CONFIDENTIAL REPORT FOR SKIN PAIN ASSESSMENT …

CONFIDENTIAL

REPORT FOR

SKIN PAIN ASSESSMENT

FOLLOWING APPLICATION OF

THREE TOPICAL FORMULATIONS

CONFIDENTIAL

REPORT FOR

SKIN PAIN ASSESSMENT FOLLOWING APPLICATION OF

THREE TOPICAL FORMULATIONS

HTR STUDY NO. 10-130293-111

SPONSOR NO. P11-001

Final Report

June 14, 2011

FOR

MEDLINE INDUSTRIES, INC.

One Medline Place

Mundelein, IL 60060

BY

HILL TOP RESEARCH

6699 13th

Avenue North

St. Petersburg, FL 33710

HTR Study No. 10-130293-111 Final Report

Sponsor No. P11-001

June 14, 2011

Page 1 of 11

1. SUMMARY

The objective of this study was to assess pain after application of test articles on tape

stripped skin. The study followed a randomized, single-blind, single dose exposure

design. The subjects evaluated a total of five test articles on this study with two or

three test sites per ventral forearm. Skin sensory perception of pain was assessed

through the use of 100 mm anchored visual analog scale (VAS) and a 10-point pain

scale.

The study was divided into a pilot phase and a main phase. A total of 26 subjects

completed the study (6 subjects completed the pilot phase and 20 subjects completed

the main phase).

The test articles used on this study were three currently marketed skin protectant

products and two controls and were identified as follows:

HTR Code Description

A SurePrep® No-Sting Protective Barrier Spray

B MARATHON Liquid Skin Protectant

C 3M™

Cavilon™

No Sting Barrier Film Spray (IO)

D Negative Control – 0.9% Physiological Saline, USP

E Positive Control – 70% Isopropyl Alcohol in water solution

There were no adverse events reported during the course of the study.

Based upon the results of this study, HTR Code A produced the least pain (mean

score = 7.81 mm), statistically significantly less than HTR Codes B (mean score =

17.15 mm) and E (mean score = 51.15 mm). Analyses of the mean pain scores found

that HTR Codes C (mean score = 8.46 mm) and B produced pain equivalent to the

negative control, HTR Code D (mean score = 10.12 mm), but significantly lower than

the positive control, HTR Code E. Though HTR Code B, MARATHON Liquid Skin

Protectant, received the second highest overall mean pain score, it should be noted

that it was the only test article that required physical touch during the application

procedure due to the nature of the supplied product.

Review of the subjective pain assessment using a 10-point scale found a similar trend

for the test articles at the end of the study visit with the lowest to highest mean pain

scores being HTR Codes C, A, D, B, and E. At the 24-hour follow-up evaluation

HTR Code B produced the highest mean pain score (2.04). It should be noted that for

all test articles at both time points, the mean pain scores were considered at the

threshold pain level or below.


Sponsor No. P11-001

June 14, 2011

Page 2 of 11

2. TABLE OF CONTENTS

1. SUMMARY ..................................................................................................................1

2. TABLE OF CONTENTS .............................................................................................2

3. SPONSOR PERSONNEL ............................................................................................3

4. INVESTIGATIVE PERSONNEL ................................................................................3

5. CLINICAL RESEARCH STANDARDS .....................................................................3

6. PROTOCOL .................................................................................................................3

6.1. Study Procedures ..........................................................................................................4

6.2. Protocol Amendments ..................................................................................................5

7. SUBJECTS ...................................................................................................................5

8. STUDY SCHEDULE ...................................................................................................6

9. TEST ARTICLES .........................................................................................................6

10. ADVERSE EVENTS....................................................................................................7

11. METHOD OF STATISTICAL ANALYSIS ................................................................8

11.1. Demographic and Baseline Variable Analysis .............................................................8

11.2. Sensory Assessment Analysis .......................................................................................8

12. RESULTS OF STATISTICAL ANALYSIS ................................................................9

13. CONCLUSIONS ........................................................................................................10

14. SIGNATURE ..............................................................................................................10

15. QUALITY STATEMENT ..........................................................................................11

APPENDICES

APPENDIX I / IRB Approval Letters

APPENDIX II / Protocol and Amendment

APPENDIX III / Statistical Tables

RECORD RETENTION AND PUBLICATION NOTICE


Sponsor No. P11-001

June 14, 2011

Page 3 of 11

3. SPONSOR PERSONNEL

Edward Drower

Clinical Project Manager

Medline Industries, Inc.

The study was monitored by Edward Drower on March 27, 2011.

4. INVESTIGATIVE PERSONNEL

Investigator: Micah Humphrey, BS

Technical Director: Jeffrey E. Berg, BS, CCRA

Study Manager: Micah Humphrey, BS

Biostatistician: James P. Bowman, MS

Report Writer: Verda Heinrichs, BA

5. CLINICAL RESEARCH STANDARDS

The clinical investigation, including the informed consent, was reviewed by an Institutional

Review Board in accordance with Title 21 of the Code of Federal Regulations, Parts 50 and 56.

Approval by the Board was obtained on February 3, 2011, prior to initiation of the investigation

(see Appendix I). Revised calendars for the pilot and main studies were approved on February

24, 2011 and Protocol Amendment No. 1 and the revised consent form were approved on March

10, 2011.

This study was conducted according to the principles of Good Clinical Practice, the Standard

Operating Procedures of Hill Top Research, the study protocol and protocol amendment.

6. PROTOCOL

The study protocol was followed (see Appendix II) with the exception of the following

deviations:

During the Day 2 procedures, the 5-minute assessment was completed 6 minutes post-

application and the 15-minute assessment was completed 16 minutes post-application for Site

1 for Subject No. 105.

During the Day 2 procedures, the 15-minute assessment was completed 20 minutes post-

application for Sites 2 and 3 for Subject No. 108.

In the opinion of the Investigator, the deviations did not compromise the integrity of the study.


Sponsor No. P11-001

June 14, 2011

Page 4 of 11

6.1. Study Procedures

This was a single center, randomized, single blind, single dose exposure study to assess the skin

sensory perception of pain following test article application on slightly abraded ventral forearm

skin on normal, healthy adult subjects. Skin sensory perception of pain was assessed through the

use of a 100mm, anchored visual analog scale (VAS) and a 10-pt pain scale. The study was

divided into a pilot phase and a main phase. During each phase, subjects were required to make

a total of up to three visits to the test facility over approximately one week. The subjects

evaluated a total of five test articles on this study with two or three test sites per ventral forearm.

The study was divided into a pilot phase and a main phase. The pilot data were reviewed by the

Sponsor and since the results were acceptable the study continued with the main phase. The

sensitivity and magnitude of the control treatment groups was evaluated to assess the validity of

the paradigm. Data was also evaluated to confirm size estimations before the main phase was

initiated.

At Visit 1, potential subjects read a HIPAA form and consent form prior to any study related

procedures being conducted. Study personnel conducted a consent form discussion with the

subject and addressed any questions or concerns related to the study procedures. Written

informed consent was obtained and the subjects received copies of the HIPAA and consent

forms.

Subjects were assigned a screening number and the study inclusion/exclusion criteria were

reviewed and documented. Subject demographics and a brief medical history were documented.

Current medication (prescription and over-the-counter) use over the two weeks prior to the

screening visit were recorded.

Subjects who met all study entrance criteria received an appointment time for Visit 2 (Day 2 –

Dosing) and were dismissed from the test facility. Study Visits 1 and 2 may have been combined

into a single visit if the schedule allowed.

If Visits 1 and 2 were not combined, subjects returned to the test facility at their scheduled

appointment time. Subjects had their study entrance criteria reviewed to confirm ongoing

eligibility and were queried as to the occurrence of any adverse events or changes in their

concomitant medications.

Following confirmation of eligibility, subjects received their final subject number, were

randomized and the following study conduct procedures were performed (Note: tape stripping,

dosing and subject pain assessments proceeded for one test site/test article completely before the

next site/test article was evaluated):

a) Two or three 10 cm2 (2.5 cm x 4 cm) test sites on each ventral forearm (5 sites in total)

were demarcated, with no test site closer than 3 cm from the wrist or antecubital fossa,

and each test site was placed at least 1 cm apart.

b) A study technician performed the tape stripping of the first test site using Blenderm™

surgical tape. The site was tape stripped until a clear glistening layer is visualized

(approximately 40 times). Further tape stripping may have been required to reach the

glistening layer.


Sponsor No. P11-001

June 14, 2011

Page 5 of 11

c) Immediately after reaching the glistening layer, either a single use applicator or two

pumps of the spray from the provided container (depending upon the designated test

article per the randomization schedule) was applied to the first assigned test site (as

randomized).

d) The subject was queried for pain assessments immediately after dosing and at 5 and 15

minutes post-application. Following the 15-minute pain assessment, the test site was

bandaged. If significant pain persisted after bandaging, the subject was to rest quietly

until there was no/minimal pain present before the next test site was tape stripped and

dosed.

e) At subsequent intervals, tape stripping, dosing, subject pain assessments and bandaging

was repeated for the remaining test sites/test articles, as described above.

Prior to release from the test facility, the subject was instructed to evaluate their pain at each site

using a 10-point pain scale. They were also instructed to wear protective clothing on the

forearms to prevent sun exposure until all the sites had completely healed. The subjects provided

the test facility with a telephone number for contact for the 24-hour pain evaluation and were

given an appointment time for Visit 3 and dismissed from the test facility.

Subjects were contacted by telephone approximately 24 hours after they were dismissed from the

facility to provide subsequent pain assessments of their sites. The subjects were queried as to the

level of pain at each site based on a 10-point scale.

