SYNOPSIS

Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore

“A COMPARATIVE STUDY OF EFFICACY OF 10%KOH AND

5%IMIQUIMOD FOR THE TREATMENT OF MOLLUSCUM

CONTAGIOSUM IN PEDIATRIC AGE GROUP”

Name of the candidate : Dr. NAMITHA CHATHRA

Guide : Dr. SUKUMAR D.

Course and Subject : M.D. (DERMATOLOGY)

Department of Dermatology,

Father Muller Medical College,

Kankanady, Mangalore – 575002.

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2011

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA, BANGALORE

ANNEXURE –II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR

DISSERTATION

1. Name of the candidate

And address

(in block letters)

Dr. NAMITHA CHATHRA

P.G. RESIDENT

DEPARTMENT OF DERMATOLOGY,

VENEROLOGY AND LEPROLOGY,

FATHER MULLER MEDICAL COLLEGE

AND HOSPITAL,

MANGALORE.

2 Name of the Institution FATHER MULLER MEDICAL COLLEGE

AND HOSPITAL.

3 Course of study and

Subject

M.D. (DERMATOLOGY,

VENEROLOGY AND LEPROLOGY)

4 Date of admission to 01/ 04/ 2011

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course

5 Title of the Topic

A COMPARATIVE STUDY OF EFFICACY OF 10%KOH AND

5%IMIQUIMOD FOR THE TREATMENT OF MOLLUSCUM

CONTAGIOSUM IN PEDIATRIC AGE GROUP.

6 BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR THE STUDY

Molluscum contagiosum is a common cutaneous infection seen in children

and young adults. It is caused by the molluscum contagiosum virus which is a

DNA virus. Its mode of transmission is by contact with an infected person or

fomites or autoinoculation. Although it is a self limiting condition, a decision

may be made in favour of active therapy to prevent further spread, relieve

symptoms, prevent scarring and for cosmetic and social reasons. The current

treatment modalities include physical destruction of the lesion by curettage,

cryosurgery or manual expression and topical application of caustic agents such

as trichloroacetic acid, cantharidin, silver nitrate etc. These therapeutic

approaches have to be undertaken in a hospital setup and are not well tolerated

by children owing to substantial pain and fear. In addition, these can also result

in scarring and abscess formation.

Topical application of 10%KOH solution and 5% Imiquimod cream are two

relatively painless modalities that have been used with success in the treatment

of molluscum contagiosum. KOH acts by dissolving the keratin and destroying

the skin whereas imiquimod is a tissue response modifier that induces IFN-, a

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potent antiviral agent. Since both can be applied at home, the patient compliance

is better.

The present study compares the efficacy of 10% KOH and 5% Imiquimod in

the treatment of molluscum contagiosum in paediatric age group.

6.2 REVIEW OF LITERATURE

Molluscum contagiosum was first detected by Bateman in the year

1814.1 Its viral etiology was established only in the year 1905 by Julisberg.2

MCV is transmitted directly by skin to skin contact or indirectly through fomites.

A study done by Rogers M et al. states that infection is rare in children under the

age of 1 year and typically occurs in the age group of 2-5years.3

Estimated incubation period varies from 14 days to 6 months. The lesion

usually presents as dome shaped, shiny, pearly white, umbilicated papules that

may have a central pore. Their size may vary from tiny 1mm papules to large

nodules over 1 cm in diameter. After trauma or spontaneously, after several

months, inflammatory changes result in the production of white fluid, crusting,

and eventual destruction of the lesion. As the old ones resolve new lesions tend

to appear as a consequence of virus spreading to other areas of skin.3 The

diagnosis of molluscum contagiosum does not pose a problem as it is evident

clinically.

Although molluscum contagiosum is a self limiting condition, a study by

Vander Wouden JC et al. cites the following reasons for intervention:

a) Alleviating discomfort, including itching;

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b) Cosmetic reasons;

c) Social stigma associated with many visible lesions;

d) Limiting its spread to other areas of the body and to other people;

e) Preventing scarring and secondary infection; and

f) Preventing trauma and bleeding of lesions. 4

The most common modalities in treatment of molluscum contagiosum are

physical destruction by cryotherapy, curettage or manual expression and topical

therapy with caustic agents such as trichloroacetic acid, cantharidin, silver

nitrate, etc. According to a study by Friedman M et al. these modalities are

painful and may result in scarring.5 Squeezing of the lesions may even lead to the

formation of secondary abscesses due to disruption of the virus into deeper layer

of the dermis.

In an open trial conducted by Mahajan BB et al. topical 20% KOH solution

was proved to be convenient, easy to apply at home, safe and inexpensive

alternative therapeutic modality for MC.6

An open label study by Barba AR et al. on safety of Imiquimod did not

find any evidence of systemic toxicity with topical application of 5% imiquimod,

thus concluding it to be a safe treatment in children with molluscum

contagiosum.7

In a comparative study by Seo SH et al. it was concluded that both 10%

KOH solution and 5% imiquimod ceam are effective and safe treatment of

molluscum contagiosum.8

Another study by Metkar A et al. concluded that though both

5%imiquimod cream and 10%KOH are equally effective, KOH has a faster onset

of action as well as side effects.9

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6.3 OBJECTIVES OF THE STUDY

1. To study the efficacy of 10%KOH in the treatment of molluscum

contagiosum .

