A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of Different Adhesive Bandages
Phase: NA
Conditions: Wound Healing
Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 1 / 75 
PROTOCOL 
The principles of the International Council for Harmonisation (ICH) Guidelines for Good Clinical Practice 
(GCP E6 (R2)) will be applied to this study. 
CONFIDENTIAL: The information in this document contains trade secrets and commercial information that are privileged or confidential and may not be 
disclosed unless such disclosure is required by Federal or State law or regulations. Subject to the foregoing, this information may be disclosed only to those 
persons involved in the study who have a need to know, but all such persons must be instructed not to further disseminate this information to others. 
These restrictions on disclosure will apply equally to all future information supplied to you, which is indicated as privileged or confidential.
PROTOCOL TITLE: 
A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-
of-Principle Study to Assess Wound Healing Efficacies of Different 
Adhesive Bandages 
PROTOCOL NUMBER: 
CCSTOH001689 
VERSION & DATE: 
Amendment 3: Final Version 4.0, 28 Aug 2019 
Amendment 2: Final Version 3.0, 20 Aug 2019 
Amendment 1: Final Version 2.0, 12 Aug 2019 
Original: Final Version 1.0, 10 Jul 2019 
SPONSOR: 
Johnson & Johnson Consumer Inc. 
199 Grandview Road, Skillman, NJ 08558 USA 
STUDY SITE: 
  
Thomas J. Stephens & Associates, Inc., Dallas Research Center 
1801 N. Glenville Dr., Suite 200 
Richardson, Texas 75081 USA 
 
PRINCIPAL INVESTIGATOR 
(PI): 
Lily Jiang, Ph.D. 
Address:  Refer to Study Site address 
 
SUB INVESTIGATOR (SUB-I): 
 
 
STUDY PHYSICIAN/SUB 
INVESTIGATOR (SUB-I): 
 
 
 
     
STUDY MANAGER (SM): 
 
  
   
STUDY DIRECTOR: 
Robin Mathew, Ph.D.  
Address:  Refer to Sponsor address   
  
DEPARTMENT HEAD: 
  
  
   
HEAD OF CLINICAL 
RESEARCH: 
 
 
  
 
DESIGNATED PHYSICIAN 
REPRESENTATIVE (DPR): 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 2 / 75 
VERSION TRACKING 
 
VERSION 
DATE 
STATE 
REASON FOR CHANGE 
DESCRIPTION OF 
CHANGE 
1 
10 Jul 2019 
Obsolete 
 N/A - new protocol 
 N/A  
2 
12 Aug 2019 
 
Obsolete 
Change the type of reinforcement tape 
used, correct SAE definition 2, correct 
question #4 and completion timing for 
Day 0 of the Self-Assessment 
Questionnaire, correct Screen Failure 
language, and clarify a few procedures 
in section 7 to match the Schedule of 
Events in Table 2. 
See Summary of 
Changes in 
Appendix VIII. 
3 
20 Aug 2019 
Obsolete 
 
 
 
 
See Summary of 
Changes in 
Appendix IX. 
4 
28 Aug 2019 
Issued 
Continue clinical grading of wound 
healing parameters until Day 16 for all 
wound sites. 
See Summary of 
Changes in 
Appendix X. 
 
[Remainder of Page Intentionally Left Blank] 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 3 / 75 
SYNOPSIS  
 
PROTOCOL TITLE 
A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-
of-Principle Study to Assess Wound Healing Efficacies of Different 
Adhesive Bandages 
PROTOCOL NUMBER 
CCSTOH001689 
SPONSOR 
Johnson & Johnson Consumer Inc. 
199 Grandview Road, Skillman, NJ 08558 USA 
STUDY SITE 
 
Thomas J. Stephens & Associates, Inc., Dallas Research Center 
1801 N. Glenville Dr., Suite 200 
Richardson, Texas 75081 USA 
 
PRINCIPAL INVESTIGATOR (PI) 
Lily Jiang, Ph.D. 
Address: Refer to Study Site address 
   
SUB-INVESTIGATOR (SUB-I): 
 
 
 
STUDY PHYSICIAN/SUB-
INVESTIGATOR (SUB-I): 
 
 
  
OBJECTIVE 
The objective of this study is to assess the wound healing efficacy 
(time to complete healing) of different adhesive bandages.  
 STUDY DESIGN 
Single center, randomized, comparator-controlled, proof-of-principle 
clinical trial. 
STUDY POPULATION 
Healthy subjects who meet the eligibility criteria, including: 
x 
Males or females, 25 – 55 years old. 
x 
Fitzpatrick Skin Types II-III 
x 
Uniform skin color on both volar forearms 
SAMPLE SIZE 
A sufficient number of subjects will be screened to enroll as many as 
40 qualified subjects to ensure completion of 30 subjects.  
INVESTIGATIONAL STUDY 
MATERIALS 
Treatment 
Code/Identification 
UPC/PR#  
Product type 
“Bandage” 
A – H  
(as randomly 
assigned by Sponsor) 
 
 
 
 
N/A – uncovered 
wound; Negative Control 
  
 
Investigational Product 
(IP) – 
 
  
 
 
IP – Benchmark Control 
1 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 4 / 75 
 
IP – Benchmark Control 
2 
 
IP 
 
IP 
 
IP 
 
IP 
 
 
 
Auxiliary Product 
DOSE AND MODE OF 
APPLICATION 
The auxiliary product will be provided to the subjects at Visit 1 to use 
on their forearms and for all body cleansing in place of their regular 
body cleanser for the duration of the study.  
 
The IPs will be applied to 7 of the 8 wound sites for each subject at 
Baseline (Day 0) by trained staff according to a preassigned 
randomization scheme. The last wound site will be left uncovered as 
an untreated control.  
 
IPs* will be removed at the beginning of each study visit from Day 1 
(Visit 3) through Day 16 (Visit 18) and replaced** at the end of each 
study visit from Day 1 (Visit 3) through Day 15 (Visit 17).  
 
 
 
 
**Wound sites will remain uncovered once completely healed. 
STUDY DURATION 
The study will be conducted over approximately 5 weeks with visits 
at Screening (Day -7 to Day -3), daily from Baseline (Day 0) to Day 16, 
on Day 21, and at the end of the study on Day 28.  
METHODOLOGY 
x 
Clinical Grading of Wound Healing Parameters (erythema, 
edema, epithelial confluence, crusting/scabbing, smoothness, 
and general wound appearance)  
x 
Scarring Assessment  
 
 
 
 
x 
TEWL Measurements  
x 
 
x 
Self-Assessment Questionnaire  
MEASUREMENT AND/OR 
EVALUATION SCHEDULE AND 
ASSOCIATED SUCCESS 
CRITERIA 
The following evaluations will be conducted for each wound site at 
the indicated time points: 
x 
Clinical Grading of Wound Healing Parameters (erythema, 
edema, epithelial confluence, crusting/scabbing, smoothness, 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 5 / 75 
and general wound appearance) – Day 0 through Day 16* 
x 
Scarring Assessment - Day 0 and Day 28 
x 
 
 
 
x 
TEWL Measurements - Day 0 through Day 14* 
x 
 
 
x 
Self-Assessment Questionnaire - Day 0 through Day 4 
 
 
 
Success Criterion: 
x 
 
STATISTICAL METHODS 
All statistical analyses will be performed using the Statistical Analysis 
System (SAS) v9.4 software. 
 
The statistical analysis will be performed by the Biostatistics Group at 
the Sponsor. 
 
All collected assessment data will be listed individually for all subjects. 
The following descriptive statistics will be presented: mean, standard 
deviation (SD), median, minimum, and maximum. Percentage change 
from baseline will also be presented. 
 
The primary endpoint, time to complete healing, is defined as the 
time (in days) elapsed from the time of wound creation to 12PM of 
the day on which the wound is evaluated as “completely healed.” 
 
Time to complete healing will be analyzed using a survival analysis 
method. The survival function (cumulative percentage of wounds 
healed at each time point) will be estimated by the Kaplan-Meier 
(KM) method for each treatment separately. The median time to 
complete healing will be derived from the estimated survival function 
and be compared using the bootstrap re-sampling method. 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 6 / 75 
LIST OF ABBREVIATIONS 
 
Abbreviation 
Definition 
3D 
Three-Dimensional 
A.A.S. 
Associate of Applied Science 
AE 
Adverse Event 
BLT 
Benzocaine/Lidocaine/Tetracaine 
cm 
Centimeter 
cm2 
Centimeter Squared 
C.M.L.S.O. 
Certified Medical Laser Safety Officer 
CRF 
Case Report Form 
DPR 
Designated Physician Representative 
EDC 
Electronic Data Capture 
EIU 
Exposure In Utero 
Er:YAG 
Erbium: Yttrium Aluminum Garnet 
f 
Focal Length 
FDA 
US Food and Drug Administration 
g 
Gram(s) 
h 
Hour 
HIPAA 
Health Insurance Portability and Accountability Act 
ICD 
Informed Consent Document 
ICH GCP 
International Council for Harmonisation Good Clinical Practice 
ID 
Identification 
IEC 
Independent Ethics Committee 
IP 
Investigational Product 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
J 
Joules 
kHz 
Kilohertz 
KM method 
Kaplan-Meier Method 
LLC 
Limited Liability Company 
m2 
Meter Squared 
M.D. 
Doctor of Medicine 
mg 
Milligram 
mm 
Millimeter 
nm 
Nanometer 
 
 
Ph.D. 
Doctor of Philosophy 
PI 
Principal Investigator 
PQC 
Product Quality Complaint 
PTAE 
Pre-Treatment Adverse Event 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
SEM 
Standard Error of the Mean 
SM 
Study Manager 
SMF 
Site Master File 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 7 / 75 
Abbreviation 
Definition 
 
 
SPF 
Sun Protection Factor 
TMF 
Trial Master File 
μm 
Micrometer 
W 
Watt 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 8 / 75 
TABLE OF CONTENTS 
 
1. 
INTRODUCTION ............................................................................................................................... 11 
2. 
OBJECTIVE ....................................................................................................................................... 11 
3. 
STUDY DESIGN ................................................................................................................................. 12 
4. 
SUBJECT SELECTION AND ENROLLMENT ......................................................................................... 12 
4.1. 
INFORMED CONSENT .......................................................................................................... 13 
4.2. 
STUDY POPULATION ........................................................................................................... 13 
4.2.1. 
Inclusion Criteria ............................................................................................................. 13 
4.2.2. 
Exclusion Criteria ............................................................................................................. 14 
4.2.3. 
Subject Responsibilities ................................................................................................... 15 
4.3. 
CONCURRENT PRODUCTS ................................................................................................... 16 
4.4. 
CONCURRENT/CONCOMITANT MEDICATION .................................................................... 16 
4.5. 
SCREEN FAILURE ................................................................................................................. 16 
5. 
SAMPLE SIZE .................................................................................................................................... 16 
6. 
INVESTIGATIONAL STUDY MATERIALS ............................................................................................ 16 
6.1. 
IDENTITY OF INVESTIGATIONAL STUDY MATERIALS ........................................................... 17 
6.2. 
LABELING ............................................................................................................................. 17 
6.3. 
STORAGE AND ACCOUNTABILITY ........................................................................................ 18 
6.4. 
PRODUCT QUALITY COMPLAINTS ....................................................................................... 18 
6.5. 
APPLICATION/USE OF THE INVESTIGATIONAL STUDY MATERIALS ..................................... 19 
6.5.1.    Auxiliary Product ............................................................................................................... 19 
6.5.2.   IPs ....................................................................................................................................... 19 
6.6. 
RANDOMIZATION/IP ALLOCATION AND BLINDING ............................................................ 22 
7. 
INVESTIGATIONAL PLAN .................................................................................................................. 23 
7.1. 
STUDY DURATION ............................................................................................................... 23 
7.2. 
STUDY PROCEDURES AND EVALUATION SCHEDULE ........................................................... 24 
7.2.1. 
Pre-Screening .................................................................................................................. 25 
7.2.2. 
Visit 1/Screening (3 to 7 days prior to Visit 2) ................................................................ 25 
7.2.3. 
Visit 2/Baseline (Day 0) – Pre-Wound Time Point .......................................................... 25 
7.2.4. 
Visit 2/Baseline (Day 0) – Wound Creation ..................................................................... 29 
7.2.5. 
Visit 2/Baseline (Day 0) – Post-Wound Time Point ......................................................... 29 
7.2.6. 
Visits 3-16 (Days 1-14) ..................................................................................................... 30 
7.2.7. 
Visit 17–18 (Day 15–16) .................................................................................................. 30 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 9 / 75 
7.2.8. 
Visit 19 (Day 21) .............................................................................................................. 31 
7.2.9. 
Visit 20 (Day 28) .............................................................................................................. 31 
7.3. 
 
 
 
7.4. 
SUBJECT COMPLIANCE METRICS ........................................................................................ 33 
7.5. 
STUDY INSTRUMENTS ......................................................................................................... 33 
7.5.1. 
 
7.5.2. 
 