Subjects returned to the test facility at their scheduled appointment time three days following the

treatment day, where a trained skin grader assessed the abraded skin sites. Subjects were queried

as to the occurrence of any adverse events or changes in their concomitant medications since

their previous visit. Subjects received their study compensation and their participation was

considered complete.

6.2. Protocol Amendments

There was one amendment to the protocol (see Appendix II). Protocol Amendment No. 1

modified the test article application procedures (Section 11.0 of the protocol). The application

procedure of Marathon Liquid Skin Protectant (HTR Code B) was changed due to the way the

product was provided to the testing facility by the Sponsor (individual application vials). Use of

glass rods for spreading the test articles was removed to avoid physically touching the wounded

test sites and rinsing of test sites with water was removed to emulate more closely the intended

use of the non-control test products which form a barrier and wear away on their own.

7. SUBJECTS

The study included a pilot phase and a main phase. Subjects were screened and signed the

Consent Form before any study procedures were completed. Only those subjects meeting the

study criteria were enrolled. A total of 27 subjects were enrolled into the study.

One subject, No. 111, withdrew consent and did not complete the study.

A total of 26 subjects completed the study.


Sponsor No. P11-001

June 14, 2011

Page 6 of 11

The disposition of subjects for the pilot and main phases of the study are provided below:

Pilot Phase Main Phase Total

Males Females Males Females

No. Enrolled 1 5 8 13 27

No. Drops 0 0 0 1 1

No. Completed 1 5 8 12 26

A listing of the demographics for each subject and descriptive statistics of the demographic and

other baseline characteristics are provided in Appendix III (see Tables 1 – 3).

8. STUDY SCHEDULE

Pilot Phase

(Subject Nos. 101 – 106)

Main Phase

(Subject Nos. 107 – 127

Date Initiated: March 12, 2011 March 26, 2011

Date Completed: March 15, 2011 March 30, 2011

9. TEST ARTICLES

The following test articles were received by Hill Top Research on March 3, 2011:

HTR

Code

Label Information Description

A SurePrep® No-Sting

N: 08327-548-09

Lot 31303

Exp 2013-10

Three white plastic bottles (28 mL), each with a green screw-

on plastic pump spray top and plastic cap.

B Marathon Liquid Skin

Protectant

Lot No. W10L022

Exp 2012-04

Five blue, black and pink cardboard boxes, each containing 10

(0.5 g) applicators. Applicators were individually sealed, clear

plastic vials with white tips containing purple liquid.

C 3M™ Cavilon™

No Sting Barrier Film Spray

Lot 34-8704-1769-7

Exp 2013-11 EA

Three blue and white plastic bottles, each with a screw-on

pump spray top and plastic cap.

Hill Top Research provided 0.9% Sodium Chloride Irrigation (Lot G086165, Exp. Mar 13) for

the negative control (HTR Code D) and CVS Pharmacy 70% Isopropyl Rubbing Alcohol (Lot

No. D9208M, Exp 4/12 and Lot No. B9217M, Exp. 2/12) for the positive control (HTR Code E).


Sponsor No. P11-001

June 14, 2011

Page 7 of 11

Test Article Application

A single application of each test article was made as shown in the following table.

HTR

Code

Concentration Amount Applied Method & Frequency of Application

A Neat 2 pumps of the spray from

provided container

Single application to designated test

site via pump spray

B Neat 1 single use applicator Singe application to designated test

site via sponge applicator tip (per

instructions in package insert).

C Neat 2 pumps of the spray from

provided container


site via pump spray

D Neat 2 pumps of the spray from

provided container


site via pump spray

E Neat 2 pumps of the spray from

provided container


site via pump spray

Test Article Storage and Disposition

Test articles were stored at room temperature in a secure location. Remaining test articles will

be returned to the study sponsor upon issuance of the final report.

10. ADVERSE EVENTS

There were no adverse events reported during the course of the study.


Sponsor No. P11-001

June 14, 2011

Page 8 of 11

11. METHOD OF STATISTICAL ANALYSIS

Safety: Safety analysis was carried out on the data of every subject who received at least one test

article treatment.

Pain Sensory Evaluation: Analysis was carried out on the data of all subjects who completed

the study. The data from withdrawn subjects was not included in the final statistical analyses.

11.1. Demographic and Baseline Variable Analysis

Descriptive statistics of the demographic and other baseline characteristics were summarized and

are presented in Table 1.

11.2. Sensory Assessment Analysis

The source data were the pain scores assigned by the subjects immediately after dosing and at 5

and 15 minutes following topical application of the test articles. The subjects’ responses,

measured in mm, were tabulated for each post-dosing assessment for each test site. Descriptive

statistics (mean, standard deviation, median, minimum, maximum) were provided for the

response to the pain sensory question for each time point post-dosing, and for the maximum

stinging response, for each of the test articles. The data used in the statistical analysis were the

maximum score assigned for each treatment. Data were analyzed using analysis of variance

techniques.

Additionally, pain scores were assigned to each test site by the subjects 24 hours after dosing

utilizing a 1 to 10 scale. These data were tabulated with descriptive statistics.

All statistical tests employed a level of significance of 0.05 and no adjustments were made for

the number of tests being conducted.


Sponsor No. P11-001

June 14, 2011

Page 9 of 11

12. RESULTS OF STATISTICAL ANALYSIS

MAXIMUM STINGING RESPONSES (VAS SCALE)

Table 1: Analysis Results of the Maximum Stinging Responses

A - SurePrep No-

Sting Protective

Barrier Spray

B - MARATHON

Liquid Skin

Protectant

C – 3M Cavilon No

Sting Barrier Film

Spray

D – Negative

Control - 0.9%

Saline

E – Positive Control

– 70% Isopropyl

Alcohol

N. 26 26 26 26 26

Mean (mm) 7.81 17.15 8.46 10.12 51.15

Median (mm) 3.5 10 5.5 5.5 53.5

Std.Dev. (mm) 10.95 20.2 11.59 13.85 34.81

Minimum (mm) 0 1 0 0 1

Maximum (mm) 42 76 57 65 100

ANOVA p-value: <0.00011

Significant Comparisons: A vs. BE and CDB vs. E 1Indicates statistically significant differences among products.

SUBJECTIVE PAIN ASSESSMENTS (10-POINT SCALE)

Table 2: Summary Statistics of the Subjective Pain Assessment

A - SurePrep No-

Sting Protective

Barrier Spray

B - MARATHON

Liquid Skin

Protectant

C – 3M Cavilon No

Sting Barrier Film

Spray

D – Negative

Control - 0.9%

Saline

E – Positive Control

– 70% Isopropyl

Alcohol

Evaluation End of

visit

24-hr.

post-appl.

End of

visit

24-hr.

post-appl.

End of

visit

24-hr. post-

appl.

End of

visit

24-hr.

post-appl.

End of

visit

24-hr.

post-appl.

N 26 26 26 26 26 26 26 26 26 26

Mean 1.65 1.08 2.08 2.04 1.62 1.04 1.77 1.15 2.15 1.04

Median 1 1 1 1 1 1 1 1 1 1

Std.Dev. 0.98 0.27 1.55 2.01 1.06 0.2 1.24 0.46 1.46 0.2

Minimum 1 1 1 1 1 1 1 1 1 1

Maximum 4 2 6 9 4 2 6 3 6 2


Sponsor No. P11-001

APPENDIX I. IRB APPROVAL LETTERS

Total number of pages including this cover page = 10


Sponsor No. P11-001

APPENDIX II. PROTOCOL AND AMENDMENT


CONFIDENTIAL

PROTOCOL FOR

SKIN PAIN ASSESSMENT FOLLOWING APPLICATION OF THREE

TOPICAL FORMULATIONS

HILL TOP RESEARCH STUDY NO. 10-130293-111

SPONSOR PROTOCOL NO. P11-001

FINAL PROTOCOL

JANUARY 28, 2011

FOR

MEDLINE INDUSTRIES, INC

ONE MEDLINE PLACE

MUNDELINE, IL 60060

BY

HILL TOP RESEARCH INCORPORATED

6699 13TH

AVENUE NORTH

ST. PETERSBURG, FL 33710

Sponsor Protocol No. P11-001 Page 3

Final HTR Study No. 10-130293-111

January 28, 2011

2. TABLE OF CONTENTS

1. PROTOCOL SIGNATURE PAGE ..............................................................................2

2. TABLE OF CONTENTS .............................................................................................3

3. SYNOPSIS ...................................................................................................................6

4. CLINICAL INVESTIGATION SITES ........................................................................8

4.1. Site Information ............................................................................................................8

4.2. Sponsor Information .....................................................................................................8

5. INTRODUCTION ........................................................................................................8

5.1. Objective .......................................................................................................................8

5.2. Efficacy Endpoints ........................................................................................................9

5.3. Safety Endpoints ...........................................................................................................9

6. STUDY DESIGN AND DURATION ..........................................................................9

7. ETHICS ........................................................................................................................9

7.1. Institutional Review Board ...........................................................................................9

7.2. Ethical Conduct of the Study ........................................................................................9

7.3. Subject Information and Consent ...............................................................................10

7.4. Authorization to Disclose Protected Health Information ...........................................10

8. STUDY POPULATION .............................................................................................10

8.1. Inclusion Criteria ........................................................................................................10

8.2. Exclusion Criteria .......................................................................................................11

8.3. Additional Study Restrictions .....................................................................................11

9. DOSAGE AND ADMINISTRATION .......................................................................12

9.1. Packaging ....................................................................................................................13

9.2. Storage, Issue and Return of Test Articles .................................................................13

10. SUBJECT NUMBERING AND IDENTIFICATION ................................................13

11. STUDY PROCEDURES ............................................................................................13

11.1. Visit 1 (Day 1 – Screening) ........................................................................................14

