difference in the means

scores of the two groups over time.

Figure 4.3 Estimated Marginal Means for Scaling

The Friedman test results as seen in Table 4.4 was used to determine the change in scaling over

the 16 day period. Group 1 and 2 both have a p value of <0.001 suggesting a statistically significant

change in scaling over time for Group 1 and Group 2.

0

1

2

3

4

5

6

7

1 2 3

Estimated Marginal Means of Scaling

Active Shampoo

Placebo Shampoo

Visit

37

Table 4.4 Friedman Test for Scaling

Group 1 N

Chi-Squared

Df

Asymp. Sig

17

29.525

2

<0.001

Group 2 N

Chi-Squared

Df

Asymp. Sig

23

29.368

2

<0.001

The Wilcoxin Signed Ranks test illustrated in Table 4.5 was used to determine at which point

during the 16 day trial significant changes in scaling took place. The p value for scaling between

visit 1 and 2 for Group 1 was 0.001 compared to <0.001 for Group 2. Both Group 1 (p = 0.001)

and 2 (p = <0.001) displayed a statistically significant change in scaling between visit 1 and 2 (p

< 0.016).

The change in scaling between visit 2 and 3 for Group 1 was statistically significant (p = 0.001)

as for Group 2 (p = 0.014). Both Group 1 and 2 had a statistically significant change in scaling

between visits 1 and 3 as p = <0.001.

Table 4.5 Wilcoxin Signed Ranks Test for Scaling

Group 1 Asymp. Sig. (2-tailed)

VAS Scaling between visit 1 and 2 0.001


VAS Scaling between visit 1 and 3 <0.001





Intergroup Analysis

Using the independent sample t test, the marginal means of scaling in Group 1 and 2 at each visit

were compared. The mean scaling for both groups at visit 1 is discussed above in the section on

comparable scaling.

38

The mean scaling for Group 1 at visit 2 was 3.53 when compared to Group 2 of 3.91. The mean

scaling of the two groups at visit 2 was found not to be statistically significant (p= 0.562).

The mean scaling for Group 1 at visit 3 was 1.231 when compared to Group 2 of 2.266. When

compared, the mean scaling of the two groups at visit 3 was found to be statistically significant (p

= 0.012). This means that the average scaling in Group 1 at visit 3 was less than the average scaling

in Group 2 at visit 3.

4.4.1.2 Researcher VAS Evaluation

Comparable Scaling

As shown in Table 4.6, at visit 1, Group 1 had a mean scaling of 5.82 whereas Group 2 had a mean

scaling of 5.87. There was found to be no statistical significance in the mean scaling in the 2 groups

when evaluated by the researcher (p = 0.941). The 2 groups were therefore comparable with

regards to scaling evaluated by the researcher at visit 1. Table 4.6 also illustrates the number of

participants, the standard deviation and the p value for Groups 1 and 2 at visit 1.


Visual Analogue Scale – Scaling (Visit 1) – Researcher evaluation

Group 1 N = 17

Mean = 5.82



Group 2 N = 23

Mean = 5.87



Intragroup Analysis

As illustrated in Figure 4.4, the mean scaling for Group 1 at visit 1 was 5.82 and by visit 2, the

mean dropped to 4.00. By visit 3 the mean scaling for Group 1 was 2.06, thus demonstrating a

total mean score improvement of 64.6% (3.76).

The mean score for Group 2 at visit 1 was 5.87 when compared to 3.74 at visit 2 and 3.35 at visit

3. This represents a 2.52 (43%) improvement in the total mean score.

39

Although Figure 4.4 shows a cross between the mean scores of the two groups, the Wilks Lambda

test for visits by group had a p value of 0.019 suggesting no significant interaction effect between

the two groups over time.

Figure 4.4 Estimated Marginal Means for Scaling – Researcher Evaluations.

The Friedman test was performed and as illustrated in Table 4.7, the p value for both groups was

<0.001 suggesting a statistically significant change in scaling over the 16 day period.

Table 4.7 Friedman Test for Scaling – Researcher Evaluations

Group 1 N

Chi-Squared

Df

Asymp. Sig

17

27.785

2

<0.001

Group 2 N

Chi-Squared

Df

Asymp. Sig

23

24.488

2

<0.001

According to the Wilcoxin Signed Ranks Test in Table 4.8, statistically significant changes in

scaling occurred between visit 1 and 2 (p = 0.006), visit 2 and 3 (p = 0.001) and between visit 1

and 3 (p = <0.001) for Group 1.

1

2

3

4

5

6

1 2 3

Estimated Marginal Means of Scaling

Active Shampoo

Placebo Shampoo

Visit

40

For Group 2, statistically significant changes in scaling only occurred between visit 1 and 2 and

visit 1 and 3 (p = <0.001). The results showed that there was no statistically significant change in

scaling between visit 2 and 3 as p = 0.232.

Table 4.8 Wilcoxin Signed Ranks Test for Scaling – Researcher Evaluations









Intergroup Analysis

As already stipulated, the mean scaling between the two groups was found to be comparable for

visit 1.

The mean scaling at visit 2 for Group 1 was 4.00, whereas Group 2 had a mean scaling of 3.47 at

visit 2. Since p = 0.587, there appears to be no statistically significant difference in the mean

scaling for both groups at visit 2.

At visit 3, Group 1 had a mean scaling of 2.06 when compared to Group 2 of 3.35. There seems to

be a statistically significant change in the mean scaling at visit 3 (p = 0.019) in favour of the

treatment group.

4.4.2 Irritation


Comparable Irritation

The mean scores for irritation at visit 1 were 5.12 in Group 1 and 4.43 in Group 2 respectively.

The mean scores for irritation in the 2 groups were comparable as there was no statistically

significant difference in the mean scores for irritation at visit 1 (p = 0.465).

41

Table 4.9 displays the mean, the standard deviation and the p value for irritation in Group 1 and 2

at visit 1.


Visual analogue scale – Irritation (Visit 1)

Group 1 N = 17

Mean = 5.12



Group 2 N = 23

Mean = 4.43



Intragroup Analysis

The mean changes for irritation between visits 1, 2 and 3 are illustrated in Figure 4.5.

For Group 1, the mean of 5.12 for irritation at visit 1 decreased to 2.35 at visit 2 and reached 1.29

by visit 3. The total mean score dropped by 3.83 (74.8%).

For Group 2, the mean of 4.43 for irritation at visit 1 decreased to 2.96 at visit 2 and reached 2.09

by visit 3. The total mean score decreased by 2.34 (52.8%).

42

Figure 4.5 Estimated Marginal Means for Irritation

According to Table 4.10, the p value for Group 1 and 2 was <0.001 proposing a statistically

weighty change in irritation from visit 1 to visit 3.

Table 4.10 Friedman Test for Irritation

Group 1 N

Chi-Squared

Df

Asymp. Sig

17

21.733

2

<0.001

Group 2 N

Chi-Squared

Df

Asymp. Sig

23

22.143

2

<0.001

Table 4.11 shows a statistically significant change in irritation from visit 1 to 2 (p = 0.001), from

visit 2 to 3 (p = 0.015) and from visit 1 to 3 (p = 0.001) in Group 1.

Group 2 also showed statistically significant changes in irritation between visits 1 and 2 (p =

0.001), 2 and 3(p = 0.012), and 1 and 3 (p = 0.001), as the p value between all 3 visits was < 0.016.

1

2

3

4

5

6

1 2 3

Estimated Marginal Means of Irritation

Active Shampoo

Placebo Shampoo

Visit

43

Table 4.11 Wilcoxin Signed Ranks Test for Irritation


VAS Irritation between visit 1 and 2 0.001







Intergroup Analysis

Using the Mann Whitney U test, the marginal means for irritation in Group 1 and 2 at each visit

were compared.

As already revealed, the mean irritation showed no statistical significance at visit 1. At visit 2, the

mean irritation for Group 1 was 2.35 whereas Group 2 had a mean of 2.96. There appeared to be

no statistically significant difference in irritation when comparing the mean irritation of Group 1

and 2 at visit 2 (p = 0.697).

At visit 3, Group 1 had a mean of 1.29 compared to Group 2 of 2.09. The p value was 0.249

indicating no statistically significant difference in the mean irritation of the 2 groups.

The average irritation was therefore relatively equal in the 2 groups at visits 1, 2 and 3.


Comparable Irritation

The mean irritation at visit 1 for Group 1 was 3.35 with Group 2 presenting a mean irritation of

3.70. There appeared to be no statistically significant difference in the mean irritation scores for

Group 1 and 2 (p = 0.414).

Figure 4.12 below illustrates the number of participants, the mean, the standard deviation and the

p value for irritation in the 2 groups at visit 1.

44


Visual Analogue Scale – Irritation (Visit 1) – Researcher Evaluation

Group 1 N = 17

Mean = 3.35



Group 2 N = 23

Mean = 3.70



Intragroup Analysis

Figure 4.6 illustrates a mean value for irritation for Group 1 at visit 1 of 3.35 with a drop to 1.65

by visit 2 and further decrease to 0.71 by visit 3. The total improvement in the mean score was

2.64 (78.8%).

Group 2 presented a decrease in the mean value of 3.70 at visit 1, to 2.00 by visit 2, and a final

decline to 0.83 at visit 3. The mean score for irritation for Group 2 thus improved by 2.87 (77.6%).

The mean irritation in both groups seemed to have declined relatively equally.

Figure 4.6 Estimated Marginal Means for Irritation – Researcher evaluations

0

1

2

3

4

5

1 2 3

Estimated Marginal Means of Irritation

Active Shampoo

Placebo Shampoo

Visit

45

According to Table 4.13, Group 1 and 2 both have a p value of <0.001 suggesting a statistically

significant change in irritation over time for Group 1 and Group 2.

Table 4.13 Friedman Test for Irritation – Researcher Evaluations

Group 1 N

Chi-Squared

Df

Asymp. Sig

17

23.288

2

<0.001

Group 2 N

Chi-Squared

Df

Asymp. Sig

23

33.787

2

<0.001


irritation occurred between visit 1 and 2 (p = 0.001), visit 2 and 3 (p = 0.015) and between visit 1

and 3 (p = 0.001) for Group 1.

For Group 2, statistically significant changes in irritation occurred between visit 1 and 2 and visit

1 and 3 (p = <0.001 for both visits), as well as between visit 2 and 3 as p = 0.004

Table 4.14 Wilcoxin Signed Ranks Test for Irritation – Researcher Evaluations






VAS Irritation between visit 1 and 2 <0.001


VAS Irritation between visit 1 and 3 <0.001

Intergroup Analysis

When comparing the marginal means for irritation for each group at each visit, the means for

irritation at visit 1 showed no statistical significance as stated above.