34 
7.5.3. 
TEWL Measurements (Tewameter TM300 or TM330T; Courage + Khazaka, Köln, 
Germany) ....................................................................................................................................... 34 
7.6. 
SUBJECT COMPLETION/WITHDRAWAL ............................................................................... 35 
7.6.1. 
Subject Completion ......................................................................................................... 35 
7.6.2. 
Subject Discontinuation .................................................................................................. 35 
8. 
STATISTICAL ANALYSIS METHODS ................................................................................................... 35 
8.1. 
SAMPLE SIZE DETERMINATION ........................................................................................... 36 
8.2. 
DATA ANALYSIS ................................................................................................................... 36 
8.3. 
ENDPOINTS ......................................................................................................................... 36 
8.3.1. 
Primary Endpoints ........................................................................................................... 36 
8.3.2. 
Secondary Endpoints ...................................................................................................... 36 
8.3.3. 
Exploratory Endpoints ..................................................................................................... 37 
8.4. 
AE ANALYSIS ........................................................................................................................ 37 
9. 
SUCCESS CRITERIA ........................................................................................................................... 38 
10. 
MANAGEMENT OF INTERCURRENT EVENTS ................................................................................... 38 
10.1. 
AMENDMENTS TO THE PROTOCOL..................................................................................... 38 
10.2. 
PROTOCOL DEVIATIONS ...................................................................................................... 38 
10.3. 
ADVERSE EVENT REPORTING .............................................................................................. 38 
10.3.1. Introduction .................................................................................................................... 38 
10.3.2. Definitions ....................................................................................................................... 38 
10.3.3. Procedures for Reporting AEs ......................................................................................... 41 
10.3.4. Monitoring and Resolution of AEs .................................................................................. 43 
10.3.5. Pregnancy Reporting and Exposure In Utero (EIU) ......................................................... 44 
11. 
ETHICAL CONSIDERATIONS ............................................................................................................. 44 
11.1. 
SUBMISSION TO INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE ... 44 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 10 / 75 
12. 
DATA HANDLING AND RECORD KEEPING ........................................................................................ 45 
13. 
STUDY MONITORING, QUALITY CONTROL, AND QUALITY ASSURANCE ......................................... 46 
14. 
SPONSOR DISCONTINUATION CRITERIA ......................................................................................... 47 
15. 
FINAL REPORT ................................................................................................................................. 47 
16. 
CONFIDENTIALITY ............................................................................................................................ 47 
17. 
PUBLICATION ................................................................................................................................... 47 
18. 
BIBLIOGRAPHIC REFERENCES .......................................................................................................... 48 
20. 
PRINCIPAL INVESTIGATOR RESPONSIBILITY STATEMENT ............................................................... 50 
21. 
APPENDICES .................................................................................................................................... 51 
Appendix I.  
Fitzpatrick Skin Type Classification .................................................................................. 52 
Appendix II. 
Body Mass Index Table6 .................................................................................................. 53 
Appendix III. 
Subject Instructions ......................................................................................................... 54 
Appendix IV. 
Ingredient Listing ............................................................................................................. 55 
Appendix V. 
Temporary (Semi-Permanent) Dot-Tattoo Procedure7 ................................................... 56 
Appendix VI. 
Subject Self-Assessment Questionnaire (Day 0 through Day 4) ..................................... 57 
Appendix VII. 
Contact Information ........................................................................................................ 58 
Appendix VIII.  
 Summary of Changes – Amendment 1 ........................................................................... 60 
Appendix IX.  
 Summary of Changes – Amendment 2 ........................................................................... 64 
Appendix X.  
 Summary of Changes – Amendment 3 ........................................................................... 72 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 11 / 75 
1. 
INTRODUCTION 
 
The primary goal in wound care is to protect the wound from further damage and to facilitate healing by 
providing the optimal environment that limits infection, inflammation and scarring. Appropriate wound 
dressings play an important role in providing this necessary protection and may promote restoration of 
skin barrier function compared to untreated wounds.1  
 
Wound healing is a complex process wherein the skin surface and the underlying tissue must go through 
an intricate process of tissue repair. The dermis of an uncovered wound is relatively more fibroplastic, 
fibrotic, and scarred compared to occluded wounds, and is likely to be more inflamed and necrotic in early 
stages of repair.  Exudate, the moisture secretion from the wound site, facilitates the healing process, by 
providing a variety of bioactive mediators such as enzymes, growth factors and hormones. Wound 
exudate may also aid in limiting inflammation by providing various immune cells with an ideal medium to 
destroy invading pathogens such as bacteria, foreign bodies and necrotic tissues. However, exudate in an 
uncovered wound can lead to scab formation, with trapped inflammatory cells, wound debris, and a layer 
of desiccated dermal tissue. Covering a wound with an occlusive dressing reduces scab formation and may 
radically alter the pattern of epidermal wound healing. 
 
Another factor that plays an important role in wound healing is the moisture in the wound environment. 
As early as 1962, Winter et al., provided the first evidence that keeping wounds moist helps them heal 
faster compared to dry wounds.2  
 
As occlusion affects both the epidermis by enhancing epithelial cell migration and the dermis by enhancing 
dermal collagen synthesis, maintaining a moist environment may promote the restoration of epidermal 
barrier function and overall wound healing while making dressing changes relatively easier. Moreover, it 
has been suggested that the scar left by an occlusively dressed wound is more cosmetically acceptable 
than that left by an uncovered wound.3  
 
 
 
 
 
 
 
 
 
 
 
 
2. 
OBJECTIVE 
 
The objective of this study is to assess the wound healing efficacy (time to complete healing) of different 
adhesive bandages.  
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 12 / 75 
3. 
STUDY DESIGN 
 
This is a single center, randomized, comparator-controlled, proof-of-principle clinical trial. The target 
population is 25- to 55-year-old males and females of Fitzpatrick skin types II-III who have uniform skin 
color on both volar forearms.  A sufficient number of subjects will be screened and enrolled to ensure 
completion of at least 30 subjects.  
 
At Screening (Visit 1; 3 to 7 days prior to Baseline), subjects will be provided with an auxiliary cleanser to 
use on their forearms and for all body cleansing in place of their regular body cleanser for the duration of 
the study. 
 
At Baseline (Visit 2), a Sciton Er:YAG 2940 laser will be used to induce eight partial-thickness (i.e. minor) 
wounds on the subjects’ forearms (four per arm).4  The wounds created by this method heal by the 
migration of epidermal cells from the dermal appendages located in the wound’s base (dermal islands) 
and/or wound borders, and mimic minor wounds similar to real life scraped skin, typically healing in at 
less than 14 days if left untreated, based on the Site’s previous experience.   
 
Each wound site will be 
 and assessed at pre-specified intervals by clinical 
grading of wound healing parameters (until Day 16), 
 
  In addition, subjects will assess the wound sites via questionnaire from Day 0 to Day 4, 
 
 
 
 
Between Baseline and Day 16, each wound site will be subjected to one of eight randomly-assigned 
treatments (see section 6) until day of complete healing.  Treatments include an adhesive bandage that is 
considered the 
 a marketed adhesive bandage benchmark control, a non-marketed adhesive bandage 
benchmark control, four non-marketed adhesive bandages, and no treatment (uncovered, negative 
control).  
 
 
 
Once a wound site has completely healed, bandage changes will be discontinued and the 
wound will be left uncovered.  
 
All wound sites will be uncovered from Day 16 to Day 28, at which point subjects will return for a scar 
assessment of each wound site5, and 
 
 
See section 7 for detailed procedures. 
 
4. 
SUBJECT SELECTION AND ENROLLMENT 
 
This study can fulfill its objective only if appropriate subjects are enrolled. The eligibility criteria are 
designed to select subjects for whom protocol procedures are considered appropriate. 
 
All relevant medical and non-medical conditions should be taken into consideration, in addition to the 
inclusion/exclusion criteria below, when deciding if a particular individual is suitable for this protocol.  
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 13 / 75 
No type of discrimination (e.g. social class, gender, skin color, ethnicity, etc.) should preclude an eligible 
subject from participating in the study.  Information that is not relevant to the conduct of the study should 
not be collected. 
 
Prior to any review of personal data, the Informed Consent Document (ICD) should be signed. 
 
4.1. 
INFORMED CONSENT  
 
The ICD must be read by the subject and explained to the subject by the PI or designee.   
 
The PI or designee must ensure that each study subject is fully informed about the nature and objectives 
of the study and possible risks associated with participation. After understanding and agreeing, the subject 
will express his/her consent to his/her participation in the study by signing the ICD.   
 
The ICD will be signed and dated by both the PI/designee and by the subject.  The signed and dated original 
will be kept in the Site Master File (SMF) and a signed and dated copy must be given to the subject.  
 
No subject will be evaluated without a signed and dated ICD, which should be kept by the PI/Site as part 
of the SMF. The ICDs of subjects who are not included in the study will also be part of the SMF.  
 
The ICD must be approved by the Sponsor and the Institutional Review Board/Independent Ethics 
Committee (IRB/IEC) and must be in compliance with the principles of ICH GCP, local regulatory 
requirements, and legal requirements. 
 
4.2. 
STUDY POPULATION 
 
The PI must ensure that an individual meets all the inclusion criteria and none of the exclusion criteria to 
be included in the study. Waivers to inclusion or exclusion criteria are not permitted. In addition, the PI or 
designee must ensure that the subject remains eligible through the entire study conduct. 
 
The initial verification of eligibility, including review of medical history and concomitant medications, may 
be conducted by a non-medically qualified individual (PI or designee).  
 
The eligibility must then be reviewed and confirmed by a medically qualified individual (the Study 
Physician) before enrollment. The medically qualified individual is not required to review the eligibility 
information if the potential subject is screen-failed by the non-medically qualified staff.  
4.2.1. Inclusion Criteria 
 
a) 
Male or female 
b) 
25 to 55 years old 
c) 
Fitzpatrick Skin Type II or III (see Appendix I) 
d) 
Uniform skin color on both volar forearms. 
e) 
Generally in good health based on medical history reported by the subject. 
f) 
Able to read, write, speak, and understand English. 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 14 / 75 
g) 
Individual has signed the Consent for Photograph Release and ICD including Health Insurance 
Portability and Accountability Act (HIPAA) disclosure. 
h) 
Has access to a computer or phone with internet access and the ability to complete online 
questionnaires. 
i) 
Willing to have temporary (semi-permanent) dot-tattoos applied to the volar forearms. 
j) 
Willing to undergo topical anesthetic and laser wound treatment on the volar forearms. 
k) 
Intends to complete the study and is willing and able to follow all study instructions (see section 
4.2.3). 
4.2.2. Exclusion Criteria 
 
a) 
Has known allergies, hypersensitivity, or adverse reactions to anesthetics, adhesive bandages, 
latex, 
wound 
treatment 
products, 
or 
any 
component/ingredient 
present 
in 
the 
IPs/auxiliary/ancillary products.  
b) 
Has a known history of a blood-clotting disorder, keloid formation, or a cardiovascular, hepatic, 
or renal disease. 
c) 
Presents with a skin condition that would, in the opinion of the PI or Study Physician, confound 
the study results, increase risk to the subject, or interfere with study evaluations (e.g., active 
psoriasis, seborrheic dermatitis, atopic dermatitis, skin dermatoses, keloids, hypertrophic scars, 
cracked/excoriated skin, acne scars, pigmentation, friable skin, or clinically infected skin lesions). 
d) 
Has excessive hair or tattoos on either volar forearm. 
e) 
Has a known history of severe systemic immune system disorders such as Systemic Lupus 
Erythematosus (SLE), Rheumatoid Arthritis (RA), Scleroderma, chronic connective tissue 
disorders, Poly Arteritis Nodosa, or immunodeficiency, including HIV infection. 
f) 
Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.  
g) 
Has self-reported uncontrolled chronic diseases such as hypertension, hyperthyroidism, 
hypothyroidism, or active or recently treated (within 1 year) skin cancer.  
h) 
Is taking a medication that would mask an Adverse Event (AE), confound the study results, or alter or 
compromise the bleeding/healing process including:  
x 
Antibiotics, corticosteroids, immunosuppressive agents, anti-coagulants, antiplatelet drugs, cytotoxic 
agents, continuous aspirin therapy, chemotherapy, or daily medications for chronic asthma, within 1 
month before Visit 1.* 
x 
Non-steroidal anti-inflammatory drugs or steroidal drugs within 5 days before Visit 1.* Low dose 
aspirin (81 mg per day) is allowed. 
x 
Antihistamines within 2 weeks before Visit 1.* 
* If an individual is taking one of these medication types, the individual is not considered eligible at 
screening.  However, if a subject begins using one of these medications during the study, the Study 
Physician should be consulted to consider the impact of the specific medication on subject safety 
and/or the study results as described in section 0 (“Concurrent/Concomitant Medication”). 
i) 
Is self-reported to be pregnant or planning to become pregnant during the study. 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 15 / 75 
j) 
Has taken/used (oral or topical) vitamin A derivatives such as Accutane, isotretinoin, or retinoic acid 
within the past 1 year. 
k) 
Has used topical leave-on products on the volar forearms within 1 week prior to Visit 1. 
l) 
Is participating or has participated in 1) any clinical trial involving a topical or systemic 
investigational drug within 30 days prior to Visit 1 or 2) any other clinical study within 10 days 
prior to Visit 1. 
m) Has a body mass index (BMI) above 35 on the BMI scale (see Appendix II), based on the subject’s self-
reported height and weight.  
n) 
Is self-reported to be an alcohol or drug abuser.  
o) 
Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor. 
p) 
Either is or lives with someone who is a current employee of any company that makes or markets 
adhesive bandages or first aid products. 
q) 
Has a history of or a concurrent health/other condition/situation which may put the individual at 
significant risk, confound the study results, or interfere significantly with the individual’s participation 
in the study. 
4.2.3. Subject Responsibilities 
 
During the study, the subject should follow the instructions below: 
 
x 
Use the provided cleanser on your forearms and body for the duration of the study in place of 
your normal body cleanser. Do not use any other products on your forearms during the study.  
For the rest of the body, continue using your normal skincare products; do not start using any 
new products/brands.  
x 
Do not wet or put your forearms in water for the duration of the study (i.e., swimming, baths, hot 
tubs, etc.). Only showering is acceptable. 
x 
Do not shower within 2 hours before a visit. 
x 
Do not expose the test sites to sunlight or use tanning booths/beds during the study. 
x 
Wear long sleeves when going outdoors and for the first 12 hours after each tattoo application 
(ink may transfer to other skin locations). 
x 
Avoid touching/scratching the test sites. 
x 
Leave the test products (the bandages) on your forearms – only the study site should remove or 
apply them.  If the bandages become loose between clinic visits, you may use the provided tape 
to secure the bandage; apply the tape only on the adhesive parts of the bandage (not on the pad 
or middle of the bandage). 
x 
If any test product (bandage) falls off, record the date and time that the bandage fell off and 
report that information at your next visit. Do not try to reapply any bandage if it falls off. Please 
bring the bandage that has fallen off to your next visit. 
x 
Whenever possible, inform the study team before you start using any new medication.  
x 
Avoid pregnancy by continuing to use a medically acceptable contraception method, if applicable. 
x 
Attend all study visits at the scheduled time and date. 
x 
Do not start any other studies during this study. 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 16 / 75 
4.3. 
CONCURRENT PRODUCTS 
 
Subjects should use only the provided auxiliary cleanser on their forearms and body in place of their 
normal body cleanser.  They should not use any other products on their forearms during the study (other 
than the auxiliary product and IPs).  For the rest of their body, they should continue using their normal 
skincare products and not start using any new products/brands. 
 
