A Multi-center, Prospective Pilot Study on Safety and Effectiveness of a Healing Ointment as a Post-surgical Care
Phase: PHASE4
Conditions: Surgical Wound
Sponsor: Galderma R&D

 
 
Page 1 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
DRAFT Protocol Version 1: 02 May, 2022 
 
 
 
Title 
A multi-center, prospective pilot study on safety and 
effectiveness of a healing ointment as a post-surgical care 
Protocol number: 
GLI.04.US.SL.017 
Sponsor name and 
address: 
Galderma Laboratories, L.P. 
14501 North Freeway 
Fort Worth, TX 76177 
USA 
Test product: 
Cetaphil® Healing Ointment 
Investigator agreement: I have read the clinical study described herein, recognize its 
confidentiality, and agree to conduct the described study in 
compliance with Good Clinical Practices (GCP), the ethical 
principles contained within the Declaration of Helsinki, this 
protocol, and all applicable regulatory requirements. 
Principle Investigator: 
 
 
 
Signature 
 
 
 
 
Date 
Name: 
Aaron Farberg, MD 
Address: 
Derm Texas 
2110 Research Row 
Dallas, TX 75235 
USA 
Telephone: (214) 845-6426 
 
Legacy Dermatology 
3140 Legacy Dr., #110 
Frisco, TX 75034 
USA 
Telephone: (972) 787-0010 

 
 
Page 2 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
 
 
A MULTI-CENTER, PROSPECTIVE PILOT STUDY ON SAFETY AND EFFECTIVENESS OF 
A HEALING OINTMENT AS A POST-SURGICAL CARE 
 
APPROVAL SIGNATURE PAGE 
 
 
_________________________________________  
 
_______________ 
Aaron Farberg, MD 
 
 
 
 
 
 
Date 
Principle Investigator 
Derm Texas and Legacy Dermatology 
 
 
_________________________________________  
 
_______________ 
Thu Q. Nguyen, PhD  
 
 
 
 
 
Date 
Project Manager 
Galderma Laboratories, L.P. 
 
 
_________________________________________  
 
_______________ 
Christine Emesiani, PharmD  
 
 
 
 
Date 
Medical Affairs Advisor, Consumer 
Galderma Laboratories, L.P. 
 
 
_________________________________________  
 
_______________ 
Matthew Meckfessel, PhD 
 
 
 
 
 
Date 
Director, Medical Affairs 
Galderma Laboratories, L.P. 
 
 

 
 
Page 3 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
1. 
SYNOPSIS 
Study Objective 
To evaluate benefits of a Healing Ointment in skin improvement 
after dermatologic procedures 
Methodology 
Multi-center, prospective study 
Number of Subjects at the 
end 
20 subjects to complete 
Study duration 
28 days 
Test product 
Cetaphil® Healing Ointment 
Conditions of use 
Twice daily topical application and as needed 
Study visits 
Day 0, day 7 or 14, day 28 
Specific Inclusion Criteria: 
o Demographics and study skin conditions 
- Any race and ethnicity (to be recorded) 
- Fitzpatrick skin type (to be recorded) 
- Women or men  
- Age: 18 to 85 years old 
- Subject who undergo Mohs surgery, skin biopsy, excision on the 
head/neck or body  
 
o Administrative 
- Ability of giving consent for participation in the study  
- Agreement to adhere to the procedures and requirements of the 
study and to report to the institute on the day(s) and at the time(s) 
scheduled for the assessments. 
Specific Exclusion Criteria: 
- History of allergy or hypersensitivity to cosmetic ingredients  
- Pregnant, planning pregnancy during the course of the study or 
breastfeeding 
- Subject with a history of keloids or hypertrophic scars 
- Presence of tattoo and/or scar in the treatment area that in the 
investigator’s opinion would interfere with study assessments 
- Subjects with history of or the presence of any skin 
condition/disease that might interfere with the diagnosis or 

 
 
Page 4 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
evaluation of study parameters (i.e., atopic dermatitis, eczema, 
psoriasis, seborrheic dermatitis) at the discretion of the 
investigator.   
- Subjects with inability to comply with all study protocol 
restrictions and visits 
Procedure 
- Subjects will report to the site as screening visit, will be given an 
informed consent form, HIPAA form, photography release form, 
Code of Conduct form, and medical history form to complete. 
- Subjects will be screened on the basis of the selection criteria 
for study qualification. At day 0, investigator assessment 
(erythema, edema, scabbing/crusting, and overall wound 
appearance) and subjective tolerability assessment (burning, 
itching, pain) will be performed based on 0-4 analog scale. 
- Subjects will undergo the assigned surgical procedure.  
- After procedure, photography of the surgical site, investigator 
assessment and subjective tolerability will be performed, and 
investigator or staff will apply Healing Ointment immediately 
followed by a standard bandage. 
- Subjects will be instructed to apply the provided Healing 
Ointment to the wound at least twice daily and reapply as needed.  
- Subjects to return to the site at day 7 (± 2 days for head/neck 
group) or day 14 (± 2 days for body group), and day 28 post-
treatment (± 3 days) for follow-ups.  
- For each follow-up visit, investigator will perform objective 
assessment and photography. Subjects will perform additional 
subjective tolerability assessment and self-assessment 
questionnaire.  
Statistical analysis 
Clinical grading and questionnaire.  
 
 

 
 
Page 5 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
2. 
TABLE OF CONTENTS 
 
1. 
SYNOPSIS ......................................................................................................................... 3 
2. 
TABLE OF CONTENTS ..................................................................................................... 5 
3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ............................................. 8 
4. 
BACKGROUND AND RATIONALE .................................................................................... 9 
5. 
STUDY OBJECTIVE AND CLINICAL HYPOTHESIS ......................................................... 9 
5.1 
Study Objective ............................................................................................................ 9 
5.2 
Clinical Hypothesis ....................................................................................................... 9 
6. 
SELECTION AND DISPOSITION OF STUDY POPULATION ............................................ 9 
6.1 
Number of Subjects ..................................................................................................... 9 
6.2 
Study Population Characteristics ................................................................................. 9 
6.3 
Inclusion Criteria .......................................................................................................... 9 
6.4 
Exclusion Criteria ........................................................................................................10 
6.5 
Concomitant Therapies ...............................................................................................10 
6.5.1. 
Authorized Therapies ...........................................................................................10 
6.5.2. 
Prohibited Therapies ............................................................................................10 
7. 
STUDY treatment ..............................................................................................................11 
7.1 
Product Identification and Use ....................................................................................11 
7.2 
Additional Products and Materials ...............................................................................11 
7.3 
Study Product Accountability ......................................................................................11 
7.4 
Method of Treatment Assignment ...............................................................................12 
7.5 
Treatment Product Dispensing ....................................................................................12 
7.6 
Treatments Compliance ..............................................................................................12 
8. 
Treatment of subjects ........................................................................................................12 
8.1 
Informed Consent Form ..............................................................................................12 
8.2 
Subject Identification ...................................................................................................12 
8.3 
Subject Instructions .....................................................................................................12 
8.3.1. 
Pre-procedure Instructions ...................................................................................12 
8.3.2. 
Treatment Product Usage Instruction: ..................................................................13 
8.3.3. 
Subject Instructions for Study Visits .....................................................................13 
8.3.4. 
General Study Instructions ...................................................................................13 
9. 
STUDY PROCEDURES ....................................................................................................13 
9.1 
Visits and Examinations ..............................................................................................14 
9.1.1. 
Visit 1 (Screening) ...............................................................................................14 