11.2. Visit 2 (Day 2 - Dosing) .............................................................................................15

11.3. Visit 2a (Telephone Pain Assessment) .......................................................................16

11.4. Visit 3 (Day 5 – Follow-up) ........................................................................................16

11.5. Tape Stripping ............................................................................................................16



January 28, 2011

11.6. Treatment Assignments ..............................................................................................16

11.7. Pain Assessments ........................................................................................................17

11.8. Surface Wash and Bandaging .....................................................................................17

12. STATISTICAL ANALYSIS ......................................................................................18

12.1. Sample Size Calculation .............................................................................................18

12.2. Evaluable Subjects ......................................................................................................18

12.3. Demographic and Baseline Variable Analysis ...........................................................18

12.4. Sensory Assessment Analysis .....................................................................................18

12.5. Adverse Event Analysis ..............................................................................................18

13. ADVERSE EVENTS..................................................................................................19

13.1. Definition of an Adverse Event ..................................................................................19

13.2. Definition of a Serious Adverse Event (SAE) ............................................................19

13.3. Definition of an Unexpected AE ................................................................................20

13.4. Eliciting Reports of Adverse Events ...........................................................................20

13.5. Reporting Adverse Events ..........................................................................................20

13.6. Causality Assessment .................................................................................................21

13.7. Severity Assessment ...................................................................................................21

13.8. Outcome Assessment ..................................................................................................22

13.9. Anticipated Reactions .................................................................................................22

14. PREMATURE DISCONTINUATION AND WITHDRAWAL CRITERIA ............22

14.1. Premature Discontinuation .........................................................................................22

14.2. Criteria for Termination ..............................................................................................23

14.3. Replacement Procedures .............................................................................................23

15. MONITORING ...........................................................................................................23

16. AMENDMENTS /MODIFICATION OF THIS PROTOCOL...................................23

17. SUBJECT CONFIDENTIALITY ..............................................................................23

18. INVESTIGATOR OBLIGATIONS ...........................................................................24

18.1. Investigator Service ....................................................................................................24

18.2. Documentation ............................................................................................................24

18.3. Institutional Review Board (IRB) ...............................................................................24

18.4. Informed Consent .......................................................................................................24

18.5. Performance ................................................................................................................24



January 28, 2011

18.6. Use of Investigational Materials .................................................................................25

18.7. Source Documents ......................................................................................................25

18.8. Final Report, Retention and Review of Records ........................................................25

19. PROTOCOL CHANGES AND DEVIATIONS ........................................................25

20. CONFIDENTIALITY ................................................................................................26

21. REFERENCES ...........................................................................................................26

LIST OF TABLES

Table 1: Test Article Identification ...........................................................................................12

Table 2: Study Schedule ...........................................................................................................14



January 28, 2011

3. SYNOPSIS

Sponsor: Medline Industries, Inc.

Title of the Study: Skin Pain Assessment Following Application of Three Topical

Formulations

Sponsor Protocol No: P11-001

HTR Study No: 10-130293-111

Objective: The objective of this study is to assess pain after test article application on tape

stripped skin.

Study Design: Randomized, single blind, single dose exposure study to assess the skin sensory

perception of pain following test article application on slightly abraded ventral forearm skin on

normal, healthy adult subjects. The study will be divided into a pilot phase and a main phase.

Number of Subjects: Approximately 6 subjects will be enrolled into the pilot phase of the

study in order to complete with 5 subjects. If the study continues into the main phase,

approximately 22 additional subjects will be enrolled in order to complete with a total of 25

subjects between the two phases.

Main Criteria for Inclusion: Normal, healthy adult male and female subjects, 18 to 65 years

of age (inclusive), with normal skin on their ventral forearms and no history of allergies or

sensitivities to the ingredients in the test articles, adhesives or latex.

Test Products, Dose, and Mode of Administration: Five test articles will be used in this

study (single dose, topically applied to designated randomized, tape-stripped sites on the

ventral forearm):

Formulation A: SurePrep® No-Sting Protective Barrier Spray

Formulation B: MARATHON Liquid Skin Protectant

Formulation C: 3M™

Cavilon™

No Sting Barrier Film Spray (IO)

Formulation D: Negative Control – 0.9% Physiological Saline, USP

Formulation E: Positive Control – 70% Isopropyl Alcohol in water solution

Criteria for Evaluation: Sensory Evaluation: Analysis will be carried out on the data

(subjective pain assessments) of all subjects who complete the study.

Safety: Safety analysis will be carried out on the data of every subject who received at least

one test article treatment. Safety will also be assessed through the collection of adverse events.

Statistical Methods: The subjects‘ pain responses, measured in mm from the visual analogue

scales, will be tabulated for each post-dosing assessment for each test site. Descriptive

statistics (mean, standard deviation, median, minimum, maximum) will be provided for the

response to the pain sensory assessment for each time point post-dosing, and for the maximum

pain response for each of the test articles. The data to be used in the statistical analysis are the

maximum score assigned for each treatment. Data will be analyzed using analysis of variance

techniques.

Additionally, pain scores will be assigned to each test site by the subjects 24 hours after dosing

utilizing a 1 to 10 scale. These data will be tabulated with descriptive statistics.



January 28, 2011

Regulatory Compliance: This clinical study, including the Informed Consent, will be

reviewed by an Institutional Review Board in accordance with Title 21 of the Code of Federal

Regulations, Parts 50 and 56. Approval by the Board will be obtained prior to the initiation of

the study. The study will be conducted in accordance with the Principles of Good Clinical

Practice, the Standard Operating Procedures of Hill Top Research and the Sponsor's Protocol

and Protocol Amendment(s).



January 28, 2011

4. CLINICAL INVESTIGATION SITES

4.1. Site Information

Subject recruitment will be conducted at a Hill Top Research (HTR) contract recruiting facility

located at 6088 Main & Mill Streets, Miamiville, OH 45147. Subject screening, enrollment, test

article assignments and dermal assessments will be conducted at Hill Top Research, 6699 13th

Avenue North, St. Petersburg, FL 33710.

CLINICAL INVESTIGATOR SITE: Hill Top Research

6699 13th

Avenue North

St. Petersburg, FL 33710

Phone: 727-344-7602

Fax: 727-345-5323

PRINCIPAL INVESTIGATOR: Micah Humphrey, B.Sc.

Technical Director: Jeffrey E. Berg, B.Sc., CCRA

Biostatistician: James P. Bowman, MS

Study Manager: Micah Humphrey, B.Sc.

4.2. Sponsor Information

STUDY SPONSOR: Edward Drower



One Medline Place

Mundelein, IL 60060

Phone: 847-473-5883

Cell: 224-221-8924

Fax: 866-758-4660

R&D Workroom: 847-643-3849

E-mail: [email protected]

5. INTRODUCTION

The use of wound barrier products has led to increased wound protection and improved overall

healing with minimal side effects.1,2

The polymer composition of these products tends to be

either silicone or cyanoacrylate based. The purpose of this study will evaluate the non-stinging

properties of three of these spray barrier products (Marathon, Sureprep® and Cavilon™).

5.1. Objective

The objective of this study is to assess pain after test article application on tape stripped skin.

mailto:[email protected]



January 28, 2011

5.2. Efficacy Endpoints

The efficacy endpoints of this study are:

Comparison of subjective pain assessments (VAS Scale at dosing, 10-pt scale at end

of dosing day, and 10-pt scale at 24-hour follow-up phone call) of all subjects who

complete the study.

5.3. Safety Endpoints

The safety endpoint of this study is:

Assessments of safety through the collection of adverse events.

6. STUDY DESIGN AND DURATION

Randomized, single blind, single dose exposure study to assess the skin sensory perception of

pain following test article application on slightly abraded ventral forearm skin on normal, healthy

adult subjects. Skin sensory perception of pain will be assessed through the use of a 100mm,

anchored visual analog scale (VAS) and a 10-pt pain scale. The study will be divided into a pilot

phase and a main phase. During each phase, subjects will be required to make a total of up to

three visits to the test facility over approximately one week. The subjects will evaluate a total of

five test articles on this study with two or three test sites per ventral forearm.

7. ETHICS

7.1. Institutional Review Board

This study will be reviewed by an appropriately constituted Institutional Review Board (IRB) as

outlined in 21 CFR Part 56. The IRB will review the protocol, any amendments, the informed

consent form (ICF), subject instructions, safety information, Investigator‘s curriculum vitae (CV)

and advertisements (if applicable).

A copy of the IRB approval opinion, along with any other documents required under local

regulations or standards must be on file at sponsor headquarters before the first shipment of

study supplies is provided to the study site.

7.2. Ethical Conduct of the Study

This study will be conducted in accordance with 21 Code of Federal Regulations (CFR) Parts 50

and 56).

Medline Industries, Inc. is responsible for the ongoing safety evaluation of the investigational

products and will promptly notify participating Investigators and regulatory authorities of

findings that could adversely affect the safety of subjects, impact the conduct of the study, or

alter the IRB‘s approval to continue the study. Medline Industries, Inc. will promptly report all

adverse reactions related to the study articles that are both serious and unexpected to the

appropriate regulatory authorities and to all Investigators and IRBs currently involved in studies

of this study article.



January 28, 2011

7.3. Subject Information and Consent

Subject consent will be obtained prior to participation in any study conduct as required by the

regulatory guidelines (21 CFR Part 50). Subjects will be given ample opportunity to read the

consent form and have all questions regarding study conduct answered prior to signing the

consent form. Each subject will be provided with a copy of the ICF to retain for his or her

records. The original signed ICF will be retained on file at the study center.

