A Randomized, Evaluator-blind, Single-center and Two Arm Clinical Study Designed to Evaluate the Local Tolerance and Cosmetic Efficacy of a Topical Skin Care Formulation in Healthy Female Subjects With Mild to Advanced Photo-damaged Facial Skin Who Have Undergone a 70% Glycolic Acid Facial Peel Procedure
Phase: NA
Conditions: Skin Care
Sponsor: GlaxoSmithKline

Copyright:  GlaxoSmithKline.  An unpublished work subject to trade secret 
protection.  This work contains confidential and proprietary information of 
GlaxoSmithKline and should not be copied, circulated, or distributed to persons not 
employed by GlaxoSmithKline unless specifically authorized.  Unauthorized 
disclosure of this work is expressly prohibited.
Clinical Protocol
207213
 
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2
CONFIDENTIAL
SUMMARY INFORMATION
Title:
A randomized, evaluator-blind, single-center and two-
arm clinical study designed to evaluate the local 
tolerance and cosmetic efficacy of a topical skin care 
formulation in healthy female subjects with moderate to 
advanced photo-damaged facial skin who have 
undergone a 70% Glycolic Acid facial peel procedure.
Protocol Number:
207213
Sponsor:
GlaxoSmithKline (GSK)
RuaHungria, 1.240 -4
0andar
Jardim Europa -Sao Paulo -SP
CEP: 01455-000, Brazil
Tel: 
Product Name:
Physiogel Calming Relief SPF 20 Cream
Development Phase:
NotApplicable
Expert Advice Outside of Normal 
Working Hours:
Tel: 
Key Protocol Authors:
Clinical Research Scientist
, PhD.
GlaxoSmithKline Consumer Healthcare 
(GSKCH)
St George’s Avenue
Weybridge, Surrey, KT13 0DE
Tel: 
PRIMARY CONTACT
Clinical Study Manager:
, MSc.
 
, PHD.
GlaxoSmithKlineConsumer Healthcare 
(GSKCH)
Rua Hungria, 1.240 -4
oandar
Jardim Europa -Sao Paulo -SP
 
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3
CEP: 01455-000, Brazil
Tel: 
Biostatistician:
, MA.
, 
MSC, CSTAT
GlaxoSmithKline Consumer Healthcare 
(GSKCH)
Tel: 
ST GEORGE’S AVENUE
WEYBRIDGE, SURREY, KT13 0DE
TEL: 
Other Protocol Authors:
Medically Qualified Person:
, MD, PhD.
Medical Affairs Lead:
, M.D., S.P.R.A.S.
Clinical Supplies:
, MSc.
Data Manager:
, B Pharm.
Principal Investigator:
Mariane Mosca, BSc.
Study Site Name & Address:
ALLERGISA -Av. Dr. Romeu Tórtima, 
452/466 –Barão Geraldo –Campinas –
SP
Study Site Telephone Number:
(business hours) or 
 (24 hours)
 
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PRINCIPAL INVESTIGATOR PROTOCOL AGREEMENT 
PAGE
I confirm agreement to conduct the study in compliance with the protocol and 
any amendments and according to the current ICH GCP guidelines.
I acknowledge that I am responsible for overall study conduct. I agree to 
personally conduct or supervise the described study.
I agree to ensure that all associates, colleagues and employees assisting in the 
conduct of the study are informed about their obligations. Mechanisms are in 
place to ensure site staff receives all appropriate information throughout the 
study.
I agree to conduct this study in full conformance with the laws and regulations 
of the country in which the research is conducted and the Declaration of 
Helsinki.
Investigator Name:
Investigator Qualifications:
Investigator Signature:
Date of Signature/ Agreement:
DD/MMM/YYYY
 
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TABLE OF CONTENTS
SUMMARY INFORMATION..............................................................................2
PRINCIPAL INVESTIGATOR PROTOCOL AGREEMENT PAGE...............4
TABLE OF CONTENTS......................................................................................5
PROCESS FOR AMENDING THE PROTOCOL..............................................12
PROTOCOL AMENDMENT PAGE...................................................................13
PROTOCOL SYNOPSIS FOR STUDY 207213...................................................17
1. INTRODUCTION.............................................................................................24
2. OBJECTIVE(S) AND ENDPOINT(S)..............................................................26
3. STUDY PLAN....................................................................................................27
3.1. Study Design..........................................................................................27
3.2. Subject Restrictions...............................................................................30
3.3. Type and Planned Number of Subjects.................................................31
3.4. Study Design and Dose Justification.....................................................31
4. SELECTION OF STUDY POPULATION AND WITHDRAWAL CRITERIA
................................................................................................................................36
4.1. Inclusion Criteria...................................................................................36
4.2. Exclusion Criteria..................................................................................37
4.3. Screening/ Baseline Failures..................................................................39
4.4. Withdrawal/ Stopping Criteria.............................................................39
4.5. Subject Replacement.............................................................................40
4.6. Subject and Study Completion..............................................................40
5. PRODUCT INFORMATION...........................................................................41
5.1. Study Product........................................................................................41
5.2. Application Schedule.............................................................................42
5.3. Application Modification.......................................................................43
5.4. Product Compliance..............................................................................43
5.5. Precautions.............................................................................................44
5.6. Overdose.................................................................................................44
5.7. Rescue Therapy......................................................................................44
 
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5.8. Product Assignment...............................................................................44
5.8.1 Randomization................................................................................44
5.8.2 Blinding...........................................................................................45
5.8.3 Code Breaks.....................................................................................45
5.9. Packaging and Labelling.......................................................................45
5.9.1. Accountability of Product..............................................................45
5.9.2. Storage of Product..........................................................................46
6. STUDY ASSESSMENTS AND PROCEDURES..............................................47
6.1. Visit 1 –Screening / Washout Visit.......................................................47
6.1.1. Informed Consent...........................................................................47
6.1.2. Demographics.................................................................................48
6.1.3. Medical History and Concomitant Medication.............................48
6.1.4. Fitzpatrick Skin Type Assessment.................................................48
6.1.5. Glogau Photoaging Type Assessment............................................48
6.1.6. Inclusion / Exclusion Criteria........................................................49
6.1.7. Subject Eligibility...........................................................................49
6.1.8. Study Material Sensitivity Test......................................................49
6.1.9. Subject Self-Assessment of Sensitivity...........................................50
6.1.10. Dermatologist Assessment of Sensitivity......................................50
6.1.11. Exclusion Criteria 9......................................................................51
6.1.12. Subject Eligibility.........................................................................51
6.1.13. Washout Products Weighing........................................................51
6.1.14. Washout Products and Washout Diary Dispensing.....................52
6.2. Visit 2 –1 day after Visit 1....................................................................52
6.2.1. Current / Concomitant Medication................................................52
6.2.2. Adverse Events...............................................................................52
6.2.3. Continued Subject Eligibility.........................................................52
6.2.4. Compliance (Diary Review)...........................................................52
6.2.5. Washout Products Weighing..........................................................53
6.2.6. Subject Self-Assessment of Sensitivity...........................................53
6.2.7. Dermatologist Assessment of Sensitivity........................................53
6.2.8. Exclusion Criteria..........................................................................53
6.2.9. Subject Eligibility...........................................................................53
6.3. Visit 3 –Day of Procedure -6 days after Visit 2...................................53
6.3.1. Current / Concomitant Medication................................................53
6.3.2. Adverse Events...............................................................................54
6.3.3. Continued Subject Eligibility.........................................................54
 
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6.3.4. Compliance (Diary Review)...........................................................54
6.3.5. Washout Product Weighing...........................................................54
6.3.6. Subject Self-Assessment of Sensitivity...........................................54
6.3.7. Dermatologist Assessment of Sensitivity........................................54
6.3.8. Exclusion Criteria..........................................................................55
6.3.9. Subject Eligibility...........................................................................55
6.3.10. Subject Randomisation................................................................55
6.3.11. Instrumental Measurements Pre-Procedure...............................55
6.3.12. Image Capture (VISIA) Pre-Procedure.......................................56
6.3.13. Subject Self-Assessment Pre-Procedure......................................56
6.3.14. Dermatologist Assessment Pre-Procedure...................................56
6.3.15. Dermatological Procedure (Facial Peel)......................................58
6.3.16. Dermatologist Assessment Post-Procedure, Pre-Treatment 
(BASELINE)............................................................................................58
6.3.17. Instrumental Measurements Post-Procedure, Pre-Treatment 
(BASELINE)............................................................................................59
6.3.18. Image Capture (VISIA) Post-Procedure, Pre-Treatment 
(BASELINE)............................................................................................59
6.3.19. Subject Self-Assessment Post-Procedure, Pre-Treatment 
(BASELINE)............................................................................................59
6.3.20. Test Product Weighing.................................................................59
6.3.21. Test Product and Test Diary Dispensing. Washout Diary 
Collection..................................................................................................59
6.3.22. Supervised Test Product Application Post-Procedure................59
6.3.23. Instrumental Measurements Post-Procedure, Post-Treatment...60
6.3.24. Subject Self-Assessment Post-Procedure, Post-Treatment.........60
6.3.25. Evaluator (Dermatologist) Assessment Post-Procedure, Post-
Treatment.................................................................................................60
6.4. Visit 4 –1 day after Visit 3....................................................................60
6.4.1. Current / Concomitant Medication................................................60
6.4.2. Adverse Events...............................................................................60
6.4.3. Continued Subject Eligibility.........................................................61
6.4.4. Compliance (Diary Review)...........................................................61
6.4.5. Washout Products Weighing..........................................................61
6.4.6. Test Product Weighing...................................................................61
6.4.7. Instrumental Measurements Post-Procedure, Post-Treatment (24±4 
hours after Facial Peel)............................................................................61
6.4.8. Image Capture (VISIA) Post-Procedure, Post-Treatment (24±4 
hours after Facial Peel)............................................................................61
 