 
 
Page 6 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
9.1.2. 
Visit 2 (Baseline/Day 0 – Surgical procedure) ......................................................14 
9.1.3. 
Visit 3 (Day 7 or Day 14 ±2 days) .........................................................................14 
9.1.4. 
Visit 4 (Day 28 ±3 days) .......................................................................................15 
9.2 
Discontinued Subjects ................................................................................................15 
10. 
STUDY ASSESSMENTS ...............................................................................................15 
10.1 
Clinical Grading by Investigator ...............................................................................15 
10.2 
Tolerability Assessments .........................................................................................16 
10.3 
Standardized Photography ......................................................................................16 
10.4 
Self-Assessment Questionnaire ..............................................................................16 
11. 
Statistical analysis ..........................................................................................................17 
12. 
ADVERSE EVENTS .......................................................................................................17 
12.1 
Definitions ...............................................................................................................18 
12.1.1. 
Adverse Events (AE) ......................................................................................18 
12.1.2. 
Local tolerability signs and symptoms (only applicable for cosmetic safety 
studies) 
18 
12.1.3. 
Serious Adverse Events (SAE) and serious undesirable effect/related SAE ...18 
12.2 
Severity Assessment ...............................................................................................19 
12.3 
Causality Assessment .............................................................................................19 
12.4 
Collection, Management and Reporting Procedures ................................................19 
12.4.1. 
Management and reporting procedures for undesirable effects (i.e. related 
adverse events ..................................................................................................................20 
12.4.2. 
Management and reporting procedures for Serious Adverse Events ..............20 
12.5 
Pregnancy ...............................................................................................................21 
12.6 
Process for Suspected Allergic Reactions ...............................................................21 
13. 
ethical and regulatory procedures...................................................................................24 
13.1 
Research Standards/Good Clinical Practice ............................................................24 
13.2 
Quality Assurance/Audit/Inspection .........................................................................24 
13.3 
Institutional Review Board .......................................................................................24 
14. 
STUDY CONDUCT CONDISERATIONS ........................................................................24 
14.1 
Clinical Monitoring ...................................................................................................24 
14.2 
Data Collection ........................................................................................................24 
14.3 
Record Retention ....................................................................................................25 
14.4 
Changes in Study Conduct/Amendments ................................................................25 
14.5 
Confidentiality ..........................................................................................................25 
15. 
REFERENCES ...............................................................................................................26 
APPENDIX I: INGREDIENT LIST..............................................................................................27 

 
 
Page 7 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
APPENDIX II: SELF-ASSESSMENT QUESTIONNAIRE ..........................................................28 
 
 
 
 
 

 
 
Page 8 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
AE  
Adverse Event 
°C 
Degrees Celsius 
CRF 
Case Report Form 
etc. 
et cetera 
e.g.  
for example (Latin; exempla gratia) 
°F 
Degrees Fahrenheit 
GCP 
Good Clinical Practice 
HA 
Hyaluronic Acid 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization  
ICT 
Information and communication technologies 
i.e. 
that is (Latin; id est) 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
N or n 
Number 
% 
percent 
SAE 
Serious Adverse Event 
SD 
Standard deviation 
SOP 
Standard Operating Procedure 
 

 
 
Page 9 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
4. 
BACKGROUND AND RATIONALE 
Post-surgical wound care is imperative to promote rapid healing without complications. The key 
principle of wound management is to create an occlusive, clean, and moist environment at the 
wound site to reduce the possibility of infection and facilitate the wound healing phases.1 Two (2) 
common topical applications to achieve this optimal condition are topical antibiotics and over-the-
counter (OTC) petrolatum-based ointments. While both methods have comparable wound-
healing properties, topical antibiotics have been shown to potentially cause drug resistance or 
allergic contact dermatitis.2-4 For this, dermatologists often opt for petrolatum-based ointment 
application for wound healing.   
Cetaphil® Healing Ointment (Galderma, Fort Worth, TX) is an OTC skin protectant that contains 
71.5% petrolatum, shea butter to soften, smooth and hydrate, as well as vitamin E to help support 
moisture barrier function. The Healing Ointment has been clinically proven to hydrate the skin’s 
natural barrier for 48 hours while quickly protecting and healing dry, irritated skin for visible 
improvement in 1 week. The product is also hypoallergenic, non-comedogenic, gentle on sensitive 
skin and accepted by the National Eczema Association. These beneficial properties make 
Cetaphil® Healing Ointment an ideal candidate as a post-surgical wound care. This study is to 
investigate safety and efficacy of Cetaphil® Healing Ointment in wound healing after dermatologic 
procedures.  
5. 
STUDY OBJECTIVE AND CLINICAL HYPOTHESIS 
5.1 
Study Objective  
To evaluate safety and efficacy of a Healing Ointment in skin improvement after 
dermatologic procedures such as Mohs surgery, skin biopsy, excision on the head/neck 
or body.   
5.2 
Clinical Hypothesis 
The Healing Ointment, consisting of skin protectant petrolatum and other beneficial 
ingredients, will be able to protect and promote healing of the wound site post-surgery. 
6. 
SELECTION AND DISPOSITION OF STUDY POPULATION 
6.1 
Number of Subjects 
A maximum 20 subjects to complete the study, in which 10 subjects with dermatologic 
procedure on the head/neck and 10 subjects with dermatologic procedure on the body.  
6.2 
Study Population Characteristics 
Males and females who undergo Mohs surgery, skin biopsy, or excision on the head/neck or 
body (inclusive and a good ratio of each surgical type within the study panel).  
6.3 
Inclusion Criteria 
1. Subjects of 18 to 85 years of age. 
2. Subjects with a clinical diagnosis that requires invasive procedure such as Mohs 
surgery, skin biopsy, excision on the head/neck or body.  
3. Subjects of any gender. 
4. Subjects of any race and ethnicity. 