4.4. 
CONCURRENT/CONCOMITANT MEDICATION 
 
If a subject is taking any medication during the course of the study and/or within 4 weeks prior to the 
study, it must be recorded. The minimum information that is required is the name of the medication. 
 
If this medication is linked to the treatment of an IP-related or study-related AE, the dose and duration of 
the treatment should be specified. 
 
Medications excluded are indicated in the section “Exclusion Criteria”; if a subject begins using an 
excluded medication during the study, the Study Physician must consider whether it will impact the 
subject’s safety and/or confound study results and document the decision. In case of impact, the subject 
should be discontinued. 
  
4.5. 
SCREEN FAILURE 
 
All individuals who sign the ICD and withdraw their consent for participation in the study or fail to meet 
at least one of the eligibility criteria during the initial evaluation will be considered a “screen failure” and 
their data will be entered in the Electronic Data Capture (EDC) system and the AEs will be included in the 
final report. 
 
5. 
SAMPLE SIZE  
 
A sufficient number of subjects will be screened to enroll as many as 40 subjects to ensure completion of 
at least 30 subjects. 
 
If the final sample size is smaller than expected, a protocol deviation should be recorded and 
communicated to the Sponsor. 
 
6. 
INVESTIGATIONAL STUDY MATERIALS  
 
The Sponsor has ensured that there is sufficient safety data to support the human use of the 
investigational study materials (IPs and auxiliary product). 
 
 
 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 17 / 75 
6.1. 
IDENTITY OF INVESTIGATIONAL STUDY MATERIALS 
 
The following IPs and auxiliary product will be provided under authorization of the Sponsor: 
 
Table 1. IP and Auxiliary Product List/Study Treatments 
Treatment 
Code/Identification 
UPC/PR #  
Product type 
Regulatory Class in USA 
“Bandage” 
A – H 
(as randomly assigned 
by Sponsor) 
 
 
N/A - uncovered wound; 
Negative Control 
N/A 
 
IP – 
 
 
 
IP – Benchmark Control 1 
 
 
IP – Benchmark Control 2 
 
 
IP 
 
 
IP 
 
 
IP 
 
 
 
IP 
 
 
 
Auxiliary Product 
Cosmetic 
 
A letter of non-significant risk, which outlines the safety of the IPs, will be provided to the IRB and the PI 
and filed in the SMF.  
 
The Ingredient List for the auxiliary product is provided in Appendix IV. 
 
All the investigational study materials will be manufactured according to Good Manufacturing Practices. 
 
6.2. 
LABELING 
 
The Sponsor will affix a study label to each IP or kit of IP.  The study labels will contain (but are not limited 
to) the following information, consistent with the requirements of 21 CFR 812.5: 
 
x 
Protocol number 
x 
Treatment Code 
x 
The name and place of business of the distributor (in accordance with 21 CFR 801.1) 
x 
The quantity of the contents 
x 
Caution statement (“CAUTION - Investigational device. Limited by United States law to 
investigational use”).  
x 
All relevant contradictions, hazards, adverse effects, interfering substances or devices, warnings, 
and precautions for the device that are not captured in the ICD/study instructions. 
 
A partial label will be affixed to each auxiliary product. The label may contain (but is not limited to) fields 
for the following information: 
x 
Protocol number 
x 
“For Participant Use Only” 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 18 / 75 
x 
Directions 
x 
Study Site Identification 
x 
Site Emergency Contact Information 
x 
Unit # 
6.3. 
STORAGE AND ACCOUNTABILITY 
 
The IPs and auxiliary product for this study will be secured in a room or cabinet that is only accessible to 
Study Site authorized personnel and kept at room temperature (15 - 30°C or 59 - 86°F), with temperature 
recorded daily. 
 
The PI or designee must maintain adequate records documenting the receipt, use, loss, or other 
disposition of the IPs and auxiliary product on the Product Dispensing and Accountability Log (or 
equivalent), which must be filed in the SMF. 
 
The log must identify the IPs and auxiliary product and account for the disposition including specific dates 
and quantities used/dispensed and returned, as applicable. 
 
The log must be signed by the Site designee who used/dispensed and retrieved the IPs and auxiliary 
product and a copy of the log must be provided to the Sponsor. 
 
At the end of the study, all unused units of the IPs and all units of the auxiliary product (used and/or 
unused) must be returned to the Sponsor at the following address: 
 
Johnson & Johnson Consumer Inc. 
199 Grandview Road 
Skillman, NJ 08558 USA 
Attn: Clinical Supplies 
 
The Sponsor will provide the return forms. 
 
All used units of the IP will be destroyed by the Site following its standard operating procedures for 
biohazardous waste.   Proof of destruction must be provided to the Sponsor. 
 
6.4. 
PRODUCT QUALITY COMPLAINTS 
 
A Product Quality Complaint (PQC) is any written, electronic, or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, or safety of a product, including its 
labeling, delivery system, or packaging integrity.  It also includes device malfunctions. 
 
No PQC form should be filed for issues identified during receipt/inventory of a shipment. Instead, these 
should be reported as indicated on the receipt letter. 
 
Subsequently, any observation/report of a PQC requires immediate notification of the Sponsor. The PI or 
designee should complete, sign, and securely send a copy of the PQC form to the SM.   The PI/Site staff is 
responsible for detecting and reporting PQCs and for instructing subjects to do the same, whenever 
applicable. The PI/Site staff must also ensure that products presenting PQCs are not used or that they have 
their use interrupted upon the identification of a PQC. 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 19 / 75 
 
PQC information must also be included on the Product Dispensing and Accountability Log (or equivalent). 
 
The SM can provide assistance and answer questions related to this process. To aid in the initial 
conversation and understanding of a PQC, the Site staff may be asked to photograph the issue and send 
the photograph to the SM. The SM will coordinate the replacement or return of the affected products, if 
necessary. 
 
6.5. 
APPLICATION/USE OF THE INVESTIGATIONAL STUDY MATERIALS 
6.5.1.    Auxiliary Product 
 
At Screening (Visit 1), subjects will be provided with the auxiliary cleanser to use on their forearms and 
for all body cleansing in place of their regular body cleanser for the duration of the study.  The labeled 
directions will be as indicated below:  
 
  
Use this cleanser on your forearms and body in place of your normal body cleanser.  Wet your skin 
with warm water, apply wash with your hand or washcloth, gently lather, and rinse. 
 
Do not use any other products on your forearms for the duration of the study. 
 
See section 4.2.3 and Appendix III for overall study instructions. 
6.5.2.   IPs 
 
All IP application and removal will be performed at the study site as described below by trained study staff 
wearing gloves and according to the randomization schedule (see section 6.6).
 
 
 
 
 
 
 
 
 Each IP unit 
is for single use; used bandages will not be re-applied and should be discarded by the Site as described in 
section 6.3. 
IP will be applied by a designated study staff member as follows: 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 20 / 75 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
  
  
 
 
 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 21 / 75 
Additional application details for all IPs: 
x 
If a wound shows signs of excessive redness, pain, or swelling or signs of infection 
(which should be documented as an AE, per section 10.3.2.1), IP will not be applied. 
x 
 
 
 
 Subjects will also be provided a roll of tape to take home for use in case IPs 
become loose between clinic visits.   
x 
If an IP falls off at home, subjects will be instructed to report the date and time that the 
IP fell off and report that information at their next visit.  IPs will not be replaced at home 
if they fall off.  Subjects will be instructed to retain any IPs that have fallen off and bring 
them to their next appointment. 
 
 
 
 
  
 
IP will be removed by a designated study staff member as follows: 
 
 
 
 
 
 
 
 
 
 
                  
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 22 / 75 
 
 
 
 
 
 
 
 
 
   
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.6. 
RANDOMIZATION/IP ALLOCATION AND BLINDING 
 
Upon signing the ICD, each subject will be sequentially issued an eight-digit subject ID. The first four digits 
will be the center ID, 1001, and the next four digits will be a unique subject identifier assigned in ascending 
numerical order beginning with 1001 (i.e. subject ID 10011001, 10011002, 10011003, etc.).  
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 23 / 75 
Qualified subjects will be assigned a randomization number sequentially from the randomization list at 
the Baseline visit (Visit 2). Once a randomization number has been assigned to a subject, it cannot be 
reassigned to another subject. 
 
Randomization of the study treatments to the eight wound sites (see section 7.2.3.3; one study treatment 
per wound site) will be based on a randomization scheme devised by the Biostatistics Group at the 
Sponsor using assigned treatment codes (A through H). 
 
 
 
Due to the nature of the IPs and the study design, it is not feasible to fully blind the IPs or to conceal the 
treatment assignments from study subjects or from all study personnel (i.e. those involved in 
applying/removing the IPs, IP accountability, or assessing subject compliance).  Staff responsible for IP 
accountability and IP application/removal (hereafter “unblinded staff”) will have access to the 
randomization schedule in order to accurately administer the study treatments.  The unblinded staff will 
not complete any subject evaluations other than the interview for compliance/AEs.   
 
The PI and staff conducting evaluations other than the interview for compliance/AEs (hereafter “blinded 
staff”) will not have access to the randomization schedule, and the IPs will be kept separate from the 
blinded staff.  Subjects will be instructed not to disclose information about their assigned study treatments 
to blinded staff, or to discuss any other information that may reveal the treatment assignment. 
 
 
 
 
 
   
 
The randomization schedule will be used by the Sponsor to generate treatment code-specific disclosure 
envelopes.  In the event that the PI or designee believes an unblinding is necessary and circumstances 
allow, the PI or designee will contact the SM who will consult with the DPR to determine whether a code 
break is needed.  If there is a medical emergency and the PI or designee deems it necessary to urgently 
know the treatment assignment for the subject’s proper medical care, the PI or designee may break the 
treatment code immediately by contacting the unblinded designee for relevant randomization 
information for that subject and opening the relevant treatment code-specific envelope.  The time, date, 
and reason for the unblinding should be noted in the subject’s source document and documentation 
should be provided to the Sponsor.  Blinding should only be broken for serious, unexpected, and related 
AEs, and only for the subject/treatment code in question, or when required by local regulatory authorities. 
 
All disclosure envelopes must be returned to the Sponsor at the conclusion of the study. 
 
7. 
INVESTIGATIONAL PLAN 
 
7.1. 
STUDY DURATION 
 
The study will consist of 20 visits over approximately 5 weeks with visits scheduled at Screening (Visit 1, 3 
to 7 days prior to Visit 2), Day 0 (Visit 2, Baseline/Pre-Wound and Post-Wound time points), daily on Days 
1 through Day 16 (Visit 3 through Visit 18), Day 21 (Visit 19), and Day 28 (Visit 20).  A subject’s Day 0 
through Day 28 study visits should be scheduled at approximately the same time of day for each visit (i.e., 
morning, afternoon, or evening). 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 24 / 75 
7.2. 
STUDY PROCEDURES AND EVALUATION SCHEDULE 
The table below presents a summary of the study procedures and evaluation schedule. 
Table 2. Schedule of Events 
Procedures: 
Visit: 
1 
Screening 
2 
Baseline 
(Pre-Wound) 
2  
(Post-
Wound) 
3 & 4 
5 
6 
7, 9, 11, 
13, & 15 
8, 10, 
12, & 14 
16 
17 
18 
19 
20 
Day: 
-7 to -3 
0 
0 
1 & 2 
3 
4 
5, 7, 9, 
11 & 13 
6, 8, 10 
& 12 
14 
15 
16 
21 
28 
ICD with HIPAA disclosure & Photo Release 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Demographics, medical history, and conmeds 
collection 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Review of eligibility/enrollment 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Dispense auxiliary cleanser & study instructions  
X 
 
 
 
 
 
 
 
 
 
 
 
 
Interview for compliance and changes in 
health/AEs/conmeds  
 
X 
X 
(AEs only) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Randomization  
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
XA 
XA 
XA 
XA 
XA 
XA 
XA 
XA 
XA 
XA 
XA 
 
Test site label application 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
IP Removal 
 
 
 
XB 
X 
XB 
X 
XB 
XB 
X 
X 
 
 
5-min acclimation 
 
X 
X 
XB 
X 
XB 
X 
XB 
XB 
X 
X 
 
X 
Clinical grading of wound healing parameters 
 
X 
X 
XB 
X 
XB 
X 
XB 
XB 
X 
X 
 
 
Scarring assessment  
 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
X 
XB 
X 
XB 
X 
XB 
XB 
X 
X 
X 
X 
 
 
X 
X 
XB 
X 
XB 
X 
XB 
XB 
 
 
 
 
TEWL measurements 
 
X 
X 
XB 
X 
XB 
X 
XB 
XB 
 
 
 
 
 
 
X 
 
XD 
 
X 
BLT cream application (30 min prior to wounding) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Test site cleaning and wounding 
 
X 
 
 
 
 
 
 
 
 
 
 
 
IP applicationE  
 
 
X 
XB 
X 
XB 
X 
XB 
XB 
X 
 
 
 
Subject self-assessment questionnaire 
 
 
XC 
X 
X 
X 
 
 
 
 
 
 
 
Collect auxiliary product 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
CAssessment will be completed remotely approximately 3-4 hours after BLT cream application once numbness is gone. 
DAt time of complete healing for a particular wound site.  
ECompletely healed wound sites will be left uncovered for the remainder of the study. 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 25 / 75 
7.2.1. Pre-Screening 
 
Potential subjects will be pre-screened using IRB-approved materials.  Subjects who meet the pre-
screening eligibility criteria will be given an appointment time for their screening visit. 
7.2.2. Visit 1/Screening (3 to 7 days prior to Visit 2) 
 
7.2.2.1.        Informed Consent 
 
Informed consent will be obtained as described in section 4.1.  The ICD will include a HIPAA disclosure and 
a Photograph Release Form.  Subjects who sign the ICD will be sequentially assigned a subject ID (see 
section 6.6). 
 