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6.4.9. Subject Self-Assessment Post-Procedure, Post-Treatment (24±4 
hours after Facial Peel)............................................................................62
6.4.10. Dermatologist Assessment Post-Procedure, Post-Treatement (24±4 
hours after Facial Peel)............................................................................62
6.4.11. Supervised Test Product Application..........................................62
6.4.12. Supervised Sunscreen Application...............................................62
6.5. Visit 5 –1 day after Visit 4....................................................................62
6.5.1. Current / Concomitant Medication................................................62
6.5.2. Adverse Events...............................................................................62
6.5.3. Continued Subject Eligibility.........................................................63
6.5.4. Compliance (Diary Review)...........................................................63
6.5.5. Washout Products Weighing..........................................................63
6.5.6. Test Product Weighing...................................................................63
6.5.7. Instrumental Measurements Post-Procedure, Post-Treatment (48±4 
hours after Facial Peel)............................................................................63
6.5.8. Subject Self-Assessment Post-Procedure, Post-Treatment (48±4 
hours after Facial Peel)............................................................................63
6.5.9. Dermatologist Assessment Post-Procedure, Post-Treatement (48±4 
hours after Facial Peel)............................................................................64
6.5.10. Supervised Test Product Application..........................................64
6.5.11. Supervised Sunscreen Application...............................................64
6.6. Visit 6 –1 day after Visit 5....................................................................64
6.6.1. Current / Concomitant Medication................................................64
6.6.2. Adverse Events...............................................................................64
6.6.3. Continued Subject Eligibility.........................................................65
6.6.4. Compliance (Diary Review)...........................................................65
6.6.5. Washout Products Weighing..........................................................65
6.6.6. Test Product Weighing...................................................................65
6.6.7. Instrumental Measurements Post-Procedure, Post-Treatment (72±4
hours after Facial Peel)............................................................................65
6.6.8. Subject Self-Assessment Post-Procedure, Post-Treatment (72±4 
hours after Facial Peel)............................................................................65
6.6.9. Dermatologist Assessment Post-Procedure, Post-Treatement (72±4 
hours after Facial Peel)............................................................................65
6.6.10. Supervised Test Product Application..........................................66
6.6.11. Supervised Sunscreen Application...............................................66
6.7. Visit 7 –4 days after Visit 6...................................................................66
6.7.1. Current / Concomitant Medication................................................66
6.7.2. Adverse Events...............................................................................66
6.7.3. Continued Subject Eligibility.........................................................66
 
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6.7.4. Compliance (Diary Review)...........................................................67
6.7.5. Washout Products Weighing..........................................................67
6.7.6. Test Product Weighing...................................................................67
6.7.7. Instrumental Measurements Post-Procedure, Post-Treatment (168±4 
hours after Facial Peel)............................................................................67
6.7.8. Subject Self-Assessment Post-Procedure, Post-Treatment (168±4 
hours after Facial Peel)............................................................................67
6.7.9. Dermatologist Assessment Post-Procedure, Post-Treatement (168±4 
hours after Facial Peel)............................................................................67
6.7.10. Supervised Test Product Application..........................................67
6.7.11. Supervised Sunscreen Application...............................................68
6.8. Visit 8 –7 days after Visit 7...................................................................68
6.8.1. Current / Concomitant Medication................................................68
6.8.2. Adverse Events...............................................................................68
6.8.3. Continued Subject Eligibility.........................................................68
6.8.4. Compliance (Diary Review)...........................................................68
6.8.5. Washout Products Weighing..........................................................69
6.8.6. Test Product Weighing...................................................................69
6.8.7. Instrumental Measurements Post-Procedure, Post-Treatment (336±4 
hours after Facial Peel)............................................................................69
6.8.8. Image Capture (VISIA) Post-Procedure, Post-Treatment (336±4 
hours after Facial Peel)............................................................................69
6.8.9. Subject Self-Assessment Post-Procedure, Post-Treatment (336±4 
hours after Facial Peel)............................................................................69
6.8.10. Subject Global Self-Assessment...................................................69
6.8.11. Dermatologist Assesment Post-Procedure, Post-Treatment (336±4 
hours after Facial Peel)............................................................................70
6.8.12. Dermatologist Global Assessment................................................70
6.8.13. Products and Test Diary Return..................................................70
6.8.14. Discharge from Study...................................................................70
7. SAFETY ASSESSMENTS................................................................................71
7.1. Definitions of an Adverse Event and Serious Adverse Event...............71
7.1.1. Adverse Events...............................................................................71
7.1.2. Serious Adverse Events..................................................................72
7.2. Recording Adverse Events and Serious Adverse Events......................73
7.3. Evaluating Adverse Events and Serious Adverse Events.....................73
7.4. Reporting Adverse Events and Serious Adverse Events......................74
7.5. Follow-up of Adverse Eventsand Serious Adverse Events..................76
 
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7.6. Collection of Pregnancy Information....................................................77
7.6.1. Time Period for Collecting of Pregnancy Information..................77
7.6.2. Action to be Taken if Pregnancy Occurs.......................................77
8. DATA MANAGEMENT...................................................................................78
8.1. Source Documents/ Data........................................................................78
8.2. Electronic Case Report Form................................................................78
8.3. Data Handling........................................................................................79
8.3.1. Data Queries...................................................................................79
8.4. External Data.........................................................................................79
9. STATISTICAL CONSIDERATIONS AND DATA ANALYSES....................81
9.1 Sample Size Determination....................................................................81
9.2. General Considerations.........................................................................81
9.2.1. Definition of Analysis Populations.................................................81
9.2.2. Exclusion of Data from Analysis....................................................81
9.2.3. Criteria for Evaluation...................................................................81
9.2.4. Criteria for Assessing Efficacy.......................................................82
9.2.5. Criteria for Assessing Local Tolerance..........................................82
9.2.6. Handling of Dropouts and Missing Data.......................................82
9.3. Statistical Methods and Analytical Plan...............................................82
9.3.1. Dem
ographic and Baseline Characteristics...................................82
9.3.2. Primary Analysis(es)......................................................................82
9.3.3. Secondary Analysis(es)...................................................................82
9.3.4. Safety Analysis(es)..........................................................................83
10. STUDY GOVERNANCE CONSIDERATIONS............................................83
10.1. Posting of Information on Publicly Available Clinical Trials Registers
83
10.2. Regulatory and Ethical Considerations, Including the Informed 
Consent.........................................................................................................83
10.3. Quality Control (Study Monitoring)...................................................84
10.4. Quality Assurance................................................................................84
10.5. Conditions for Terminating the Study................................................84
10.6. Records Retention................................................................................85
10.7. Provision of Study Results to Investigators, posting of Information on 
Publicly Available Clinical Trials Registers and Publication.....................86
 
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11. REFERENCES................................................................................................87
12. APPENDICES..................................................................................................88
12.1. Appendix 1 -Abbreviations and Trademarks....................................88
12.2. Appendix 2 -Fitzpatrick Skin Type....................................................89
12.3. Appendix 3 -Glogau Photoaging Scale...............................................89
12.4. Appendix 4 -Exclusion Criteria for Review at Visit 2 and 3.............89
 
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12
PROCESS FOR AMENDING THE PROTOCOL
Protocol modifications to ongoing studies which could potentially adversely affect the 
safety of subjects or which alter the scope of the investigation, the scientific quality of 
the study, the experimental design, dosages, duration of therapy, assessment 
variables, the number of subjects treated, or subject selection criteria are considered 
major/substantial amendments and must be made only after appropriate consultation 
between an appropriate representativeof GSKCH and the investigator.
Details of amendments to the protocols should be recorded on the following page. 
Protocol modifications must be prepared by a representative of GSKCH.  All changes 
must be justified in the Reason for Amendment section of the following Protocol 
Amendment Page. Approval of amendments will be made by the original protocol 
signatories or their appropriate designees.
All major/substantial protocol modifications must be reviewed and approved by the 
appropriateIndependent Ethics Committee (IEC)in accordance with local 
requirements, before the revised edition can be implemented. 
All non-substantial/ minor/ administrative amendments should be submitted to the 
IECas per country specific requirements. In some countries pre-approval of a minor 
amendment is not required and will just be held on file by the sponsor and 
investigator.
 