 
 
Page 10 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
5. Subjects of any Fitzpatrick skin type. 
6. Subjects who are able and willing to provide written informed consent prior to any study 
related procedures.  
7. Subjects who agree to be photographed at each visit. 
8. Subjects apprised of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA) and applicable state Bill of Rights. 
9. Subjects who agree to adhere to the procedures and requirements of the study, to report 
to the institute on the day(s) and at the time(s) scheduled for the assessments, and to 
complete all required visits. 
6.4 
Exclusion Criteria 
1. Subjects with history of allergy or hypersensitivity to cosmetic ingredients or skincare 
products. 
2. Subjects who are pregnant or breast-feeding, or who plan to become pregnant or breast 
feed during the course of the trial. 
3. Subjects with a history of keloid or hypertrophic scars. 
4. Subjects with presence of tattoo and/or scar in the treatment area that in the 
investigator’s opinion would interfere with study assessments. 
5. Subjects with any diseases, condition or presentation that may, in the opinion of the 
investigator, may put the subject at risk, may confound study results, or may interfere 
with participation in the study. 
6. Subject with inability to comply with all study protocol restrictions and visits. 
7. Subjects that are relatives of the investigator or are themselves or a relative of any study 
staff or any Galderma employee. 
8. Subjects who have participated in an investigational study within 30 days of enrollment; 
participated in biologic investigational studies within 90 days of enrollment, or subjects 
planning to participate in any other interventional clinical research study while enrolled in 
this trial. 
9. Subjects with known immunosuppression or immunosuppressive illness. 
10. Subjects with uncontrolled diabetes or autoimmune disorders. 
11. Use of concomitant medications that have the potential to prolong bleeding times such 
as anticoagulants or inhibitors of platelet aggregation (e.g., aspirin or other nonsteroidal 
anti-inflammatory drugs, Omega 3 or Vitamin E), within 14 days prior to surgical 
procedures. Omega 3 and Vitamin E were acceptable only as part of a standard 
multivitamin formulation. 
6.5 
Concomitant Therapies 
All treatments and therapies used 30 days prior to enrollment (visit 1/screening) or 90 days prior 
to enrollment for biologics and all treatments or therapies used during the course of the study 
must be recorded in the Case Report Form (CRF) or electronic Case Report Form (eCRF). 
6.5.1. Authorized Therapies 
Unless listed under the exclusion criteria (Section 6.4) or in Prohibited Therapies (Section 
6.5.2), other therapies to treat ongoing conditions are authorized. 
6.5.2. Prohibited Therapies 
None other than as specified in the Inclusion/Exclusion criteria.  

 
 
Page 11 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
The decision to administer a prohibited medication/treatment should be made with the safety of 
the subject being the primary consideration. Whenever possible, Galderma Laboratories, L.P. 
should be notified before the prohibited medication/treatment is administered to discuss 
possible alternatives. 
If a subject receives prohibited therapy during the study, the subject may be allowed (at the 
discretion of the investigator / Galderma Laboratories, L.P.) to continue in the study for safety 
evaluation purposes, only. 
7. 
STUDY TREATMENT 
The term “study treatment” refers to the study product (see Section 7.1) 
7.1 
Product Identification and Use 
Study product: Cetaphil® Healing Ointment 
Form 
Opaque ointment 
Mode of Administration 
Topical 
Formula code 
 1748 
Formula number 
B50H48 
Lot numbers 
0281N14C 
Storage and Handling 
The product is to be stored under controlled room 
temperature conditions 20°C to 25°C (68°F to 77°F), 
protected from freezing and sunlight. 
 
The ingredient list of the study product is included in Appendix I. 
7.2 
Additional Products and Materials 
The Sponsor will only provide Cetaphil® Healing Ointment for the study. The study overhead 
will cover any additional materials or supplies.  
7.3 
Study Product Accountability 
Upon receipt of the study products, the investigator or designee will conduct an inventory. In 
accordance with federal regulations, the investigator must agree to keep all test articles in a 
secure location with restricted access. Designated study personnel will provide the test article to 
the subjects in accordance with the protocol.  
During the study, the investigator must maintain records of study treatment dispensation and 
collection for each subject. This record must be made available to the study monitor for the 
purposes of verifying the accounting of clinical supplies. Any discrepancies and/or deficiencies 
between the observed disposition and the written account must be recorded along with an 
explanation. At the conclusion of the study, the investigator will be responsible for returning all 
unused study product (i.e., Cetaphil® Healing Ointment) unless otherwise instructed by the 
Sponsor. Shipping label and cost will be provided to the investigator by the Sponsor. 

 
 
Page 12 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
7.4 
Method of Treatment Assignment 
Subjects will be numbered sequentially in the order in which they qualify for entry into the study. 
7.5 
Treatment Product Dispensing 
All treatment products will be administered only to subjects enrolled in the study, at no cost to 
subjects, and in accordance with the conditions specified in the protocol. 
7.6 
Treatments Compliance 
Subjects will complete a daily diary, recording treatment product applications and comment 
during the study. Treatment product and diaries will be dispensed to subjects at Day 0 and 
reviewed for compliance at Day 28 visit. Treatment product will be visually inspected and 
weighed prior to distribution at Day 0 and at Day 28. Subjects will be instructed to return the 
treatment product and daily diary at Day 28 visit. If subjects do not return their treatment product 
or diary at the end of the study, a verbal confirmation will be obtained for usage compliance, and 
it will be documented as a note to file. 
Any suspected noncompliance with the treatment product or study instructions will be 
addressed by the Investigator or clinic staff. The Investigator will determine whether a subject’s 
noncompliance will affect the study outcome and whether the data should be excluded from 
statistical analyses. 
8. 
TREATMENT OF SUBJECTS 
8.1 
Informed Consent Form 
An IRB-approved informed consent form (ICF), consistent with the requirements in 21 Code of 
Federal Regulations (CFR) 50.25, will be given to each prospective subject. Prospective 
subjects will be given as much time as needed to read the ICF and will have the opportunity to 
have any study-related questions answered to their satisfaction prior to signing the ICF. If 
further questions exist, prospective subjects will be given sufficient time during the first visit to 
have questions regarding the study and/or the ICF answered by the Investigator, or clinic staff 
prior to signing.  
8.2 
Subject Identification 
Enrolled subjects will be assigned a 3-digit subject number when used in conjunction with their 
initials. This will uniquely identify every subject on the study. These numbers will remain with the 
subjects throughout the study and should be used in all references to the individual in this study. 
No subject number will be reassigned once the study begins.  
8.3 
Subject Instructions 
Subjects will be provided with the following instruction to follow upon the surgical procedure 
completion: 
8.3.1. Post-procedure Instructions 
• 
Keep procedure/surgical bandage in place for 36-48 hours. Remove and clean incision 
with warm soapy water or half-strength peroxide as needed. Do not submerge in water. 
Pat dry with clean towel. Limit strenuous activity.  