46

The means for visits 2 and 3 were compared yielding values of 1.65 for Group 1 and 2.00 for

Group 2 at visit 2, and 0.71 for Group 1 and 0.83 for Group 2 at visit 3. There seems to be no

statistically significant difference in the mean values for irritation at visit 2 (p = 0.483) and visit 3

(p = 0.412) between the 2 groups.

4.4.3 Itching


Comparable Itching

Table 4.15 demonstrates the number of participants, the mean, standard deviation and p value for

itching at visit 1 for Group 1 and 2.

The mean for itching at visit 1 for Group 1 was 5.82 when compared 2 Group to of 4.70. The p

value for itching at visit 1 was 0.259 therefore concluding that the groups were comparable at visit

1 with regards to itching.


Visual Analogue Scale – Itching (Visit 1)

Group 1 N = 17

Mean = 5.82



Group 2 N = 23

Mean = 4.70



Intragroup Analysis

According to Figure 4.7, the mean for itching for Group 1 decreased from 5.82 at visit 1 to 2.35 at

visit 2 and 1.35 at visit 3. The total improvement in the mean score for itching was 4.47 (76.8%).

The mean for itching for Group 2 decreased from 4.70 at visit 1 to 2.96 at visit 2 and 2.13 at visit

3 indicating a 2.57 (54.7%) total improvement from visit 1 to visit 3.

47

Figure 4.7 Estimated Marginal Means for Itching


<0.001 suggesting a statistically significant change in itching over the 16 day period.

Table 4.16 Friedman Test for Itching

Group 1 N

Chi-Squared

Df

Asymp. Sig

17

21.031

2

<0.001

Group 2 N

Chi-Squared

Df

Asymp. Sig

23

19.753

2

<0.001


itching occurred between visit 1 and 2 (p = 0.001), visit 2 and 3 and between visit 1 and 3 (p =

0.001) for Group 1 and 2.

No statistically significant change in itching was shown between visit 2 and 3 in both groups as p

= 0.020.

0

1

2

3

4

5

6

1 2 3

Estimated Marginal Means of Itching

Active Shampoo

Placebo Shampoo

Visit

48

Table 4.17 Wilcoxin Signed Ranks Test for Itching


VAS Itching between visit 1 and 2 0.001




VAS Itching between visit 1 and 2 <0.001


VAS Itching between visit 1 and 3 <0.001

Intergroup Analysis

Using the Mann Whitney U test, the means of itching was compared at visit 1, already stated

above, visit 2 and visit 3.

The mean itching for Group 1 at visit 2 was 2.35 when compared to Group 2 of 3.96. The mean

itching was found not to be statistically significant for both groups at visit 2 (p = 0.749).

The mean itching for Group 1 at visit 3 was 1.35 when compared to Group 2 of 2.13. The mean

itching was found not to be statistically significant for both groups at visit 3 (p = 0.418). Therefore,

there was no statistically significant difference in the average scores for itching for both groups at

all 3 visits.

4.4.4 Greasiness


Comparable Greasiness

The mean scores for greasiness at visit 1 were 5.12 in Group 1 and 4.48 in Group 2. The mean

scores for greasiness in the 2 groups were comparable as there was no statistically significant

difference in the mean scores for greasiness at visit 1 (p = 0.535).

Table 4.18 displays the mean, the standard deviation and the p value for greasiness in Group 1 and

2 at visit 1.

49


Visual Analogue Scale – Greasiness (Visit 1)

Group 1 N = 17

Mean = 5.12



Group 2 N = 23

Mean = 4.48



Intragroup Analysis

Figure 4.8 demonstrates the changes in the mean greasiness for Group 1 and Group 2 at all 3 visits

The mean greasiness for Group 1 was 5.12 at visit 1, dropping to 1.59 by visit 2 and 1.06 by visit

3. This indicates a total 4.06 (79.3%) improvement in the mean scores for greasiness over time.

The mean greasiness for Group 2 was 4.48 at visit 1, dropping to 2.52 by visit 2 and 1.74 by visit

3. This indicates a total 2.74 (61.2%) improvement in the mean scores for greasiness over time.

Figure 4.8 Estimated Marginal Means for Greasiness

0

1

2

3

4

5

6

1 2 3

Estimated Marginal Means of Greasiness

Active Shampoo

Placebo Shampoo

Visit

50

The Friedman test was performed and as illustrated in Table 4.19, the p value for Group 1 was

<0.001 and for Group 2 p = 0.001 suggesting a statistically significant change in greasiness over

the 16 day period.

Table 4.19 Friedman Test for Greasiness

Group 1 N

Chi-Squared

Df

Asymp. Sig

17

26.433

2

<0.001

Group 2 N

Chi-Squared

Df

Asymp. Sig

23

13.671

2

0.001


greasiness occurred between visit 1 and 2 (p = 0.001), and between visit 1 and 3 (p < <0.001) for

Group 1.There was no statistically significant change in greasiness between visit 2 and 3 in Group

1 as p = 0.058.

For Group 2, statistically significant changes in greasiness occurred between visit 1 and 2 (p =

0.003), and between visit 1 and 3 (p = 0.001).No statistically significant change in greasiness was

shown between visit 2 and 3 in Group 2 as p = 0.068.

Table 4.20 Wilcoxin Signed Ranks Test for Greasiness


VAS Greasiness between visit 1 and 2 0.001


VAS Greasiness between visit 1 and 3 <0.001





51

Intergroup Analysis

The comparison of the means scores for greasiness of Group 1 and 2 (as already discussed) was

found to be statistically insignificant with means of 5.12 for Group 1 and 4.48 for Group 2 with a

p value of 0.535.

The mean score for Group 1 at visit 2 was 1.59 when compared to Group 2 of 2.52 with a p value

of 0.468. When compared, the mean scores for greasiness at visit 2 were found to be statistically

insignificant.

The mean score for Group 1 at visit 3 was 1.06, and the mean score for Group 2 was 1.74 with a

p value of 0.115. When compared, the mean scores for greasiness at visit 3 were found to be

statistically insignificant (p = 0.115). This means that there was no significant difference in the

average greasiness between the 2 groups at visits 1, 2 and 3.


Comparable Greasiness

Table 4.21 demonstrates the number of participants, the mean, standard deviation and p value for

greasiness at visit 1 for group 1 and 2.

The mean for greasiness at visit 1 for Group 1 was 3.647 when compared to Group 2 of 3.957. The

p value for greasiness at visit 1 was 0.558 therefore concluding that the groups were comparable

at visit 1 with regards to greasiness.


Visual Analogue Scale – Greasiness (Visit 1) – Researcher Evaluation

Group 1 N = 17

Mean = 3.647



Group 2 N = 23

Mean = 3.957



52

Intragroup Analysis

According to Figure 4.9, the mean for greasiness for Group 1 decreased from 3.647 at visit 1 to

1.41 at visit 2 and 0.71 at visit 3. The total improvement in the mean score for greasiness was

2.937 (80.5%).

The mean for greasiness for Group 2 decreased from 3.957 at visit 1 to 2.22 at visit 2 and 1.03 at

visit 3 indicating a 2.927 (74%) total improvement from visit 1 to visit 3.

Figure 4.9 Estimated Marginal Means for Greasiness – Researcher Evaluation


<0.001 suggesting a statistically significant change in greasiness over the 16 day period in favour

of Group 1.

0

1

2

3

4

5

6

1 2 3

Estimated Marginal Means of Greasiness

Active Shampoo

Placebo Shampoo

Visit

53

Table 4.22 Friedman Test for Greasiness – Researcher Evaluations

Group 1 N

Chi-Squared

Df

Asymp. Sig

17

22.677

2

<0.001

Group 2 N

Chi-Squared

Df

Asymp. Sig

23

25.310

2

<0.001


greasiness occurred between visit 1 and 2 (p = 0.001) and visit 1 and 3 (p = 0.001) for Group 1.

No statistically significant change was shown in greasiness between visit 2 and 3 in Group 1 as p

= 0.047.

Statistically significant changes in greasiness for Group 2 occurred between visit 1 and 2 (p =

0.003) and visit 1 and 3 (p = <0.001)

The results showed there to be no statistically significant change in greasiness between visit 2 and

3 in group 1 as p = 0.017.

Table 4.23 Wilcoxin Signed Ranks Test for Greasiness – Researcher Evaluations








VAS Greasiness between visit 1 and 3 <0.001

54

Intergroup Analysis

Using the Mann Whitney U test, the means of greasiness was compared at visit 1, already stated

above, visit 2 and visit 3.

The mean greasiness for Group 1 at visit 2 was 3.647 when compared to Group 2 of 3.957. The

mean greasiness was found not to be statistically significant between groups at visit 2 (p = 0.141).

The mean greasiness for Group 1 at visit 3 was 0.71 when compared to Group 2 of 1.03. The mean

greasiness was found not to be statistically significant for between at visit 3 (p = 0.307). Therefore,

there was no statistically significant difference in the average scores for greasiness for both groups

at all 3 visits.

4.4.5 Global Impression


Comparable Global Impression

The mean global impression for Group 1 at visit 1 was 5.71 when compared to Group 2 of 4.59.

The mean global impression of the two groups at visit 1 was found not to be statistically significant

(p= 0.225). Therefore, the mean global impression in the two groups at visit 1 was comparable.


for global impression of groups 1 and 2 at visit 1.

Table 4.24 Group statistics

Visual Analogue Scale – Global Impression (Visit 1)

Group 1 N = 17

Mean = 5.71



Group 2 N = 23

Mean = 4.59



55

Intragroup Analysis

Figure 4.10 demonstrates the changes in the means of global impression in the two groups between

visits 1 and 2, visits 2 and 3 and visits 1 and 3.

For Group 1 the mean of 5.71 for global impression at visit 1 dropped to 3.47 at visit 2. The mean

then dropped to 2.00 by visit 3, indicating a total mean score improvement of 3.71 (65%).

For Group 2 the mean of 4.57 for global impression at visit 1 dropped to 4.04 at visit 2. The mean

then dropped to 3.17 by visit 3. This indicates a total mean score improvement of 1.40 (30.6%).

Figure 4.10 Estimated Marginal means for Global Impression

The Friedman test as seen in Table 4.25 was used to determine the change in global impression

over the 16 day period. Group 1 and 2 both have a p value of <0.001 suggesting a statistically

significant change in global impression over time for Group 1 and Group 2.

1

2

3

4

5

6

1 2 3

Estimated Marginal Means of Global Impression

Active Shampoo

Placebo Shampoo

Visit

56

Table 4.25 Friedman Test for Global Impression

Group 1 N

Chi-Squared

Df

Asymp. Sig

17

29.525

2

<0.001

Group 2 N

Chi-Squared

Df

Asymp. Sig

23

29.368

2

<0.001

The Wilcoxin Signed Ranks test illustrated in Table 4.26 was used to determine at which point

during the 16 day trial significant changes in global impression took place.