7.2.2.2.        Demographics, Medical History, Concomitant Medications, BMI, and Review of Eligibility 
 
The demographics, medical history, and concomitant medications of each candidate subject will be 
collected and reviewed. 
 
BMI will be calculated using the subject’s self-reported height and weight and the Body Mass Index Table 
(Appendix II). 
 
All of the eligibility requirements of the study will also be reviewed to assess each candidate subject’s 
eligibility, according to the inclusion/exclusion criteria. As part of this review, trained study personnel will 
examine the subject’s volar forearms to determine if the subject meets the eligibility criteria. 
 
The Study Physician will review the above information (medical history, concomitant medications, and 
eligibility review) to confirm the eligibility of each subject prior to their enrollment in the study as 
described in section 4.2. 
 
7.2.2.3.        Distribution of Auxiliary Cleanser 
 
Enrolled subjects will be provided with a unit of the auxiliary cleanser along with written and verbal study 
instructions (Appendix III).    
7.2.3. Visit 2/Baseline (Day 0) – Pre-Wound Time Point  
 
Subjects will return to the clinic for Visit 2.  The following study procedures will be performed at the 
Baseline/Pre-Wound time point:   
 
7.2.3.1.  Interview for Compliance, Changes in Health/ConMeds, and AEs  
 
Subjects will be interviewed for compliance with study instructions and for any changes in their health or 
concomitant medications.  Any AEs will be recorded. 
 
7.2.3.2.  Randomization 
 
A unique randomization number will be assigned to each subject as described in section 6.6. 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 26 / 75 
7.2.3.3.  Identification of Test Sites and Application of Temporary (Semi-Permanent) Dot-Tattoos and 
Test Site Labels 
 
Eight test sites (i.e. wound sites) will be identified on the volar forearms, four on each forearm, as shown 
in Figure 6.  
 
Figure 6.  Wound Site Placement 
                            
 
Going from the elbow to the wrist, the test sites on the right volar forearm will be designated test sites 1, 
2, 3, and 4, and those on the left volar forearm will be designated test sites 5, 6, 7, and 8.  The test sites 
will be spaced such that the wounds (see section 7.2.4.3.) will be created at least 4.0 cm apart so that the 
IPs will not overlap when applied.      
 
 
 
 
 
 
 
 
 
7.2.3.4.  Acclimation  
 
Subjects will acclimate in a controlled environment with the relative humidity maintained at 35-60% and 
temperature maintained at 19-22°C in the test facility for at least 5 minutes before further evaluations 
are performed. 
 
7.2.3.5.  Clinical Grading of Wound Healing Parameters 
 
After the acclimation period is complete, clinical grading of each test site will be performed by the PI or 
designee for each parameter listed below: 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 27 / 75 
x 
Erythema  
0 = none/absent 
1 = mild 
2 = moderate 
3 = marked 
4 = severe 
 
x 
Edema  
0 = none/absent 
1 = mild 
2 = moderate 
3 = marked 
4 = severe 
 
x 
Epithelial Confluence 
0 = none, no epithelial coverage  
1 = slight (up to 30%) 
2 = moderate (31-60%) 
3 = extensive (61-90%) 
4 = almost complete or complete (91-100%), covered with a full layer of new epithelial growth 
 
x 
Crusting/Scabbing 
0 = none 
1 = slight (up to 30%) 
2 = moderate (31%-60%) 
3 = extensive (61%- 90%) 
4 = almost complete or complete (91%-100%)  
 
x 
Smoothness 
0 = rough, uneven wound 
1 = mild smoothness 
2 = moderate smoothness 
3 = extensive smoothness 
4 = complete smooth, even wound 
 
x 
General Wound Appearance 
0 = Poor  
1 = Fair 
2 = Good 
3 = Very good 
4 = Excellent 
 
Half-point grading will be allowed. 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 28 / 75 
7.2.3.6.     Scarring Assessment 
 
A scarring assessment of each test site will be performed by the PI or designee using the Manchester 
Scar Scale5 as follows:  
 
x 
Color 
1 = Perfect 
2 = Slight mismatch with surrounding skin 
3 = Obvious mismatch with surrounding skin 
4 = Gross mismatch with surrounding skin 
 
x 
Finish (matte versus shiny) 
1 = Matte 
2 = Shiny 
 
x 
Contour 
1 = Flush with surrounding skin 
2 = Slightly proud/indented 
3 = Hypertrophic 
4 = Keloid 
 
x 
Distortion 
1 = None 
2 = Mild 
3 = Moderate 
4 = Severe 
 
x 
Texture 
1 = Normal 
2 = Just palpable 
3 = Firm 
4 = Hard 
 
7.2.3.7.  Instrumental Assessments 
 
 
 
 
  
 
 
7.2.3.7.3.  Trans-Epidermal Water Loss (TEWL) Measurements 
 
TEWL measurements will be performed on each test site as described in section 7.5.3. 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
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7.2.4. Visit 2/Baseline (Day 0) – Wound Creation 
 
7.2.4.1. Benzocaine/Lidocaine/Tetracaine Cream Application 
 
Anhydrous numbing Benzocaine/Lidocaine/Tetracaine (BLT) cream (20%/8%/8%) will be topically 
applied as a thick layer (approximately 2 cm x 2 cm area) at each test site, approximately 30 minutes 
prior to wounding procedure.  
 
7.2.4.2. Wound Site Cleaning 
 
The subjects’ forearms will be cleaned with alcohol wipes after the cream application before the wounding 
procedure is performed. 
 
7.2.4.3. Wounding Procedure with Er:YAG 2940 Laser (Sciton, Palo Alto, CA, USA) 
 
A certified laser specialist will create 8 uniform wounds on the volar forearms of each subject at the 
designated wound sites (see section 7.2.3.3) using a Sciton Er:YAG 2940 laser.  
x 
The wounds will be induced with erbium at an energy setting of 12.2 J/cm2 
x 
Number of passes:  3 passes of ~50μm depth per pass 
x 
Each wound will be a circle, 6 mm in diameter 
x 
The wound sites will be at least 4 cm apart, as indicated in section 7.2.3.3. 
7.2.5. Visit 2/Baseline (Day 0) – Post-Wound Time Point 
 
7.2.5.1. Clinical/Instrumental Evaluations 
 
After wound creation, the following evaluations will be completed on each test site in the order below: 
x 
Clinical grading of wound healing parameters, as described in section 7.2.3.5. 
x 
 
x 
 
x 
TEWL Measurements, as described in section 7.2.3.7.3 
 
7.2.5.2. IP Application 
 
After completion of the clinical grading and instrumental evaluations, IPs will be applied to the randomly 
assigned test sites, as described in section 6.  The untreated test site will remain uncovered. 
 
Subjects will be reminded of the study instructions (Appendix III).  
 
7.2.5.3. Self-Assessment Questionnaire 
 
Subjects will be asked to remotely complete a self-assessment questionnaire (see Appendix VI) 
approximately 3-4 hours after the BLT cream application, when numbness is gone. 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 30 / 75 
7.2.6. Visits 3-16 (Days 1-14)  
 
The following procedures will be completed: 
x 
Subjects will be interviewed for any changes in their medical history or concomitant medications 
since the last visit.  Any AEs will be recorded. 
x 
 
 
 
 
 
 
 
  
x 
Test site labels will be applied as described in section 7.2.3.3. 
x 
 
 
 
 
 
 
x 
Subjects will acclimate as described in section 7.2.3.4.   
x 
After the acclimation period, the following evaluations will be conducted for each test site: 
o Clinical Grading of Wound Healing Parameters, as described in section 7.2.3.5. 
o Instrumental measurements, as described in section 7.2.3.7. 
o 
 
x 
The designated IP will be applied to each test site per the randomization schedule.i 
x 
At Visits 3-6:  Subjects will complete the self-assessment questionnaire at the study site 
(Appendix VI) after the IP application. 
 
7.2.7. Visit 17–18 (Day 15–16) 
 
The following procedures will be completed: 
x 
Subjects will be interviewed for any changes in their medical history or concomitant medications 
since the last visit.  Any AEs will be recorded. 
x 
 
 
 
 
 
  
x 
Test site labels will be applied as described in section 7.2.3.3. 
x 
All IPs will be removed from the wound sites prior to acclimation. 
x 
Subjects will acclimate as described in section 7.2.3.4.   
x 
After the acclimation period, the following evaluations will be conducted for each test site: 
x 
Clinical Grading of Wound Healing Parameters, as described in section 7.2.3.5. 
x 
  
 
 
   
                                                          
 
i Completely healed wound sites will be left uncovered for the remainder of the study. 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 31 / 75 
x 
At Visit 17: The designated IP will be applied to each test site per the randomization schedule.ii 
x 
At Visit 18: Subjects will be reminded of the study instructions. Wound sites will remain 
uncovered for the remainder of the study. 
 
7.2.8. Visit 19 (Day 21)  
 
The following procedures will be completed: 
x 
Subjects will be interviewed for any changes in their medical history or concomitant medications 
since the last visit.  Any AEs will be recorded. 
x 
 
 
 
 
 
 
  
x 
 
 
7.2.9. Visit 20 (Day 28)  
 
The following procedures will be completed: 
x 
Subjects will be interviewed for any changes in their medical history or concomitant medications 
since the last visit.  Any AEs will be recorded. 
x 
Test site labels will be applied as described in section 7.2.3.3. 
x 
Subjects will acclimate as described in section 7.2.3.4.   
x 
After the acclimation period, the following evaluations will be conducted for each test site: 
x 
Scar assessment, as described in section 7.2.3.6 
x 
 
 
x The auxiliary cleanser will be collected. 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
__________________________ 
 
ii Completely healed wound sites will be left uncovered for the remainder of the study. 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 32 / 75 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
  
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 33 / 75 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
7.4. 
SUBJECT COMPLIANCE METRICS 
 
Compliance of study subjects will be monitored by a visual inspection of the IPs and interview to ensure 
that the subjects are complying with the study instructions.  
 
Any missed subject visits or other noncompliance will be documented as a protocol deviation. 
   
7.5. 
STUDY INSTRUMENTS 
 
 
 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 34 / 75 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
7.5.3. TEWL Measurements (Tewameter TM300 or TM330T; Courage + Khazaka, Köln, Germany) 
 
TEWL, the passive transfer of water through the stratum corneum, will be measured for each wound site 
at Visit 2 Baseline/Pre-Wound time point, Visit 2 Post-Wound time point, and Visits 3-16 using the 
Tewameter TM300 or TM330T (Courage + Khazaka electronic GmbH, Köln, Germany).  The same 
instrument (Tewameter TM300 or TM330T) that is used at Day 0 for one subject will be used for all 
subsequent measurements.  
 
The measurement of water evaporation is based on the diffusion principle in an open chamber and the 
density gradient is measured indirectly by two pairs of sensors located inside the hollow cylindrical probe. 
Data are analyzed by a microprocessor and reported in g/m2/h. A decrease in TEWL values reflects a 
decrease in the rate of water loss of the skin.  
 
Duplicate 30-second measurements will be taken for each wound site; if the TEWL reading is not stable 
within 30 seconds, the measurement should be expanded to 60 seconds. A sterile metal adaptor ring (C+K 
Catalog # Z00812) will be mounted on the measuring head of the probe.  The metal adaptor ring will be 
cleaned with an ethanol wipe between wound sites on the same subject and allowed to completely air 
dry before each reading. The metal adaptor rings will be thoroughly cleaned and autoclaved between 
subjects. 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
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7.6. 
SUBJECT COMPLETION/WITHDRAWAL 
 
7.6.1. Subject Completion 
 
Subjects are considered to have completed the study when all study procedures have been completed as 
designated by the protocol. Completion should be noted on the Screening and Enrollment Log (or 
equivalent). 
 
7.6.2. Subject Discontinuation 
 
When an individual who has signed the ICD is not included in the study or discontinues/is discontinued 
prior to completing the study, the reason is to be documented on the Screening and Enrollment Log (or 
equivalent) and in the final study report. Reasons for subject discontinuation may include: 
 
x 
Screen Failure (i.e. fails to meet inclusion/exclusion criteria or chooses not to participate) 
 
x 
Participant is determined to be ineligible after enrollment 
x 
Subject’s choice to withdraw 
x 
Investigator terminated (e.g. noncompliance, etc.) 
x 
AE/SAE (must be reported in accordance with the reporting requirements defined in the AE/SAE 
section “Adverse Event Reporting”). 
x 
Lost to follow-up 
x 
Protocol Violation 
x 
Lack of efficacy 
x 
Study terminated by sponsor 
x 
Death 
x 
Pregnancy 
x 
Other 
 
Subjects may withdraw from the trial at any time at their request, or they may be withdrawn at any time 
at the discretion of the Sponsor, PI, or designee for safety, behavioral, or administrative reasons. If a 
subject does not return for a scheduled visit, at least 3 documented attempts will be made to contact the 
subject in order to establish the reason for withdrawal, and the outcome will be documented. The PI or 
designee should inquire about the reason for withdrawal, request that the subject return for a final visit, 
if applicable, and follow-up with the subject regarding any unresolved AEs.  
 
When a subject withdraws from the trial and also withdraws consent for disclosure of future information, 
no further evaluations should be performed, and no additional data should be collected.  The PI and staff 
may retain and continue to use any data collected before such withdrawal of consent. 
 
Additional subjects may be enrolled in the study to compensate for early subject withdrawal. 
 
8. 
STATISTICAL ANALYSIS METHODS 
 
The analyses will be based on the Intent-to-Treat (ITT) principle, i.e., all subjects who received laser-
induced wounds and started the study treatments will be included in the analysis. 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 36 / 75 
8.1. 
SAMPLE SIZE DETERMINATION 
 
As this is a proof-of-principle study to estimate the effect size, and no prior data are available on these 
endpoints from previously conducted studies of similar study design on these prototypes, a sample size 
of 40 with a target completion of at least 30 subjects should provide a reliable estimation of the effect 
size.  
 