 
 
Page 13 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
8.3.2. Treatment Product Usage Instruction: 
• 
Apply the provided treatment product liberally to the surgical site at least twice a day. 
Reapply as needed throughout the day. Apply bandage as needed. 
8.3.3. Subject Instructions for Study Visits 
• 
Bring the treatment product and daily diary with you to every visit.  
8.3.4. General Study Instructions 
• 
Avoid extended periods of sun exposure for the duration of the study.  
• 
Do not use any topical products (except sunscreen as needed) on the surgical site other 
than the provided treatment product for the duration of the study.  
9. 
STUDY PROCEDURES 
The table below represents a summary of the study procedures and evaluation schedule:  
1. Visit 1 – Screening 
2. Visit 2 – Baseline/Day 0 (surgical procedure) 
3. Visit 3 – Day 7 (for head/neck group) or Day 14 (for body group) 
4. Visit 4 – Day 28 
Test design / flow chart 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Screening 
Baseline 
Day 0 
Pre-
procedure 
Baseline 
Day 0 
Post-
procedure 
Day 7 or 
Day 14 
Day 28 
ICF and qualification/enrollment 
X 
 
 
 
 
Photo consent 
X 
 
 
 
 
Demographics/Med History 
X 
 
 
 
 
Concomitant Meds. 
X 
 
 
 
 
Inclusion and exclusion criteria 
X 
 
 
 
 
CRF 
 
X 
X 
X 
X 
Investigator grading 
 
X 
X 
X 
X 
Subjective tolerability grading 
 
X 
X 
X 
X 
Standardized photography 
 
X 
X 
X 
X 
Self-assessment questionnaire 
 
 
 
X 
X 
AE reporting 
 
 
X 
X 
X 
Treatment product 
 
W 
D 
W 
C/W 
Daily diaries 
 
 
D 
C/D 
C 
For treatment product and/or daily diaries: W = Weigh, D = Distribute, C = Collect 

 
 
Page 14 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
9.1 
Visits and Examinations 
9.1.1. Visit 1 (Screening) 
1. Subjects will report to the clinic for screening to determine if they are eligible to be in the 
study. 
2. Prior to beginning of any study related activities, subjects will be informed about the 
purpose and nature of the study, the expected post-procedure events, and the potential 
risks involved with the surgical procedure and treatment product. 
3. Subjects will be given an ICF, HIPAA form, and photography release form to read. 
4. Once subjects have completed reading, they will be interviewed to ensure their 
understanding of the aforementioned forms and be given the opportunity to ask any 
study related questions. 
5. Subjects who agree to sign the aforementioned forms will be asked to complete a 
demographic information, medical history form, and concomitant medication form. 
Subjects declining to sign any of the forms will be dismissed from the study. 
6. Subjects will be screened and qualified on the basis of the subject inclusion and 
exclusion criteria. Subjects failing to meet criteria will be dismissed from the study. 
9.1.2. Visit 2 (Baseline/Day 0 – Surgical procedure) 
1. Investigator or clinic staff will ask the subjects if they have experienced any changes in 
their health since the previous visit.  
2. Before the surgical procedure, the assessments below will be completed: 
a. Clinical grading by Investigator as described in section 10.1 
b. Tolerability assessment by the subjects as described in section. 
3. The surgical area will be assessed and prepped for the procedures, followed by 
procedure execution by Investigator. 
4. After the surgical procedure, the assessments below will be completed: 
a. Standardized photography as described in section 10.3 
b. Clinical grading by Investigator as described in section 10.1 
c. Tolerability assessment by the subjects as described in section 10.2 
5. Investigator or clinic staff will apply the treatment product to the surgical site followed by 
standard bandage. 
6. Subjects will be given the treatment product with instruction of application, a diary to 
record usage of the treatment product, and when to contact the Investigator in case of 
emerging AEs.  
7. Subjects will be scheduled for a follow-up visit at Day 7 or 14 (±2 days) and dismissed 
from the Clinic.  
9.1.3. Visit 3 (Day 7 or Day 14 ±2 days) 
1. Clinic staff or Investigator will record any AEs that are observed or reported. 
2. The surgical site will be assessed in the following: 
a. Clinical grading by Investigator as described in section 10.1 
b. Tolerability assessment by the subjects as described in section 10.2 
c. Standardized photography as described in section 10.3 
d. Self-assessment questionnaire as described in section 10.4 
3. Clinic staff or Investigator will collect and review the treatment product and diary for 
compliance purpose.  

 
 
Page 15 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
4. Subjects will be scheduled for a follow-up visit at Day 28 (±3 days) and dismissed from 
the Clinic. 
9.1.4. Visit 4 (Day 28 ±3 days) 
1. Clinic staff or Investigator will record any AEs that are observed or reported. 
2. The surgical site will be assessed in the following: 
a. Clinical grading by Investigator as described in section 10.1 
b. Tolerability assessment by the subjects as described in section 10.2 
c. Standardized photography as described in section 10.3 
d. Self-assessment questionnaire as described in section 10.4 
3. Clinic staff or Investigator will collect and review the treatment product and diary for 
compliance purpose. 
4. Once completed, subjects will be dismissed from the Clinic. 
9.2 
Discontinued Subjects 
Any subject is free to discontinue his/her participation in this study at any time and for whatever 
reason, specified or unspecified, and without prejudice.   
Investigator may decide to discontinue a subject from the study for safety reasons or when it is 
in the best interest of the subject. Galderma Laboratories, L.P. may also decide to prematurely 
terminate or suspend the study or the participation of a subject in the study. All data gathered on 
the subject prior to termination should be made available to Galderma Laboratories, L.P. 
Criteria for the discontinuation of a subject during the study will include the following:  
• 
Adverse Event 
• 
Lack of Efficacy 
• 
Pregnancy 
• 
Subject Request 
• 
Protocol Violation 
• 
Lost to Follow-up 
• 
Any unmanageable factor, in the Investigator’s opinion, that may significantly interfere 
with the protocol or interpretation of results.  
10. 
STUDY ASSESSMENTS 
All data and images taken from the study will be saved and shared to the Sponsor via a data-
protected platform. 
10.1 
Clinical Grading by Investigator 
Investigator will perform clinical grading at the surgical site on each subject at baseline (pre- and 
post-procedure), day 7/14, and day 28. Investigator will grade the severity of wound parameters 
based on a visual analog scale, described in the table below (for erythema, edema, overall 
wound appearance, half-point scores can be used as necessary to better describe the 
condition):  
Parameters 
Score 0 
Score 1 
Score 2 
Score 3 
Erythema 
None/absent 
Mild 
Moderate 
Severe 