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PROTOCOL AMENDMENT PAGE
Details of all amendments should be recorded in the table below. Affected sections should be listed in the table; the actual 
amendment/ change should be made in the relevant section of the main protocol. 
To highlight the change, the following features will be used: 
To addtext: Use of CAPITAL LETTERS, BOLD AND UNDERLINE
To delete text: Use of Strikethrough e.g. strikethrough
Amendment 
No. & New 
Protocol 
Version No.
Type of Amendment
Reason for Amendment
Other Documents 
Requiring 
Amendment
Section(s) 
Amended 
PI Amendment 
Agreement
Signature & 
Date
Amendment 
No.:1
Non-Substantial/Minor    To clarify that the primary 
assessment of subject 
compliance will be made 
using the data in the subject 
diary
Informed Consent   
Yes No
Safety Statement     
Yes No
CRF                       
Yes No
5.4. Product 
Compliance
Page 44
Signature:
Protocol 
Version 
No.:4
Substantial/ Major           
Date:
Amendment 
No.:2
Non-Substantial/Minor    To update the Study Manager 
and Biostatistician 
information
Informed Consent   
Yes No
Safety Statement     
Yes No
CRF                       
Yes No
Summary 
information 
Pages2and 3
Signature:
Protocol 
Version 
No.:4
Substantial/ Major           
Date:
 
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Amendment 
No. & New 
Protocol 
Version No.
Type of Amendment
Reason for Amendment
Other 
Documents 
Requiring 
Amendment
Section(s)Amended 
PI Amendment 
Agreement
Signature & 
Date
Amendment 
No.:
Non-Substantial/Minor    
Informed 
Consent   
Yes No
Safety 
Statement     
Yes No
CRF                       
Yes No
Signature:
Protocol 
Version 
No.:
Substantial/ Major           
Date:
Amendment 
No.:
Non-Substantial/Minor    
Informed 
Consent   
Yes No
Safety 
Statement     
Yes No
CRF                       
Yes No
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SCHEDULE OF EVENTS
Procedure/ Assessment
Visit 1
Day 1
Visit 2
Day 2
Visit 31
Day 8
Visit 41
Day 9
Visit 51
Day 10
Visit 61
Day 11
Visit 71
Day 15
Visit 81
Day 22
Screening/
Washout
1 Day After
Visit 1
6 Days after 
Visit 2, Day 
of Procedure 
1 Dayafter 
Visit 3
1 Day after 
Visit 4
1 Day after
Visit 5
4 Daysafter 
Visit 6
7 Days after 
Visit 7
Informed Consent
X
Demographics
X
Medical History
X
Current / Concomitant Medication
X
X
X
X
X
X
X
X
Adverse Events
X
X
X
X
X
X
X
Continued Subject Eligibility
X
X
X
X
X
X
X
Compliance (Diary review)2
X
X
X
X
X
X
X
Fitzpatrick Skin Type Assessment 
(Appendix 2)
X
Glogau Photoaging Type Assessment 
(Appendix 3)
X
In/Exclusion Criteria
X3
X4
X4
Subject Eligibility
X
Study Material Sensitivity Test
X5
Subject Self-Assessment Sensitivity
X6
X7
X8
Dermatologist Assessment Sensitivity
X6
X7
X8
Exclusion Criteria 9
X
X
X
Subject Eligibility
X
X
X
Subject Randomisation
X
Instrumental Measurements Pre-Procedure
X
Image capture (VISIA) Pre-Procedure 
X
Subject Self-Assessment Pre-Procedure 
X
Dermatologist Assessment Pre-Procedure
X
Dermatological Procedure (Facial Peel)
X9
Dermatologist Assessment Post-Procedure, 
Pre-Treatment (BASELINE)
X10
Instrumental Measurements Post-
Procedure, Pre-Treatment (BASELINE)
X10
Image capture (VISIA) Post-Procedure, 
Pre-Treatment (BASELINE)
X10
Subject Self-Assessment Post-Procedure, 
Pre-Treatment (BASELINE)
X10
Washout Products Weighing
X
X
X
X
X
X
X
X
Washout Products and Washout Diary 
Dispensing
X
Test Product Weighing
X
X
X
X
X
X
Test Product and Test Diary Dispensing, 
Washout Diary return.
X11
Supervised Test-Product Application Post-
Procedure
X12
Instrumental Measurements Post-
Procedure, Post-Treatment13
X
X
X
X
X
X
Image capture (VISIA) Post-Procedure, 
Post-Treatment14
X
X
Subject Self-Assessment Post-Procedure, 
Post-Treatment15
X
X
X
X
X
X
Subject Global Self-Assessment
X
Dermatologist Assessment Post-Procedure, 
Post-Treatment15
X
X
X
X
X
X
Dermatologist Global Assessment of 
Tolerance
X
Supervised Test-Product Application16
X
X
X
X
Supervised Sunscreen Application17
X
X
X
X
Products and Test Diary Return
X
Discharge from Study
X
 
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16
1.
For Visits 3-8, subjects will be instructed to cleanse their face at home using the cleanser provided and must not use any other product on their face, 
including the test product (Group I only) and sunscreen. Subjects will be instructed to bring the dispensed cleanser, sunscreen and test product (Group I
only) with them to all visits.Subjects will be invited to the site in the morning (prior to 9 am) to avoid exposure to strong sunlight. 
2.
The Investigator or designee will review the diary to monitor and encourage compliance. Additional or missed product applications will be recorded as 
deviations. The Evaluator must be blind to diary review.
3.
Exclusion Criteria 9will not be included for this assessment. Exclusion criteria 9is evaluated based on the results from the sensitivity test.
4.
To include a review of the inclusion/exclusion criteria specified in Appendix 4.Subjects must be considered compliant with these inclusion/exclusion 
criteria in order to remain eligible for the study.
5.
Peel regimen (70% Glycolic Acid facial peel solution, Bicarbonate Neutralizing Solution andSunmax SensitiveSPF 50) to be applied to the volar forearm 
of each subject by a qualified dermatologist. 
6.
Assessments to be taken 45±15 minutes after completion of the study materialsensitivity test.
7.
Assessments to be taken 24±4 hours after completion of the study material sensitivity test.
8.
Assessments to be taken 7 days after completion of the study material sensitivity test.
9.
70% Glycolic Acid facial peel to be administered by a qualified dermatologist who must be blind to randomization.The Glycolic Acid treatment and 
neutralizing solution will be sourced commercially by the study site. 
10. Assessments to be taken60±15 minutes after completion of the facial peel procedure.
11. Only subjects randomised to Group I will be dispensed test product.Subjects in Group I and II will be dispensed different test diaries to reflect the 
difference in treatment allocation. The washout diary will be returned at the same time as test diary dispensing. 
12. Test product application will occur immediately afterthepost-procedure, pre-treatment (Baseline) assessments are complete and under the supervision of 
the Investigator or designeeto subjects in Group I, only. Subjects in Group II will not apply anything to their face. The Evaluator must be blind to test 
product application.
13. Measurements to be taken180±15minutes, 360±15minutes,24±4 hours, 48±4 hours, 72±4 hours, 168±4 hours and 336±4 hours after completionof the 
facial peel procedure.At Visit 3, there must be at least 30 minutes between test product application (Group I, only) and instrumental measurements.  
14. Images to be captured 24±4 hours after completion of the facial peel procedure and at Visit 8 (Day 22).
15. Assessments to be taken180±15minutes, 24±4 hours, 48±4 hours, 72±4 hours, 168±4 hours and 336±4 hoursafter completion of the facial peel 
procedure.
16. Test product application will be conducted under the supervision of the Investigator or designee to subjects in Group I, only. Subjects in Group II will not 
apply the test product to their face.
17. Sunscreen application will be conducted under the supervision of the Investigator or designee to all subjects.
 
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17
PROTOCOL SYNOPSIS FOR STUDY207213
Brief Summary
This is a randomized, evaluator-blind, single-center and two-arm clinical study 
designed to evaluate the local tolerance and cosmetic efficacy of a topical skin care 
formulation in healthy female subjects with moderateto advanced photo-damaged 
facial skin who have undergone a 70% Glycolic Acid facial peel procedure. It is 
hypothesized that the test product, which is specifically designed as a moisturizing 
cream for dry, sensitive skin, will present a favorable local tolerance profile in this 
population.
Objective(s) and Endpoint(s)
Objective(s)
Endpoint(s)
Primary
Assessment ofthelocal 
tolerance of the test product 
in subjects who have 
undergone a 70% Glycolic 
Acid facial peel
Evaluator(Dermatologist) global assessment of 
tolerance
Secondary
Assessment of skin
recovery (change from 
baseline) over a period of 
14 days in subjects who 
have undergone a 70% 
Glycolic Acid facial peel
Combined (sum of) Evaluator (Dermatologist)scores 
for signs/symptoms of erythema, edema, desquamation 
and dryness
Individual Evaluator (Dermatologist) scores for 
erythema, edema, desquamation and dryness
Combined (sum of) subject self-assessment scoresfor 
redness, pain, stinging/burning, itching, tightness and 
dryness
Individual subject self-assessment scores for redness, 
pain, stinging/burning, itching, tightnessand dryness
Instrumental measurement of barrier function 
(Tewameter)andmoisturisation (Corneometer)
Subject global self-assessment
 