8.2. 
DATA ANALYSIS  
 
The Biostatistics Group at the Sponsor will be responsible for the statistical analysis of the primary and 
secondary endpoints. Summary statistics will be provided at each time point for the primary and 
secondary efficacy and safety assessments. For continuous variables, descriptive summaries will include 
number of subjects, mean, standard deviation, median, minimum and maximum values. Distributions of 
categorical variables will be summarized by presenting the number and percent of subjects in each 
response category. 
 
8.3. 
ENDPOINTS 
8.3.1. Primary Endpoints 
 
The primary endpoint of the study will be “Time to Complete Healing” defined as the time (in days) elapsed 
from the time of wound creation to 12 PM of the day on which the composite healing score (calculated 
from the clinical grading of wound healing parameters, as defined below) first meets the complete healing 
criterion of being at least a score of 8. If a composite healing score does not meet the complete healing 
criterion by Day 16, the time to complete healing will be censored at the last day on which the composite 
healing score is available. 
 
The composite healing score will be calculated from the clinical grading of wound healing parameters as 
follows: 
Composite Healing Score = [general wound appearance score + smoothness score + epithelial 
confluence score] – [erythema score + edema score + crusting/scabbing score] 
 
The composite healing score on a 25-point scale (-12 thru +12) is indicative of the extent of wound healing 
and will be calculated for each wound site at each evaluation day. 
 
Time to complete healing will be analyzed using a survival analysis method. The survival function 
(cumulative percentage of wounds healed at each time point) will be estimated by the Kaplan-Meier 
method for each treatment separately. The median time to complete healing will be derived from the 
estimated survival functions and be compared using the bootstrap re-sampling method. 
8.3.2. Secondary Endpoints 
 
The secondary endpoints for this study are the change from baseline* to each applicable time point (see 
Table 2) for the following parameters:  
 
x 
Change from baseline* to each applicable time point (see Table 2) for the following parameters:   
o TEWL measurements 
o Clinical Grading of Wound Healing – Erythema 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
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o Clinical Grading of Wound Healing – Edema   
o Subject self-assessment questions 1, 3, and 5. 
o Composite Scar Score – calculated as the sum of the individual parameters on the 
Manchester Scar Scale (Color, Finish, Contour, Distortion and Texture).  Composite Scare 
Scores range from 5 to 18, with 5 representing clinically best scars and 18 representing 
clinically worst scars. 
x 
Subject self-assessment questions 2 and 4 at each applicable time point. 
 
*Baseline is considered the Day 0 Pre-Wound time point for all endpoints except the subject self-
assessment questions. For the subject self-assessment questions, baseline is considered the Day 0 Post-
Wound time point. 
 
TEWL measurements, erythema, edema, the composite scar score, and self-assessment questions 1, 3, 
and 5 will be analyzed within-treatment and between-treatment.  The within-treatment comparison will 
be performed at each post-baseline time point by comparing the post-baseline scores with the baseline 
score within each treatment using the paired t-test.  The between-treatment comparison will be 
performed by comparing the change from baseline between treatments using a mixed effect analysis of 
covariance (ANCOVA) model. The ANCOVA model will include the treatment as the factor and the baseline 
value as the covariate. The model will include subject as a random effect to incorporate the within-subject 
correlation. 
 
Self-assessment questions 2 and 4 will be summarized by frequency distribution for each treatment at 
each collection time point.   
8.3.3. Exploratory Endpoints 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8.4. 
AE ANALYSIS 
 
All subjects who have IP applied at least once will be included in the safety analysis.  All AEs reported 
during the AE reporting period will be listed by subject number.  The number of subjects experiencing AEs 
will be presented by body system, preferred term, and treatment (if assessed as related to a particular 
IP).  The latest version of the Medical Dictionary for Regulatory Activities (MedDRA) will be used as the 
adverse event classification system. 
   
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
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9. 
SUCCESS CRITERIA 
 
 
 
 
 
10. 
MANAGEMENT OF INTERCURRENT EVENTS 
 
10.1. 
AMENDMENTS TO THE PROTOCOL 
 
Neither the PI/Site nor the Sponsor will modify this protocol without obtaining the agreement of the 
other.  
 
Amendments must be approved by the Sponsor and the IRB/IEC prior to implementation. 
 
The only circumstance in which an amendment may be initiated prior to IRB/IEC approval is where the 
change is necessary to eliminate apparent immediate hazards to the subjects. In that event, the PI must 
notify the IRB/IEC and the Sponsor in writing within 3 working days after the implementation. 
 
10.2. 
PROTOCOL DEVIATIONS 
 
Protocol deviations should be avoided whenever possible. When a protocol deviation occurs, it must be 
captured on the Protocol Deviation Log (or equivalent). 
 
If a significant deviation occurs, the PI or designee will also contact the SM (see contact information on 
front page or in Appendix VII). Contact with the SM will be made as soon as possible in order to discuss 
the situation and agree on an appropriate action.  If it is determined that a subject’s safety/well-being was 
affected, the IRB/IEC will also be notified, as applicable.  The final study report will describe any deviation 
from the protocol and the circumstances requiring it. 
 
10.3. 
ADVERSE EVENT REPORTING 
10.3.1. Introduction 
 
Timely, accurate, and complete reporting and analysis of safety information from clinical studies are 
crucial for the protection of subjects, investigators, and the Sponsor, and are mandated by regulatory 
agencies worldwide. The Sponsor has established procedures in conformity with regulatory requirements 
to ensure appropriate reporting of safety information.  
 
10.3.2. Definitions 
 
10.3.2.1. Adverse Event (AE) 
 
An AE is any untoward medical occurrence in a clinical study subject temporally associated with the clinical 
investigation, whether or not the event has a causal relationship to the subject’s participation in the trial. 
It is therefore any unfavorable and unintended sign (including an abnormal finding), symptom, or disease 
that occurs during the trial. This can include any occurrence that is new in onset, an aggravation of 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 39 / 75 
severity/frequency of a baseline condition, or abnormal results of diagnostic procedures, including 
laboratory test abnormalities. 
 
Examples of AEs include but are not limited to: 
x 
Abnormal test findings, 
x 
Clinically important symptoms and signs, 
x 
Changes in physical examination findings, 
x 
Hypersensitivity, and 
x 
Progression/worsening of underlying disease. 
 
Any change in existing medical condition (medical history) may be considered an AE and recorded 
appropriately. 
 
Additionally, they may include the signs or symptoms resulting from: 
x 
Product overdose, 
x 
Product withdrawal, 
x 
Product abuse, 
x 
Product misuse, 
x 
Product interactions, 
x 
Medication errors, 
x 
Product dependency, 
x 
Exposure in utero (EIU), and 
x 
Study related procedures. 
 
The criteria for determining whether an abnormal objective test finding should be reported as an AE are 
as follows: 
x 
Test result is associated with accompanying symptoms, and/or 
x 
Test result requires additional diagnostic testing or medical/surgical intervention, and/or 
x 
Test result leads to a discontinuation from the study, significant additional concomitant 
treatment, or other therapy, and/or  
x 
Test result is considered to be an AE by the Study Physician or the Sponsor. 
 
Merely repeating an abnormal test, in the absence of any of the above conditions, does not constitute an 
AE. Any abnormal test result that is determined to be an error does not require reporting as an AE. 
 
Expected Events 
 
Expected mild reactions (e.g. bleeding, pain, itching, etc.) related to the laser wounding procedure, normal 
healing process, and IP removal will not be captured as AEs unless there is exacerbation (moderate or 
severe) of these reactions as judged by the PI or designee. All reactions will be documented in the source 
documents.  
 
Pre-Treatment AE (PTAE) 
 
A PTAE is defined as any AE present prior to the initiation of the treatment/administration of IP. 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
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10.3.2.2. Serious Adverse Event (SAE) 
 
An AE (untoward medical occurrence) will be considered an SAE if it meets either of the following 
definitions: 
Definition 1:   
 
The event fulfills at least one of the following criteria: 
x Results in death 
x Is life-threatening (immediate risk of death) 
x Requires inpatient hospitalization or prolongation of existing hospitalization  
x Results in a persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions 
x Is a congenital anomaly/birth defect 
x Is considered a medically significant event (medical and scientific judgmentshould be exercised in 
deciding whether expedited reporting isappropriate in other situations, such as important medical 
events that may not result in death, be life-threatening, or require hospitalization but may be 
considered a serious adverse drug experience when, based upon appropriate medical judgment, 
they may jeopardize the patient or subject and may require medical or surgical intervention to 
prevent one of the other outcomes listed above. Examples of such medical events include allergic 
bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasia, 
or convulsions that do not result in hospitalization; or development of drug dependency or drug 
abuse, or malignancy) 
x Is a suspected transmission of any infectious agent via a product (medically significant) 
Definition 2:   
 
x 
the event involves subject contact with a device AND 
x 
the event results in: 
o Death 
o Serious injury, which means an injury or illness that: 
 
Is life-threatening (immediate risk of death) 
 
Results in permanent impairment of a body function or permanent damage to a 
body structure, or 
 
Necessitates medical or surgical intervention to preclude permanent impairment 
of a body function or permanent damage to a body structure (permanent means 
irreversible impairment or damage to a body structure or function, excluding 
trivial impairment or damage). 
o Persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions 
o A malfunction that the device (or similar device marketed by the same manufacturer or 
importer) would be likely to cause death or similar injury if the malfunction were to recur. 
o Any suspected transmission of any infectious agent via a product (medically significant). 
 
10.3.2.3. Severity 
 
The severity of all AEs must be assessed by the Study Physician.  
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
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The severity classifications are: 
x 
Severe – Extreme distress, causing significant impairment of functioning or incapacitation; 
interferes significantly with subject's usual function; prevents normal everyday activities. 
x 
Moderate – Sufficient discomfort is present to cause interference to some extent with subject's 
usual function or normal everyday activity.  
x 
Mild – Awareness of symptoms that are easily tolerated, causing minimal discomfort and not 
interfering with subject's usual function or normal everyday activities. 
 
Note the distinction between the severity and the seriousness of an AE. A severe event is not necessarily 
a serious event. For example, a headache may be severe (interferes significantly with subject's usual 
function) but would not be classified as serious unless it met one of the criteria for SAEs, listed above. 
 
10.3.2.4. Causality Assessment 
 
An AE (serious or non-serious) is considered “study-related” if the causality assessment is possible, 
probable, or very likely.  The Study Physician determines the causality by using the following definitions: 
 
x 
Not related – an AE that is not related to the participation in the study. 
x 
Doubtful – an AE for which an alternate explanation is more likely (e.g. concomitant drug), or the 
relationship in time suggests that a causal relationship is unlikely. 
x 
Possible – an AE that might be a result of participation in the study. An alternative explanation is 
inconclusive and the relationship in time is reasonable so a causal relationship cannot be 
excluded. 
x 
Probable – an AE that might be a result of participation in the study. The relationship in time is 
suggestive (e.g. confirmed by the challenge). An alternative explanation is less likely. 
x 
Very Likely – an AE that is listed as a possible adverse reaction and cannot be reasonably explained 
by an alternative explanation. The relationship in time is very suggestive (e.g. confirmed by 
dechallenge and rechallenge). 
 
10.3.3. Procedures for Reporting AEs 
 
All AEs will be reported from the time a signed and dated ICD is obtained until completion of the subject’s 
last study procedure or visit (or termination if the subject terminates early from the study for any reason). 
 
AEs that occur within 30 calendar days after completion of the study will only be reported to the Sponsor 
if they are serious (i.e. SAEs). SAEs are reportable beyond this period if the event is considered study-
related. The Sponsor will evaluate any safety information that is spontaneously reported by the PI/Site 
beyond this time frame. 
 
Subjects are encouraged to report AEs spontaneously and in response to questioning during the visit (e.g. 
if they have had any side effects/issues or changes in their health since their last appointment). For each 
AE reported by the subject or observed by the Site team, the Site team member should notify the PI or 
designee, who will collect information about the event. 
 
All AEs, regardless of seriousness, severity, or presumed relationship to study procedures, must be 
recorded using medical terminology. Whenever possible, diagnoses should be given when signs and 
symptoms are due to a common etiology (e.g., cough, runny nose, sneezing, sore throat, and head 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 42 / 75 
congestion should be reported as “upper respiratory infection”). The Study Physician must record or 
confirm their opinion concerning the seriousness, severity, and relationship of the AE to the study. All 
measures required for AE management must be recorded and reported according to Sponsor instructions. 
 
These events must then be entered into the EDC system within 3 business days of the Site’s awareness. 
 
Tabulation of AEs  
 
AEs will be reported in a table detailing the different AE types highlighted in this protocol: 
x 
Pre-Treatment AEs (PTAEs) 
x 
Expected AEs  
x 
AEs related to the product(s)/study 
x 
AEs not related to the product(s)/study 
x 
SAEs related to the product(s)/study 
x 
SAEs not related to the product(s)/study 
 
Additional Reporting Procedures 
 
The PI or designee must also report AEs to the appropriate IRB/IEC unless otherwise required and 
documented by the IRB/IEC.  
 
If a SAE occurs, in addition to the above reporting procedures, the Site will immediately upon SAE 
awareness notify the SM or designee by telephone or encrypted email (see contact information in 
Appendix VII and on front page). 
  
Subsequent to a telephone or encrypted email report of an SAE and within 24 hours of awareness of the 
SAE, the Site will complete and securely send (MBOX, Cisco, Secure mail) the Clinical Investigation SAE 
Report Form signed by the Study Physician to the SM or designee with as much information as possible, 
including: 
x 
The Study Physician’s assessment of causality  
x 
The subject identification number, the identity of SAE reporter, the IP/auxiliary product 
information (if applicable), the SAE description/outcome 
x 
Any relevant supporting documentation (e.g., medical history, concomitant medications). Note 
that if relevant supporting documentation requires translation, these translations must be sent 
securely within 3 business days after initial notification. 
This above process also applies to additional new information (follow-up) on previously forwarded SAE 
reports.  
 
The PI may be requested by the Sponsor to obtain specific additional follow-up information or more 
detailed information in an expedited fashion. In general, this will include a description of the SAE in 
sufficient detail to allow for a complete medical assessment of the case and independent determination 
of possible causality.  Information on other possible causes of the event, such as concomitant medications 
and illnesses, must be provided.  
 