7.4. Authorization to Disclose Protected Health Information

Subjects will be informed of the following information: The purpose of the protected health

information (PHI) being collected, the possibility that the PHI may be re-disclosed, the duration

of the authorization, the right to revoke the authorization, and the right to refuse signature and

limit access to PHI during and following the conduct of the trial. Written authorization to

disclose PHI will be incorporated into the informed consent process and will be obtained prior to

the subject entering the study per HTR standard operating procedures (SOPs). Each subject will

be provided with a signed copy of the authorization and the original will be retained on file at the

study center.

8. STUDY POPULATION

Approximately 6 subjects will be enrolled into the pilot phase of the study in order to complete

with 5 subjects. If the study continues into the main phase, approximately 22 additional subjects

will be enrolled in order to complete with a total of 25 subjects between the two phases of the

study.

All subjects will fulfill the inclusion and exclusion criteria as outlined in Sections 8.1 and 8.2.

8.1. Inclusion Criteria

To participate in the study, each subject must satisfy the following inclusion criteria:

a. Subject has been informed of the nature of the study and has read, understands and

signed an informed consent form and HIPAA statement.

b. Subject is between 18 and 65 years of age, inclusive.

c. Subject is male or female and in reasonably good health.

d. Females of childbearing potential agree to use an adequate method of birth control

during study participation (including oral contraceptives, hormone implant, IUD,

spermicide with barrier method [condom or diaphragm], male sexual partner(s)

surgically sterile or abstinence). Subjects of childbearing potential include those

women who are not postmenopausal (no menses) for at least 1 year or surgically

sterile (hysterectomy or bilateral tubal ligation [both tubes tied] or bilateral

oophorectomy [both ovaries removed]).



January 28, 2011

8.2. Exclusion Criteria

A subject will be excluded from participation in the test period for any of the following criteria:

a. Subject has a history of significant skin condition or disorder, such as psoriasis,

atopic dermatitis, eczema, skin cancer, etc.

b. Subject has a current skin condition on the test sites (ventral surface of the forearms),

such as scar tissue, sunburn, tattoos, scratches, bruises, excessive hair or uneven skin

tones that may interfere with the placement of the test sites, their assessments or

could compromise the safety of the subject.

c. Subject has a history of allergy to soaps, lotions, emollients, ointments, creams,

cosmetics, adhesives or latex.

d. Subject has a history of sensitivity/allergy to the ingredients found in the test articles,

isopropyl alcohol or a history of adverse reactions to topical formulations.

e. Subject has a history of keloid formation (abnormal scarring).

f. Subject has heavily pigmented skin that could heal with abnormal darkening at the

test sites.

g. Subject has a medical condition or uses a medication that, in the Investigator‘s

judgment, places the subject at an undue risk.

h. Subject is currently taking, or has been taking on a continuous basis in the last 14

days prior to study start, corticosteroids, nonsteroidal anti-inflammatory drugs,

acetylsalicylic acid (81 mg per day is allowed) or other pain relief medications.

i. Subject is currently taking, or has taken in the last 14 days prior to study start,

anticoagulant medications (e.g. Coumadin).

j. Subject reports intending to start, stop or change dose of any prescription or over-the-

counter (OTC) medication within 48 hours prior to or throughout the study.

Acetaminophen may be taken by the subject, if needed.

k. Subject has used prescription or OTC topical medications on the ventral forearms

within one month prior to study conduct.

l. Subject has a history of alcohol or drug abuse within one year prior to study conduct.

m. Subject is pregnant, lactating or breast-feeding (self report only – urine pregnancy

testing will not be required).

n. Subject has used an investigational drug within the 30 days prior to study start.

Any exceptions to the inclusion/exclusion criteria will be considered on a case-by case basis and

will be documented in the Source Documentation. All exceptions need approval from the Study

Sponsor and Principal Investigator prior to enrollment in the study.

8.3. Additional Study Restrictions a. No exercise with either arm, and no strenuous exercise overall for 24 hours prior to

test article administration and throughout the study.

b. Following the test article applications, subjects will be instructed to wear protective

clothing on the forearms to prevent sun exposure.



January 28, 2011

9. DOSAGE AND ADMINISTRATION

The Sponsor will provide all test articles. All of the test articles being evaluated on this study are

currently marketed products. The following test articles will be used during this study:

Table 1: Test Article Identification

HTR

Code Treatment Description Concentration

Amount

Applied

Method & Frequency of

Application

A Formulation A

SurePrep® No-Sting

Protective Barrier

Spray (Medline

Industries, Inc)

Neat

2 pumps of the

spray from

provided

container

Single application to

designated test site, evenly

spread and gently distributed

throughout test site with a

glass rod

B Formulation B MARATHON Liquid

Skin Protectant Neat 50 μL





glass rod

C Formulation C 3M

™ Cavilon

™ No Sting

Barrier Film Spray (IO) Neat

2 pumps of the

spray from

provided

container





glass rod

D Formulation D

Negative Control – 0.9%

Physiological Saline,

USP

Neat 50 μL





glass rod

E Formulation E

Positive Control – 70%

Isopropyl Alcohol in

water solution

Neat 50 μL





glass rod

Two or three 10 cm2 (2.5 cm x 4 cm) test sites on each ventral forearm (5 sites in total) will be

demarcated, with no test site closer than 3 cm from the wrist or antecubital fossa, and each test

site placed at least 1 cm apart. A skin-safe marking pen will be used to mark the test sites.

A study technician will perform the tape stripping of the first site using Blenderm™

surgical tape

(see section 11.5). The site will be tape stripped until a clear glistening layer is visualized

(approximately 40 times). Further tape stripping may be required to reach the glistening layer.

Immediately after the glistening layer has been reached, either 50 μL (delivered via pipette) or

two pumps of the spray from the provided container (depending upon the designated test article

per the randomization schedule) will be applied to the first assigned test site (as randomized).

The dose will be evenly spread and gently distributed throughout the test site with a glass rod.

Following the 15-minute pain assessment, the test site will be rinsed with water to remove

residual test article and the site will be bandaged. This process will be repeated until all five test

sites/test articles have been assessed.



January 28, 2011

A randomization schedule will be generated by Hill Top Research that will identify the number

and location of the five test sites (i.e. 2 or 3 sites on the left or right ventral forearm) and the test

articles will be randomly assigned (HTR Codes A-E) within these five test sites so that each

subject receives each test article one time to one of the five test sites.

9.1. Packaging

The test articles will be provided by the sponsor in plain packaging with labels on each

container. The test article containers will be packaged accordingly so that the subjects will be

blinded with respect to the treatment assignments.

9.2. Storage, Issue and Return of Test Articles

The Sponsor will provide the study site with the study supplies. The study site will administer

the test articles on the appropriate days according to the randomization schedule.

All test articles are to be stored at the study site in a controlled access room at room temperature

15oC-30

oC (59

oF-86

oF).

The Investigator will maintain an accurate record of the receipt of the test articles as shipped by

the Sponsor, including the date and quantity received. The record will also include the test article

code and may include the final weight, as necessary. This inventory record must be available for

inspection at any time.

At the completion of the study, all test articles will be returned to the Sponsor upon issue of the

final study report. The Sponsor will also be notified of any subsequent changes in test article

accountability as they occur.

10. SUBJECT NUMBERING AND IDENTIFICATION

Subjects will be identified by their initials and a unique subject number. Screening numbers (i.e.

01, 02, 03…) will be assigned consecutively by the Investigator or designee. Subjects who

qualify and enter the treatment phase of the study will be assigned a subject number (i.e. 101,

102, 103…).

11. STUDY PROCEDURES

The study will be divided into a pilot phase and a main phase. The Sponsor will review the

results of the pilot phase and if acceptable results occur, the study will continue into the main

phase. The pilot data will be reviewed prior to the continuation of the main phase. The

sensitivity and magnitude of the control treatment groups will be evaluated to assess the validity

of the paradigm. Data will also be evaluated to confirm size estimations before the main phase is

initiated.

The procedures for each study visit for both the pilot and main phase of the study are identical

and are outlined in Table 2 below:



January 28, 2011

Table 2: Study Schedule

Procedure

Visit 1*

Day 1

Visit 2*

Day 2 (-1)

Visit 2a

Day 3 (-1)

Visit 3

Day 5 (-1)

Screening Dosing Phone Call Follow-up

Informed Consent / HIPAA X

Inclusion/Exclusion Criteria/Concomitant Medications X

Continuation Criteria Assessment X^

AE‘s/Con Meds review X^ X

Test Site Identification & Randomization X

Subject Instructions X X

Sites 1-5 (these procedures will be completed for one site before

moving on to next site):

a) Tape Stripping to Glistening

b) Apply Test Article

c) Pain Assessments: Immediate, 5 min & 15 min post-application

d) Wash site to remove residual test article, apply bandage

X

Follow-up phone call to assess pain at sites X

Healing Assessment X

Subject Compensation X

* Study Visits 1 and 2 may be combined ^ Procedure will only be conducted if visits are separate

11.1. Visit 1 (Day 1 – Screening)

Approximately 40 subjects will participate in screening visits to ensure that approximately 28

subjects are enrolled (6 into pilot phase, 22 into main phase) into the study so that a minimum of

25 subjects complete all phases of the study.

Subjects will be pre-screened over the telephone by the recruiting department of Hill Top

Research. Recruiters will determine subject eligibility after a review of the relevant

inclusion/exclusion criteria, study restrictions, ability to meet study schedule requirements and

an interest in participating in the study. Subjects who meet all screening criteria will be provided

an appointment time for their screening visit.

Upon arrival at the study site, potential subjects will read a HIPAA form and consent form prior

to any study related procedures being conducted. Study personnel will conduct a consent form

discussion with the subject and address any questions or concerns related to the study

procedures. Written informed consent will be obtained and the subjects will receive copies of

the HIPAA and consent forms.