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18
Assessment of skin 
recovery (change from 
baseline)between treatment 
groups.
All assessments and measurements listed above
Study Design
Overall Design
This is a randomized, evaluator-blind, single-center and two-arm clinical study 
designed to evaluate the local tolerance and cosmetic efficacy of a topical skin care 
formulation in healthy female subjects with moderateto advanced photo-damaged 
facial skin who have undergone a 70% Glycolic Acid facial peel procedure. It is 
hypothesized that the test product, which is specifically designed as a moisturizing 
cream for dry, sensitive skin, will present a favorable local tolerance profilein this 
population.
Visit 1/ Day 1 (Screening/ Washout)
The following assessments will be conducted in the order written:
1. Informed Consent
2. Demographics
3. Medical History
4. Current / Concomitant Medication
5. Fitzpatrick Skin Type Assessment (Appendix 2)
6. Glogau Photoaging Type Assessment (Appendix 3)
7.In/Exclusion Criteria (Not including Exclusion Criteria 9)
8. Subject Eligibility
9. Study Material Sensitivity Test
10.Subject Self-Assessment Sensitivity*
11.Dermatologist Assessment Sensitivity*
12.Exclusion Criteria 9
13.Subject Eligibility
14.Washout Products Weighing
15. Washout Products andWashout Diary Dispensing
*Assessments to be taken 45±15 minutes after completion of the study material sensitivity 
test
Visit 2/ Day 2 (1 Day after Visit 1)
The following assessments will be conducted in the order written:
1. Current / Concomitant Medication
2. Adverse Events
3. Continued Subject Eligibility
 
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4. Compliance (Diary review)
5. Washout Products Weighing
6. Subject Self-Assessment Sensitivity*
7. Dermatologist Assessment Sensitivity*
8. Exclusion Criteria(Appendix 4)
9. Subject Eligibility
* Assessments to be taken 24±4 hours after completion of the study material sensitivity test
Visit 3/ Day 8 (6Days after Visit 2 -Day of Procedure)
The following assessments will be conducted in the order written:
1. Current / Concomitant Medication
2. Adverse Events
3. Continued Subject Eligibility
4. Compliance (Diary review)
5. Washout Products Weighing
6. Washout Diary Return
7. Subject Self-Assessment Sensitivity*
8. Dermatologist Assessment Sensitivity*
9. Exclusion Criteria(Appendix 4)
10.Subject Eligibility
11.Subject Randomisation
12.Instrumental Measurements Pre-Procedure
13.Image capture (VISIA) Pre-Procedure 
14.Subject Self-Assessment Pre-Procedure 
15.Dermatologist Assessment Pre-Procedure
16.Dermatological Procedure (Facial Peel)
17.Dermatologist Assessment Post-Procedure, Pre-Treatment (BASELINE)**
18.Instrumental Measurements Post-Procedure, Pre-Treatment (BASELINE)**
19.Image capture (VISIA) Post-Procedure, Pre-Treatment (BASELINE)**
20.Subject Self-Assessment Post-Procedure, Pre-Treatment (BASELINE)**
21.Test Product Weighing
22.Test Product and Test Diary Dispensing
23.Supervised Test-Product Application Post-Procedure
24.Instrumental Measurements Post-Procedure, Post-Treatment***
25.Subject Self-Assessment Post-Procedure, Post-Treatment****
26.Dermatologist Assessment Post-Procedure, Post-Treatment****
* Assessments to be taken 7 daysafter completion of the study material sensitivity test
**Assessments to be taken 60±15 minutes after completion of the facial peel procedure
***Assessments to be taken 180±15 and 360±15 minutes after completion of the facial peel 
procedure. 
 
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****Assessments to be taken 180±15 minutes after completion of the facial peel procedure. 
Subjects should remain at the site until 5:00 PM to prevent exposure to intense sunlight.
Visit 4/ Day 9 (1 Day after Visit 3)
The following assessments will be conducted in the order written:
1. Current / Concomitant Medication
2. Adverse Events
3. Continued Subject Eligibility
4. Compliance (Diary review)
5. Washout Products Weighing
6. Test Product Weighing
7. Instrumental Measurements Post-Procedure, Post-Treatment*
8. Image capture (VISIA) Post-Procedure, Post-Treatment*
9. Subject Self-Assessment Post-Procedure, Post-Treatment*
10.Dermatologist Assessment Post-Procedure, Post-Treatment*
11.Supervised Test-Product Application
12.Supervised Sunscreen Application
*Assessments to be taken 24±4 hours after completion of the facial peel procedure
Visit 5/ Day 10 (1 Day after Visit 4); Visit 6/ Day 11 (1 Day after Visit 5), Visit 7
/ Day 15(4 Days After Visit 6)
The following assessments will be conducted in the order written:
1. Current / Concomitant Medication
2. Adverse Events
3. Continued Subject Eligibility
4. Compliance (Diary review)
5. Washout Products Weighing
6. Test Product Weighing
7. Instrumental Measurements Post-Procedure, Post-Treatment*
8. Subject Self-Assessment Post-Procedure, Post-Treatment*
9. Dermatologist Assessment Post-Procedure, Post-Treatment*
10.Supervised Test-Product Application
11.Supervised Sunscreen Application
*Assessments to be taken 48±4(Visit 5), 72±4 (Visit 6) and 168±4 (Visit 7) hours after 
completion of the facial peel procedure
Visit 8/ Day 22(7 Days after Visit 7)
The following assessments will be conducted in the order written:
1. Current / Concomitant Medication
2. Adverse Events
3. Continued Subject Eligibility
 
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4. Compliance (Diary review)
5. Washout Products Weighing
6. Test Product Weighing
7. Instrumental Measurements Post-Procedure, Post-Treatment*
8. Image capture (VISIA) Post-Procedure, Post-Treatment*
9. Subject Self-Assessment Post-Procedure, Post-Treatment*
10.Subject Global Self-Assessment
11.Dermatologist Assessment Post-Procedure, Post-Treatment*
12.Dermatologist Global Assessment of Tolerance
13.Products and Test Diary Return
14.Discharge from Study
*Assessments to be taken 336±4 hours after completion of the facial peel procedure
Type and Planned Number of Subjects
Approximately 130 healthy females within the ages of 30 and 60 years (inclusive) 
with Fitzpatrick Skin Classification II-IV and moderate to advanced photo-damaged 
skin will be screened to randomize 80 subjects to ensure approximately 60 subjects 
(30 subjects per group) successfully complete the study. 
 
With 30 subjects per treatment group, a change from baseline inTransepidermal 
Water Loss (TEWL) at least half the magnitude of the standard deviation  
 
) can be 
detected at two-sided alpha=0.05 with 80% power.
Main Criteria for Inclusion
Healthy female subjects aged 30-60 years (inclusive) with aFitzpatrick skin 
phototype II-IV and Glogau photoaging type II-IIIwill be recruited for this study.
 
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CCI
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22
Product Information
Reference / 
Washout Cleanser
Test Product
Reference/ 
Washout
Sunscreen
Product Name 
Simple
TM Kind to 
Skin Moisturising 
Facial Wash
Physiogel Calming 
Relief SPF 20 
Cream 
Sunmax Sensitive 
SPF50
Product 
Formulation 
Code
Not Applicable
(Commercial, UK)
(Commercial, 
Brazil)
Application 
Quantity
Approximately 0.6-1 grams (g)
Route of 
Application
Topical
Application 
Instructions
Wet face with water. 
In your hands, work 
a small amount into 
a lather. Massage 
onto wet skin, rinse 
with water. 
Avoid contact with 
eyes. Ifcontact 
occurs, rinse 
thoroughly with 
water.
Use twice a day 
(morning and 
evening) 
Dispensetwo pumps 
of product onto the 
fingertips andapply 
to the full face. 
Avoid contact with 
eyes. If contact 
occurs rinse 
thoroughly with 
water.
Apply twice a day 
(morning and 
evening)
Do not apply in the 
morning if you are 
visiting the site on 
the same day.
Dispense a pea-sized 
quantity onto the 
fingertips and apply 
to the full face.
Avoid contact with 
eyes. If contact 
occurs rinse 
thoroughly with 
water.
Apply twice a day 
(morning and 
lunchtime) 
Do not apply in the 
morning if you are 
visiting the site on 
the same day. 
Statistical Methods
Descriptive statistics (N, %, 95% confidence intervals) will be used to summarize the 
global assessment of tolerance. Changes from baseline in the evaluator, subjective 
and instrumental endpoints will be tabulated by product group and summarized 
descriptively and assessed for significance (different from zero) using t-tests or 
Wilcoxon signed rank tests dependent upon the distribution of the data. Differences 
between product groups in the evaluator, subjective and instrumental endpoints will 
 
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CCI
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23
also beexplored and the magnitude of product differences in the change from 
baseline for each will be estimated. Adverse events will be tabulated by product 
group.
 