In the case of a subject death, a summary of autopsy findings (if available) and death certificate should be 
collected if permission is obtained from the subject’s family.  

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 43 / 75 
 
For a hospitalization, a copy of the hospital discharge summary should be requested. If obtained, these 
documents (with subject’s personal identifiers redacted) should be securely submitted as soon as possible 
to the SM or designee. 
 
All the documentation pertaining to the SAE will be filed in the SMF. 
 
10.3.4. Monitoring and Resolution of AEs 
 
10.3.4.1. Non-Serious AEs 
 
All study-related AEs will be followed until resolution, until a stable clinical endpoint is reached, or at least 
30 days post-study withdrawal/completion. This information will be captured and entered into the EDC 
system. 
 
10.3.4.2. Serious AEs (SAEs) 
 
All SAEs will be followed by the Study Physician until resolution or until one of the conditions in the next 
section (“Resolution”) is met. This information will be captured and entered into the EDC system.  The 
PI/designee will also document follow-up information on an updated Clinical Investigation SAE Report 
Form, which will be reviewed by the Study Physician and sent securely to the SM or designee as described 
above. 
 
10.3.4.3. Resolution 
 
The Study Physician will be required to assess the outcome of each AE as one of the following:  
x 
Resolved 
x 
Not Resolved 
x 
Fatal 
x 
Resolved with sequelae 
x 
Resolving 
x 
Unknown 
 
SAEs that have not been resolved by the end of the study, or that have not been resolved upon 
discontinuation of the subject’s participation in the study, must be followed until any of the following 
occurs:  
 
x 
the event resolves 
x 
the event stabilizes 
x 
the event returns to baseline, if a baseline value is available 
x 
the event can be attributed to factors unrelated to study conduct 
x 
when it becomes unlikely that any additional information can be obtained (subject or healthcare 
practitioner refusal to provide additional information; lost to follow-up after demonstration of 
due diligence with follow-up efforts). 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 44 / 75 
10.3.5. Pregnancy Reporting and Exposure In Utero (EIU) 
 
Pregnancy in a female study subject is reportable to the Sponsor. Pregnancies will be reported from the 
time a signed and dated ICD is obtained until completion of the subject’s last study procedure (or 
termination if the subject terminates early from the study for any reason). Pregnancies that occur 
between the subject’s last visit and 30 calendar days after their last visit will only be reported to the 
Sponsor if there could have been EIU (according to date of last menses). 
 
Pregnancies occurring in subjects classified as screen failures do not require follow-up unless the 
screening procedures could have had an effect on the pregnancy outcome or the screen failure was 
detected after the study procedures or application/use of the investigational study material(s) was already 
started.  
 
Follow-up on pregnancy data (e.g., outcome of pregnancy) must occur regardless of whether or not the 
subject remains in the study. The PI or designee will follow-up the pregnancy until its successful 
completion or early termination (i.e. abortion) and then notify the Sponsor of the outcome. 
 
If a reportable pregnancy/EIU occurs, the PI or designee must: 
x 
For initial notification, complete and send securely the “Pregnancy Notification and Update Form” 
to the SM or designee within 24 hours of awareness. 
x 
Provide any updates using the “Pregnancy Notification and Update Form.” 
x 
Follow-up with the subject to determine the pregnancy outcome. At the end of the pregnancy, 
complete and send securely the “End of Pregnancy Collection Form” within 24 hours from when 
the information becomes available. 
 
The PI or designee should follow the procedures for reporting SAEs if the outcome of the pregnancy meets 
the criteria for immediate classification as a SAE, such as spontaneous abortion, stillbirth, neonatal death, 
congenital anomaly (including that in an aborted fetus, stillbirth, or neonatal death), or any infant death 
that the Study Physician assesses as possibly related to EIU. 
 
In the case of a live birth, the viability of the newborn will be assessed at the time of birth; no minimum 
follow-up period of a presumably normal infant is required before an “End of Pregnancy Collection Form” 
can be completed. 
 
All the documentation pertaining to the pregnancy will be filed in the SMF. 
 
11. 
ETHICAL CONSIDERATIONS 
 
11.1. 
SUBMISSION TO INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE 
 
This study (protocol, ICD, recruiting material [advertisements, phone script, etc.], and all addenda) will be 
reviewed and approved by an IRB/IEC contacted by the Study Site.  
 
Details of the IRB/IEC for this study are located in Appendix VII. 
 
It is the responsibility of the PI to have IRB/IEC approval of the study protocol, protocol amendments, 
ICD(s), and other relevant documents, e.g., advertisements, as applicable.  
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 45 / 75 
The study will not be activated and subjects will not be recruited, consented, or receive study materials 
until such time as the IRB/IEC has approved the required documentation. In addition, the IRB/IEC will 
review the study before any significant change in the protocol is initiated. After each review, the IRB/IEC’s 
approval letter will be forwarded to the Sponsor. All correspondence with the IRB/IEC should be retained 
in the SMF.  
 
12. 
DATA HANDLING AND RECORD KEEPING 
 
All subject source documents are the Site’s subject records and are to be maintained at the Study Site. 
The study source documents must be attributable, legible, contemporaneous, original, accurate, and 
complete, and must collect only relevant data required by this protocol. All documentation should be 
completed using good documentation and data integrity practices. 
 
The following source data will be captured on paper source documents: 
x 
ICD, HIPAA Disclosure, and Photograph Release 
x 
Inclusion/Exclusion Criteria 
x 
BMI 
x 
Medical History 
x 
Concomitant Medications 
x 
Investigational Study Materials Accountability Information 
x 
Protocol Deviations 
 
Subject self-assessment questionnaires will be completed using Qualtrics (Provo, UT), an online survey 
platform. If needed, subjects may complete these questionnaires on paper and the Site will enter the 
information into Qualtrics or Medidata Rave. 
 
The following data will be captured directly in the Sponsor’s EDC system: 
x 
Demographics 
x 
Fitzpatrick Skin Type Classification 
x 
Randomization 
x 
Clinical Grading of Wound Healing Parameters 
o Erythema score 
o Edema score 
o Epithelial confluence score 
o Crusting/scabbing score 
o Smoothness score 
o General wound appearance score 
x 
Manchester Scar Scale 
o Color score 
o Finish (matte versus shiny) score 
o Contour score 
o Distortion score 
o Texture score 
x 
TEWL Measurements 
x 
Adverse Events 
x 
Subject Disposition 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 46 / 75 
In the rare event that the electronic system is not functioning, the study will continue and the assessments 
will be captured on a paper source documents and entered into the system once it is functional. 
 
EDC pages should be completed for each enrolled subject. The completed pages of the EDC system are 
the sole property of the Sponsor and should not be made available in any form to third parties, except for 
authorized representatives of the Sponsor or appropriate regulatory authorities, without written 
permission from the Sponsor. 
 
It is the PI’s responsibility to ensure completion and to review and approve all information captured in the 
EDC system. The subject’s data in the EDC system must be electronically signed by the PI. These signatures 
serve to attest that the information contained in the EDC system is true. At all times, the PI has final 
personal responsibility for the accuracy and authenticity of all clinical data entered in the EDC system. 
 
The Sponsor or its designee will have responsibility for verifying for accuracy of the data entered into the 
EDC system against the source documents (as applicable). 
 
All data entered into the EDC system and Qualtrics will be sent to the Sponsor’s Quantitative Sciences 
Department for statistical analysis.  All final data recorded in the EDC system will be kept by the Sponsor 
and at the clinical site.  
 
The Study Site shall maintain and archive the SMF for 2 years from the time the final report is issued.  
 
The Sponsor must be notified before the disposal of any study record, even if retention requirements are 
met. 
 
If it becomes necessary for the Sponsor or a Regulatory Authority to review any documentation relating 
to the study, the PI/Site must permit access to such records.  
 
If the PI relocates, retires, or for any reason withdraws from the study, the Sponsor must be prospectively 
notified. 
 
13. 
STUDY MONITORING, QUALITY CONTROL, AND QUALITY ASSURANCE 
 
The study will be monitored by the Sponsor in accordance with a site or study-specific monitoring plan. 
Frequent communications (via telephone or email) will be utilized to provide Sponsor oversight and to 
assist in resolving any difficulties encountered while the study is in progress. Monitoring visits may occur 
during the study or after study completion to ensure that the investigation is/was conducted according to 
the protocol and that the principles of ICH GCP are/were being followed. The monitors may review study 
documents to confirm that the data recorded is complete and accurate. 
 
The PI/Site will allow the Sponsor’s monitors or its representatives and appropriate regulatory authorities 
direct access to study documents to perform monitoring. If there are any issues noted, the PI will be 
notified. 
 
Any contact concerning this study should be made with the SM or designee (see contact information on 
the front page or in Appendix VII). 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 47 / 75 
The Study Site may be subject to review by the IRB/IEC (if applicable), to quality assurance audits 
performed by the Sponsor, and/or to inspection by appropriate regulatory authorities. 
 
It is important that the PI and relevant Site personnel are available during monitoring and possible audits 
or inspections and that sufficient time is devoted to the process. 
 
14. 
SPONSOR DISCONTINUATION CRITERIA 
 
Premature termination of this clinical trial may occur because of a change in opinion of the IRB/IEC, IP or 
study safety problems, or at the discretion of the Sponsor. If a trial is prematurely terminated or 
discontinued, the Sponsor will promptly notify the PI/Site. After notification, the PI or designated staff 
must contact all participating subjects within 10 business days (phone, voicemail, or certified letter), as 
applicable. As directed by the Sponsor, all trial materials must be collected, all documents completed to 
the greatest extent possible, and termination reported to the IRB/IEC. 
 
15. 
FINAL REPORT 
 
The draft report will be prepared by Thomas J. Stephens and Associates. 
 
The draft report will be submitted to the Sponsor for review and changes may be made to the draft report 
at the Sponsor’s request. Upon Sponsor’s/study team’s approval, the report will be finalized and 
forwarded to the Sponsor. The final report will include (but is not limited to) the following information: 
study design and protocol, subject population demographics, statistical methods used, results, description 
of AEs (if any), protocol deviations, discussions, and conclusions.  
 
 
 
 
 
 
16. 
CONFIDENTIALITY 
 
All of the subjects’ private information, the data, and the study results are confidential. This information 
will only be made available to the study team, authorized Sponsor personnel or designees, and authorized 
external personnel and the data will be managed according to the local Data Privacy requirements and 
regulations. 
 
17. 
PUBLICATION 
 
The publication agreement, if any, between the Sponsor and the site is detailed in the clinical trial 
agreement.   
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 48 / 75 
18. 
BIBLIOGRAPHIC REFERENCES 
 
1) 
Mancini AJ, Sookdeo-Drost S, Madison KC, Smoller BR, Lane AT. Semipermeable dressings 
improve epidermal barrier function in premature infants. Pediatr Res., 36(3):306-14, 1994.  
 
2) 
Winter GD. Formation of the scab and the rate of epithelization of superficial wounds in the skin 
of the young domestic pig. Nature. 193:293-4, 1962. 
 
3) 
Winter G.D. Some factors affecting skin and wound healing. J Tissue Viability. 16(2):20-3, 2006.  
 
4) 
Trookman NS, Rizer RL, Weber T. Treatment of minor wounds from dermatologic procedures: a 
comparison of three topical wound care ointments using a laser wound model. J Am Acad 
Dermatol., 64(3 Suppl): S8-15, 2011.  
 
5) 
Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring devices. 
Eplasty, 10: e43, 2010. 
 
 
6) 
NIH Publication No. 98-4083 (1998, September). Adapted from Clinical Guidelines on the 
Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence 
Report. Retrieved from URL. 
https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmi_tbl.htm. 22 May 2019. 
 
7) 
Easy.Ink™ Semi-Permanent Tattoo Freehand Ink – Full Kit.  2019.  Retrieved from 
https://easy.ink/collections/freehand-ink/products/freehand-ink-full-kit. 
 
8) 
Buckenmaier CC, Galloway KT, Polomano RC, McDuffie M, Kwon N, Gallagher RM. Preliminary 
validation of the Defense and Veterans Pain Rating Scale (DVPRS) in a military population.  Pain 
Medicine, 14(1):110-23, 2013. 
 
 [Remainder of Page Intentionally Left Blank] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 49 / 75 
19. 
PROTOCOL SIGNATURE PAGE 
 
 
 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 50 / 75 
20. 
PRINCIPAL INVESTIGATOR RESPONSIBILITY STATEMENT 
 
I have read and understood this study protocol, attached appendices, and any amendments and/or 
supplements thereto. 
 
I agree to conduct the study in compliance with this protocol and in accordance with U.S. Food and Drug 
Administration (FDA) regulations, applicable local regulations, and the principles of ICH GCP as outlined 
herein.  
 
Furthermore, I agree to make no additions and/or changes without the consent of the Sponsor, except 
when necessary to protect the safety of the subjects.  
 
I will provide copies of the final approved protocol and all pertinent information to all individuals 
responsible to me who assist in the conduct of this study. I will discuss this material with them to ensure 
that they are fully informed regarding the protocol and conduct of this study.  
 
I undertake the responsibility of promptly communicating to the IRB/IEC or other applicable Institution 
and to the Sponsor any complications that may occur during the course of the study. 
 
I further undertake the responsibility of following up on all the measures required to ensure the safety 
and the rights of the subjects. 
 
 
Signature and Date: 
 
  
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 51 / 75 
21. 
APPENDICES 
 
Appendix I.  
Fitzpatrick Skin Type Classification .................................................................................. 52 
Appendix II. 
Body Mass Index Table6 .................................................................................................. 53 
Appendix III. 
Subject Instructions ......................................................................................................... 54 
Appendix IV. 
Ingredient Listing ............................................................................................................. 55 
Appendix V. 
Temporary (Semi-Permanent) Dot-Tattoo Procedure7 ................................................... 56 
Appendix VI. 
Subject Self-Assessment Questionnaire (Day 0 through Day 4) ..................................... 57 
Appendix VII. 
Contact Information ........................................................................................................ 58 
Appendix VIII.  
 Summary of Changes – Amendment 1 ........................................................................... 60 
Appendix IX.  
 Summary of Changes – Amendment 2 ........................................................................... 64 
Appendix X.  
 Summary of Changes – Amendment 3 ........................................................................... 72 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 52 / 75 
Appendix I.  
Fitzpatrick Skin Type Classification 
 
The skin classification is based on the subject-reported, unprotected skin response to the first 30 to 45 
minutes of sun exposure after a winter season without sun exposure.  The categories of skin types are as 
follows: 
 
 
 
 
 
 
 
 
 
 
This study will only be enrolling Fitzpatrick Skin Types II – III. 
 