Subjects will be assigned a screening number and the study inclusion/exclusion criteria will be

reviewed and documented. Current medication (prescription and over-the-counter) use over the

two weeks prior to the screening visit will be recorded. The name of the medication, start and

end date, dose, frequency and indication will be documented on the subject‘s data collection



January 28, 2011

form. During the course of the study, if a subject is given any over-the-counter or prescription

medications or if administration of any medication becomes necessary during the study, the

name of the medication, reason for use, dosage information, date and frequency of administration

will also be documented on the subject‘s source documents.

Subjects who meet all study entrance criteria will receive an appointment time for Visit 2 (Day 2

– Dosing) and will be dismissed from the test facility. Study Visits 1 and 2 may be combined

into a single visit if the schedule allows.

11.2. Visit 2 (Day 2 - Dosing)

Study Visits 1 and 2 may be combined into a single visit if the schedule allows.

If Visits 1 and 2 are not combined, subjects will return to the test facility at their scheduled

appointment time. Subjects will have their study entrance criteria reviewed to confirm ongoing

eligibility and will be queried as to the occurrence of any adverse events or changes in their

concomitant medications.

Following confirmation of eligibility, subjects will receive their final subject number, be

randomized and the following study conduct procedures will be performed (Note: tape stripping,

dosing and subject pain assessments will proceed for one test site/test article completely before

the next site/test article is evaluated):

a) Two or three 10 cm2 (2.5 cm x 4 cm) test sites on each ventral forearm (5 sites in total)

will be demarcated, with no test site closer than 3 cm from the wrist or antecubital fossa,

and each test site placed at least 1 cm apart. A skin-safe marking pen will be used to

identify the test sites.

b) A study technician will perform the tape stripping of the first test site using Blenderm™

surgical tape (see section 11.5). The site will be tape stripped until a clear glistening

layer is visualized (approximately 40 times). Further tape stripping may be required to

reach the glistening layer.

c) Immediately after reaching the glistening layer, either 50 μL or two pumps of the spray

from the provided container (depending upon the randomization schedule) will be applied

to the first assigned test site (as randomized). The dose will be evenly spread and gently

distributed throughout the test site with a glass rod. A fresh glass rod will be used for

each test site to prevent cross contamination between the test sites.

d) The subject will be queried for pain assessments immediately after dosing and at 5 and 15

minutes post-application (see section 11.7 – VAS Scale). Following the 15-minute pain

assessment, the test site will be rinsed with water to remove residual test article and the

site will be bandaged. If significant pain persists after rinsing and bandaging, the subject

will rest quietly until there is no/minimal pain sensations present before the next test site

is tape stripped and dosed.

e) At subsequent intervals, tape stripping, dosing, subject pain assessments and

rinsing/bandaging will be repeated for the remaining test sites/test articles, as described

above.



January 28, 2011

f) Prior to release from the test facility, the subject will be instructed to evaluate their pain

at each site using a 10-point pain scale (see section 11.7 – 10-point scale). They will also

be instructed to wear protective clothing on the forearms to prevent sun exposure until all

the sites have completely healed. The subject will provide the test facility with a

telephone number for contact for the 24 hour pain evaluation (Visit 2a) and be given an

appointment time for Visit 3 and will be dismissed from the test facility.

11.3. Visit 2a (Telephone Pain Assessment)

Subjects will be contacted by telephone at approximately 24 hours after they are dismissed from

the facility to provide subsequent pain assessments of their sites. The subjects will be queried as

to the level of pain at each site based on a 10-point scale.

11.4. Visit 3 (Day 5 – Follow-up)

Subjects will return to the test facility at their scheduled appointment time three days following

the treatment day, where a trained skin grader will assess the abraded skin sites. Subjects will be

queried as to the occurrence of any adverse events or changes in their concomitant medications

since their previous visit. Subjects will receive their study compensation and their participation

will be considered complete.

11.5. Tape Stripping

Blenderm™

surgical tape (3M™

) will be used for tape stripping. Gloves or finger cots will be

worn by the study staff performing the tape stripping to avoid wound contact. Gloves/finger cots

will be changed between subjects. Skin sites will undergo a tape stripping procedure to create a

superficial wound down to the glistening layer and compromise the skin barrier. The procedure

is outlined below:

Cut strips of Blenderm™

tape to approximately 7.0 x 2.5 cm. Tape strips may be

prepared ahead of time.

Place a tape strip on the marked area of the test site, press it down, rub firmly within

the site marks and remove the strip with a strong and quick stroke. Discard the tape

in the trash.

Repeat stripping using other tape strips, in alternate directions, until a clear glistening

layer can be visualized or after 39 times (40 strips total), whatever comes first. The

number of strippings necessary to reach the glistening layer varies among subjects.

Although not anticipated, further stripping (beyond the 40 strips) may be required to

reach the glistening layer.

11.6. Treatment Assignments

There are a total of two or three sites on each arm for a total of five test sites. Of these, three

sites will be dosed with one of the three test articles (see section 9, Table 1). The remaining two

sites will be dosed with either the negative control (0.9% physiological saline) or the positive

control (70% isopropyl alcohol). Treatment assignments to the test sites will be randomized and

order of application of the test articles to their assigned sites will be randomized. The subjects



January 28, 2011

will be blinded with respect to the treatment assignments. The randomization schedule will be

provided by Hill Top Research.

11.7. Pain Assessments

VAS Scale

Immediately after dosing and at approximately 5 and 15 minutes after dose application of each

test article, the subject will be asked the question: ―Do you feel any stinging, pain, or discomfort

sensation at this site?‖. The subject will respond using a 100 mm visual analogue scale

anchored at one end with ‗None‘ (equal to 0 mm) and the other end with ‗Severe‘ (equal to 100

mm). The subject will be instructed to place a single vertical line on the scale that best indicates

the degree of stinging/pain/discomfort. Using calipers, a technician will measure the distance

from zero (i.e. ‗None‘) to the mark on the scale made by the subject, and will record this value

for each post-dosing pain assessment for each test site.

10-point Scale

Prior to leaving the test site following application of the test articles, subjects will be asked the

question: ―How would you rate the pain at site X?‖. The subject will respond for each of their

sites using the 10-pt. scale below:

1 = None, no pain

2 = Threshold pain

3 = Very slight pain

4 = Slight pain

5 = Slight to moderate pain

6 = Moderate pain

7 = Slightly strong pain

8 = Moderately strong pain

9 = Strong pain

10 = Very strong pain

11.8. Surface Wash and Bandaging

After the 15 minute pain assessment (VAS Scale) for each site, the site will be rinsed with water

to remove residual test article. Sites not yet dosed should be protected from the water rinse of an

adjacent site. Following rinsing, the site will be covered with a bandage (i.e. Band-Aid or gauze)

by the subject, with assistance by the study staff if needed. For the first four test sites, if stinging

persists after rinsing and bandaging, the subject will rest quietly until there is no/minimal pain

before the next test site is tape stripped and dosed.

If a site presents with intolerable pain within the 15 minute assessment period, it will be rinsed

with water and the last score carried forward through the remaining assessment times.



January 28, 2011

12. STATISTICAL ANALYSIS

12.1. Sample Size Calculation

This is a study to determine the potential for pain sensory response to the application of currently

marketed topical formulations. The sample size is based on clinical judgment and is believed to

be sufficient to satisfy the objectives.

12.2. Evaluable Subjects

Safety: Safety analysis will be carried out on the data of every subject who received at least one

test article treatment.

Pain Sensory Evaluation: Analysis will be carried out on the data of all subjects who completed

the study. The data from withdrawn subjects will not be included in the final statistical analyses.

12.3. Demographic and Baseline Variable Analysis

Descriptive statistics will be provided to summarize the demographic and other baseline

characteristics.

12.4. Sensory Assessment Analysis

The source data are the pain scores assigned by the subjects immediately after dosing and at 5

and 15 minutes following topical application of the test articles (see section 11.6). The subjects‘

responses, measured in mm, will be tabulated for each post-dosing assessment for each test site.

Descriptive statistics (mean, standard deviation, median, minimum, maximum) will be provided

for the response to the pain sensory question for each time point post-dosing, and for the

maximum stinging response, for each of the test articles. The data to be used in the statistical

analysis are the maximum score assigned for each treatment. Data will be analyzed using

analysis of variance techniques.

Additionally, pain scores will be assigned to each test site by the subjects 24 hours after dosing

utilizing a 1 to 10 scale. These data will be tabulated with descriptive statistics.

All statistical tests will employ a level of significance of 0.05 and no adjustments will be made

for the number of tests being conducted.

12.5. Adverse Event Analysis

The frequency of adverse events will be tabulated. A listing of adverse events, including start

and end date/time, severity, relationship to test article, and outcome, will be provided.



January 28, 2011

13. ADVERSE EVENTS

13.1. Definition of an Adverse Event

An Adverse Event or Adverse Experience (AE) is any untoward medical occurrence in a subject

administered a test article. It is not necessary that the AE have a causal relationship to treatment

with the test article.

An AE therefore is any unfavorable and unintended sign (for example, a clinically significant

abnormal laboratory finding) symptom, or disease temporally associated with the use of a test

article, whether or not considered related to the test article.

AEs include:

Changes in the general condition of the subject

Subjective symptoms offered by or elicited from the subject

Objective signs observed by the Investigator or study personnel

All concurrent diseases that occur after the start of the trial, including any change in

severity or frequency of pre-existing disease

All clinically relevant laboratory abnormalities or physical findings that occur during the

trial.