For Group 1, statistically significant changes in global impression occurred between visit 1 and 2

(p = 0.005), visit 2 and 3 (p = 0.003) and between visit 1 and 3 (p = 0.001).

No statistically significant change was shown in global impression between all 3 visits namely

visit 1 and 2 (p = 0.282), visit 2 and 3 (p = 0.023) and visit 1 and 3 (p = 0.033) for Group 2 as p >

0.016.

Table 4.26 Wilcoxin Signed Ranks Test for Global Impression


VAS Global Impression between visit 1 and 2 0.005







57

Intergroup Analysis

Using the Mann Whitney U test, the marginal means of global impression in Group 1 and 2 at each

visit were compared. The mean global impression for both groups at visit 1 is stipulated above in

the section comparable global impression.



(p= 0.248).


When compared, the mean global impression of the two groups at visit 3 was found to be

statistically significant (p= 0.048). This means that the average global impression in Group 1 at

visit 3 was less than the average global impression in Group 2 at visit 3.


Comparable Global Impression

The mean scores for global impression at visit 1 were 4.41 in Group 1 and 4.83 in Group 2. The

mean scores for global impression in the 2 groups were comparable as there was no statistically

significant difference in the mean scores for global impression at visit 1 (p = 0.381).

Table 4.27 displays the mean, the standard deviation and the p value for global impression in

Group 1 and 2 at visit 1.


Visual Analogue Scale – Global Impression (Visit 1) – Researcher Evaluation

Group 1 N = 17

Mean = 4.41



Group 2 N = 23

Mean = 4.83



58

Intragroup Analysis

Figure 4.11 demonstrates the changes in the mean global impression for Group 1 and Group 2 at

all 3 visits

The mean global impression for Group 1 was 4.41 at visit 1, dropping to 3.35 by visit 2 and 1.94

by visit 3. This indicates a total 2.47 (56%) improvement in the mean scores for global impression

over time.

The mean global impression for Group 2 was 4.83 at visit 1, dropping to 3.31 by visit 2 and 2.78

by visit 3. This indicates a total 2.05 (42.4%) improvement in the mean scores for global

impression over time.

Figure 4.11 Estimated Marginal Means for Global Impression – Researcher Evaluation

The Friedman test was performed and as illustrated in Table 4.28, the p value for Group 1 and for

Group 2 was <0.001 suggesting a statistically significant change in global impression over the 16

day period favouring Group 1.

0

1

2

3

4

5

6

1 2 3

Estimated Marginal Means of Global Impression

Active Shampoo

Placebo Shampoo

Visit

59

Table 4.28 Friedman Test for Global Impression – Researcher Evaluation

Group 1 N

Chi-Squared

Df

Asymp. Sig

17

22.426

2

<0.001

Group 2 N

Chi-Squared

Df

Asymp. Sig

23

22.582

2

<0.001

According to the Wilcoxin Signed Ranks Test in Table 4.29, for Group 1, statistically significant

changes in global impression occurred between visit 2 and 3 (p = <0.001), and between visit 1 and

3 (p = 0.001) in favour of Group 1.

There was no statistically significant change shown in global impression between visit 1 and 2 in

Group 1 as p = 0.080.

For Group 2, statistically significant changes in global impression occurred between visit 1 and 2

(p = <0.001), and between visit 1 and 3 (p = 0.002).

There showed to be no statistically significant change in global impression between visit 2 and 3

in Group 2 as p = 0.295.

Table 4.29 Wilcoxin Signed Ranks Test for Global Impression – Researcher Evaluation



VAS Global Impression between visit 2 and 3 <0.001



VAS Global Impression between visit 1 and 2 <0.001



60

Intergroup Analysis

Using the Mann Whitney U test, the marginal means of global impression in Group 1 and 2 at each

visit were compared. The mean global impression for both groups at visit 1 is stipulated above in

the section comparable global impression.



(p = 0.943).


When compared, the mean global impression of the two groups at visit 3 was found to be

statistically insignificant (p = 0.209) in favour of Group 1.

4.4.6 Adherent Scalp Flake Score Grading (ASFS)

Comparable ASFS

The comparability of the ASFS has already been discussed under section 4.3.4 hHas ala

Intragroup Analysis

The mean changes for the ASFS between visits 1, 2 and 3 are illustrated in Figure 4.12.

For Group 1, the mean 34.00 of for the ASFS at visit 1 decreased to 18.88 at visit 2 and reached

10.93 by visit 3. The total mean score dropped by 23.07 (67.9%).

For Group 2, the mean 35.48 for the ASFS at visit 1 decreased to 18.27 at visit 2 and reached 17.48

by visit 3. The total mean score dropped by 17.97 (50.6%).

61

Figure 4.12 Estimated Marginal Means for the ASFS

According to Table 4.30, the p value for Group 1 and 2 was <0.001 proposing a statistically

weighty change in the ASFS from visit 1 to visit 3.

Table 4.30 Friedman Test for the ASFS

Group 1 N

Chi-Squared

Df

Asymp. Sig

17

26.000

2

<0.001

Group 2 N

Chi-Squared

Df

Asymp. Sig

23

29.429

2

<0.001

Table 4.31 shows a statistically significant change in the ASFS from visit 1 to 2 (p = 0.003), from

visit 2 to 3 (p = 0.001) and from visit 1 to 3 (p = <0.001) in Group 1.

Group 2 also showed statistically significant changes in the ASFS between visit 1 and 2 (p =

<0.001) and 1 and 3 (p = 0.001) as the p value was < 0.016.

10

15

20

25

30

35

40

1 2 3

Estimated Marginal Means of the ASFS

Active Shampoo

Placebo Shampoo

Visit

62

There appeared to be no statistically significant change in the ASFS between visit 2 and 3 (p =

0.396) for Group 2.

Table 4.31 Wilcoxin Signed Ranks Test for the ASFS


ASFS between visit 1 and 2 0.003


ASFS between visit 1 and 3 <0.001





Intergroup Analysis

Using the Mann Whitney U test, the marginal means for the ASFS in Group 1 and 2 at each visit

were compared.

As already revealed, the mean ASFS showed no statistical significance at visit 1. At visit 2, the

mean ASFS for Group 1 was 18.88 whereas Group 2 had a mean of 18.87. There was no

statistically significant change in the ASFS when comparing the mean ASFS of Group 1 and 2 at

visit 2 (p = 0.945).

At visit 3, Group 1 had a mean of 10.94 when compared to Group 2 of 17.48. The p value was

0.035 indicating a statistically significant difference in the mean ASFS of the 2 groups in favour

of Group 1.

The decrease in the average ASFS was therefore greater in Group 1 than Group 2 at visit 3.

63

CHAPTER 5: DISCUSSION

5.1 Introduction

This chapter discusses the various results obtained during the study and provides possible

explanations to assist in the understanding of the results and the effect of the research study.

Data collected for scaling was normally distributed according to the Shapiro Wilk test allowing

for parametric data analysis. All other variables showed an abnormal distribution of data, therefore

non-parametric tests were used in order to analyse the data.

5.2 Demographic Data

5.2.1 Gender Distribution

The results of the gender distribution disclose a balanced proportion between males and females

in the two groups. The total number of females far exceeded the number of males in the study as

Group 1 consisted of 14 females and 3 males and Group 2 consisted of 19 females and 4 males.

This contradicts the literature which states a higher prevalence rate of dandruff in post-pubertal

males (Pierard–Franchimont et al., 2001). A larger number of female participants that responded

and were recruited for the study could be due to cosmetic reasons as females are more likely to

seek help with cosmetic problems than males as well a higher tendency towards social stigma

(Frederick et al., 2007). Since gender is proposed to play a role in the aetiology of dandruff, either

only one gender or matched pairing is advised for studies of this nature in order to have an equal

number of males and females so that the results of the 2 genders can be compared.

5.2.2 Age Distribution

The demographic data pertaining to age reveals that the mean age for Group 1 (24.82) and Group

2 (27.78) was comparable. The mean ages found in the 2 groups also validates the ages (15- 50

years) at which dandruff is most commonly prevalent according to the literature (Robbins, 2012).

5.2.3 Race Distribution

The race distribution of the study is of interest as it shows that the greatest population of

participants in both groups are of Indian descent (85%). Since dandruff is most commonly found

in individuals of African descent (Proctor and Gamble Company, 2002), the recruitment areas used

for this study could account for the large proportion of Indian participants in this study. The

tendency to relate better to people of the same culture could have also played a role in obtaining

64

an Indian majority. Ideally, participants of the same race group should be used for studies such as

this as race affects the predisposition to dandruff.

5.3 Primary Visit Scores

At the commencement of the study, the primary scores for scaling, irritation, itching, greasiness,

global impression and ASFS for Groups 1 and 2 were comparable, eradicating the possibility that

the primary scores may have influenced the results of the 2 groups when compared to each other.

5.4 Scaling

Scaling was measured using a Visual Analogue Scale (VAS). The scaling was graded by

visualisation of the scalp as well as the shoulder area for flakes using two separate evaluations:

one by the participant themselves and one by the researcher.

Over the duration of the study, the scaling in the treatment group was found to improve by 76.9%

(p = <0.001), and by 45.1% in Group 2 (p = <0.001) when considering the participant evaluation.

Despite significant improvements for both groups over the course of the study, it was revealed that

there was still a significant difference (p = 0.012) between the groups at the last visit (visit 3).

Since both groups had comparable degrees of scaling at visit 1, this result suggests that both groups

experienced improvement with respect to the appearance of scaling, but that the treatment group

(Group 1) appeared to gain a more significant improvement.

With respect to the same criteria using the researcher evaluation, a similar trend was observed

where an overall improvement of 64.6% in scaling occurred in Group 1 (p = <0.001) whereas

Group 2 showed an improvement of only 43% (p = <0.001). Although both groups showed

significant improvements during the study, a statistically significant difference (p = 0.019) was

found at visit 3 between the two groups. At visit 1 both groups were comparable with regards to

scaling therefore, similar to the participant evaluations, there was a greater improvement in the

appearance of scaling for Group 1 when compared to Group 2.

Non-utilized unsaturated fatty acids generated from the sebum on the scalp are postulated as a

contributing factor to scaling on the scalp (Ashiati et al., 2013). Since the increased frequency of

washing the hair facilitates in removal of sebum from the scalp, a decrease in scaling may be

evident on the scalp (Gerson, 2004), just as a result of the frequency of washing in both groups.

While the improvement in both groups may be explained by the increased frequency of washing,

the presence of the active ingredient may provide an explanation for the greater improvement in

65

scaling seen in the treatment group (Group 1). According to Willet (2010), shale oil (the active

ingredient in the treatment shampoo) has an effect in the treatment of desquamation or scaling

disorders such as dandruff.