 
Skin 
Type 
Characteristics 
I 
Always burns easily, never tans (sensitive) 
II 
Always burns easily, tans minimally (sensitive) 
III 
Burns moderately, tans gradually (light brown) (normal) 
IV 
Burns minimally, always tans well (moderate brown) (normal) 
V 
Rarely burns, tans profusely (dark brown) (insensitive) 
VI 
Never burns, deeply pigmented (insensitive) 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 53 / 75 
Appendix II. 
Body Mass Index Table6 
 
 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 54 / 75 
Appendix III. 
Subject Instructions 
 
During the study, please follow the instructions below: 
 
x 
Use the provided cleanser on your forearms and body for the duration of the study in place of 
your normal body cleanser. Do not use any other products on your forearms during the study.  
For the rest of the body, continue using your normal skincare products; do not start using any 
new products/brands.  
x 
Do not wet or put your forearms in water for the duration of the study (i.e., swimming, baths, hot 
tubs, etc.). Only showering is acceptable. 
x 
Do not shower within 2 hours before a visit. 
x 
Do not expose the test sites to sunlight or use tanning booths/beds during the study. 
x 
Wear long sleeves when going outdoors and for the first 12 hours after each tattoo application 
(ink may transfer to other skin locations). 
x 
Avoid touching/scratching the test sites. 
x 
Leave the test products (the bandages) on your forearms – only the study site should remove or 
apply them.  If the bandages become loose between clinic visits, you may use the provided tape 
to secure the bandage; apply the tape only on the adhesive parts of the bandage (not on the pad 
or middle of the bandage). 
x 
If any test product (bandage) falls off, record the date and time that the bandage fell off and 
report that information at your next visit. Do not try to reapply any bandage if it falls off. Please 
bring the bandage that has fallen off to your next visit. 
x 
Whenever possible, inform the study team before you start using any new medication.  
x 
Avoid pregnancy by continuing to use a medically acceptable contraception method, if applicable. 
x 
Attend all study visits at the scheduled time and date. 
x 
Do not start any other studies during this study. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 55 / 75 
 
Appendix IV. 
Ingredient Listing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 56 / 75 
Appendix V. 
Temporary (Semi-Permanent) Dot-Tattoo Procedure7 
 
How to Apply: 
 
1) Wear gloves throughout the dot-tattoo procedure. 
2) Shake the bottle to make sure the ink is uniformly mixed. 
3) Unscrew lid to ink bottle and place tip on bottle. 
4) Squeeze out a small amount of ink onto a paper towel to get the air out of the tip.  (Wipe the tip 
regularly to keep it clean and avoid clogging). 
5) Squeeze a small amount of ink (~1mm thick) onto the desired location (a template may be 
used).   
a. First application:  apply dot-tattoos to the skin adjacent to the wound sites (ideally 
equidistant between the wound sites).  The tattoos must be 
 
 
 but should be placed so as not to interfere with evaluations. 
b. Subsequent applications:  apply dot-tattoos to the skin adjacent to the previous dot-
tattoos (e.g. may alternate between two locations for each wound site).  In all instances, 
the tattoos 
 
 but should be 
placed so as not to interfere with evaluations.  
6) Let ink sit on skin for a minimum of 30 minutes.  Note:  the tattoo will not be visible for a few 
hours once the ink is removed, so all evaluations should be complete prior to ink removal 
(especially at Visit 2 [Baseline]) to ensure consistent identification of wound sites and visibility of 
tattoos 
 
7) Use a moist paper towel to carefully remove ink once all evaluations are complete. 
8) Tattoo will appear a few hours after ink removal. 
9) Subjects should be reminded to wear long sleeves for 12 hours after tattoo applications to 
prevent transfer of ink to other skin locations. 
 
Storage:  Refer to package instructions. 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 57 / 75 
Appendix VI. 
Subject Self-Assessment Questionnaire (Day 0 through Day 4) 
 
<Additional Day 0 Instructions: Please complete this questionnaire as soon as the numbness is gone (this 
will be around 3-4 hours after the numbing cream was applied).> 
 
Please answer the following questions for each wound on your forearms.  Focus on each wound itself (not 
the surrounding skin that might also be covered by a bandage).  The wound sites are numbered as shown 
in Picture 1.  Some of the questions will use the scale in Picture 2. 
 
   Picture 1. Wound Site Numbering                   Picture 2. Scale for Answering Questions 1, 3, and 5 
 
Note: If you cannot provide an answer for a specific wound site because you cannot distinguish the 
pain/itch sensation from neighboring wounds, choose “Cannot Distinguish” or enter an X. 
 
 
 
Wound Site (see Picture 1 above) 
Question 
1 
2 
3 
4 
5 
6 
7 
8 
1) With your arm resting by your side, how painful/sore is 
each wound site? Use the scale in Picture 2. 
 
 
 
 
 
 
 
 
2) Is the pain (described in #1) brief (B), periodic (P), or 
constant (C)? 
 
 
 
 
 
 
 
 
3) With your arm in normal motion, how painful/sore is 
each wound site? Use the scale in Picture 2. 
 
 
 
 
 
 
 
 
4) Is the pain (described in #3) brief (B), periodic (P), or 
constant (C)? 
 
 
 
 
 
 
 
 
5) How itchy is each wound site? Use the scale in Picture 
2. 
 
 
 
 
 
 
 
 
 
8 Buckenmaier CC, Galloway KT, Polomano RC, McDuffie M, Kwon N, Gallagher RM. Preliminary validation of the Defense and Veterans Pain Rating 
Scale (DVPRS) in a military population.  Pain Medicine. 2013 Jan 1;14(1):110-23. 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 58 / 75 
Appendix VII. Contact Information 
 
SPONSOR: 
Johnson & Johnson Consumer Inc. 
199 Grandview Road 
Skillman, NJ 08558 
 
STUDY SITE: 
 
Thomas J. Stephens & Associates, Inc. 
Dallas Research Center 
1801 N. Glenville Dr., Suite 200 
Richardson, Texas 75081 USA 
 
 
STUDY MANAGER: 
 
   
  
 
STUDY DIRECTOR: 
Robin Mathew, Ph.D.  
Address:  Refer to Sponsor address   
  
 
DEPARTMENT HEAD: 
  
   
   
 
HEAD OF CLINICAL RESEARCH: 
 
 
   
  
 
DESIGNATED PHYSICIAN 
REPRESENTATIVE: 
 
 
STATISTICIAN: 
 
 
 
STUDY MONITIOR: 
 
 
 
 
 
 
 
 
 
 
 
PRINCIPAL INVESTIGATOR: 
Lily Jiang, Ph.D. 
1801 N. Glenville Dr., Suite 200, Richardson, Texas 75081 USA 
  
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 59 / 75 
STUDY PHYSICIAN: 
 
 
 
SUB-INVESTIGATOR: 
 
   
 
 
 
 
 
IRB/IEC:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 60 / 75 
 
Appendix VIII.   Summary of Changes – Amendment 1 
 
CLINICAL PROTOCOL CCSTOH001689 
AMENDMENT 1 
 
A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle 
Study to Assess Wound Healing Efficacies of Different Adhesive Bandages  
 
 
SUMMARY OF CHANGES 
 
Study Product Name: N/A 
Protocol Number: 
CCSTOH001689 
IND/IDE/Eudra CT: 
N/A 
Phase: 
N/A 
Sponsor: 
Johnson & Johnson Consumer, Inc. 
Version and Date 
Amendment 1: Final Version 2.0, 12 Aug 2019 
Original: Final Version 1.0, 10 Jul 2019 
 
 
 
 
CONFIDENTIAL:  This document contains privileged and confidential information belonging to the 
Sponsor.  Except as otherwise agreed to in writing, by accepting or reviewing this document, you agree 
to hold the information contained herein in confidence and not copy or disclose it to others (except where 
required by applicable law) or use it for unauthorized purposes. In the event information is disclosed to 
others, as required by applicable law, they must be informed that the information is privileged and 
confidential and may not be further disclosed by them. These restrictions on disclosures will apply equally 
to all future information supplied to you that is indicated as privileged and confidential. You agree that no 
unpublished information contained herein will be published or disclosed without the prior written approval 
of Sponsor. In the event of any actual or suspected breach of this obligation, Sponsor must be promptly 
notified. 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 61 / 75 
1. 
REASONS FOR THE AMENDMENT TO THE FINAL PROTOCOL 
 
Sections of protocol CCSTOH001689, “A 28-Day, Single Center, Randomized, Comparator-
Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of Different Adhesive 
Bandages”, dated July 10, 2019 (Final Version 1.0), have been revised to change the type of 
reinforcement tape used, correct SAE definition 2, correct question #4 and completion timing for 
Day 0 of the Self-Assessment Questionnaire, correct Screen Failure language, and clarify a few 
procedures in section 7 to match the Schedule of Events in Table 2. 
 
2. 
PROTOCOL SECTIONS REVISED 
 
The protocol sections that were revised are detailed below. The format is as follows: 
 
x 
The “Deleted” section represents the original text in Protocol # CCSTOH001689, 
Final Version 1.0, dated July 10, 2019, that was deleted for Final Version 2.0, dated 
August 12, 2019. 
x 
The “Changed From” section represents original text in Protocol # CCSTOH001689, 
Final Version 1.0, dated July 10, 2019, that was changed to new text in Final Version 
2.0, dated August 12, 2019. The revised text is indicated in the “Changed To” 
section. 
x 
The “Added” section represents new text in Protocol # CCSTOH001689, Final 
Version 2.0, dated August 12, 2019. 
 
2.1. 
Screen Failure (Section 4.5) 
 
Changed From: 
 
All individuals who sign the ICD and withdraw their consent for participation in the study or fail 
to meet at least one of the eligibility criteria during the initial evaluation will be considered a 
“screen failure” and their data will not be considered in the final report (except for screen failed 
subjects with an AE, in which case the demography, subject disposition, and AE information 
will be entered in the Electronic Data Capture (EDC) system and the AEs will be included in 
the final report). 
 
Changed To: 
 
All individuals who sign the ICD and withdraw their consent for participation in the study or fail 
to meet at least one of the eligibility criteria during the initial evaluation will be considered a 
“screen failure” and their data will be entered in the Electronic Data Capture (EDC) system 
and the AEs will be included in the final report. 
 
2.2. 
Additional application details for all IPs (Section 6.5.2) 
 
Changed From: 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 62 / 75 
Changed To: 
 
 
 
 
2.3. 
Study Procedures and Evaluation Schedule (Section 7.2, Table 2) 
 
Changed From: 
 
CAssessment will be completed remotely approximately 2-4 hours after BLT cream application 
once numbness is gone. 
 
Changed To: 
 
CAssessment will be completed remotely approximately 3-4 hours after BLT cream application 
once numbness is gone. 
 
2.4. 
Self-Assessment Questionnaire (Section 7.2.5.3) 
 
Changed From: 
 
2-4 hours 
 
Changed To: 
 
3-4 hours 
 
2.5. 
Visit 17-18 (Day 15-16) (Section 7.2.7) 
 
Changed From: 
 
x 
Subjects will be reminded of the study instructions. Wound sites will remain uncovered for 
the remainder of the study. 
 
Changed To: 
 
x 
At Visit 17: The designated IP will be applied to each test site per the randomization 
schedule. 
x 
At Visit 18:  Subjects will be reminded of the study instructions. Wound sites will remain 
uncovered for the remainder of the study. 
 
 
 
 
Changed From: 
 
Visits 3-19 
 
Changed To: 
 
       Visits 3-20 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 63 / 75 
2.7. 
Serious Adverse Event (SAE) Definition 2 (Section 10.3.2.2) 
 
Added: 
 
x 
A malfunction that the device (or similar device marketed by the same manufacturer or 
importer) would be likely to cause death or similar injury if the malfunction were to recur.  
 
Deleted: 
 
x 
Congenital anomaly/birth defect  
 
2.8. 
Subject Self-Assessment Questionnaire (Day 0 through Day 4) (Appendix VI)  
 
Changed Form: 
 
<Additional Day 0 Instructions: Please complete this questionnaire as soon as the numbness 
is gone (this will be around 2-4 hours after the numbing cream was applied).> 
 
… 
 
4) is the pain (described in #4) brief (B), periodic (P), or constant (C)? 
 