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1. INTRODUCTION
A total of 11.7 million cosmetic procedures were performed in 2007 in the United 
States, and the majority (82%) of these were non-surgical in nature. Non-surgical 
techniques are aimed at reducing the signs of facial aging, such as hyperpigmentation, 
loss of elasticity, and wrinkles.  
With all of thesenon-surgical procedures, there is an intentional generation of 
damage to the cutaneous barrier in order to promote the repair of the epidermis and 
increased cell renewal. By promoting damage to the stratum corneum or epidermis, 
some degree of irritation, which translates into erythema and/or edema, in addition to 
desquamation of greater or lesser intensity, is expected to occur clinically.
Facial chemical exfoliation is a well-established procedure in which the dermatologist 
uses some agent (usually acids) to insult the skin, with consequent damage to the 
cutaneous barrier. There are different types of chemical exfoliant (peels),used in 
dermatologic practice, with the most common being theuse of retinoids and alpha-
hydroxy acids (AHAs), including glycolic acid (GA).  AHA peels have anti-
inflammatory, keratolytic, and antioxidant effects and glycolic acid targets the 
corneosome by enhancing breakdown and decreasing cohesiveness, causing 
desquamation. The intensity of peel is determined by the concentration of the acid, 
the vehicle used to carry it, the amount of acid applied, and the technique used.70% 
GA applied to skin for 1-3 minutes, followed by neutralization with a bicarbonate 
base is classified as a superficial facial peel procedure [Guerriero 2014].
Prior to and following facial resurfacing procedures, physicians often recommend that 
subjects use a range of topical skin care products.   
Pre-procedure Regimen:
Pre-procedure, subjectsmay be instructed to use a gentle, nonirritating cleanser, an 
exfoliant, and creams containing a retinoid and hydroquinone. Such a regimen may 
help asubject’sskin to be in optimal condition at the time of a procedure. 
Post-procedure Regimen:
In the period immediately afterthe procedure, it is recommended that the 
dermatologist instruct the subject in the use of sunscreen and moisturizing agents that 
are able to provide a restorative action on the cutaneous barrier. This helps to relieve 
symptoms (such as burning, scaling, and erythema) and promotes the quick and 
 
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efficient repair of the superficial structures of the epidermis, in particular the stratum 
corneum. Some post-procedure products, such as a 1% hydrocortisone cream, can 
help to manage the adverse effects of the procedure such as swelling and erythema. 
Others, like a sunscreen, help protect healing skin during recovery.
Physiogel Calming Relief SPF 20 Cream is a moisturising oil in water emulsion, 
formulated to be free of colourants and fragrances and is clinically proven to be 
suitable for use bysubjects with dry, sensitive skin. It is therefore expected that this 
product willhelp relieve some of the adverse effects of cosmetic procedures, 
including glycolic acid facial peels, and will be of benefit to subjects.
Side-effectsof the Procedure:
Proper selection ofsubjects,timing of peel, and neutralization on-time should ensure 
good results and minimize side effects [Sharad 2013].The minor side effects reported 
are: erythema, desquamation, stinging sensation, sensation of pulling of facial skin, 
mild burning, and transient post-inflammatory hyperpigmentation. Unbuffered GA 
can cause erosive blisters and scarring. In rare cases, hypopigmentation, persistent 
erythema, and flare-up of pimples have been reported [Perić 2011].
 
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2. OBJECTIVE(S) AND ENDPOINT(S)
Objective(s)
Endpoint(s)
Primary
Assessment ofthelocal 
tolerance of the test product 
in subjects who have 
undergone a 70% Glycolic 
Acid facial peel
Evaluator (Dermatologist) global assessment of 
tolerance
Secondary
Assessment of skin 
recovery (change from 
baseline) over a period of 
14 days in subjects who 
have undergone a 70% 
Glycolic Acid facial peel
Combined (sum of) Evaluator (Dermatologist) scores 
for signs/symptomsof erythema, edema, desquamation 
and dryness
Individual Evaluator (Dermatologist) scores for 
erythema, edema, desquamation and dryness
Combined (sum of) subject self-assessment scores for 
redness, pain, stinging/burning, itching, tightness and 
dryness
Individual subject self-assessment scores for redness, 
pain, stinging/burning, itching, tightness and dryness
Instrumental measurement of barrier function 
(Tewameter)andmoisturisation (Corneometer)
Subject global self-assessment
Assessment of skin 
recovery (change from 
baseline)between treatment 
groups.
All assessments and measurements listed above
 
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3. STUDY PLAN
3.1. Study Design
Overall Design
This is a randomized, evaluator-blind, single-center and two-arm clinical study 
designed to evaluate the local tolerance and cosmetic efficacy of a topical skin care 
formulation in healthy female subjects with moderate to advanced photo-damaged 
facial skin who have undergone a 70% Glycolic Acid facial peel procedure. It is 
hypothesized that the test product, which is specifically designed as a moisturizing 
cream for dry, sensitive skin, will present a favorable local tolerance profile in this 
population.
Visit 1/ Day 1 (Screening/ Washout)
The following assessments will be conducted in the order written:
1. Informed Consent
2. Demographics
3. Medical History
4. Current / Concomitant Medication
5. Fitzpatrick Skin Type Assessment (Appendix 2)
6. Glogau PhotoagingType Assessment (Appendix 3)
7. In/Exclusion Criteria (Not including Exclusion Criteria 9)
8. Subject Eligibility
9. Study Material Sensitivity Test
10.Subject Self-Assessment Sensitivity*
11.Dermatologist Assessment Sensitivity*
12.Exclusion Criteria 9
13.Subject Eligibility
14.Washout Products Weighing
15.Washout Products and Washout Diary Dispensing
*Assessments to be taken 45±15 minutes after completion of the study material sensitivity 
test
Visit 2/ Day 2 (1 Day after Visit 1)
The following assessments will be conducted in the order written:
1. Current / Concomitant Medication
2. Adverse Events
3. Continued Subject Eligibility
4. Compliance (Diary review)
5. Washout Products Weighing
 
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6. Subject Self-Assessment Sensitivity*
7. Dermatologist Assessment Sensitivity*
8. Exclusion Criteria (Appendix 4)
9. Subject Eligibility
* Assessments to be taken 24±4 hours after completion of the study material sensitivity test
Visit 3/ Day 8 (6 Days after Visit 2 -Day of Procedure)
The following assessments will be conducted in the order written:
1. Current / Concomitant Medication
2. Adverse Events
3. Continued Subject Eligibility
4. Compliance (Diary review)
5. Washout Products Weighing
6. Washout Diary Return
7. Subject Self-Assessment Sensitivity*
8. Dermatologist Assessment Sensitivity*
9. Exclusion Criteria (Appendix 4)
10.Subject Eligibility
11.Subject Randomisation
12.Instrumental Measurements Pre-Procedure
13.Image capture (VISIA) Pre-Procedure 
14.Subject Self-Assessment Pre-Procedure 
15.Dermatologist Assessment Pre-Procedure
16.Dermatological Procedure (Facial Peel)
17.Dermatologist Assessment Post-Procedure, Pre-Treatment (BASELINE)**
18.Instrumental Measurements Post-Procedure, Pre-Treatment (BASELINE)**
19.Image capture (VISIA) Post-Procedure, Pre-Treatment (BASELINE)**
20.Subject Self-Assessment Post-Procedure, Pre-Treatment (BASELINE)**
21.Test Product Weighing
22.Test Product and Test Diary Dispensing
23.Supervised Test-Product Application Post-Procedure
24.Instrumental Measurements Post-Procedure, Post-Treatment***
25.Subject Self-Assessment Post-Procedure, Post-Treatment****
26.Dermatologist Assessment Post-Procedure, Post-Treatment****
* Assessments to be taken 7 daysafter completion of the study material sensitivity test
**Assessments to be taken 60±15 minutes after completion of the facial peel procedure
***Assessments to be taken 180±15 and 360±15 minutes after completion of the facial peel 
procedure. 
****Assessments to be taken 180±15 minutes after completion of the facial peel procedure. 
Subjects should remain at the site until 5:00 PM to prevent exposure to intense sunlight.
 