Findings not considered clinically significant that are related to the Investigator‘s assessments

are not to be recorded on the AE reporting page. They should instead be recorded on the

relevant source documents.

13.2. Definition of a Serious Adverse Event (SAE)

The Investigator or other study personnel must immediately (within 24 hours) inform Medline

Industries, Inc of all Serious Adverse Events (SAEs) that occur in study subjects.

An SAE is one that:

Results in death

Is an immediate threat to life

Requires inpatient hospitalization, or prolongation of existing hospitalization

Results in persistent or significant disability/incapacity

Is a congenital anomaly or birth defect.

In addition to the above, other important medical events that have not resulted in death, are not

life-threatening, or do not require hospitalization may be considered serious adverse experiences

when, based upon appropriate medical judgment, they are considered to jeopardize the patient or

subject and may require medical or surgical intervention to prevent one of the outcomes listed

above.



January 28, 2011

Examples of medical events that might be included as "serious" under this criterion include:

Emergency room treatment or evaluation for signs and symptoms of potentially

serious AEs (e.g., unwitnessed loss of consciousness, allergic bronchospasm

requiring intensive treatment at home or in ER, blood dyscrasias or convulsions that

do not result in hospitalization, anaphylactoid reactions, or the development of drug

dependence or drug abuse). However, emergency room visits that can be defined as

routine outpatient care (e.g., suture removal, treatment for a sprained ankle, earache,

etc.) do not meet this criterion and do not require immediate notification.

Symptomatic overdose if it results in a serious outcome.

Intentional overdose/suicide attempt—with or without any sign or symptom—when

considered to be a threat to life.

Neoplasia (benign or malignant) if judged to be medically serious.

Although not a serious AE in itself, exposure to study article during pregnancy—even if no AE

is produced in the mother—should be reported within 24 hours.

13.3. Definition of an Unexpected AE

An Unexpected Adverse Event or UAE is any adverse experience, the specificity or severity of

which is not consistent with the Investigator‘s Brochure / Manufacturer‘s Safety Information.

13.4. Eliciting Reports of Adverse Events

At each study visit (and during any contact with a subject occurring outside of a defined study

visit, including any contact after study completion), all adverse events reported by the subject or

subject representative or observed or otherwise identified by the Investigator or other study

personnel will be documented.

13.5. Reporting Adverse Events

All AEs must be recorded on the appropriate AE reporting page of the subject‘s source

documents. All AEs must be reported, whether or not they are considered causally related to

study article. For every AE, the Investigator must provide an assessment of the severity,

chronicity, causal relationship to study article, and seriousness of the event; document all actions

taken with regard to study article; and detail any other treatment measures taken for the AE. The

Investigator or other study personnel must immediately (within 24 hours) inform Medline

Industries, Inc. of any AE considered serious or otherwise significant as described in Section

13.2 above. Reporting should not be delayed pending resolution or outcome of an event. If an

outcome for an AE is not available at the time of the initial report, Medline Industries, Inc.

expects follow-up to proceed until such time as an outcome is known.



January 28, 2011

Notification may be via telephone or facsimile transmission of a written report. The following

staff at Medline Industries, Inc. should be contacted:

Edward Drower



One Medline Place

Mundelein, IL 60060

Phone: 847-473-5883

Cell: 224-221-8924

Fax: 866-758-4660

R&D Workroom: 847-643-3849

E-mail: [email protected]

13.6. Causality Assessment

For all AEs, the Investigator will provide an assessment of causal relationship to study article.

The causality assessment must be recorded on the appropriate AE reporting page of the subject‘s

source document. Causal relationship will be classified according to the following criteria:

Unrelated suggests a clearly evident relationship to other etiologies such as

concomitant medications or conditions or subject‘s known clinical state.

Possible suggests that the association of the AE with the study article is unknown.

Other etiologies are also possible.

Probable suggests that a reasonable temporal sequence of the AE with article

administration exists and based upon the Investigator's clinical experience, the

association of the AE with study article seems likely.

Definite suggests that a causal relationship exists between the study article and the

AE, and other conditions (concomitant illness, progression or expression of the

disease state, reaction to concomitant medication) do not appear to explain the AE.

13.7. Severity Assessment

The Investigator will provide an assessment of the severity of each adverse reaction by recording

a severity rating on the appropriate AE reporting page of the subject‘s source document.

(Severity, which is a description of the intensity of manifestation of the AE, is distinct from

seriousness, which implies a patient outcome or AE-required treatment measure associated with

a threat to life or functionality.) Severity will be assessed according to the following scale:

Mild - The AE was an annoyance to the subject, but did not further hinder baseline

functioning; the AE may have been intermittent or continuous.

Moderate - The AE caused the subject to experience some discomfort or some

interference with normal activities, but was not hazardous to health; prescription drug

therapy may have been employed to treat the AE.

mailto:[email protected]



January 28, 2011

Severe - The AE caused the subject to experience severe discomfort or severely

limited or prevented normal activities and represented a definite hazard to health;

prescription drug therapy and/or hospitalization may have been employed to treat the

AE.

13.8. Outcome Assessment

The Investigator will determine the outcome of the AE. Outcome will be assessed according to

the following scale:

Resolved Without Sequelae - The AE completely healed by end of study (or ongoing

yet unrelated to study, therefore resolved for purposes of study).

Resolved With Sequelae – The AE healed by the end of the study, but aftereffect,

disease or injury is present. Examples would include a stroke that resulted in partial

paralysis; the stroke resolved, but there was residual paralysis or erythema from a

skin reaction that resolved but hyperpigmentation remained.

Ongoing at the End of the Study – The AE had not healed by the end of the study.

This does not mean that the AE was not followed until resolution.

Death

13.9. Anticipated Reactions

During study conduct, the subject will be prompted by the Investigator or designate to report any

new or worsening adverse event.

Subjects may experience some reactions as a result of the test article application, which could

include pain, burning, stinging, tingling, and/or itching or other irritation. In addition, the tape

stripping may cause some minor discomfort (similar to removing a bandage) and dryness,

redness or flaking. These reactions are expected to be confined to the test article application

areas. These responses will not be considered an adverse event except for when the subject

declares it intolerable and requires or requests the test article be removed prior to the 15 minute

test site pain assessment.

It is possible that subjects may have an allergic reaction to the test articles. The occurrence of an

allergic reaction will be considered an adverse event. If any of the test sites become infected,

that will also be considered an adverse event.

14. PREMATURE DISCONTINUATION AND WITHDRAWAL

CRITERIA

14.1. Premature Discontinuation

Every effort will be made to conduct the final evaluation on subjects who discontinue from the

trial prematurely regardless of cause. Final evaluation is defined as completion of the evaluations

scheduled for the final visit.



January 28, 2011

14.2. Criteria for Termination

Test article treatment may be terminated for the following reasons:

An Adverse Event that requires study article to be discontinued.

Withdraws consent to continue participation in the study.

Subject is lost to Follow-up

Protocol violation (including lack of compliance)

Other Reasons, such as Administrative Reasons

14.3. Replacement Procedures

Subjects who prematurely drop out of the study will not be replaced.

15. MONITORING

A Sponsor representative may meet with the Investigator and his/her staff prior to the entrance of

the first subject to review the procedures to be followed in conducting the study. After the

enrollment of the first subject, the Investigator will permit the Sponsor to monitor the progress of

the trial on site periodically. The Investigator will make available the source documents as well

as the subjects‘ records and signed consent forms. The Investigator will review the source

documents for any corrected data, and sign the appropriate page(s). Copies of the relevant source

documents will be sent to Hill Top Data Management for data input and analysis. Original

source documents will be maintained by the Investigator.

16. AMENDMENTS /MODIFICATION OF THIS PROTOCOL

Any amendments to the protocol will be proposed to the Investigator in writing by Medline

Industries, Inc. No protocol changes may be implemented before the amended protocol has been

approved by the Institutional Review Board and the signature page, signed by the Investigator

has been received by Medline Industries, Inc.

17. SUBJECT CONFIDENTIALITY

All subject records will be identified only by initials and screening and/or final subject number.

The subject's names are not to be acquired by the Sponsor or their representatives. The

Investigator will keep a master sheet on which the identification information of each subject is

kept.



January 28, 2011

18. INVESTIGATOR OBLIGATIONS

18.1. Investigator Service

The Investigator or a designated Sub-Investigator will be readily available by phone at all times

during the study sessions.

18.2. Documentation

The Investigator must provide the following to Medline Industries, Inc. prior to the start of the

study:

Curriculum vitae for the Investigator.

A copy of the original approval for conducting the trial by the Institutional Review

Board as well as amendments and any advertisements. Renewals, with continuance

of the study, must be submitted at least yearly intervals.

A copy of the IRB approved informed consent form.

The Investigator signature page of this protocol signed and dated by the Investigator.

IRB membership roster.

18.3. Institutional Review Board (IRB)

This clinical study, including the Informed Consent, will be reviewed by an Institutional Review

Board in accordance with Title 21 of the Code of Federal Regulations, Parts 50 and 56.

Approval by the Board will be obtained prior to the initiation of the study. Approval of the IRB

prior to the start of the study will be the responsibility of the Investigator. A copy of the

approval letter must be supplied to Medline Industries, Inc. along with a roster of IRB

membership. If an Investigator or any sub-Investigator is on the IRB he must abstain from

voting on this project. During the course of the study, the Investigator shall make timely and

accurate reports to the IRB on the progress of the trial, at intervals not exceeding one year (or as

appropriate), and notify the IRB of SAEs or other significant safety findings as required.

18.4. Informed Consent

The study will be explained to each prospective subject and written informed consent must be

obtained before participation in any study related procedures. Copies of the informed consent

should be given to the subject and placed in the Investigator‘s study files. Each subject who

agrees to participate in the study must sign and date the informed consent.