 
 
Page 16 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
Edema 
None/absent 
Mild 
Moderate 
Severe 
Overall wound 
appearance 
Excellent (absent 
of wound) 
Good (slightly 
visible wound) 
Fair (moderately 
visible wound) 
Poor (marked 
visible wound) 
 
Parameters 
Score 0 
Score 1 
Score 2 
Score 3 
Score 4 
Scabbing/crusting 
None 
Slight 
(up to 30%) 
Moderate 
(31-60%) 
Extensive 
(61-90%) 
Almost complete 
or complete 
(91-100%) 
 
10.2 
Tolerability Assessments 
Tolerability assessments will be performed by subjects at the surgical site at baseline (pre- and 
post-procedure), day 7/14, and day 28. Subjects will grade the degree of irritation parameters 
that they experience based on a 4-point analog scale, described in the table below (with half-
point scores used as necessary to better describe the clinical condition):  
Parameters 
Score 0 
Score 1 
Score 2 
Score 3 
Burning 
None 
Mild 
Moderate 
Severe 
Itching 
None 
Mild 
Moderate 
Severe 
Pain 
None 
Mild 
Moderate 
Severe 
 
10.3 
Standardized Photography 
Standardized digital photography of the surgical site will be taken at baseline (pre- and post-
procedure), day 7/14, and day 28. 
The following guidelines of digital photography are followed: 
• 
Surgical site position is the same in before and after photos 
• 
Same lighting conditions are used and the distance from the camera is same for both 
before and after photos 
• 
Same room and white background are used for both before and after photos 
• 
Clean skin 
• 
Avoid any object that could interfere with the images such as hair, jewelry, etc. 
A total of 4 digital images will be taken of each subject’s surgical site using a Canon EOS Rebel 
T5 digital camera (Canon Inc., Taiwan) under the standard lighting condition. 
10.4 
Self-Assessment Questionnaire 
Subjects will complete self-assessment questionnaire at day 7/14 and day 28. See Appendix II: 
Self-assessment questionnaire.  

 
 
Page 17 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
11. 
STATISTICAL ANALYSIS 
A descriptive statistical summary will be provided for clinical grading and tolerability 
assessments. The descriptive summery will be performed for each parameter, including N, 
mean, median, standard deviations, minimum, and maximum of values at all applicable time 
points.  
Mean of the change from baseline (pre-procedure) will be estimated at applicable post-baseline 
time point. The null hypothesis, that the mean change from baseline (pre-procedure) is zero, will 
be tested using methods described in the Statistical Analysis Plan table. 
The following will be calculated and reported for each evaluation parameter at applicable post-
baseline (pre-procedure) time point: 
Percent mean change from baseline = 
(postprocedure or visit mean score – baseline preprocedure mean score)
baseline preprocedure mean score
 x 100 
Percent of subjects improved/worsened = 
(number of subjects improved/worsened from baseline preprocedure)
total number of subjects
 x 100 
Questionnaires will be tabulated, and the percentage of all response options (favorable and 
unfavorable) will be reported for each question and each timepoint.  
Statistical Analysis Plan 
Evaluation 
Change from Baseline Pre-
Procedure 
Notes/Interpretation 
Clinical grading 
Paired t-test; If normality fails, a 
Wilcoxon signed-rank test will be 
used. 
A decrease in scores indicates 
an improvement 
Tolerability assessment 
Paired t-test; If normality fails, a 
Wilcoxon signed-rank test will be 
used. 
A decrease in scores or lack of 
significant increase indicates 
tolerability/safety of the 
treatment product 
Self-assessment 
questionnaire 
N/A 
Percentage of favorable and 
unfavorable responses will be 
provided for each question.  
 
All statistical tests will be 2-sided at significance level alpha = 0.05 unless specified otherwise. P 
values will be reported to 3 decimal places.  
12. 
ADVERSE EVENTS 
Throughout the course of the study, all adverse events will be monitored and reported on an 
adverse event CRF/eCRF without omitting any requested and known information. When AEs 
occur, the main concern is the safety of the study subjects. At time of the informed consent 
signature, each subject must be given the name and phone number of investigational site 
personnel for reporting AEs and medical emergencies. 
At each visit, after the subject has had the opportunity to spontaneously mention any problems, 
the investigator should inquire about AEs by asking the standard questions: 

 
 