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Visit 4 / Day 9 (1 Day after Visit 3)
The following assessments will be conducted in the order written:
1. Current / Concomitant Medication
2. Adverse Events
3. Continued Subject Eligibility
4. Compliance (Diary review)
5. Washout Products Weighing
6. Test Product Weighing
7. Instrumental Measurements Post-Procedure, Post-Treatment*
8. Image capture (VISIA) Post-Procedure, Post-Treatment*
9. Subject Self-Assessment Post-Procedure, Post-Treatment*
10.Dermatologist Assessment Post-Procedure, Post-Treatment*
11.Supervised Test-Product Application
12.Supervised Sunscreen Application
*Assessments to be taken 24±4 hours after completion of the facial peel procedure
Visit 5 / Day 10 (1 Day after Visit 4); Visit 6/ Day 11 (1 Day after Visit 5), Visit 7
/ Day 15(4 Days After Visit 6)
The following assessments will be conducted in theorder written:
1. Current / Concomitant Medication
2. Adverse Events
3. Continued Subject Eligibility
4. Compliance (Diary review)
5. Washout Products Weighing
6. Test Product Weighing
7. Instrumental Measurements Post-Procedure, Post-Treatment*
8. Subject Self-Assessment Post-Procedure, Post-Treatment*
9. Dermatologist Assessment Post-Procedure, Post-Treatment*
10.Supervised Test-Product Application
11.Supervised Sunscreen Application
*Assessments to be taken 48±4(Visit 5), 72±4 (Visit 6) and 168±4 (Visit 7) hours after 
completion of the facial peel procedure
Visit 8 / Day 22 (7 Days after Visit 7)
The following assessments will be conducted in the order written:
1. Current / Concomitant Medication
2. Adverse Events
3. Continued Subject Eligibility
4. Compliance (Diary review)
5. Washout Products Weighing
6. Test Product Weighing
 
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7. Instrumental Measurements Post-Procedure, Post-Treatment*
8. Image capture (VISIA) Post-Procedure, Post-Treatment*
9. Subject Self-Assessment Post-Procedure, Post-Treatment*
10.Subject Global Self-Assessment
11.Dermatologist Assessment Post-Procedure, Post-Treatment*
12.Dermatologist Global Assessment of Tolerance
13.Products and Test Diary Return
14.Discharge from Study
*Assessments to be taken 336±4 hours after completion of the facial peel procedure
3.2. Subject Restrictions
Lifestyle/ Dietary
During the entire study (screening –Last-Subject, Last-Visit (LSLV));
1. Not toparticipate inany other cosmetic or therapeutic study
2. Not toadd any new cosmetic product to their current personal care regimen 
(e.g. shampoo, shower gel, hand soap) or switchbrands of laundry products 
during the study
Medications and Treatments
On the day of site visit;
1. Not toapply any detergents (e.g. soaps, shampoos, bath and shower products) 
to their faceother than the cleanser provided(Simple Kind to Skin 
Moisturising Facial Wash)
2. Not to apply any leave-on cosmetics (e.g. creams, lotions, oily cleansing 
products, mascara)including the test product (Physiogel Calming Relief SPF 
20 Cream) and sunscreen (Sunmax Sensitive SPF 50) to their face or 
eyelashes
3. Not toconsume any caffeine
4. Not to smoke (includes cigarettes, shisha, cigars)
During the entire study (screening –LSLV);
1. Not toapply any detergents (e.g. soaps, shampoos, bath and shower products) 
to their faceother than the cleanser provided(Simple Kind to Skin 
Moisturising Facial Wash)
2. Not to use any facial skin treatmentsor cosmetic products other than the 
products provided for this study. Subjects are permitted to wear their usual 
mascara during this study
3. Not to use any study prohibited medication as specified in the exclusion 
criteria, including anti-inflammatory, analgesic or photosensitizing treatments
4. To avoiddirect exposure to sunlightby seeking the shade and to wear a sun 
hat and sunglasses when outsideas far as practically possible
 
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5. To avoid ultraviolet (UV)treatments and tanning salons
6. Female subjects of child-bearing potential must use effective contraception
7. Subjects must not changeany hormonal treatment or contraception that they 
may be receiving and must have used the same contraception for 3 months 
prior to screening
8. Subjects must not undergo any aesthetic, cosmetic or dermatological treatment 
inthe treatment area (face or eyes)
9. Use of facial scrubs, depilatory creams, waxing, bleaching, 
microdermabrasion, and laser hair removal  
3.3. Type and Planned Number of Subjects
Approximately 130 healthy females within the ages of 30 and 60 years with 
Fitzpatrick Skin Classification II-IV and moderate to advanced photo-damaged skin 
will be screened to randomize 80 subjects to ensure approximately 60 subjects (30 
subjects per group) successfully complete the study. 
 
With 30 subjects per treatment group, a change from baseline in TEWL at least half 
the magnitude of the standard deviation (
 
) can be detected at two-sided 
alpha=0.05 with 80% power.
Subjects will be recruited from the site database and via local advertisement.
3.4. Study Design and Dose Justification
This study isarandomized, evaluator-blind, single-center andtwo-arm clinical study 
designed to evaluate the local tolerance and cosmetic efficacy of a topical skin care 
formulation in healthy female subjects with moderateto advanced photo-damaged 
facial skin who have undergone a 70% Glycolic Acid facial peel procedure.Glycolic 
acid is selected due to its widespread use and favourable tolerance profile. [Sharad] 
The test product (Physiogel Calming Relief SPF 20 Cream) is designed for subjects 
with dry, irritated skin and there is favourable local tolerance clinical data to support 
its use for application to sensitive, post-procedure skin.  The test product will be 
applied twice daily, as consistent with the marketed instructions for use. 
A 7 day washout phase is included to standardize subjects’ skin care regimens. 
Subjects will be provided with a commercially available facial cleanser (Simple Kind 
 
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to Skin Moisturising Facial Wash) and sunscreen (Sunmax Sensitive SPF 50) as 
standard of care. Subjects will be instructed to use the facial cleanser during the 
morning and evening, and to applythe sunscreen in the morning (after cleansing) and 
at lunchtime. Sunmax Sensitive SPF 50 is designed for subjects with sensitive skin 
and has favourable local tolerance clinical data to support its use for application to 
sensitive, post-procedure skin. Simple Kind to Skin Moisturising Facial Washis also 
designed for subjects with sensitive skin. 
Within the washout phase, a study materialsensitivity test is included to identify 
subjects who may be sensitive to the study materials in order to determine whether 
they are suitable to undergo the facial peel procedure. A qualified dermatologist will 
dispense a thin layer of the 70% glycolic acid peel solution to cover a demarcated 5 x 
5 cm square areaon the volar surface of the forearmand, within a period of 30-60 
seconds, will neutralize the 70% glycolic acid peel solution with the bicarbonate 
neutralizing agent andthenrinse the skin thoroughly with water and pat dry with a 
soft towel. Once dry, the dermatologist will apply a thin layer of the Sunmax 
Sensitive SPF50 Sunscreen to the5 x 5 cm square area. Dermatologist and subject 
self-assessments will be used to evaluate local tolerance. If subject data for the study 
materialsensitivity study containsa dermatologist or subject self-assessment score of
“Severe” for any attribute,this subject will be deemed to be in violation of exclusion 
criteria 9and must be dischargedfrom the study.
Upon completion of the washout phase, subjects considered to be eligible for the test 
phase will be randomised to two groups (Group I: Test product; Group 2: No-
treatment) and a qualified dermatologist with experience administering facial peels  
will conduct the 70% Glycolic Acid procedure.
Subjects randomised to Group I will be instructed to apply the test product twice-
daily (morning and evening) after cleansing, for a total of 14 consecutive days. All 
subjects will be instructed to continue using the facial cleanser twice-daily during the 
morning and evening, and toapply the sunscreen in the morning and at lunchtime.A 
summary of the subject’s post-randomization regimen is included below for clarity.
Randomized 
Group
Morning
Lunchtime*
Evening
Group 1
1. Cleansing
2. Test Product
3. Sunscreen
1. Sunscreen
1. Cleansing
2. Test Product
Group 2
1. Cleansing
1. Sunscreen
1. Cleansing
 
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2. Sunscreen
*Lunchtime application must be at least 3 hours after previous sunscreen application
Subjects will not apply any sunscreen on the day of the facial peel procedure (Day
 8), 
since they will remain at site until the evening (after 5 pm).  On the morning of each 
visit, priorto arriving at the site, subjectswill be instructed to cleanse their face and 
not to apply any test product or sunscreen until after all measurements and 
assessments have been completed. Before leaving the site, subjects will undergo
supervisedtest product and/or sunscreen application. After leaving the site, subjects 
should apply the sunscreen a second time, but no sooner than 3 hours after the 
previous application.
Measurements of skin hydration (Corneometer) and transepidermal water loss 
(Tewameter), Dermatologist and Subject self-assessments and photographs (image 
capture) will be performed throughout the study on the scheduled days. Subjects will 
be instructed to complete a diary every day to encourage and record compliance. The 
diary will be reviewed by the Investigator or designee at each visit and any additional 
or missed product applications will be recorded as deviations.Dermatologistsand 
other members of the study staffinvolved inthe assessment of any study endpoints 
will be blind to randomization. All practical efforts will be made to ensure the same 
Dermatologistassesses the same subject throughout the study.
 