18.5. Performance

The Investigator must demonstrate reasonable efforts to obtain qualified subjects for the study.



January 28, 2011

18.6. Use of Investigational Materials

The Investigator acknowledges that the test articles are investigational and as such must be used

strictly in accordance with the protocol and only under the supervision of the Investigator or sub-

Investigators. Upon receipt of the documentation package, Medline Industries, Inc. will arrange

for the shipping of study supplies. The Investigator must maintain adequate records documenting

the receipt and disposition of all study supplies. Hill Top/Medline Industries, Inc. will supply

forms to record the test articles were received, and document (as appropriate) the lot number of

the test articles, expiration/manufacture date, and a dispensing record to record each subjects use.

This is separate from the dispensing records maintained for each subject in the source

documents. All unused test articles must be returned to Medline Industries, Inc.

18.7. Source Documents

Study data will be captured on appropriately designed source documents. All source document

entries must be made in black ink for duplication purposes. The Investigator or designee must

review all entries for completeness and correctness. When changes or corrections are made on

any source document, a single line must be drawn through the error and initials of the person

making the change and the date of the correction recorded.

18.8. Final Report, Retention and Review of Records

The final report will summarize the method, data and conclusions (when applicable) relative to

the test articles and the subjects. Original source data will be retained by the testing facility for

at least two years. The source data will then be retained on microfilm or another readily

retrievable form indefinitely. A copy of the source documents may be obtained upon request of

the Study Sponsor. Data tables will be incorporated in the report.

The Investigator must maintain all documentation relating to this study. If Medline Industries,

Inc. requests to review any documentation relating to the study, the Investigator must permit

access to such records.

If the Investigator retires, relocates, or for other reasons withdraws from the responsibility of

keeping the study records, custody must be transferred to a person who will accept the

responsibility. Medline Industries, Inc. must be notified in writing of the name and address of

the new custodian.

19. PROTOCOL CHANGES AND DEVIATIONS

For medical, regulatory, or administrative purposes, the Sponsor reserves the right to change the

protocol at any time. The Sponsor also reserves the right to discontinue the study at any time.

If in the interest of safety and/or well being of a particular subject, it is necessary to depart from

the protocol that protocol deviation will be for that subject only. The Investigator must

document this divergence from the protocol for that subject on the appropriate source documents.



January 28, 2011

20. CONFIDENTIALITY

The Protocol and source documents provided to Hill Top Research for review by the

Investigator, the staff, and applicable Institutional Review Board(s) are confidential. It is

understood that this information provided to Hill Top Research by Medline Industries, Inc. in

connection with this study, will not be disclosed to others without written authorization from


21. REFERENCES

1. Marathon Brochure

2. Sureprep Brochure



January 28, 2011

MarathonTM

Brochure



January 28, 2011



January 28, 2011



January 28, 2011



January 28, 2011



January 28, 2011



January 28, 2011



January 28, 2011



January 28, 2011



January 28, 2011



January 28, 2011

Sureprep Brochure


Sponsor No. P11-001

APPENDIX III. STATISTICAL TABLES


Table 1 Tabulation of Subject Demographics

Table 2 Frequency Distribution of Gender and Fitzpatrick Skin Type, by Population

Table 3 Summary Statistics – Age, by Population

Table 4 Overall Pain Assessment, with Maximum Stinging Response

Table 5 Summary Statistics – Overall Pain Assessment

Table 6 Summary Statistics – Maximum Stinging Response

Table 7 Analysis of Variance of Maximum Stinging Response

Table 8 Subjective Pain Assessment

Table 9 Summary Statistics – Subjective Pain Assessment

Medline Project P11-001 Monday, April 4, 2011

HTR Project 10-130293-111

Table 1. Tabulation of Subject Demographics

Subject 111 withdrew before the first treatment and is thus not included in the Safety or Sensory Analysis Population.

1

Subject number

Safety Population

Sensory Analysis

Population

Withdrew before

Treatment Gender Age Fitzpatrick Skin Type

101 Y Y Female 47 III


103 Y Y Male 63 III





108 Y Y Female 44 II


110 Y Y Male 43 V

111 N N Y Female 18 II


113 Y Y Male 40 IV

114 Y Y Male 60 IV

115 Y Y Male 47 III

116 Y Y Male 44 III

117 Y Y Female 65 IV


119 Y Y Male 47 II

120 Y Y Male 45 IV

121 Y Y Female 55 II






127 Y Y Male 43 IV



Table 2. Frequency Distribution of Gender and Fitzpatrick Skin Type, by Population

2

Safety

Population

Sensory Analysis

Population

Withdrew before

Treatment

N % N % N %

Gender Female 17 65.4 17 65.4 1 100.0

Male 9 34.6 9 34.6 0 0.0

Total 26 100.0 26 100.0 1 100.0

Fitzpatrick Skin Type II 3 11.5 3 11.5 1 100.0

III 15 57.7 15 57.7 0 0.0

IV 7 26.9 7 26.9 0 0.0

V 1 3.8 1 3.8 0 0.0

Total 26 99.9 26 99.9 1 100.0



Table 3. Summary Statistics - Age, by Population

3

Safety

Sensory Analysis Withdrew

Num 26 26 1

Mean 47.19 47.19 18

Median 46 46 18

StDev 10.49 10.49

Minimum 22 22 18

Maximum 65 65 18



Table 4. Overall Pain Assessment, with Maximum Stinging Response

Treatment: A - SurePrep No-Sting Protective Barrier Spray

Subject 111 withdrew before treatment with the first test product and is therefore excluded from analysis.

4

Immediate

5 minutes post-application


Maximum Stinging

Response

(mm) Pain (mm) Pain (mm) Pain (mm)