5.5 Irritation of the scalp

Irritation was measured using a VAS separately by the participant and the researcher. Irritation

comprised of redness or abrasions on the scalp from consistent itching.

For Group 1, irritation (scored by the participant) improved by a total of 74.8% (p = <0.001),

whereas for Group 2, a total of 52.8% improvement occurred (p = <0.001). Groups 1 and 2 both

demonstrated a statistically significant improvement, which shows that both groups improved

significantly in the scores for irritation. However, despite the improvement of both groups there

was shown to be no statistically significant difference between the two groups at visit 2 and 3 (p

= 0.697 and p = 0.249).

When scored by the researcher, the total improvement for irritation improved in Group 1 by 78.8%

(p = 0.001) and in Group 2 by 77.3% (p = <0.001). There was found to be no statistical significance

in irritation between the two groups at visit 2 and 3 (p = 0.483 and 0.412, respectively).

Since the Malassezia yeast is unable to metabolise lipids independently, it relies on the lipids

present in the sebum of the scalp. The sebum on the scalp degrades into 3 fatty acids through

oxidation. The Malassezia relies on the saturated fatty acids for consumption while the unsaturated

fatty acids remain on the scalp. The penetration of the unsaturated fatty acids into the scalp may

lead to irritation and inflammation of the scalp (Ashiati et al., 2013). A decrease in sebum on the

scalp as a result of more frequent washing may validate the decrease in irritation found in both

groups.

According to Barel et al (2010), cocamidopropyl betaine, one of the ingredients present in the base

of both shampoos used in this study, assists in the reduction of irritation on the scalp. This may

account for the reduced irritation found in both groups.

Shale oil is proposed to have anti-inflammatory actions (Willet, 2010) which may assist in the

treatment of scalp irritation. Frequent washing of the scalp may also reduce the irritation caused

by excess sebum on the scalp (Gerson, 2004). According to the literature, fungal conditions of the

66

skin often cause irritation (Pray, 2006). Thus, the anti-fungal properties (Willet, 2010) present in

shale oil may have assisted to reduce irritation found on the scalp.

According to Metcalf (2013) it may take up to several weeks to see noticeable changes in the

symptoms of dandruff especially when using natural or home remedies. Therefore, a greater length

of time for this study may be warranted to determine whether the active shampoo may outperform

the control substance.

5.6 Itching of the scalp

This symptom was also measured using an 11 point VAS. Itching was only evaluated by the

participant as it was a subjective measure.

Although both Group 1 and 2 displayed statistically significant improvements in itching, Group 1

(76.8%) had a higher overall improvement when compared to group 2 (54.7%). The p value for

Group 1 was <0.001 similar to <0.001 of Group 2 indicating that both the treatment and placebo

shampoo assisted in significantly reducing the presence of itching on the scalp.

Group 1 and 2 were comparable at visit 1 and by visit 2 and 3, there still appeared to be no statistical

significance (p = 0.418 and 0.749 respectively) in the presence of itching.

One of the common manifestations of fungal conditions is itching (Hall and Hall, 2010). By using

anti-fungal treatments, fungal conditions can be treated adequately. The anti-fungal properties

found in shale oil (Willet, 2010) may explain the reduction in itching in Group 1. Sweet almond

amphoacetate, another of the ingredients which contributes to the base of the shampoo, is proposed

to relieve itching when used on the skin – this ingredient may explain why itching also decreased

in Group 2 (Brown, 2010).

According to Jennifer (2011), dandruff makes the sufferer feel embarrassed and self-conscious due

to the visible flakes as well the itching of the scalp which often results in the need to scratch the

scalp. Due to the embarrassment associated with the condition, participants in both groups may

have been conscious about rating this symptom accurately. This may explain why both Group 1

and 2 improved significantly with regards to itching.

Itching was also the only symptom evaluated solely by the participant. Taking this into account,

social desirability or the tendency for people to display themselves in a favourable manner

67

(Craighead and Weiner 2010), may have influenced the results obtained for itching as participants

were aware that the researcher was not able to evaluate this symptom.

5.7 Greasiness

The measurement for greasiness was also done for the participant and the researcher separately

using the VAS. The scalp was visualised and the hair was also felt for greasiness.

Both Group 1 and 2 had a total improvement for greasiness according to the participant

evaluations. Group 1 improved by 79.3% (p= <0.001) compared to group 2 with a 61.2% (p =

0.001) improvement. Both groups yielded a p value of <0.05 indicating a statistically significant

change in greasiness over the period of the study. This indicates that both shampoos produced

similar results with regards to greasiness. Similar to visits 1, no statistically significant difference

occurred between Group 1 and 2 by visit 2 and 3 (p = 0.468 and 0.115 respectively).

Overall improvements for greasiness were present in the researcher results for Group 1 with an

80.5% (p = 0.001) improvement and Group 2 with a 74% (p = <0.001) improvement. Similar to

the participant evaluations, no statistically significant differences occurred between the 2 groups

at visit 2 and 3 (p = 0.141 and 0.307 respectively)

The results from the participant and researcher evaluations indicate a similar outcome. Greasiness

of the scalp can be caused by numerous factors such as hormonal fluctuations, environmental

factors, hair washing frequency and the use of styling products (Johnson, 2013). One the major

hormonal changes that may possible have influenced the results for greasiness is menstruation.

Since the majority of the participants in the study were females and of reproductive age, hormonal

fluctuations may have influenced the results for greasiness of the scalp.

During the course of the study, participants were requested to wash their every second day. This

criteria may have resulted in participants washing their hair more often that what they usually

would. Due to more frequent hair washing, sebum accumulation (Gerson, 2004) – which is the

cause of greasiness – was kept to a minimum resulting in less greasy hair.

Participants were also advised to refrain from using any other shampoo or styling products on the

scalp which usually results in product build up at the roots of the hair and consequently increased

greasiness of the hair (Ahmed et al., 2007).

68

5.8 Global Impression

The term ‘global impression’ was used to indicate the social and psychological effects of the

condition on the sufferer which was also measured independently by the participants and the

researcher using the Visual Analogue Scale.

The overall participant global impression rating for both groups showed significant improvements

for Group 1 of 65% (p = 0.001). On the other hand, Group 2 showed less than half the improvement

of Group 1 (30.6%) with no statistical significance (p = 0.033).

Both groups were comparable with respect to global impression at visit 1. On the contrary, at visit

3 significant differences (p = 0.048) in the average global impression occurred between the 2

groups.

As indicated in the researcher results, Group 1 produced an overall average improvement of 56%

(p = 0.001) whereas Group 2 produced an overall improvement of 42.2% (p = 0.002) in global

impression. Although both groups showed improvements, at visit 3 (p = 0.209), no significant

difference was found between the 2 groups contrary to the results obtained in the participant

evaluation.

When compared, the results obtained from the ratings for global impression indicate that the

participant evaluations showed a greater improvement than the researcher evaluations.

According to Sage (2005), the psychological effects of dandruff are noteworthy due to the

increased concern in society regarding appearance. A scaly scalp may look unsanitary leaving the

sufferer embarrassed and self-conscious. The most visible symptom of dandruff is the presence of

flakes or scaling either on the scalp or over the shoulders. As discussed in section 5.4 above,

differences in the scaling between Group 1 and 2 was evident supporting why global impression

may have improved more in Group 1.

Interestingly, the global impression results suggest a greater significance for the participant

evaluations in Group 1 when compared to the researcher evaluations for Group 1. This may be

explained by the greater social impact of the condition on the sufferer when compared to the view

of an outsider viz. the researcher in this case. Similarly, in a study conducted by Ahmed et al.

(2007), at least 63.3% of sufferers were embarrassed by their condition.

69

5.9 Adherent Scalp Flake Score (ASFS)

The Adherent Scalp Flake Score (ASFS) grading is an 80 point system which divides the scalp

into 8 sections and allows the researcher to visualise and grade the scaling in each section of the

scalp out of 10. The score is then added to give a total score out of 80.

According to the results, it is indicated that both groups 1 and 2 showed significant improvements

of 67.9% (p = <0.001) and 50.6% (p = <0.001) respectively in the ASFS grading over the period

of the study.

At visit 1 there appeared to be no statistically significant difference for the inter group analysis as

both groups were comparable with regards to ASFS grading. However, at visit 3, as indicated in

the results the p value was 0.035 indicating a statistically significant difference in the mean ASFS

of the 2 groups.

The ASFS grading looks at scaling on the entire scalp. Since the results for scaling as seen in

section 5.4 above showed greater improvements in Group 1 than Group 2, the results of the ASFS

grading are congruent with those of scaling. Reasons such as those explained above in section 5.4

can be employed to explain the outcomes obtained for the ASFS grading of Group 1 as the ASFS

grading and the scaling of the VAS both look at the same symptom of dandruff. According to Nina

(2013), great emphasis is placed on clean hair which is believed to activate the hair follicle, reduce

excess sebum accumulation and prevent the build-up of excess cell on the scalp. Therefore the

increased frequency for hair washing may also account for the change in ASFS grading in Group

1.

70

CHAPTER 6: CONCLUSION AND RECOMMENDATIONS

6.1 Conclusion

The study aimed to ascertain the effect of sodium shale oil sulphonate 1% shampoo in the

appearance of dandruff using the following parameters: Scaling, irritation, itching, greasiness and

global impression and ASFS grading.

It was found that both sodium shale oil sulphonate 1% shampoo and the control shampoo may

contribute significantly to the improvement of the appearance of dandruff with respect to all of the

aforementioned parameters. No significant difference was found between the sodium shale oil

sulphonate 1% shampoo and the control shampoo relevant to irritation, itching, greasiness or

researcher global impression.

The sodium shale oil sulphonate 1% shampoo was shown to yield a higher percentage

improvement for each measured parameter than the control substance and showed a significant

improvement over and above the control shampoo with respect to only the following parameters:

scaling (participant rated p = 0.012; researcher rated p = 0.020) and the global impression

(participant rated p = 0.048). Higher numbers of participants and longer study periods are however

required to verify these results.

Comparable to the results presented for scaling, significant changes in ASFS grading occurred

overall at visit 3 for the sodium shale oil sulphonate 1% (67.9%) versus the control shampoo

(50.6%) (p = 0.035). The presence of a significant difference is indicative of the possibility that

sodium shale oil sulphonate 1% may be further suggest the verification of these results in the

management of dandruff by sodium shale oil sulphonate 1% shampoos.

The improvements in scaling and significant global impression recorded by the participant could

imply that sodium shale oil sulphonate 1% shampoo may decrease the appearance of scaling in a

relatively short period of time (16 days). Wide scale research and further verification of these is

mandated prior to the finalisation of any claim of beneficial improvement. The null hypothesis

therefore cannot be accepted.

The conclusion or results of this study may not be quoted for use or proof of efficacy nor

substantiation of any effect in any context without the express permission of the Department of

Homoeopathy, University of Johannesburg.