Page 18 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
• 
“Have you had any health problems since your last study visit?” 
• 
“Have there been any changes in the medicines you take since your last study visit?” 
AEs should be reported for any clinically relevant change, as determined by the Investigator, in 
concomitant medication(s) that is the result of an untoward (unfavorable and unintended) 
change from baseline in a subject's medical health following exposure to the study treatment. 
Changes from baseline in any protocol-specific parameter evaluated during the study are to be 
reviewed by the Investigator. In addition, the subject’s responses to any questionnaire utilized 
during the study are to be reviewed by the investigator. Any untoward (unfavorable and 
unintended) change from baseline in a protocol-specific parameter or question response that is 
clinically relevant, in the opinion of the investigator, is to be reported as an AE. These clinically 
relevant changes will be reported regardless of causality. 
12.1 
Definitions 
12.1.1. Adverse Events (AE) 
An adverse event (AE) is defined as any untoward medical occurrence in a subject taking part in 
the clinical study, and which does not necessarily require a causal relationship with the 
investigational product and/or a clinical trial procedure.  
An AE can be any unfavourable and unintended sign (including an abnormal laboratory value), 
symptom, or disease temporally associated with the use of the investigational product, whether 
or not related to this product. 
When an AE has a likely or very likely causal relationship with the investigational product and/or 
a clinical trial procedure, it is named undesirable effect or related AE (see Section 3).  
12.1.2. Local tolerability signs and symptoms (only applicable for cosmetic safety studies) 
In cosmetic studies, local skin tolerability includes some expected functional and/or physical 
signs on the application area, observed by the Investigator or reported by the subjects (see 
Appendix). Those signs are collected in the final report based on scales or a diary. If the 
severity of a local skin tolerability sign or symptom, is such that the product application is 
permanently discontinued and/or a corrective concomitant treatment (except moisturizer or 
emollient) is prescribed, it is recorded as an undesirable effect (related AE). 
12.1.3. Serious Adverse Events (SAE) and serious undesirable effect/related SAE 
A Serious Adverse Event (SAE) is any adverse event which results in death, is life-threatening, 
requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent 
or significant disability/incapacity, or is a congenital anomaly/birth defect.  
Notes: 
The term “immediate vital risk” refers to an event in which the subject was at risk of death at the 
time of the event; it does not refer to an event that hypothetically might have caused death if it 
was more severe. 

 
 
Page 19 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
Inpatient hospitalization is considered to have occurred if the subject has had to stay for a night 
at the hospital.  Hospitalization solely for the purpose of a diagnostic test (even if related to an 
AE), elective hospitalization for an intervention that was already planned before subject enrolment 
in the clinical trial, admission to a day-care facility, social admission (e.g., if the subject has no 
place to sleep), or administrative admission (e.g., for a yearly examination) should not be 
considered as a SAE. 
A serious undesirable effect/related SAE is defined as any SAE which the Investigator classifies 
as having a reasonable possibility for a causal relationship with the investigational product 
and/or the clinical trial procedure. 
12.2 
Severity Assessment 
For all AEs occurring during the clinical trial, the Investigator is to classify and report the intensity 
of AEs using the following definitions as a guideline: 
- 
Mild: awareness of signs and symptoms, but easily tolerated 
- 
Moderate: discomfort, enough to cause interference with usual activity 
- 
Severe: incapacitating, with inability to work or perform usual activity. 
12.3 
Causality Assessment 
The Investigator is to assess the causal relationship (causality) between an adverse event and 
the investigational product and/or the clinical trial procedure according to the following definitions 
(Decision of 25 November 2013 on Guideline on Annex I to Regulation (EC) No 1223/2009 
(2013/674/EU) - Causality assessment of undesirable effect caused by cosmetic products): 
• 
Very likely 
• 
Likely 
• 
Not clearly attributable 
• 
Unlikely 
• 
Excluded 
Medical judgment should be used to determine the relationship, considering all relevant factors 
including the pattern of reaction, temporal relationships, positive de-challenge or re-challenge, 
relevant medical history, and confounding factors such as co-medication or concurrent diseases. 
12.4 
Collection, Management and Reporting Procedures 
The period of collection of adverse events starts from the time of signature of the Informed 
Consent Form (ICF) by the subject (and/or, for subjects who are minor, by the parents/legal 
representatives) until the end of the subject’s participation in the clinical study.  
If a Serious Adverse Event (SAE) is on-going at the final clinical trial visit, it should be followed by 
the Investigator until it has resolved or has reached a stable condition.  
After the subject completes the clinical study, the Investigator should also inform the Sponsor 
(see Sponsor’s contact details below) if he/she becomes aware of an SAE involving a subject 
who has participated in the clinical study.  
At each post-enrollment visit, the Investigator will question the subject about AEs using an open 
non-persuasive question to elicit reporting of AEs, for example “Have you noticed any change in 
your health since the last visit?” Direct questioning and examination will be performed when 
appropriate.  

 
 
Page 20 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
The Investigator will obtain and maintain in the subject’s files all pertinent medical records, and (if 
applicable) information and medical judgment from colleagues who assisted in the treatment and 
follow-up of the subject.  If necessary, the Investigator will contact the subject’s personal physician 
or hospital staff to obtain further details.  
As a minimum, Investigators are requested to report in the Case Report Form (CRF) and 
in the report all related adverse events (i.e. undesirable effects) and all Serious Adverse 
Events, whether related or not. 
12.4.1. Management and reporting procedures for undesirable effects (i.e. related adverse 
events 
Undesirable effects should be recorded in the CRF and summarized in the report in a summary 
table with at minimum the subject number, AE number, AE diagnosis or signs and symptoms, 
location, date of onset, seriousness, severity, action taken, relationship, date of resolution and 
concomitant treatment associated as well as a detailed narrative of the event. 
In addition, based on his/her medical judgment, the Investigator will assess whether an 
undesirable effect requires immediate (i.e. within 24 hours) reporting to the Sponsor. In such 
cases, the summary table will be sent to the Sponsor, along with the AE narrative and any other 
relevant information (concomitant treatments, product weighing, …).  
All undesirable effects should be appropriately documented, i.e. any relevant information such as 
demographics, medical history and concomitant therapies should be recorded in the CRF. 
The Investigator is to monitor and record the progress of the adverse effect until the last subject’s 
study visit. 
The Investigator is to update the AE narrative as appropriate, each time follow-up information is 
collected and when the final outcome of the adverse effect is known. 
12.4.2. Management and reporting procedures for Serious Adverse Events  
The Investigator is to take the following steps: 
1. Take prompt and appropriate medical action, if necessary. The safety of clinical trial 
subjects is the first priority 
2. Ensure the AE is classified as an SAE. Immediately inform the Sponsor’s representative 
of the event by email or fax (see contact details below) and discuss further actions to be 
taken: 
e-mail: pharmacovigilance@galderma.com 
3. Complete the Serious Adverse Event (SAE) form provided by the Sponsor’s 
representative Within 24 hours, fax or send by e-mail to the Sponsor’s representative 
the completed SAE form, accompanied any other relevant information (e.g. test results or 
medical records).  
4. Monitor, record and send to Sponsor’s representative the progress of the event until it 
resolves or reaches a stable outcome, with or without sequelae (send the updated SAE 
form with follow-up information and any other relevant information to Sponsor’s 
representative). 
5. Obtain and maintain in the subject’s file all pertinent medical records, information, and 
medical judgments from colleagues who assisted in the treatment and follow-up of the 

 
 