Subject Site

6 12 9 12 101 2

102 2 0 0 1 1

103 4 9 8 7 9

104 3 3 1 1 3

105 1 0 2 0 2

106 4 42 12 3 42

107 3 1 1 0 1

108 5 4 1 3 4

109 1 1 3 4 4

110 5 0 1 0 1

112 2 0 0 0 0

113 5 8 2 1 8

114 4 0 0 0 0

115 3 29 28 27 29

116 5 1 0 0 1

117 3 2 2 2 2

118 4 1 4 2 4

119 1 6 1 1 6

120 2 4 11 5 11

121 1 2 1 1 2

122 3 5 10 4 10

123 5 2 1 2 2

124 2 11 3 2 11

125 5 35 6 1 35

126 4 0 0 0 0

127 2 0 3 1 3

Mean 6.62 4.35 2.96 7.81






5

Immediate



Maximum Stinging

Response


STD 11.16 6.21 5.40 10.95

N 26 26 26 26




Treatment: B - MARATHON Liquid Skin Protectant


6

Immediate



Maximum Stinging

Response


Subject Site

1 1 1 1 101 5

102 3 0 0 1 1

103 1 4 3 4 4

104 2 9 5 1 9

105 5 0 0 1 1

106 3 60 51 20 60

107 4 1 1 1 1

108 1 4 3 3 4

109 4 2 2 4 4

110 2 0 18 3 18

112 5 3 13 11 13

113 1 16 7 5 16

114 1 3 1 1 3

115 2 40 39 38 40

116 2 3 1 0 3

117 4 2 4 5 5

118 3 28 5 3 28

119 4 1 0 1 1

120 3 11 14 9 14

121 4 52 31 3 52

122 2 34 12 3 34

123 1 20 15 12 20

124 5 3 1 3 3

125 2 76 15 1 76

126 1 3 4 24 24

127 3 11 2 2 11

Mean 14.88 9.54 6.15 17.15






7

Immediate



Maximum Stinging

Response


STD 20.91 12.90 8.78 20.20

N 26 26 26 26




Treatment: C - 3M Cavilon No Sting Barrier Film Spray


8

Immediate



Maximum Stinging

Response


Subject Site

3 6 2 6 101 4

102 1 5 2 0 5

103 2 19 16 16 19

104 1 2 1 2 2

105 3 2 1 0 2

106 5 57 4 5 57

107 5 1 1 1 1

108 3 5 6 5 6

109 2 1 4 3 4

110 4 0 0 0 0

112 4 0 0 7 7

113 3 7 3 2 7

114 2 1 1 1 1

115 1 22 24 19 24

116 4 3 1 0 3

117 5 1 3 1 3

118 5 1 1 0 1

119 2 1 1 0 1

120 1 10 3 4 10

121 2 1 2 0 2

122 1 6 10 10 10

123 3 3 4 3 4

124 4 18 4 5 18

125 4 7 2 0 7

126 2 0 0 9 9

127 1 11 1 1 11

Mean 7.19 3.88 3.69 8.46






9

Immediate



Maximum Stinging

Response


STD 11.87 5.38 4.97 11.59

N 26 26 26 26




Treatment: D - Negative Control - 0.9% Saline


10

Immediate



Maximum Stinging

Response


Subject Site

8 8 13 13 101 1

102 4 0 0 0 0

103 5 24 16 13 24

104 5 10 2 2 10

105 2 0 0 0 0

106 2 48 65 18 65

107 1 1 1 1 1

108 4 4 3 3 4

109 3 0 0 0 0

110 3 0 20 0 20

112 1 0 9 0 9

113 4 11 3 1 11

114 5 1 0 1 1

115 5 29 25 29 29

116 3 1 0 0 1

117 1 3 3 2 3

118 2 1 8 0 8

119 3 1 0 1 1

120 4 11 9 3 11

121 3 0 0 1 1

122 5 7 4 3 7

123 4 1 2 2 2

124 1 22 8 2 22

125 3 4 13 3 13

126 5 0 0 4 4

127 4 3 2 3 3

Mean 7.31 7.73 4.04 10.12






11

Immediate



Maximum Stinging

Response


STD 11.54 13.46 6.81 13.85

N 26 26 26 26




Treatment: E - Positive Control - 70% Isopropyl Alcohol


12

Immediate



Maximum Stinging

Response


Subject Site

14 11 7 14 101 3

102 5 2 0 0 2

103 3 84 27 11 84

104 4 24 1 1 24

105 4 1 0 0 1

106 1 76 37 10 76

107 2 8 3 1 8

108 2 6 4 5 6

109 5 28 7 3 28

110 1 98 3 2 98

112 3 71 0 0 71

113 2 29 6 1 29

114 3 80 1 1 80

115 4 53 38 30 53

116 1 96 3 0 96

117 2 41 4 1 41

118 1 54 0 2 54

119 5 60 0 0 60

120 5 98 22 25 98

121 5 1 0 0 1

122 4 76 20 3 76

123 2 19 10 7 19

124 3 76 33 4 76

125 1 91 37 1 91

126 3 100 10 11 100

127 5 44 13 2 44

Mean 51.15 11.15 4.92 51.15






13

Immediate



Maximum Stinging

Response


STD 34.81 13.09 7.51 34.81

N 26 26 26 26



Table 5. Summary Statistics - Overall Pain Assessment

14

Immediate



A - SurePrep No-Sting Protective Barrier Spray Num 26 26 26

Mean 6.62 4.35 2.96

Median 2 2 1

StDev 11.16 6.21 5.4

Minimum 0 0 0

Maximum 42 28 27

B - MARATHON Liquid Skin Protectant Num 26 26 26

Mean 14.88 9.54 6.15

Median 3.5 4 3

StDev 20.91 12.9 8.78

Minimum 0 0 0

Maximum 76 51 38

C - 3M Cavilon No Sting Barrier Film Spray Num 26 26 26

Mean 7.19 3.88 3.69

Median 3 2 2

StDev 11.87 5.38 4.97

Minimum 0 0 0

Maximum 57 24 19

D - Negative Control - 0.9% Saline Num 26 26 26

Mean 7.31 7.73 4.04

Median 2 3 2

StDev 11.54 13.46 6.81

Minimum 0 0 0

Maximum 48 65 29

E - Positive Control - 70% Isopropyl Alcohol Num 26 26 26

Mean 51.15 11.15 4.92

Median 53.5 5 2

StDev 34.81 13.09 7.51

Minimum 1 0 0

Maximum 100 38 30



Table 6. Summary Statistics - Maximum Stinging Response

15

A - SurePrep

No-Sting Protective

Barrier Spray

B - MARATHON Liquid Skin

Protectant

C - 3M Cavilon No Sting Barrier Film

Spray D - Negative Control

- 0.9% Saline

E - Positive Control - 70% Isopropyl

Alcohol

Num 26 26 26 26 26

Mean 7.81 17.15 8.46 10.12 51.15

Median 3.5 10 5.5 5.5 53.5

StDev 10.95 20.2 11.59 13.85 34.81

Minimum 0 1 0 0 1

Maximum 42 76 57 65 100



Table 7. Analysis of Variance of Maximum Stinging Response

The GLM Procedure

16

Class Level Information

Class Levels Values

sbj1n 27 101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127

trt 5 A B C D E

Number of Observations Read 135

Number of Observations Used 130




The GLM Procedure

Dependent Variable: maxsting

17

Source DF Sum of

Squares Mean Square F Value Pr > F

Model 29 58709.09231 2024.45146 7.20 <.0001

Error 100 28112.41538 281.12415

Corrected Total 129 86821.50769

R-Square Coeff Var Root MSE maxsting Mean

0.676204 88.53284 16.76676 18.93846

Source DF Type I SS Mean Square F Value Pr > F

sbj1n 25 23543.50769 941.74031 3.35 <.0001

trt 4 35165.58462 8791.39615 31.27 <.0001

Source DF Type III SS Mean Square F Value Pr > F

sbj1n 25 23543.50769 941.74031 3.35 <.0001

trt 4 35165.58462 8791.39615 31.27 <.0001




The GLM Procedure

t Tests (LSD) for maxsting

18

Note: This test controls the Type I comparisonwise error rate, not the experimentwise error rate.

Alpha 0.05

Error Degrees of Freedom 100

Error Mean Square 281.1242

Critical Value of t 1.98397

Least Significant Difference 9.226

Means with the same letter are not significantly

different.

t Grouping Mean N trt

A 51.154 26 E

B 17.154 26 B

B

C B 10.115 26 D

C B

C B 8.462 26 C

C

C 7.808 26 A



Table 8. Subjective Pain Assessment



19

End of visit

evaluation 24-hour

post-application

score score

Subject Site

1 1 101 2

102 2 1 1

103 4 3 1

104 3 1 1

105 1 2 1

106 4 3 2

107 3 1 1

108 5 4 1

109 1 1 1

110 5 1 1

112 2 1 1

113 5 4 1

114 4 1 1

115 3 3 1

116 5 1 1

117 3 2 1

118 4 1 1

119 1 1 1

120 2 1 1

121 1 1 1

122 3 2 1

123 5 1 1

124 2 2 2

125 5 1 1

126 4 2 1

127 2 1 1

Mean 1.65 1.08






20

End of visit

evaluation 24-hour

post-application

score score

STD 0.98 0.27

N 26 26






21

End of visit

evaluation 24-hour

post-application

score score

Subject Site

1 1 101 5

102 3 1 1

103 1 2 1

104 2 1 1

105 5 1 1

106 3 4 1

107 4 1 1

108 1 1 4

109 4 2 9

110 2 1 1

112 5 5 2

113 1 3 1

114 1 1 2

115 2 5 2

116 2 1 1

117 4 1 1

118 3 2 1

119 4 1 1

120 3 1 3

121 4 4 1

122 2 1 1

123 1 3 1

124 5 6 3

125 2 3 7

126 1 1 1

127 3 1 4

Mean 2.08 2.04






22

End of visit

evaluation 24-hour

post-application

score score

STD 1.55 2.01

N 26 26






23

End of visit

evaluation 24-hour

post-application

score score

Subject Site

1 1 101 4

102 1 1 1

103 2 3 1

104 1 1 1

105 3 2 1

106 5 3 1

107 5 1 1

108 3 1 1

109 2 2 1

110 4 1 1

112 4 1 1

113 3 2 1

114 2 1 1

115 1 1 1

116 4 4 1

117 5 4 1

118 5 1 1

119 2 1 1

120 1 1 1

121 2 1 1

122 1 1 1

123 3 1 1

124 4 4 1

125 4 1 1

126 2 1 2

127 1 1 1

Mean 1.62 1.04






24

End of visit

evaluation 24-hour

post-application

score score

STD 1.06 0.20

N 26 26






25

End of visit

evaluation 24-hour

post-application

score score

Subject Site

1 1 101 1

102 4 1 1

103 5 6 2

104 5 3 1

105 2 1 1

106 2 3 1

107 1 1 1

108 4 1 1

109 3 1 1

110 3 1 1

112 1 1 1

113 4 4 1

114 5 2 2

115 5 3 1

116 3 1 1

117 1 1 1

118 2 1 1

119 3 1 1

120 4 1 3

121 3 2 1

122 5 2 1

123 4 1 1

124 1 1 1

125 3 1 1

126 5 2 1

127 4 3 1

Mean 1.77 1.15






26

End of visit

evaluation 24-hour

post-application

score score

STD 1.24 0.46

N 26 26






27

End of visit

evaluation 24-hour

post-application

score score

Subject Site

1 1 101 3

102 5 1 1

103 3 3 1

104 4 1 1

105 4 1 1

106 1 3 1

107 2 1 1

108 2 1 1

109 5 5 1

110 1 1 1

112 3 1 1

113 2 3 1

114 3 2 2

115 4 4 1

116 1 1 1

117 2 3 1

118 1 1 1

119 5 6 1

120 5 4 1

121 5 1 1

122 4 1 1

123 2 1 1

124 3 3 1

125 1 3 1

126 3 1 1

127 5 3 1

Mean 2.15 1.04






28

End of visit

evaluation 24-hour

post-application

score score

STD 1.46 0.20

N 26 26



Table 9. Summary Statistics - Subjective Pain Assessment

29

A - SurePrep No-Sting Protective Barrier Spray B - MARATHON Liquid Skin Protectant

C - 3M Cavilon No Sting Barrier Film Spray

End of visit evaluation

24-hour post-application





Num 26 26 26 26 26 26

Mean 1.65 1.08 2.08 2.04 1.62 1.04

Median 1 1 1 1 1 1

StDev 0.98 0.27 1.55 2.01 1.06 0.2

Minimum 1 1 1 1 1 1

Maximum 4 2 6 9 4 2

D - Negative Control - 0.9% Saline

E - Positive Control - 70% Isopropyl Alcohol





Num 26 26 26 26

Mean 1.77 1.15 2.15 1.04

Median 1 1 1 1

StDev 1.24 0.46 1.46 0.2

Minimum 1 1 1 1

Maximum 6 3 6 2


Sponsor No. P11-001

RECORD RETENTION AND PUBLICATION NOTICE

Hill Top Research submits this report with the understanding that the Sponsor may use the study

report for its own purposes. The Sponsor agrees, however, not to use the name Hill Top

Research, or any derivation thereof, in advertising or marketing without the prior written

consent of Hill Top.

All study documents and a copy of the final report will be on file in the Hill Top Research

Records Center at Main and Mill Streets, Miamiville, Ohio 45147, for a period of not less than

two years, unless indicated otherwise on the study protocol or financial contract. A permanent

record will be retained in the form of microfilm or in another readily retrievable form.