71

6.2 Recommendations

Should further research be conducted on sodium shale oil sulphonate 1% shampoo, the following

recommendations are advised based on the experience of the study:

A greater number of participants should be used in future studies in order for the results to

be more statistically significant with respect to parametric analysis.

The duration of the study should be extended in order to evaluate whether the shampoo has

effects on certain parameters such as irritation, itching and greasiness.

One gender may be used or matched pairing for gender can be employed to ensure an equal

gender distribution between the two groups. This may also assist in comparing the results

for gender.

A greater variation in ethnic groups should be included in future studies in order to compare

the results between ethnic groups and to allow for the demographics to be studied equally,

considering the cultural diversity in South Africa

As dandruff is described as a chronic condition a follow up should be performed after the

treatment is complete in order to evaluate the long lasting effects of the shampoo.

The shampoo may also be compared with commercially available shampoos in order to

determine its performance.

72

REFERENCES

Acton, Q. A. (2013). Sulphur acids – Advances in research and application. Georgia: Scholarly

Editions. p 240.

Adamski, Z. (2006). The treatment of dandruff of the scalp. Journal of Aesthetic Dermatology,

9(2):49-55.

Ahmed, M.K., Raza, N. & Ejaz, A. (2007). Knowledge, attitude and practice regarding dandruff

among soldiers. J Coll Physicians Surgical Pakistan, 17(3):128-3.

American Shale Oil Corp. (2015). Oil shale extraction method. Available from: <www.amso.net

/about-oil-shale-extraction-method.>. [Last accessed: 2 March 2015].

Arndt, K. A., Hsu, J. T. S. (2007). Manual of dermatologic therapeutics. 7th ed. Philadelphia:

Lippincot Williams and Wilkin Publishers. p. 180-182.

Ashbee, R., Bignell, M. H. (2010). The yeast handbook: Pathogenic yeasts. Berlin: Springer-

Verlag. p. 200-210.

Ashianti, A. H., Rastegar, H., Aghaei, M., Ehsani, A., Barikbin, B., Salout, M. H. (2013). Clinical

efficacy of natural formulated shampoo in subjects with dandruff and seborrheic dermatitis.

American Journal of Research Communication. 1 (8):72-75.

Bacon, R. A. (2012). Assessing therapeutic effectiveness of scalp treatments for dandruff and

seborrheic dermatitis, Part 1: A reliable and relevant method based on the adherent scalp flaking

score (ASFS). Journal of Dermatological Treatment, 1 (5):2-4.

Baran, R., Maibach, H, I. (1998). Textbook of cosmetic dermatology. 2nd ed. London: Martin

Dunitz Ltd. p 149-152.

Barel, O. A., Paye, M., Maibach, H. I. (2010). Handbook of cosmetic science and technology. 3rd

ed. Florida: CRC Press. p 462.

73

Beckert, S, Warnecke, J., Zelenkova, H., Kovnerystyy, O., Stege, H., Colcha, W., Konigsrainer,

A., Coerper, S. (2005). Efficacy of topical pale sulfonated shale oil in the treatment of venous leg

ulcers: A randomized, controlled, multicenter study. Journal of Vascular Surgery, 43(1): 92.

Blenkinsopp, A., Paxton, P., Blenkinsopp, J. (2014). Symptoms in the pharmacy: A guide to the

management of common illnesses. West Sussex: John Wiley and Sons Ltd. p. 100-110.

Boarder, M., Newby, D., Navti, P. (2010). Pharmacology for pharmacy and health sciences: A

patient-centred approach. New York: Oxford University Press. p 588.

Bolognia, J. L., Jorizzo, J. L., Rapini, R. P. (2003). Dermatology. U.S.A: Mosby Publishers. p 200.

Born, S. (2015). Shampoo free: A DIY guide to putting down the bottle and embracing healthier

hair. New York: Skyhorse and Skyhorse Publishing. p. 52.

Brown, D. W. (2010). Change your mood with aromatherapy. London: Hodder Education. p 42.

Case, H. (2013). The dangers of cocamidopropyl betaine. Available from: <http://www.livestr

ong.com/article/226739-dangers-ofcocamidopropylbetaine/>. [Last Accessed: 2 November 2015].

Chhavi, S., Sushma, D., Mohammad, A. (2011). Potential of herbals as anti-dandruff agents.

International Research Journal of Pharmacy, 2(3):16-18.

Colcha, W., Leuschner, J., Leuschner, F. (2004). The tolerability of pale sulfonated shale oil

following local and systemic administration. Arzneimittel-Forschung, 44(2):170-177.

Colledge, N. R., Walker, B. R., Ralston, S. H. (2010). Davidson’s principles and practice of

medicine. 21st ed. New York: Churchill Livingstone. p 1237-1240.

Colon, K. (2014). Fight back against dandruff with home remedies. The Huffington Post.

Available from: <www.huffingtonpost.com/kristen-colon/dandruff-remedies>. [Last accessed: 2

March 2015].

Craighead, W. E., Weiner, B. I. (2010). The Corsini encyclopedia of psychology. New Jersey: John

Wiley and Sons Inc. p 1628.

http://www.huffingtonpost.com/kristen-colon/dandruff-remedies

74

DeAngelis, Y, M., Gemmer, C. M., Kaczvinsky, J. R., Kenneally, D. C., Schwartz, J. R., Dawson,

T. L. (2005). Three etiologic facets of dandruff and seborrheic dermatitis: Malassezia fungi,

sebaceous lipids, and individual sensitivity. Journal of Investigative Dermatology, 10:295-297.

Dermweb. (2008). Diagrammatic representation of hair anatomy. Available from: <http://www.d

ermweb.com/hairnailsmucousmembranes/diagram3page.htm>. [Last accessed: 15 September

2015].

Frederick, D. A., Lever, J., Peplau, A. L. (2007). Interest in cosmetic surgery and body image:

views of men and women across the lifespan. Journal of Plastic and Reconstructive Surgery,

120(5):1414.

Gayko, G. (2004). Pale sulphonated shale oil exhibits antimicrobial and tissue repairing effects in

wound healing. Veterinary Dermatology, 15(1):20-40

Gerson, J. (2004). Milady’s standard fundamentals of estheticians. 9th ed. Canada: Delmar

Learning. p. 190-192.

Gift, A. (1989). Visual analogue scales: measurement of subjective phenomena. Nursing

Research, 38(5):286-288.

Goodheart, H. P. (2009). Goodheart’s photoguide to common skin disorders: Diagnosis and

management. Philadelphia: Lippincott Williams and Wilkins. p 16.

Gupta, A., Madzia, S., Batra, R. (2004). Etiology and management of seborrheic dermatitis.

Dermatology, 208(2):89-93.

Hall, B. J., Hall, J. C. (2010). Sauer’s manual of skin disease. 10th ed. Philadelphia: Lippincot

Williams and Wilkin Publishers. p 149-152.

Harding, C., Moore A., Rogers, J., Meldrum, H., Scott, A., McGlone, F. (2002). Dandruff: a

condition characterized by decreased levels of intercellular lipids in scalp stratum corneum and

impaired barrier function. Archives of Dermatological Research, 294(5): 221-230.

75

Hauser, K., Walsh, D. (2008). Visual analogue scales and assessment of quality of life in cancer.

Journal of Supportive Oncology, 6(6):277-282.

Hull, K. L. (2011). Human form, human function: Essentials of anatomy and physiology. 1st ed.

Philadelphia: Lippincot Williams and Wilkin Publishers. p 94-104.

Jacknin, J. (2001). Smart medicine for your skin: a comprehensive guide to understanding

conventional and alternative therapies to heal common skin problems. U.S.A: Penguin Putnam

Inc. p 271-273.

Jacoby, D., Moungson, R. M. (2005). Encyclopedia of family health. 2nd ed. New York: Marshall

Cavendish Corporation. p 151.

Jadhav, B. B. (2004). Practice of homeopathy at home. 4th ed. New Delhi: B. Jain Publishers. p

268-272.

Jennifer, A. (2011). Seborrheic dermatitis: A clinical practice snapshot. The American Journal of

Primary Health Care, 36(8):32 – 37.

Johnson, J. (2013). Greasy hair. Available from: <http://www.hygieneexpert.co.uk/greasyha

ir.html>. [Last accessed: 3 September 2015].

Johnson, B., Nunley, J. (2000). Treatment of seborrheic dermatitis. American Family Physician,

61(9):2703-2710.

Johnson, J. (1997). Visual Analogue Scales: Part I and II. A quarterly publication of the

Department of Clinical Investigation. Available from: <http: //www.bamc.amedd.army.mil/ DCI/

articles>. [Last Accessed 10 March, 2015].

Kandarova H., Kejlova K., Jirova D. (2005). ECVAM Feasibility Study: Can the pre-validated in

vitro skin model phototoxicity assay be upgraded to quantify phototoxic potency of topical

phototoxins? Poster Presentation, 5th World Congress on Alternatives & Animal Use in the Life

Sciences. Germany. p 10-25.

http://www.hygieneexpert.co.uk/greasyha%20ir.html

http://www.hygieneexpert.co.uk/greasyha%20ir.html

http://www.bamc.amedd.army.mil/DCI/articles

http://www.bamc.amedd.army.mil/DCI/articles

76

Kelly, A. M. (2001). The minimum clinically significant difference in the visual analogue scale

score does not differ with severity of pain. Emergency Medicine Journal, 18:205-207.

Kent, K. (2005). The effectiveness of an oral homoeopathic preparation of Selenium Sulphide 12X

in the management of dandruff. Unpublished. M. Tech Dissertation. Supervisor: Dr M. Maharaj.

M Tech Hom (TN). Co-supervisor: Dr I Couchman. M Tech Hom (TN). Durban University of

Technology. p 70-75.

Korting, H. C., Schmid, M. H. (1998). Coal tar, pine tar and sulfonated shale oil preparations:

comparative activity, efficacy and safety. Dermatology Journal 193 (1): 1-5.

Korting, H, C., Schollman, C., Cholcha, W., Wolff, L. (2010). Efficacy and tolerability of pale

sulfonated shale oil cream 4% in the treatment of mild to moderate atopic eczema in children: a

multicentre, randomized vehicle-controlled trial. Journal of the European Academy of

Dermatology and Venereology, 24:1176-1182.

Laden, K., Finkelstein, P. (2000). An objective measure for evaluation of dandruff severity.

Journal of the Society of Cosmetic Chemists, 19:669-673.

Leigh, K. (2015). Ingredients in shampoos and conditioners. Available from: <http://www.lives

trong.com/article/73827-ingredients-shampoos-conditioners-cause-hair>. [Last Accessed: 2 Nov

ember 2015].

Loden, M., Maibach, E. (2000). Dry skin and moisturizers. U.S.A: CRC Press LLC. p 136-163.