Page 21 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
subject. If necessary, contact the subject’s personal physician or hospital staff to obtain 
further details. 
6. If applicable, comply with the regulatory requirement(s) related to the reporting of SAEs 
to the Institutional Review Board (IRB) / Independent Ethics Committee (IEC). 
12.5 
Pregnancy 
Pregnancy itself is not to be considered as an adverse event. If a pregnancy occurs during the 
clinical trial, the product application should be stopped immediately, the subject should be 
withdrawn from the clinical study and Sponsor’s representative (see Sponsor’s contact details 
above) should be informed within 24 hours.  
Pregnancy must be recorded as a reason for discontinuation in the exit form of the CRF.  
No specific follow-up of pregnancy is required, except if it is a regulatory requirement in the 
country(ies) where the clinical trial is conducted. 
12.6 
Process for Suspected Allergic Reactions 
In case of a positive reaction (suspicion of allergy) in the clinical study, the Investigator will inform 
the Sponsor if the reaction occurs with the Sponsor’s company product(s) following the procedure 
below. The Investigator will also inform if products other than the Sponsor’s product(s) were 
concomitantly tested in the clinical trial, and if there were positive reaction(s) for these other 
products.  
 
Stop the investigational product. 
 
Take a picture of the affected area and the surrounding skin. 
 
Report the event by email within 24 hours to the Sponsor’s representative (see Sponsor’s 
contact details above). The Sponsor will then contact you to explain the general procedure to 
be followed.  
 
Follow the procedure detailed below: 
1. 
After all signs and symptoms of the event have resolved and after a minimum of at 
least two weeks from last dose application perform a re-challenge test with the 
assigned study product  
2. 
Ensure the subject has not been under any treatment with corticosteroids or 
antihistaminics within the week before testing 
3. 
Ensure that the skin on the back has not been irradiated by the sun or artificial 
ultraviolet sources within the week before testing 
4. 
Apply an appropriate quantity of the study product to fill in the cupule of the test 
chamber and then to the upper part of the back skin (or the inner forearm if more 
appropriate) either at right or left from the central line. If no test chamber is available 
on site, patch test units will be provided by the Sponsor. The use of semi-occlusive 
conditions can be preferred depending on the irritant potential of the study product 
and the intensity of the reaction which was reported. The method to be used should 
be discussed with the Sponsor.  
Choose a skin site that was not previously involved in the inflammatory skin reaction. Cover 
it for 48 hours with a hypoallergenic tape 
5. 
Subject should be informed about avoiding exercise, showers, etc. to keep the test 
system dry 

 
 
Page 22 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
6. 
After 48 hours, remove the tests and evaluate the site reactions: 
 
30 minutes after patch test removal (1st reading), 
 
48 hours after patch removal (2nd reading).   
 
72 or 96 hours after patch removal (3rd reading). 
 
Pictures of the tested areas will be taken systematically at each reading and properly documented 
 
7. 
Use the following scoring system (International Contact Dermatitis Research Group) 
at each reading:  
 
Score Morphology 
Interpretation 
- 
No reaction 
Negative 
? 
Erythema only, no infiltration 
Doubtful reaction 
+ 
Erythema, infiltration, possibly 
discrete papules 
Weak positive reaction 
++ 
Erythema, infiltration, papules, 
vesicles 
Strong positive reaction 
+++ 
Erythema, infiltration, confluent 
vesicles, bullae 
Extreme positive reaction 
ir 
 Inflammation sharply limited to the 
exposed area, lack of infiltrate, 
small petechiae, pustules, and 
efflorescences other than papules 
and vesicles 
Irritant reaction 
Nt 
 
Not tested 
 
8. 
At last reading, the investigator will provide an assessment regarding a possible 
sensitization reaction using the following scale: 
 
Sensitization Reaction 
0 
Negative (absence of reaction or might be irritative reaction) 
1 
Equivocal 
2 
Positive 
 

 
 
Page 23 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
9. 
Report the results from the re-challenge test as directed by the Sponsor and document 
with photographs. 
10. In case of absence of reaction after quotation with the ICDRG scale, the subject may 
resume product application, if appropriate. 
11. After quotation with the ICDRG scale, if the re-challenge is positive, equivocal or in 
favour of an irritation, notify the Sponsor immediately. Except specific situations, a new 
series of patch test will be initiated as directed by the Sponsor (with individual 
ingredients at different concentrations and possibly negative and positive controls) 
after a minimum of additional two weeks (but not later than 6 months) and after all 
signs and symptoms have resolved.  The patch tests will be placed on a back skin site 
(or the inner forearm if more appropriate) distant from the site of re-challenge test (e.g. 
at the left upper back skin if the re-challenge test was done on the right). Follow the 
same procedure for the patch test as for the re-challenge.  
 
 

 
 
Page 24 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
13. 
ETHICAL AND REGULATORY PROCEDURES 
13.1 
Research Standards/Good Clinical Practice 
This study will be conducted in accordance with all applicable guidelines for the protection of 
human subjects for research as outlined in 21 CFR 50 the accepted standards for Good Clinical 
Practice (GCP), and the standard practices of SGS Stephens in accordance with the protocol 
and amendment(s) as applicable. 
13.2 
Quality Assurance/Audit/Inspection 
To ensure compliance with GCP and all applicable regulatory requirements, Galderma 
Laboratories, L.P. may conduct a quality assurance audit of the site records, and the regulatory 
agencies may conduct a regulatory inspection at any time during or after completion of the 
study. The investigator must agree to grant the auditor(s) and inspector(s) direct access to all 
relevant documents and to allocate their time and the time of their staff to discuss any 
findings/relevant issues. 
13.3 
Institutional Review Board 
This study (protocol, ICF and all addenda) will be reviewed and approved by Sterling IRB. The 
study will not be activated and subjects will not be consented, receive any study products, or 
participate in any study procedures until the IRB has approved the protocol and the ICF. In 
addition, the IRB will review the study before any significant change in the protocol is initiated. 
After each review, the IRB's approval will be documented in a letter to the Investigator and a 
copy of the IRB approval letter will be forwarded to the Sponsor. 
14. 
STUDY CONDUCT CONDISERATIONS 
14.1 
Clinical Monitoring 
The conduct of the study will be closely monitored by representatives of Galderma Laboratories, 
L.P. following GCP, ICH guidelines, applicable SOPs, guidelines, and all local regulations. The 
clinical investigation will be monitored to ensure that:  the rights and well-being of the subjects 
are protected; the reported data are accurate, complete and verifiable from applicable source 
documents; and the study is conducted in accordance with the currently approved protocol and 
any other study agreements, GCP, and all applicable regulatory requirements. The investigator 
will allow the Galderma Laboratories, L.P. representatives to have access to all study records, 
CRF/eCRFs, corresponding subject medical records, and any other documents considered 
source documentation. The investigator also agrees to assist the representatives, if required, 
which can include AE reporting. All study monitoring details will be detailed in the Clinical 
Monitoring Plan. 
14.2 
Data Collection 
Investigators must keep accurate records of all subjects' visits and all procedures done, being 
sure to include all pertinent study related information from which CRF/eCRF data will be 
recorded. Data for this study may be recorded in the subject's chart (e.g. source documents / 
electronic records) or if approved by the Galderma Laboratories, L.P. directly into CRF/eCRFs. 
If electronic records are maintained, the method of verification must be determined in advance 
of starting the study. The process of administering the informed consent must also be 
documented. Any and all side effects and AEs with the concomitant therapies associated must 