 
 
 
In particular, Sulimovic (2002) studied the cosmetic benefits provided by topical 
application ofa water treatment (Avene Extra Gentle Cleanser) compared to placebo
(Petroleum)in a sample of 74 subjects who underwent CO2pulsed-laser treatment. 40 
subjects were randomised to the cosmetic water group and 23 subjects to the placebo. 
Subjects were examined regularly over a total post-treatment period of 84 days.  
During the treatment course, the overall severity of erythema was less in the water 
group than in the control group, a difference shown to be statistically significant 
 
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PPD

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(p<0.04) from day 14 until the end of treatment,except at day 28 (p<0.07). 
Evolutions of the functional symptoms (pain, itching, stinging and tightening) in the 
two groups were all statistically significantly improved compared to the post-
procedure baseline (p<0.05) after 3-4 weeks of treatment,although inter-group 
significance was only observed for mean itching (Day 28), stinging (Days 14 and 21) 
and tightening (Days 12 and 21). Investigator-assessed global efficacy and subject
self-assessed global tolerance at the end of the study was statistically significantly in 
favour of the water group compared to placebo (p<0.05). Three treatment-related 
local side-effects were reported during the study. One subject experienced an allergic 
contact dermatitis of undetermined origin and was withdrawn from the study at the 
28-day visit. One subject presented peri-labial pustules and was withdrawn at Day 7. 
A third subject presented cleanser-imputed contact allergy at the end of study. No 
systemic adverse effects that were considered possible or probably related to test 
treatment were recorded for either group.
Narurkar (2010) conducted a 14-week open-label study to evaluate the efficacy and 
safety of a topical cosmetic skin care regimen for minimizing localizedAdverse 
Events (AEs)during two 6-week procedure cycles with fractionated laser or intense 
pulsed light. The skin care regimen consisted of a 2-week pre-procedure phase, a 1-
week post-procedure phase and a 3-week maintenance phase. Investigators and 
subjects rated the presence and severity of erythema, itching, stinging/burning, 
edema, pain, pruritus, swelling, crusts/erosions and photo-damage. Two days after 
each procedure, most assessments were near baseline values and at 4 weeks all 
investigator scores were comparable to baseline.  Two weeks post-procedure, mean 
subject ratings for most endpoints were ‘none’ to ‘mild’. Fourteen subjects reported a 
total of 16 AE’s. Of these, 4 subjects (15%) reported AE’s considered possibly 
related to the non-ablative cosmetic procedure or the test product regimen. These 
AE’s included acne and facial rash and were mild in intensity. Two subjects withdrew 
from the study due to an AE. One subject had a severe rash was considered probably 
related to the study treatment and one subject developed shingles, which was 
considered unrelated to treatment.
Schalka (2013) published the results of aclinicalstudy which investigated the 
efficacy and safety of a novel cosmetic skin care product in subjects who underwent a 
5% retinoic acid facial peel. This comparative,open-label clinical study randomized 
52 subjects who were divided into two groups, with 26 subjects allocated to each 
group. One group was provided with aSun Protection Factor (SPF)30 cream 
(control) and the other group was provided with the test product and SPF30 control. 
Regular clinical assessment and biophysical measurements were conducted for a 
 
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period of 1 week post-procedure. Fifty subjects completed the study, with one subject 
withdrawing for personal reasons and the other discontinued from the study due to the 
occurrence of mild contact dermatitis in the test product plus sunscreen group. 
Statistically significant (p<0.05) cosmetic benefits were observed for clinically-
assessed desquamation (Days 4 to 7) and instrumental Corneometer measurements 
(Days 2to 4) for the treatment group over the control group. Crucially, the magnitude 
of cosmetic assessments between groups was numerically largest between days 2 and 
4,presumably because the skin’s natural repair processes were continually reducing 
thecutaneous damage for both groups, making it more difficult to measure a cosmetic 
benefit over time.  Barrier function was observed to gradually worsen over the 
duration of the study, with weak indicationsof improvement between days 4 and 7.  
There was nostatistically significant barrier function benefit between groups at any 
time point.
Based on this literature review, subject visits have been included at 24-72 hours post-
procedure, where differences between control and test groups are expected to be 
largest. While it is expected the skin’s barrier function will return to normal 24 to 48 
hoursfollowing the procedure, the total duration of the testphase is 14 days to enable 
sufficient time to monitor desquamation and erythema compared to the post-
procedure, pre-treatmentbaseline. 
 
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4. SELECTION OF STUDY POPULATION AND 
WITHDRAWAL CRITERIA
Specific information regarding warnings, precautions, contraindications, adverse 
events, and other pertinent information on the GSK investigational product or other 
study treatment that may impact subject eligibility is provided in the Product Label.
Deviations from inclusion and exclusion criteria are not allowed because they can 
potentially jeopardize the scientific integrity of the study, regulatory acceptability or 
subject safety. Therefore, adherence to the criteria as specified in the protocol is 
essential.
4.1. Inclusion Criteria
A subject will be eligible for inclusion in this study only if all of the following criteria 
apply:
1. CONSENT
Demonstrates understanding of the study procedures, restrictions and willingness to 
participate as evidenced by voluntary written informed consent and has received a 
signed and dated copy of the informed consent form.
2. AGE
Aged between 30and 60years inclusive.
3. GENDER
Female.
4. GENERAL HEALTH
Good general and mental health with, in the opinion of the investigator or medically 
qualified designee no clinically significant and relevant abnormalities in medical 
history or upon physical examination.
5. COMPLIANCE
Willingness to actively participate in the study and to attend all scheduled visits.
6. SKIN TYPE
A) Fitzpatrick phototype II-IV (Appendix 2).
B) Subjects with Glogau photoaging type II-III(Appendix 3).
7. CONTRACEPTION
 
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Females of childbearing potential who are, in the opinion of the investigator, 
practising a reliable method of contraception.  Adequate contraception is defined as 
abstinence, oral contraceptive, either combined or progestogen alone OR injectable 
progestogen OR implants of levonorgestrel OR estrogenic vaginal ring OR 
percutaneous contraceptive patches OR intrauterine device or intrauterine system OR 
double barrier method (condom or occlusive cap [diaphragm or cervical vault caps] 
plus spermicidal agent [foam, gel, film, cream, suppository]) OR male partner 
sterilization prior to the female subject
's entry into the study, and this male is the sole 
partner for that subject.
4.2. Exclusion Criteria
A subject will not be eligible for inclusion in this study if any of the following criteria 
apply:
1. PREGNANCY
Women who are known to be pregnant or who are intending to become pregnant over 
the duration of the study.
2. BREAST-FEEDING
Women who are breast-feeding.
3. CONCURRENT MEDICATION/ MEDICAL HISTORY 
A. Active skin disease or open wound in the test area.
B. Medical history of using a medicated acne treatment (e.g. Benzoyl Peroxide, 
Clindamycin, isotretinoin) within the last 24 months.
C. Medical history of dysplastic nevi or melanoma.
D. Preexisting inflammatory dermatoses such as psoriasis, atopic dermatitis
E. Moles, tattoos, scars, irritated skin, hairs, etc. at the test area that could, in the 
opinion of the investigator, influence the investigation.
F. Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or 
antihistamines within 7 days prior to screeningand/or throughout the entire 
course of the study.
G. Systemic use of over-the-counter (OTC)analgesicsor anti-inflammatory 
drugs24 hours prior to screening.
H. Systemic use of any photosensitizing medication 2weeks prior to screening.
I. Intense sun exposure, UV-treatments or tanning salon visit within two weeks 
prior to screening.
J. One of the following illnesses that might require regular systemic medication: 
Insulin-dependent diabetes, cancer.
K. One of the following illnesses if not medicated: Asthma, hypertension
 
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L. Medical history of abnormal response to sunlight.
M. Subjects with a history of mental illness.
N. Ocular surgery within the last 12 months.
O. Ocular trauma, infection or inflammation within the last 3 months.
P. Active blepharitis, conjunctivitis, uveitis.
Q. Any ocular pathology requiring topical ocular treatment within the last1
month.
R. Ocular laser within the last 3 months.
S. Aesthetic, cosmetic or dermatological treatment in the treatment area (face), 
including the use of skin tone lightning products, within the last 3months. 
T. Use of facial scrubs, depilatory creams, waxing and/orbleaching within the 
last 2 weeks prior to screening.
U. Microdermabrasion and/or laser hair removal within the last4weeksprior to 
screening.
V. Medical history of Herpes Simplex (Cold Sores).
4. ALLERGY/ INTOLERANCE
A. Known or suspected intolerance or hypersensitivity to the study materials (or 
closely related compounds) or any of their stated ingredients.
B. Documented allergies to cosmetic products or study ingredients.
5. CLINICAL STUDY/ EXPERMENTAL PRODUCT
A. Participation in another clinical study (including cosmetic studies) or receipt 
of an investigational drug within 30days of the screening visit.
B. Previous participation in this study.
6. SUBSTANCE ABUSE
Recent history (within the last 5 years) of alcohol or other substance abuse.
 
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7. PERSONNEL
An employee of the sponsor or the study site or members of their immediate family.
8. LIFESTYLE
A. Required to work outside during daylight hours over the duration of the study.
B. Required or otherwise intending to spend prolonged periods of time outside 
during daylight hours over the duration of the study (e.g. holiday, sunbathing, 
and gardening).
9. STUDY MATERIAL SENSITIVITY TEST
A score of “Severe” for any Dermatologist or Subject Self-Assessed endpoint at any 
time for the study material sensitivity test. 
4.3. Screening/ Baseline Failures
Screen failures are defined as subjects who consent to participate in the study but are 
never subsequently randomized.  In order to ensure transparent reporting of screen 
failure subjects, a minimal set of screen failure information is required including 
Demography, Screen Failure details, Eligibility Criteria, and any Serious Adverse 
Events(SAEs). Re-screening of subjects will not be allowed in thisstudy.
4.4. Withdrawal/ Stopping Criteria
A subject may withdraw from the study at any time at his/her own request, or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioural or 
administrative reasons.
If the reason for removal of a subject from the study is an AE or an abnormal 
laboratory test result, the principal specific event or test will be recorded on the 
electronic Case Report Form (eCRF).  If a subject is withdrawn from the study 
because of a product limiting AE, thorough efforts should be clearly made to 
document the outcome. Any AEs ongoing at the final visit will be followed up until 
resolved, the condition stabilizes, is otherwise explained, or the subject is lost to 
follow-up.
The following actions must be taken in relation to a subject who fails to attend the 
clinic for a required study visit:
The site must attempt to contact the subject and re-schedule the missed visit as 
soon as possible. 
 