Lunar Pharmaceuticals. (2014). Information on Ichthyol Pale®. Available from: Lunar

Pharmaceuticals. [Last accessed: 23rd April 2014].

Lyman Ott. R, Longnecker. M. T. (2015). An introduction to statistical analysis and data

collection. U.S.A: Cengage Learning. p 300-315.

Malassez, L. (1874). Note sur le champignon de pityriasis simplex. Archives of Physiology and

Pathology. p. 202.

77

Marieb, N. M., Hoehn, K. (2013). Human anatomy and physiology. 9th ed. U.S.A: Pearson

Publishers. p 246.

Martini, F., Nath, J. L. (2009). Fundamentals of anatomy and physiology. 8th ed. San Francisco:

Pearson Benjamin Cummings. p 158-174.

Matthews, L. (2012). Dermis anatomy of the skin. Available from: <http://www.naturallyhealthy

skin.org/anatomy-of-the-skin/the-dermis/dermis-anatomy-of-the-skin/>. [Last accessed: 8 April

2015].

Metcalf, E. (2013). How to handle dandruff. Available from: <http://www.webmd.com/skin-

problems-and-treatments/dandruff-13/natural-fixes?page=1>. [Last accessed: 21 September

2015].

Mercola, D. (2013). Sodium laureth sulphate: Fact vs. Fairytale. Available from: <http://articles

.mercola.com/sites/articles/archive/2010/07/13/sodium-lauryl-sulfate.aspx>. [Last Accessed: 2

November 2015].

Nathan, A. (2010). Non-prescription medicines. 4th ed. Great Britian: Pharmaceutical Press. p 77-

85.

Nina, M. (2013). 14 simple steps to deal with dandruff. Available from: < http://www.14steps.or

g/14-steps-to-deal-with-dandruff.html>. [Last accessed: 3 September 2015].

Nowicki, R. (2006). Modern management of dandruff. NCBI. Available from: <http://www.ncbi

.nlm.nih.gov/pubmed/16617752>. [Last accessed: 15th August 2014].

Percival, S., Cutting, K. (2010). Microbiology of wounds. Florida: CRC Press. p. 69-72.

Pierard–Franchimont, C., Pierard, G., Aresse, J. and De Doncker, P. (2001). Effect of ketoconazole

1% and 2% shampoo on severe dandruff and seborrheic dermatitis: clinical, squamometric and

mycological assessment. Dermatology, 202(2):171-179.

Pierard, G. (2008). Seborrheic dermatitis today, gone tomorrow? The link between Biocene and

treatment. Dermatology, 206(3):187-188.

http://www.webmd.com/skin-problems-and-treatments/dandruff-13/natural-fixes?page=1

http://www.webmd.com/skin-problems-and-treatments/dandruff-13/natural-fixes?page=1

78

Prambhamanju, M., Shankar, G. S., Babu, K., Ranjith, M. S. (2009). Herbal vs. chemical

substances as anti-dandruff agents: which are more effective in management of dandruff: An

overview. Egyptain Dermatology Journal, 5(2):1-8.

Pray, S. W. (2006). Non-prescription product therapeutics. 2nd ed. U.S.A: Lippincot Williams and

Wilkin Publishers. p. 470-486.

Preedy, V. R. (2012). Handbook of hair in health and disease. Germany: Wageningen Academic

Publishers. p 70-76.

Proctor and Gamble Company. (2002). Dermatology; P & G scientists pinpoint cause of dandruff.

Health and Medicine Weekly, 19(11):10-12.

Rastegar, H. (2009). A comparison of clinical efficacy between a basic shampoo with herbal

extracts containing Climbazole and its similar sample containing piroctone olamine in the

treatment of dandruff and seborrheic dermatitis. Iranian Journal of Dermatology, 12 (3):82-84.

Ravichandran, D., Bharadwaj, V. S., Kolhapure, S. A. (2004). Evaluation of the clinical efficacy

and safety of “Anti-Dandruff Shampoo” in the treatment of dandruff. The Antiseptic. 202(1):5-8.

Reiman, P. (2003). Fighting the flakes. Dermatology Times, 24(8):52.

Robbins, C. R. (2012). Chemical and physical behavior of human hair. 5th ed. Berlin: Springer-

Verlag. p. 419-422.

Roger, W. (2010). Dandruff. Available from: <http://www.mayoclinic.com/health /dandruff/DS0

0456>. [Last accessed: 15th Aug 2014].

Sage, S. (2005). How to overcome dandruff and other scalp disorders. U.S.A: eBook wholesaler

Publications. p. 5-10.

Saint-Ledger, A., Kligman, M., Stoudemayer, T. J. (2000). A new method to quantify scaling in

dandruff. Journal of the Society of Cosmetic Chemists, 39:179-19.

.

http://www.mayoclinic.com/

79

Sample, D, G., Ravichandra, G., Desni, I. (2000). Evaluation of safety and efficacy of

ketoconazole 2% and zinc pyrithione 1% shampoo in patients with moderate to severe dandruff –

post marketing study. Journal of the Indian Medical Association, 92(12):810-811.

Sanders, P. J. (2008). Healthy skin plain and simple.1st ed. Bloomington: iUniverse Publishers. p

78.

Schwanke, J. (2002). Studies get to the root of dandruff; reveal new causes, cures for ailment.

Dermatology Times, 23(7):22.

Schwarts, J. (2012). A reliable and relevant method for assessing dandruff product efficacy based

on the adherent scalp flaking score (ASFS). Journal of the American Academy of Dermatology,

68 (4):81-85.

Schwarts, J. R. (2003). Dandruff and seborrheic dermatitis. Florida: TRI Publications. p. 5-30.

Schwartz, J, R., Cardin, C, W., DeAngelis, Y, M., Dawson, T, L., (2010). Textbook of cosmetic

dermatology. U.S.A: Elsevier. p. 230-241.

SLS Free. (2015). Sodium laureth sulphate in shampoos. Available from: <http://slsfree.net/an-

sls-free-shampoo-list>. [Last Accessed: 2 November 2015].

SpecialChem. (2013). Cocamidopropyl betaine. Available from: <http://cosmetics.specialchem

.com/cocamidopropyl-betaine>. [Last Accessed: 2 November 2015].

Stubbs, R., Hughes, D., Johnstone, A., Rowley, E., Reid, C., Elia, M., Stratton, R., Delargy, H.,

King, N. and Blundell, J. (2000). The use of visual analogue scales to assess motivation to eat in

human subjects: a review of their reliability and validity with an evaluation of new hand-held

computerized systems for temporal tracking of appetite ratings. British Journal of Nutrition,

84:405-415.

Thomas, P, H., Campbell, J, L., Quitadamo, M, J., Zug, K, A. (2001). Skin disease: Diagnosis and

treatment. Missouri: Mosby Inc. p 94-96.

http://slsfree.net/an-sls-free-shampoo-list

http://slsfree.net/an-sls-free-shampoo-list

80

Van Staden, J. (2014). Statkon, Personal Discussion. 13 May 2014, Chiselhurst House, APK, UJ,

(+27 (011) 559-2851), (email: [email protected]).

Warner, R, R., Schwartz, J, R., Boissy, Y., Dawson, T, L. (2001). Dandruff altered stratum

corneum ultrastructure that is improved with zinc pyrithione shampoo. Journal of Americam

Academic Dermatology, 45: 897-903.

Wiles, R, M., Williams, J., Ahmad, A, K. (2011). Essentials of dermatology for chiropractors.

United Kingdom: Jones and Bartlett Publications LLC. p. 140.

Willet, J. (2010). The American beauty industry encyclopedia. U.S.A: Greenwood Press. p. 81-

85.

mailto:[email protected]

81

APPENDIX A

Advertisement

Are you between the ages of 18 and 45?

You may qualify to participate in a research study conducted at the Department of

Homoeopathy of the University of Johannesburg on:

The effect of the Sodium Shale Oil Sulphonate 1% Shampoo on Dandruff

This research study has been approved by the Faculty of Health Sciences Higher Degrees

and Ethics Committee

Ethical Clearance No:

If you are interested please contact:

Zeenat Mia – 0767617019

DO YOU SUFFER FROM

DANDRUFF?

82

APPENDIX B

Participant Information Form

Dear Prospective Participant

My name is Zeenat Mia and I am currently in my final year at the University of Johannesburg

studying homoeopathy. I would like to extend to you a warm invite to participate in my research

study which I am currently commencing for my master’s degree qualification.

The purpose of the study is to determine the effect of Sodium shale oil sulphonate 1% shampoo

on dandruff.

Sodium shale oil sulphonate is made from the oil found in the keragon rock. Based on internal

research done on the shampoo, the shampoo has anti-bacterial and anti-fungal properties which all

facilitate in the treatment of dandruff. Sodium shale oil sulphonate 1% shampoo is well tolerated

and safe for use in many skin disorders with no anticipated risks or known side effects to the use

of the shampoo.

The study will be performed in the form of a double-blind controlled study where participants will

be divided into two groups: an experimental and a control group. One group will receive a bottle

of shampoo containing active anti-dandruff ingredients (experimental group) whereas the other

group will receive a bottle of shampoo containing no active anti-dandruff ingredients (control

group).

You are warmly invited to participate if you:

• Are within the age group of 18-45 years;

• Have good general health;

• Are suffering from mild to moderate dandruff with itching, flaking, irritation, greasiness

and possibly hair loss;

• Have a baseline Adherent Scalp Flaking Score grading of ≥24.

Unfortunately you may not participate in the study if you:

• Suffer from severe scalp conditions such as psoriasis, atopic dermatitis, contact dermatitis

or tinea capitis;

83

• Have been diagnosed with chronic or systemic diseases including diabetes mellitus,

epilepsy, rheumatic fever, hypertension, thyroid disease, hypercholesterolemia or

autoimmune conditions;

• Are currently on chronic medication;

• Are currently on treatment for dandruff;

• Are pregnant or lactating.

The study will be conducted at the University of Johannesburg, Doornfontein Campus over a 16

day period. At your first visit, an assessment will be done of your blood pressure, temperature,

respiratory rate and pulse rate as well as a general examination to assess your overall health status.

Thereafter, the current condition of your dandruff will be assessed as follows. At each consult you

will be given a form to objectively score your dandruff. I will also fill out an amended version of

the form to rate your dandruff and observe your scalp to note the severity of your condition.

After the above has been performed, you will be given a bottle of shampoo which will be used to

wash your hair once a day, every second day starting from day one. At each wash, only 25ml of

shampoo must be used. This will be measured out using a measuring cup supplied to you. No other

shampoo should be used for the duration of the study. I will send you an SMS the night before to

remind you to wash your hair the following day.

Follow up consultations will be performed every 8 days. At each follow up consultation, your

dandruff will be assessed using the same methods performed at your initial consultation.