 
 
Page 25 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
be thoroughly documented. Results of any diagnostic tests conducted during the study should 
be included in the source documentation. Pertinent telephone conversations with the subjects 
and/or Galderma Laboratories, L.P. concerning the study will be documented and kept on file. 
It is required that the author of an entry in the source documents be identifiable. Direct access to 
all source documentation (medical records) must be allowed for the purpose of verifying that the 
data recorded in the CRF/eCRF are consistent with the original source.  
Only designated individuals may complete the CRF/eCRFs. The principal investigator will 
review the reported data and certify that the CRF/eCRFs are accurate and complete.  
After monitoring has occurred at the clinical site(s) and the CRF/eCRFs have been reviewed, 
additional data clarifications and/or additions may be needed including AE reporting. Data 
clarifications and/or additions are documented and are part of each subject’s CRF/eCRFs. 
14.3 
Record Retention 
The investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by Galderma Laboratories, L.P. and the investigator’s files will be reviewed as part of 
the ongoing study monitoring. The records must be easily accessible when needed (e.g., for a 
Galderma Laboratories L.P.’s audit or regulatory inspection) and must be available for review in 
conjunction with assessment of the facility, supporting systems, and relevant site personnel. 
Financial information is not subject to regulatory inspection and should be kept separately.  
Galderma Laboratories, L.P. will inform the investigator of the time period for retaining the site 
records in order to comply with all applicable regulatory requirements. The minimum retention 
time will meet the strictest standard applicable to a particular site, as dictated by local 
laws/regulations, Galderma Laboratories, L.P. SOPs, and/or institutional requirements. 
The investigator should take measures to prevent accidental or premature destruction of these 
documents. If the investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. Galderma Laboratories, L.P. must be notified in writing of the name 
and address of the new custodian. 
14.4 
Changes in Study Conduct/Amendments 
No amendment will be done for modification(s) due to change in logistical or administrative 
aspect of the study (e.g., change in monitors, change of telephone numbers). In such a case, 
the appropriate institution(s) and/or person(s) will be notified of the changes. 
Modification of the protocol is prohibited without prior written agreement in the form of a protocol 
amendment. All amendments will be created by Galderma Laboratories, L.P. and must be 
approved by the IRB prior to implementation except when required to mitigate immediate safety 
risks or when the changes involve only logistical or administrative revisions.  
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all Subjects/subjects currently enrolled in the study may 
be required by the IRB to sign the approved, revised informed consent form. 
14.5 
Confidentiality 
All the data provided to the investigator and his/her staff and all data obtained through this 
Galderma Laboratories, L.P. protocol will be regarded as confidential and proprietary in nature 

 
 
Page 26 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
and should not be disclosed to any third party without Galderma Laboratories, L.P.’s written 
consent” 
 
15. 
REFERENCES 
1. Doughty, D. Dressings and more: guidelines for topical wound management. Nurs Clin 
North Am. 2005;40:217-31. 
2. Ross JI, Snelling AM, Carnegie E, et al. Antibiotic-resistant acne: lessons from 
Europe. Br J Dermatol. 2003;148:467-78. 
3. Gehrig KA, Warshaw EM. Allergic contact dermatitis to topical antibiotics: epidemiology, 
responsible allergens, and management. J Am Acad Dermatol. 2008;58:1-21. 
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. 2011;64(3 Suppl):S8-S15. 
 
 

 
 
Page 27 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
APPENDIX I: INGREDIENT LIST 
HEALING OINTMENT 
Active ingredient: 
Petrolatum 71.5% 
Inactive ingredients:  
Cetearyl Ethylhexanoate 
Butyrospermum Parkii (Shea) Butter 
Beeswax 
Microcrystalline Wax 
Tocopheryl Acetate (Vitamin E Acetate) 
 
 

 
 
Page 28 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
APPENDIX II: SELF-ASSESSMENT QUESTIONNAIRE 
 
 
 
Testimonials (please provide any comments on the study product, your experience, 
satisfaction/dissatisfaction, or anything related to this study) 
____________________________________________________________________________ 
____________________________________________________________________________ 
Day 7/14 
Strongly 
Agree 
Agree 
Neither 
Agree 
nor 
Disagree 
Disagree 
Strongly 
Disagree 
My wound feels moisturized 
  
  
  
  
  
This product soothes the wound and 
surrounding skin 
  
  
  
  
  
I have noticed an improvement in my 
wound 
  
  
  
  
  
This product leaves the wound feeling 
pleasant 
  
  
  
  
  
This product does not irritate the wound 
area 
  
  
  
  
  
Day 28 
Strongly 
Agree 
Agree 
Neither 
Agree 
nor 
Disagree 
Disagree 
Strongly 
Disagree 
This product does not feel greasy on the 
skin 
  
  
  
  
  
This product provides a protective layer 
for my wound 
  
  
  
  
  
This product keeps the wound surface 
clean and moisturized 
  
  
  
  
  
This product helps heal the wound 
effectively 
  
  
  
  
  
My wound is much improved since using 
this product 
  
  
  
  
  
Yes 
No 
I would recommend this product for post-surgical wound care 
  
  
I would purchase this product for post-surgical wound care 
  
  
I would prefer this product over my previous ointment or 
petrolatum based-product (for those who used ointment or 
petrolatum based-product only) 
  
  

 
 
Page 29 of 29 
Protocol GLI.04.US.SL.017 
CONFIDENTIAL 
Protocol Version 1:  
This document contains confidential, proprietary information. 
____________________________________________________________________________ 
____________________________________________________________________________ 
____________________________________________________________________________