2. To study the efficacy of 5% imiquimod in the treatment of molluscum

contagiosum.

3. To compare the efficacy of 10% KOH and 5% imiquimod in the treatment of

molluscum contagiosum

7. MATERIALS AND METHODS

7.1. Source of Data :

Patients attending the Dermatology out patient department of Fr. Muller

Medical College and Hospital, Kankanady , Mangalore.

Inclusion criteria :

1. Presence of minimum 3 lesions in patients belonging to paediatric age

group

2. Patients who are willing to undergo the treatment and come for follow up

Exclusion Criteria :

1. Patients with eyelid involvement

2. Patients with secondary infection.

3. History of hypersensitivity to imiquimod.

.

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7.2. Method of Collection of Data :

Data will be collected by purposive sampling from 40 patients in the

paediatric age group presenting with molluscum contagiosum. Randomly

patients will be allocated to two groups consisting of 20 each(lottery method);

Group A and Group B. Patients in group A will be given 5% imiquimod cream

in 0.25g sachets and their parents will be advised to apply a thin layer, rubbing it

until it is no longer visible. Patients in group B will be given 10% KOH solution

with instructions to the parents to apply using a cotton swab and avoid any

spillage over normal skin. Both the groups will be advised to apply the

respective agents at night and wash off in the morning, three times a week for

twelve weeks or until the lesions clear, whichever is early.

Patients will be followed up on the 4th, 8th and 12th week of treatment. On

each visit, clinical response to treatment, efficacy and tolerability parameters will

be evaluated. The clinical response to treatment will be graded as complete

clearance, marked improvement, mild improvement and no change.

Statistical Analysis : Collected data will be analysed by frequency, percentage,

Mann-Whitney test and Chi-square test.

7.3 Does the study require any investigation/intervention to be conducted on

patients/other humans/animals? If so,please describe briefly.

No

7.4 Has ethical clearance been obtained from your institution in case of 7.3.

Yes

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8. LIST OF REFERENCES

1. Criton S “Viral Infections”, Chapter 14 in IADVL text book and Atlas of

Dermatology, 3rd ed. Valia RG and Valia AR editors, Mumbai:

Bhalani Publishing House ,2008. 333pp.

2. Sterling JC. “Virus Infections”, Chapter 33 in Rook’s Textbook of

Dermatology. 8th ed. Burns T, Breathnach S, Cox S, Griffiths C

editors, West Sussex, U.K: Blackwell Publishing Ltd., 2010. 33.11pp.

3. Rogers M, Barneson RSC. Diseases of the skin. In : Campbell AGM,

McIntosh N, et al. Forfar and Arneil’s textbook of pediatrics. 5 th

edition. New York: Churchill Livingstone, 1998:1633-5.

4. Van der Wouden JC, van der Sande R, van Suijlekom-Smit LWA, Berger M,

Butler CC, Koning S. “Interventions for cutaneous molluscum

contagiosum”. Cochrane Database of Systematic Reviews 2009, Issue

4. Art. No.:CD004767.

5. Friedman M, Gal D. Keloid scars as a result of CO2 laser for molluscum

contagiosum. Obstetrics and Gynecolgy 1987;70:394-6.

6. .Mahajan BB, Pall A, Gupta RR. Topical 20% KOH-An effective therapeutic

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modality for molluscum contagiosum in children. Indian J Dermatol

Venerol Leprol 2003;69:175-7.

7. Barba AR, Kapoor S, Berman B. An open label safety study of tpical

imiquimod 5% cream in the treatment of molluscum contagisum in

children. Dermatology Online Journal 7(1):20

8. Seo SH, Chin HW, Jeong DW. An Open, Randomized, Comparative Clinical

and Histological Study of Imquimod 5% Cream Versus 1% Potassium

Hydroxide Solution in the Treatment of Molluscum Contagiosum. Ann

Dermatol.2010 May; 22(2); 156-62.

9. Metkar A, Pandey S, Khopkar U. An open, nonrandomized, comparative

study of imiquimod 5% cream versus 10% potassium hydroxide

solution in the treatment of molluscum contagiosum. Indian J

Dermatol Venerol Leprol 2008;74:614-18.

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9. Signature of the candidate

10. Remarks of the guide

11 Name of the designation of ( in

block letters)

11.1 Guide

11.2 Signature

DR. SUKUMAR D.

MD.

PROFESSOR,

DEPARTMENT OF DERMATOLOGY,

VENEREOLOGY & LEPROSY,

FATHER MULLER MEDICAL

COLLEGE,

KANKANADY,

MANGALORE-575002.

11.5 Head of Department DR. RAMESH BHAT.M MD. DVD, DNB,MNAMS

PROFESSOR AND HOD,

DEPARTMENT OF DERMATOLOGY,

VENEREOLOGY & LEPROSY,

FATHER MULLER MEDICAL COLLEGE,

KANKANADY,

MANGALORE-575002.

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11.6 Signature

12 12.1 Remarks of the Chairman & Principal

12.2 Signature

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