Participation in this study is free of charge, voluntary and there is no reimbursement. You are free

to leave or withdraw from the study at any time. All information provided to me during the study

will remain anonymous and private as none of your details will be disclosed in the write up and

all files will be kept in a secure cabinet for five years with your name being replaced by a case

number. Files will only be assessed by me (the researcher) and my supervisor.

By taking part in the study you may be provided with possible treatment to eradicate and improve

the condition of your dandruff and, there are no anticipated risks involved in the study.

If you have any questions, concerns or problems relating to this study, please feel free to contact

me or, if necessary, my supervisor on the contact details listed below. If you wish to view the

results of the research, they will be made available as per your request.

84

Your participation in this research study will be highly appreciated and will contribute to

knowledge and further effective treatment of dandruff using Sodium shale oil sulphonate 1%

shampoo.

Thank you

Zeenat Mia

Contact details

Researcher: Zeenat Mia Tel: 0767617019

Supervisor: Dr Neil. T. Gower Tel: 0115596779

85

APPENDIX C

Participant Consent Form

I,___________________________________, participant in the research, have been correctly

informed of the research procedure, risks, and potential benefits of the study. I understand what

the study is about and by signing the consent form I agree to participate in the study and agree to

the methods and treatment therein. I understand that my participation is voluntary and I can

withdraw at any point during the process. I understand that the researcher will be available to

answer any questions at any time.

Date: Signature:

I, Zeenat Mia, the researcher, have fully explained the study procedures and treatment used to

conduct this research. I agree to answer any questions that arise from the participants to the best

of my ability.

Date: Signature:

Contact details

Researcher: Zeenat Mia Tel: 0767617019

Supervisor: Dr Neil. T. Gower Tel: 0115596779

86

APPENDIX D

Physical Examination

Vital Signs

Temperature:

Blood pressure:

Respiratory rate:

Pulse rate:

Weight:

Height:

General examination: CAJCOLD

Cyanosis

Anaemia

Jaundice

Clubbing

Oedema

Lymphadenopathy

Dehydration

87

APPENDIX E

Modified Visual Analogue Scale for Participant

Date:

Participant number:

88

APPENDIX F

Modified Visual Analogue Scale for Researcher

Date:

Participant number:

1. Scaling:

2. Irritation:

3. Greasiness:

4. Global impression:

Severity Rating

0: None

1 – 2: Almost none/ Very slight

3 – 4: Mild

5 – 6: Moderate

7 – 8: Marked

9 – 10: Severe/ Heavy

89

APPENDIX G

Adherent Scalp Flaking Score Grading

90

APPENDIX H

Matching Procedure

The medication and placebo will be classified and ascribed by Lunar Pharmaceuticals. The groups

will be labelled 1 or 2.

The motive of this process is to match each participant according severity of dandruff while

randomly allocating each to one of the two groups.

This procedure will be assisted by using 3 different envelopes with the number 1 or 2 dividing the

groups according to severity of dandruff as per scoring on ASFS grading

• 24 – 42

• 43 – 61

• 62 – 80

Each participant will be asked to withdraw a number from the applicable envelope for their severity

of dandruff. This will assign them to the treatment or control group respectively, thus ensuring an

even distribution between the two groups. Once the envelope is empty the numbers will be

restocked.

91

APPENDIX I

Data Collection for Statistical analysis

92

93

APPENDIX J

Statistical Analysis

Descriptives – Gender and Age

Gender

Frequency Percent Valid Percent

Cumulative Percent

Valid Female 33 82,5 82,5 82,5

Male 7 17,5 17,5 100,0

Total 40 100,0 100,0

Group

Frequency Percent Valid Percent

Cumulative Percent

Valid Active Shampoo 17 42,5 42,5 42,5

Placebo Shampoo 23 57,5 57,5 100,0

Total 40 100,0 100,0

Test Statisticsa

Age

Mann-Whitney U 147,500

Wilcoxon W 300,500

Z -1,318

Asymp. Sig. (2-tailed) ,187

Exact Sig. [2*(1-tailed Sig.)]

.191b

Descriptives

Group Statistic Std. Error

Age Active Shampoo

Mean 24,82 1,252

95% Confidence Interval for Mean

Lower Bound 22,17

Upper Bound 27,48

5% Trimmed Mean 24,47

Median 24,00

Variance 26,654

Std. Deviation 5,163

Minimum 18

Maximum 38

Range 20

Interquartile Range 6

Skewness 1,251 ,550

Kurtosis 1,708 1,063

Placebo Shampoo

Mean 27,78 1,515

95% Confidence Interval for Mean

Lower Bound 24,64

Upper Bound 30,93

5% Trimmed Mean 27,40

Median 25,00

Variance 52,814

94

Std. Deviation 7,267

Minimum 18

Maximum 45

Range 27

Interquartile Range 9

Skewness ,815 ,481

Kurtosis ,014 ,935

Scaling – Participant Evaluation

Group Statistics

Group N Mean Std. Deviation

Std. Error Mean

Visual Analogue Scale - Scaling (Visit 1)

Active Shampoo 17 6,35 2,370 ,575

Placebo Shampoo 23 5,39 2,369 ,494


Active Shampoo 17 3,53 1,875 ,455



Active Shampoo 17 1,47 1,231 ,298


Independent Samples T Test

Independent Samples Test

Levene's Test for Equality of

Variances

t-test for Equality of Means

F Sig. t df Sig. (2-

tailed)

Mean Differenc

e

Std. Error Differenc

e

95% Confidence Interval of the

Difference

Lower

Upper


Equal variances assumed

,137 ,714 1,269

38 ,212 ,962 ,758 -,573 2,496

Equal variances not assumed

1,269

34,624

,213 ,962 ,758 -,578 2,501



,417 ,522 -,584

38 ,562 -,384 ,656 -1,713

,945


-,598

37,008

,554 -,384 ,642 -1,684

,917



6,802 ,013 -2,44

5

38 ,019 -1,486 ,608 -2,716

-,256


-2,65

9

35,328

,012 -1,486 ,559 -2,620

-,352

95

ANOVA

Multivariate Tests

Value F Hypothesis df

Error df Sig. Partial Eta Squared

Pillai's trace ,770 62.018a 2,000 37,000 ,000 ,770

Wilks' lambda ,230 62.018a 2,000 37,000 ,000 ,770

Hotelling's trace 3,352 62.018a 2,000 37,000 ,000 ,770

Roy's largest root 3,352 62.018a 2,000 37,000 ,000 ,770

Friedman Test

Test Statisticsa

Active Shampoo N 17

Chi-Square 29,525

df 2

Asymp. Sig. ,000

Placebo Shampoo N 23

Chi-Square 29,368

df 2

Asymp. Sig. ,000

Wilcoxin Signed Ranks Test

Test Statisticsa

Group Visual Analogue Scale - Scaling (Visit 2) - Visual

Analogue Scale - Scaling (Visit 1)

Visual Analogue

Scale - Scaling

(Visit 3) - Visual


Visual Analogue

Scale - Scaling

(Visit 3) - Visual


Active Shampoo Z -3.329b -3.219b -3.526b

Asymp. Sig. (2-tailed)

,001 ,001 ,000

Placebo Shampoo Z -3.639b -2.463b -3.969b


,000 ,014 ,000

96

Scaling – Researcher Evaluations

Group Statistics


Std. Error Mean

Visual Analogue Scale - Reseacher - Scaling (Visit 1)

Active Shampoo 17 5,82 2,157 ,523



Active Shampoo 17 4,00 1,541 ,374



Active Shampoo 17 2,06 1,249 ,303


Independent Samples T Test

Independent Samples Test

Levene's Test for Equality of Variances

t-test for Equality of Means

F Sig. t df Sig. (2-

tailed)

Mean Differenc

e

Std. Error Differenc

e

95% Confidence

Interval of the Difference

Lower

Upper



1,048 ,313 -,074 38 ,941 -,046 ,621 -1,302

1,210


-,072 30,357

,943 -,046 ,640 -1,352

1,260



,485 ,490 ,547 38 ,587 ,261 ,477 -,704 1,226


,542 33,432

,591 ,261 ,481 -,717 1,239



5,877 ,020 -2,285

38 ,028 -1,289 ,564 -2,431

-,147


-2,454

36,811

,019 -1,289 ,525 -2,354

-,224

97

ANOVA

Multivariate Testsa

Effect Value F Hypothesis df

Error df Sig. Partial Eta

Squared

Visit Pillai's Trace ,684 40.020b 2,000 37,000 ,000 ,684

Wilks' Lambda ,316 40.020b 2,000 37,000 ,000 ,684

Hotelling's Trace

2,163 40.020b 2,000 37,000 ,000 ,684

Roy's Largest Root

2,163 40.020b 2,000 37,000 ,000 ,684

Visit * Group Pillai's Trace ,193 4.414b 2,000 37,000 ,019 ,193

Wilks' Lambda ,807 4.414b 2,000 37,000 ,019 ,193

Hotelling's Trace

,239 4.414b 2,000 37,000 ,019 ,193

Roy's Largest Root

,239 4.414b 2,000 37,000 ,019 ,193

Friedman Test

Test Statisticsa

Active Shampoo N 17

Chi-Square 27,785

df 2

Asymp. Sig. ,000


Chi-Square 24,488

df 2

Asymp. Sig. ,000


Test Statisticsa

Group Visual Analogue Scale - Reseacher - Scaling

(Visit 2) - Visual Analogue Scale -

Reseacher - Scaling (Visit 1)

Visual Analogue

Scale - Reseacher -

Scaling (Visit 3) -

Visual Analogue

Scale - Reseacher -

Scaling (Visit 2)

Visual Analogue

Scale - Reseacher -

Scaling (Visit 3) -

Visual Analogue

Scale - Reseacher -

Scaling (Visit 1)


Asymp. Sig. (2-tailed) ,006 ,001 ,000


Asymp. Sig. (2-tailed) ,000 ,232 ,000

98

Irritation – participant evaluation

Group Statistics


Std. Error Mean

Visual Analogue Scale - Irritation (Visit 1)

Active Shampoo 17 5,12 2,547 ,618



Active Shampoo 17 2,35 1,367 ,331



Active Shampoo 17 1,29 1,359 ,329


Friedman Test

Test Statisticsa

Active Shampoo N 17

Chi-Square 21,733

df 2

Asymp. Sig. ,000


Chi-Square 22,143

df 2

Asymp. Sig. ,000


Test Statisticsa

Group Visual Analogue Scale - Irritation (Visit 2) -


Visual Analogue

Scale - Irritation (Visit 3) -

Visual Analogue

Scale - Irritation (Visit 2)

Visual Analogue

Scale - Irritation (Visit 3) -

Visual Analogue

Scale - Irritation (Visit 1)