Changed To: 
 
<Additional Day 0 Instructions: Please complete this questionnaire as soon as the numbness 
is gone (this will be around 3-4 hours after the numbing cream was applied).> 
 
… 
 
4) Is the pain (described in #3) brief (B), periodic (P), or constant (C)? 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 64 / 75 
Appendix IX.  
 Summary of Changes – Amendment 2 
 
CLINICAL PROTOCOL CCSTOH001689 
AMENDMENT 2 
 
A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle 
Study to Assess Wound Healing Efficacies of Different Adhesive Bandages  
 
 
SUMMARY OF CHANGES 
 
Study Product Name: N/A 
Protocol Number: 
CCSTOH001689 
IND/IDE/Eudra CT: 
N/A 
Phase: 
N/A 
Sponsor: 
Johnson & Johnson Consumer, Inc. 
Version and Date 
Amendment 2: Final Version 3.0, 20 Aug 2019 
Amendment 1: Final Version 2.0, 12 Aug 2019 
Original: Final Version 1.0, 10 Jul 2019 
 
 
 
 
CONFIDENTIAL:  This document contains privileged and confidential information belonging to the 
Sponsor.  Except as otherwise agreed to in writing, by accepting or reviewing this document, you agree 
to hold the information contained herein in confidence and not copy or disclose it to others (except where 
required by applicable law) or use it for unauthorized purposes. In the event information is disclosed to 
others, as required by applicable law, they must be informed that the information is privileged and 
confidential and may not be further disclosed by them. These restrictions on disclosures will apply equally 
to all future information supplied to you that is indicated as privileged and confidential. You agree that no 
unpublished information contained herein will be published or disclosed without the prior written approval 
of Sponsor. In the event of any actual or suspected breach of this obligation, Sponsor must be promptly 
notified. 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 65 / 75 
1. 
REASONS FOR THE AMENDMENT TO THE FINAL PROTOCOL 
 
Sections of protocol CCSTOH001689, “A 28-Day, Single Center, Randomized, Comparator-
Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of Different Adhesive 
Bandages”, dated August 12, 2019 (Final Version 2.0), 
 
 
  
 
2. 
PROTOCOL SECTIONS REVISED 
 
The protocol sections that were revised are detailed below. The format is as follows: 
 
x 
The “Deleted” section represents the original text in Protocol # CCSTOH001689, 
Final Version 2.0, dated August 12, 2019, that was deleted for Final Version 3.0, 
dated August 20, 2019. 
x 
The “Changed From” section represents original text in Protocol # CCSTOH001689, 
Final Version 2.0, dated August 12, 2019, that was changed to new text in Final 
Version 3.0, dated August 20, 2019. The revised text is indicated in the “Changed 
To” section. 
x 
The “Added” section represents new text in Protocol # CCSTOH001689, Final 
Version 3.0, dated August 20, 2019. 
 
2.1. 
Synopsis (Dose and Mode of Application) 
 
Added: 
 
**Wound sites will remain uncovered once completely healed. 
 
2.2. 
Synopsis (Measurement and/or Evaluation Schedule) 
 
Changed From: 
 
The following evaluations will be conducted for each wound site at the indicated time points: 
x 
Clinical Grading of Wound Healing Parameters (erythema, edema, epithelial confluence, 
crusting/scabbing, smoothness, and general wound appearance) – Day 0 through Day 16*  
x 
Scarring Assessment - Day 0 and Day 28 
x 
 
x 
 
x 
TEWL Measurements - Day 0 through Day 14* 
x 
  
x 
Self-Assessment Questionnaire - Day 0 through Day 4 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 66 / 75 
Changed To: 
 
The following evaluations will be conducted for each wound site at the indicated time points: 
x 
Clinical Grading of Wound Healing Parameters (erythema, edema, epithelial confluence, 
crusting/scabbing, smoothness, and general wound appearance) – Day 0 through Day 16* (or until 
completely healed, if earlier) 
x 
Scarring Assessment - Day 0 and Day 28 
x 
 
x 
 
 
TEWL Measurements - Day 0 through Day 14* 
x 
 
 
x 
Self-Assessment Questionnaire - Day 0 through Day 4 
 
 
 
 
2.3. 
Study Design (Section 3.0) 
 
Changed From: 
 
 
 
 
 
 
 
Between Baseline and Day 16, each wound site will be subjected to one of eight randomly-assigned 
treatments (see section 6).  Treatments include an adhesive bandage that is considered the 
 a 
marketed adhesive bandage benchmark control, a non-marketed adhesive bandage benchmark control, 
four non-marketed adhesive bandages, and no treatment (uncovered, negative control).  
 
 
 
 
 
  
 
Changed To: 
 
 
 
 and TEWL (until Day 14).  In addition, subjects will assess the wound sites via questionnaire from 
Day 0 to Day 4, 
 
 
 
 
Between Baseline and Day 16, each wound site will be subjected to one of eight randomly-assigned 
treatments (see section 6) until day of complete healing.  Treatments include an adhesive bandage that is 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 67 / 75 
considered the 
, a marketed adhesive bandage benchmark control, a non-marketed adhesive bandage 
benchmark control, four non-marketed adhesive bandages, and no treatment (uncovered, negative 
control).  
 
 
 
Once a wound site has completely healed, bandage changes will be discontinued and the 
wound will be left uncovered.  
 
2.4. 
IPs (Section 6.5.2) 
 
Changed From: 
 
All IP application and removal will be performed at the study site as described below by trained study staff 
wearing gloves and according to the randomization schedule (see section 6.6). 
 
 
 
 
 
 
 
 
Each IP unit is for single use; used bandages will not be re-applied and should be discarded by 
the Site as described in section 6.3. 
 
… 
 
 
 
 
 
 
Changed To: 
 
All IP application and removal will be performed at the study site as described below by trained study staff 
wearing gloves and according to the randomization schedule (see section 6.6).
 
 
 
 
 
 
 
 
 Each IP unit 
is for single use; used bandages will not be re-applied and should be discarded by the Site as described in 
section 6.3. 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 68 / 75 
… 
 
 
 
 
 
 
Added: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
       
 
 
 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 69 / 75 
 
 
 
 
 
 
 
 
 
 
 
 
2.5. 
Study Procedures and Evaluation Schedule (Section 7.2) 
 
Note:  formatting change made in Table 2 to add footnotes to “Clinical grading of wound healing 
parameters” and “IP application” rows.  
 
 
 
Changed From: 
 
DHealed test sites only. 
 
Changed To: 
 
D At time of complete healing for a particular wound site. 
EClinical grading of wound healing parameters will be performed for a particular test site only until time 
of complete healing.  
FCompletely healed wound sites will be left uncovered for the remainder of the study 
 
 
2.6.    Identification of Test Sites and Application of Temporary (Semi-Permanent) Dot-
Tattoos and Test Site Labels (Section 7.2.3.3) 
 
Changed From: 
 
Eight test sites (i.e. wound sites) will be identified on the volar forearms, four on each forearm, as shown 
in Figure 5.  
 
Figure 5.  Wound Site Placement 
 
Changed To: 
 
Eight test sites (i.e. wound sites) will be identified on the volar forearms, four on each forearm, as shown 
in Figure 6.  
 
Figure 6.  Wound Site Placement 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 70 / 75 
2.7. 
Visits 3-16 (Day 1-14) (Section 7.2.6) 
 
Changed From: 
 
x 
After the acclimation period, the following evaluations will be conducted for each test site: 
o Clinical Grading of Wound Healing Parameters, as described in section 7.2.3.5. 
o Instrumental measurements, as described in section 7.2.3.7. 
x 
The designated IP will be applied to each test site per the randomization schedule. 
 
Changed To: 
 
x 
After the acclimation period, the following evaluations will be conducted for each test site: 
o Clinical Grading of Wound Healing Parameters, as described in section 7.2.3.5.i 
o Instrumental measurements, as described in section 7.2.3.7. 
o 
 
 
x 
The designated IP will be applied to each test site per the randomization schedule.ii 
 
i Clinical grading of wound healing parameters will be performed for a particular test site only until time of complete healing 
ii Completely healed wound sites will be left uncovered for the remainder of the study. 
 
2.8. 
Visit 17-18 (Day 15-16) (Section 7.2.7) 
 
Changed From: 
 
x 
After the acclimation period, the following evaluations will be conducted for each test site: 
x 
Clinical Grading of Wound Healing Parameters, as described in section 7.2.3.5. 
x 
  
 
  
x 
At Visit 17: The designated IP will be applied to each test site per the randomization schedule. 
 
Changed To: 
 
x 
After the acclimation period, the following evaluations will be conducted for each test site: 
x 
Clinical Grading of Wound Healing Parameters, as described in section 7.2.3.5.i 
x 
  
x 
 
   
x 
At Visit 17: The designated IP will be applied to each test site per the randomization schedule.ii 
 
i Clinical grading of wound healing parameters will be performed for a particular test site only until time of complete healing 
ii Completely healed wound sites will be left uncovered for the remainder of the study. 
 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 71 / 75 
2.9. 
 
 
 
 
 
 
e 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 72 / 75 
Appendix X.  
 Summary of Changes – Amendment 3 
 
CLINICAL PROTOCOL CCSTOH001689 
AMENDMENT 3 
 
A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle 
Study to Assess Wound Healing Efficacies of Different Adhesive Bandages  
 
 
SUMMARY OF CHANGES 
 
Study Product Name: N/A 
Protocol Number: 
CCSTOH001689 
IND/IDE/Eudra CT: 
N/A 
Phase: 
N/A 
Sponsor: 
Johnson & Johnson Consumer, Inc. 
Version and Date 
Amendment 3: Final Version 4.0, 28 Aug 2019 
Amendment 2: Final Version 3.0, 20 Aug 2019 
Amendment 1: Final Version 2.0, 12 Aug 2019 
Original: Final Version 1.0, 10 Jul 2019 
 
 
 
 
CONFIDENTIAL:  This document contains privileged and confidential information belonging to the 
Sponsor.  Except as otherwise agreed to in writing, by accepting or reviewing this document, you agree 
to hold the information contained herein in confidence and not copy or disclose it to others (except where 
required by applicable law) or use it for unauthorized purposes. In the event information is disclosed to 
others, as required by applicable law, they must be informed that the information is privileged and 
confidential and may not be further disclosed by them. These restrictions on disclosures will apply equally 
to all future information supplied to you that is indicated as privileged and confidential. You agree that no 
unpublished information contained herein will be published or disclosed without the prior written approval 
of Sponsor. In the event of any actual or suspected breach of this obligation, Sponsor must be promptly 
notified. 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 73 / 75 
1. 
REASONS FOR THE AMENDMENT TO THE FINAL PROTOCOL 
 
Sections of protocol CCSTOH001689, “A 28-Day, Single Center, Randomized, Comparator-
Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of Different Adhesive 
Bandages”, dated August 20, 2019 (Final Version 3.0), have been revised to continue the clinical 
grading of wound healing parameters until Day 16 for all wound sites.  
 
2. 
PROTOCOL SECTIONS REVISED 
 
The protocol sections that were revised are detailed below. The format is as follows: 
 
x 
The “Changed From” section represents original text in Protocol # CCSTOH001689, 
Final Version 3.0, dated August 20, 2019, that was changed to new text in Final 
Version 4.0, dated August 28, 2019. The revised text is indicated in the “Changed 
To” section. 
 
2.1. 
Synopsis (Measurement and/or Evaluation Schedule) 
 
Changed From: 
 
x 
Clinical Grading of Wound Healing Parameters (erythema, edema, epithelial confluence, 
crusting/scabbing, smoothness, and general wound appearance) – Day 0 through Day 16* (or until 
completely healed, if earlier) 
 
Changed To: 
 
x 
Clinical Grading of Wound Healing Parameters (erythema, edema, epithelial confluence, 
crusting/scabbing, smoothness, and general wound appearance) – Day 0 through Day 16*  
 
2.2. 
Study Design (Section 3.0) 
 
Changed From: 
 
Each wound site will be photographed (at all time points) and assessed at pre-specified intervals by clinical 
grading of wound healing parameters (until Day 16 or completely healed, if earlier), 
 
 and TEWL (until Day 14).  In addition, subjects will assess the wound sites via questionnaire from 
Day 0 to Day 4, and 
 
 
 
 
Changed To: 
 
Each wound site will be photographed (at all time points) and assessed at pre-specified intervals by clinical 
grading of wound healing parameters (until Day 16), 
and TEWL (until Day 
14).  In addition, subjects will assess the wound sites via questionnaire from Day 0 to Day 4, 
 
 
 
 

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 74 / 75 
2.3. 
Study Procedures and Evaluation Schedule (Section 7.2) 
 
Note:  formatting change were made in Table 2 to remove the footnote from the “Clinical grading 
of wound healing parameters” row and to change the footnote on the “IP application” row from F 
to E. 
 
Changed From: 
 
EClinical grading of wound healing parameters will be performed for a particular test site only until time 
of complete healing.  
FCompletely healed wound sites will be left uncovered for the remainder of the study 
 
Changed To: 
 
ECompletely healed wound sites will be left uncovered for the remainder of the study. 
 
2.4. 
Visits 3-16 (Day 1-14) (Section 7.2.6) 
 
Changed From: 
 
x 
After the acclimation period, the following evaluations will be conducted for each test site: 
o Clinical Grading of Wound Healing Parameters, as described in section 7.2.3.5.i 
o Instrumental measurements, as described in section 7.2.3.7. 
o 
 
x 
The designated IP will be applied to each test site per the randomization schedule.ii 
 
i Clinical grading of wound healing parameters will be performed for a particular test site only until time of complete healing 
ii Completely healed wound sites will be left uncovered for the remainder of the study. 
 
Changed To: 
 
x 
After the acclimation period, the following evaluations will be conducted for each test site: 
o Clinical Grading of Wound Healing Parameters, as described in section 7.2.3.5. 
o Instrumental measurements, as described in section 7.2.3.7. 
o 
 
x 
The designated IP will be applied to each test site per the randomization schedule.i 
 
i Completely healed wound sites will be left uncovered for the remainder of the study. 
 
2.5. 
Visit 17-18 (Day 15-16) (Section 7.2.7) 
 
Changed From: 
 
x 
After the acclimation period, the following evaluations will be conducted for each test site: 
x 
Clinical Grading of Wound Healing Parameters, as described in section 7.2.3.5.i 
x 
  

Protocol Title: A 28-Day, Single-Center, Randomized, Comparator-Controlled, Proof-of-Principle Study to Assess Wound Healing Efficacies of 
Different Adhesive Bandages 
Protocol Number: CCSTOH001689 
Version & Date:  Amendment 3: Final Version 4.0, 28 Aug 2019 
 
Based on EFRM-0000805 Master Protocol Template – SOP-022190/SOP-0000574  
Page 75 / 75 
x 
 
  
x 
At Visit 17: The designated IP will be applied to each test site per the randomization schedule.ii 
 
i Clinical grading of wound healing parameters will be performed for a particular test site only until time of complete healing 
ii Completely healed wound sites will be left uncovered for the remainder of the study. 
 
Changed To: 
 
x 
After the acclimation period, the following evaluations will be conducted for each test site: 
x 
Clinical Grading of Wound Healing Parameters, as described in section 7.2.3.5. 
x 
  
 
 
   
x 
At Visit 17: The designated IP will be applied to each test site per the randomization schedule.ii 
 
ii Completely healed wound sites will be left uncovered for the remainder of the study.