Asymp. Sig. (2-tailed) ,001 ,015 ,001


Asymp. Sig. (2-tailed) ,001 ,012 ,001

99

Mann Whitney U Test

Test Statisticsa



Visual Analogue

Scale - Irritation (Visit

3)

Mann-Whitney U 169,000 181,500 154,500

Wilcoxon W 445,000 334,500 307,500

Z -,730 -,389 -1,152

Asymp. Sig. (2-tailed) ,465 ,697 ,249


.481b .705b .265b

Irritation- Researcher Evaluation

Group Statistics


Std. Error Mean

Visual Analogue Scale - Reseacher - Irritation (Visit 1)

Active Shampoo 17 3,35 2,448 ,594



Active Shampoo 17 1,65 1,412 ,342



Active Shampoo 17 ,71 1,047 ,254

Placebo Shampoo 23 ,83 ,937 ,195

Friedman Test

Test Statisticsa

Active Shampoo N 17

Chi-Square 23,288

df 2

Asymp. Sig. ,000


Chi-Square 33,787

df 2

Asymp. Sig. ,000

100


Test Statisticsa

Group Visual Analogue Scale - Reseacher - Irritation (Visit 2) - Visual Analogue

Scale - Reseacher - Irritation (Visit 1)

Visual Analogue

Scale - Reseacher - Irritation (Visit 3) -

Visual Analogue


Visual Analogue

Scale - Reseacher - Irritation (Visit 3) -

Visual Analogue




,001 ,015 ,001



,000 ,004 ,000

Mann Whitney U Test

Test Statisticsa

VASR_1_Irritation Visual Analogue Scale -

Reseacher - Irritation (Visit 1)

VASR_2_Irritation Visual Analogue Scale -

Reseacher - Irritation (Visit 2)

VASR_3_Irritation Visual Analogue

Scale - Reseacher -

Irritation (Visit 3)

Mann-Whitney U 166,000 170,500 168,000

Wilcoxon W 319,000 323,500 321,000

Z -,816 -,702 -,821

Asymp. Sig. (2-tailed) ,414 ,483 ,412


.432b .498b .464b

Itching – Participant Evaluation

Group Statistics


Std. Error Mean

Visual Analogue Scale - Itchiness (Visit 1)

Active Shampoo 17 5,82 2,481 ,602



Active Shampoo 17 2,35 1,455 ,353



Active Shampoo 17 1,35 1,057 ,256


Friedman Test

Test Statisticsa

Active Shampoo N 17

Chi-Square 21,031

df 2

Asymp. Sig. ,000


101

Chi-Square 19,753

df 2

Asymp. Sig. ,000


Test Statisticsa

Group Visual Analogue Scale - Itchiness (Visit 2) - Visual

Analogue Scale - Itchiness (Visit 1)

Visual Analogue Scale - Itchiness (Visit 3) - Visual

Analogue Scale - Itchiness (Visit 2)

Visual Analogue Scale - Itchiness (Visit 3) - Visual Analogue Scale - Itchiness (Visit

1)


Asymp. Sig. (2-tailed) ,001 ,020 ,000


Asymp. Sig. (2-tailed) ,001 ,020 ,000

Mann Whitney U Test

Test Statisticsa



Visual Analogue

Scale - Itchiness (Visit

3)

Mann-Whitney U 154,500 184,000 167,000

Wilcoxon W 430,500 337,000 320,000

Z -1,129 -,320 -,809

Asymp. Sig. (2-tailed) ,259 ,749 ,418

Exact Sig. [2*(1-tailed Sig.)] .265b .766b .448b

Greasiness – Participant Evaluation

Group Statistics

Group Group N Mean Std. Deviation

Std. Error Mean

VAS_1_Greasiness Visual Analogue Scale - Greasiness (Visit 1)

Active Shampoo 17 5,12 2,233 ,542



Active Shampoo 17 1,59 1,121 ,272



Active Shampoo 17 1,06 1,088 ,264


102

Friedman Test

Test Statisticsa

Active Shampoo N 17

Chi-Square 26,433

df 2

Asymp. Sig. ,000


Chi-Square 13,671

df 2

Asymp. Sig. ,001


Test Statisticsa

Group Group VAS_2_Greasiness Visual Analogue

Scale - Greasiness (Visit 2) -

VAS_1_Greasiness Visual Analogue

Scale - Greasiness (Visit 1)











,001 ,058 ,000



,003 ,068 ,001

Mann Whitney U Test

Test Statisticsa

VAS_1_Greasiness Visual Analogue Scale -

Greasiness (Visit 1)

VAS_2_Greasiness Visual Analogue Scale -




Mann-Whitney U 173,000 169,500 140,000

Wilcoxon W 449,000 322,500 293,000

Z -,621 -,726 -1,575

Asymp. Sig. (2-tailed) ,535 ,468 ,115


.551b .481b .134b

Greasiness – Researcher Evaluation

Group Statistics


Std. Error Mean

VASR_1_Greasiness Visual Analogue Scale - Reseacher - Greasiness (Visit 1)

Active Shampoo 17 3,647 1,8689 ,4533

Placebo Shampoo 23 3,957 2,0775 ,4332


Active Shampoo 17 1,41 1,121 ,272


Active Shampoo 17 ,71 1,047 ,254

103



Friedman Test

Test Statisticsa

Active Shampoo N 17

Chi-Square 22,677

df 2

Asymp. Sig. ,000


Chi-Square 25,310

df 2

Asymp. Sig. ,000


Test Statisticsa

Group Group VASR_2_Greasiness Visual Analogue Scale -

Reseacher - Greasiness (Visit 2) - VASR_1_Greasiness

Visual Analogue Scale - Reseacher -


VASR_3_Greasiness Visual Analogue

Scale - Reseacher - Greasiness (Visit 3) - VASR_2_Greasiness

Visual Analogue Scale - Reseacher - Greasiness (Visit 2)


Scale - Reseacher - Greasiness (Visit 3) - VASR_1_Greasiness

Visual Analogue Scale - Reseacher - Greasiness (Visit 1)



,001 ,047 ,001



,003 ,017 ,000

Mann Whitney U Test

Test Statisticsa

VASR_1_Greasiness Visual Analogue Scale - Reseacher - Greasiness

(Visit 1)

VASR_2_Greasiness Visual Analogue Scale - Reseacher - Greasiness

(Visit 2)


Scale - Reseacher - Greasiness (Visit 3)

Mann-Whitney U 174,500 143,000 161,000

Wilcoxon W 327,500 296,000 314,000

Z -,586 -1,472 -1,022

Asymp. Sig. (2-tailed) ,558 ,141 ,307


.570b .156b .356b

104

Global Impression – Participant Evaluation

Group Statistics


Std. Error Mean

VAS_1_Globalimpression Visual Analogue Scale - Globalimpression (Visit 1)

Active Shampoo 17 5,71 2,801 ,679



Active Shampoo 17 3,47 2,035 ,493



Active Shampoo 17 2,00 2,236 ,542


Friedman Test

Test Statisticsa

Active Shampoo N 17

Chi-Square 17,556

df 2

Asymp. Sig. ,000


Chi-Square 14,632

df 2

Asymp. Sig. ,001


Test Statisticsa

Group Group VAS_2_Globalimpression Visual Analogue Scale -

Globalimpression (Visit 2) -

VAS_1_Globalimpression Visual Analogue Scale -

Globalimpression (Visit 1)









Active Shampoo

Z -2.778b -3.001b -3.393b


,005 ,003 ,001

Placebo Shampoo

Z -1.075b -2.278b -2.136b


,282 ,023 ,033

Mann Whitney U Test

Test Statisticsa







Mann-Whitney U

153,500 173,500 124,000

Wilcoxon W

429,500 326,500 277,000

Z -1,156 -,608 -1,980


,248 ,543 ,048


.254b .551b .051b

105

Global Impression – Researcher Evaluation

Group Statistics


Std. Error Mean

VASR_1_Globalimpression Visual Analogue Scale - Reseacher - Globalimpression (Visit 1)

Active Shampoo 17 4,41 2,152 ,522

Placebo Shampoo

23 4,83 1,800 ,375


Active Shampoo 17 3,35 1,455 ,353

Placebo Shampoo

23 3,13 1,254 ,262


Active Shampoo 17 1,94 1,144 ,277

Placebo Shampoo

23 2,78 2,044 ,426

Friedman Test

Test Statisticsa

Active Shampoo N 17

Chi-Square 22,426

df 2

Asymp. Sig. ,000


Chi-Square 22,582

df 2

Asymp. Sig. ,000


Test Statisticsa

Group Group VASR_2_Globalimpression Visual Analogue Scale -

Reseacher - Globalimpression (Visit 2) - VASR_1_Globalimpression



VASR_3_Globalimpression Visual Analogue Scale -








Active Shampoo

Z -1.753b -3.611b -3.316b


,080 ,000 ,001

Placebo Shampoo

Z -3.785b -1.047b -3.084b


,000 ,295 ,002

106

Mann Whitney U Test

Test Statisticsa


Reseacher - Globalimpression (Visit 1)





Mann-Whitney U

164,000 193,000 150,500

Wilcoxon W 317,000 469,000 303,500

Z -,876 -,071 -1,257


,381 ,943 ,209


.401b .957b .221b

Adherent Scalp Flake Score Grading

Group Statistics


Std. Error Mean


Active Shampoo 17 34,00 11,597 2,813

Placebo Shampoo 23 35,48 10,891 2,271


Active Shampoo 17 18,88 10,185 2,470

Placebo Shampoo 23 18,87 7,671 1,600


Active Shampoo 17 10,94 7,110 1,725

Placebo Shampoo 23 17,48 9,949 2,075

Friedman Test

Test Statisticsa

Active Shampoo N 17

Chi-Square 26,000

df 2

Asymp. Sig. ,000


Chi-Square 29,429

df 2

Asymp. Sig. ,000


Test Statisticsa

Group Adherent Scalp Flake Score Grading (Visit 2) -


Adherent Scalp Flake

Score Grading (Visit 3) - Adherent Scalp Flake

Score Grading (Visit

2)

Adherent Scalp Flake

Score Grading (Visit 3) - Adherent Scalp Flake

Score Grading (Visit

1)


Asymp. Sig. (2-tailed) ,003 ,001 ,000

Placebo Shampoo Z -4.212b -.848b -3.976b

Asymp. Sig. (2-tailed) ,000 ,396 ,000

107

Mann Whitney U Test

Test Statisticsa



Adherent Scalp Flake Score

Grading (Visit 3)

Mann-Whitney U 170,000 193,000 119,000

Wilcoxon W 323,000 346,000 272,000

Z -,700 -,069 -2,103

Asymp. Sig. (2-tailed) ,484 ,945 ,035

Exact Sig. [2*(1-tailed Sig.)] .498b .957b .037b

Documents

DISSERTATION o Attribution - UJ IR