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The site must counsel the subject on the importance of maintaining the 
assignedvisit schedule and ascertain whether or not the subject wishes to 
and/or should continue in the study. 
In cases where the subject is deemed ‘lost to follow up’, the investigator or 
designee must make every effort to regain contact with the subject (where
possible, at least2 telephone calls). The contact attempt should be 
documented in the subject’s record. 
Should the subject continue to be unreachable, only then will he/she be 
considered to have withdrawn from the study with a primary reason of “Lost 
toFollow-up”.
4.5. Subject Replacement
Subjects who withdraw from the study post-randomization will not bereplaced.
4.6. Subject and Study Completion
A completed subject is one who has completed all phases of the study.
The end of the study is defined as the date of the last subject’s last visit.
 
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5. PRODUCT INFORMATION
5.1. Study Product
The following study products will be supplied by the Clinical Supplies Department, 
GSKCH:
Reference / 
Washout Cleanser
Test Product
Reference/ 
Washout
Sunscreen
Product Name 
Simple
TM Kind to Skin
Moisturising Facial 
Wash
Physiogel Calming 
Relief SPF 20 Cream 
Sunmax Sensitive SPF 
50
Product 
Formulation 
Code
N/A  
(Commercial, UK)
Application 
Quantity
Approximately 0.6-1 g
Route of 
Application
Topical
Application 
Instructions
In your hands, work 
a small amount into 
a lather. Massage 
onto wet skin, rinse 
with water. 
Avoid contact with 
eyes. Ifcontact 
occurs, rinse 
thoroughly with 
water.
Apply twice a day 
(morning and 
evening)  
Dispense two pumps 
of product onto the 
fingertips andapply 
to the full face. 
Avoid contact with 
eyes. If contact 
occurs rinse 
thoroughly with 
water.
Apply twice a day 
(morning and 
evening)
Do not apply in the 
morning if you are 
visiting the site on 
the same day.
Dispense a pea-sized 
quantity onto the 
fingertips and apply 
to the full face.
Avoid contact with 
eyes. If contact 
occurs rinse 
thoroughly with 
water.
Apply twice a day 
(morning and 
lunchtime) 
Do not apply in the 
morning if you are 
visiting the site on 
the same day. 
 
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CCI
CCI

42
Other items to besupplied by the Clinical Supplies Department, GSKCH:
Name of Item
Purpose
Not Applicable
Not Applicable
Other items to be supplied by the Site:
Name of Item
Purpose
70% Glycolic Acid Treatment-SM 
Emprendimentos Farmacêuticos (Fagron) 
from MagisPharma
Glycolic acid solution with which to 
execute the facial peel procedure
Sodium Bicarbonate Neutralizing 
Solution -Labsynth Produtos para 
Laboratórios (Synth) from MagisPharma
Neutralizing agent used in the final step 
of the facial peel procedure
5.2. ApplicationSchedule
A 7 day washout phase is included to standardize subjects’ skin care regimens. 
Subjects will be provided with a commercially available facial cleanser (Simple Kind 
to Skin Moisturising Facial Wash) and sunscreen (Sunmax Sensitive SPF 50) as 
standard of care. Subjects will be instructed to use the facial cleanser during the 
morning and evening, and to applythe sunscreen in the morning (after cleansing) and 
at lunchtime. Sunmax Sensitive SPF 50 is designed for subjects with sensitive skin 
and has favourable local tolerance clinical data to support its use for application to 
sensitive, post-procedure skin. Simple Kind to Skin Moisturising Facial Wash is also 
designed for subjects with sensitive skin. 
Within the washout phase, a study materialsensitivity test is included to identify 
subjects who may be sensitive to the study materials in order to determine whether 
they are suitable to undergo the facial peel procedure. A qualified dermatologist will 
dispense a thin layer of the 70% glycolic acid peel solution to cover a demarcated 5 x 
5 cm square areaon the volar surface of the forearmand, within a period of 30-60 
seconds, will neutralize the 70% glycolic acid peel solution with the bicarbonate 
neutralizing agent and then rinse the skin thoroughly with water and pat dry with a 
soft towel. Once dry, the dermatologist will apply a thin layer of the Sunmax 
Sensitive SPF50 sunscreen to the 5 x 5 cm square area. Dermatologist and subject 
self-assessments will be used to evaluate local tolerance. If subject data for the study 
materialsensitivity study contains a dermatologist or subject self-assessment score of
“Severe” for any attribute, this subject will be deemed to be in violation of exclusion 
criteria 9and must be dischargedfrom the study.
 
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Upon completion of the washout phase, subjects considered to be eligible for the test 
phase will be randomised to two groups (Group I: Test product; Group 2: No-
treatment) and a qualified dermatologist with experience administering facial peels  
will conduct the 70% Glycolic Acid procedure.
Subjects randomised to Group I will be instructed to apply the test product twice-
daily (morning and evening) after cleansing, for a total of 14 consecutive days. All 
subjects will be instructed to continue using the facial cleanser twice-daily during the 
morning and evening, and to apply the sunscreen in the morning and at lunchtime.A 
summary of the subject’s post-randomization regimen is included below for clarity. 
Randomized 
Group
Morning
Lunchtime*
Evening
Group 1
1. Cleansing
2. Test Product
3. Sunscreen
2. Sunscreen
1. Cleansing
2. Test Product
Group 2
1. Cleansing
2. Sunscreen
2. Sunscreen
2. Cleansing
*Lunchtime application must be at least 3 hours after previous sunscreen application
Subjects will not apply any sunscreen on the dayof the facial peel procedure (Day 8), 
since they will remain at site until the evening (after 5 pm).  On themorning of each 
visit, prior to arriving to the test site, subjects will be instructed to cleanse their face 
and not to apply any test product or sunscreen until after all measurements and 
assessments have been completed. Before leaving the site, subjects will undergo test 
product and/or sunscreen applicationunder supervision. After leaving the site, 
subjects should apply the sunscreen a second time, but no sooner than 3 hours after 
the previous application.
5.3. ApplicationModification
Nomodification of product application is permitted in this study.
5.4. Product Compliance
A daily dairywill be used to monitor and promotecompliance. Subjects will not be 
excluded due to missed applications, but will be reminded to use the products as per 
the instructions provided and to complete the diary card on a daily basis to encourage 
compliance.Missed or additional product applications will be recorded by the 
Investigator or designee as deviations.Subjects will be asked to bring their washout 
 
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and test products to each site visit where it will be weighed tofurther confirm 
compliance with product usage.
To be considered compliant and part of the per-protocol (PP) population, a subject 
must have used the test product and/or sunscreen at least 80% of the instructed 
number of applications following completion of the facial peel procedure.THE 
SUBJECT DIARY WILL BE USED AS THE PRIMARY DATA SOURCE 
WITH WHICH TO ASSESSSUBJECT COMPLIANCE.
5.5. Precautions
No special precautions are required providing the study is carried out in accordance 
with this protocol.
5.6. Overdose
An overdose is a deliberate or inadvertent administration of a product at a dose higher 
than specified in the protocol.
Overdose is not likely to occur in this study.  Limited quantities of the product will be 
supplied, and closely monitored by the site for each subject.
Overdose per se is not an AE.  However, any clinical sequelae of an overdose should 
be reported as an AE (and serious adverse event (SAE), if appropriate).  For 
reporting, follow the AE and SAE reporting instructions.
5.7. Rescue Therapy
No rescue therapy is required in this study.
5.8. Product Assignment
Subjects will be assigned to study product in accordance with the randomization 
schedule generated by the Biostatistics Department, GSKCH, prior to the start of the 
study, using validated internal software.
5.8.1Randomization
A unique screening number will identify each subject screened for study 
participation.  Screening numbers will be assigned in ascending numerical order as 
each subject signs their consent form.  Subjects who meet all inclusion and exclusion 
criteria will be randomized according to the randomization schedule.  Randomization 
numbers will be assigned in ascending numerical order as each subject is determined 
to be fully eligible.
 
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5.8.2Blinding
This is an evaluator-blind clinical study. Therefore, allpersonnel and evaluators who 
may influence study outcomes are blinded to the product allocation of subjectsand 
their diaries.The Investigator or their designees who are not involved in procedures 
or processes which may influence study outcomes are not required to be blinded to 
the product allocation of subjectsand will have visibility of the subject diary.
5.8.3Code Breaks
The blind must only be broken in an emergency where it is essential to know which 
product a subject received in order to give the appropriate medical care.  Wherever 
possible the Investigator (or designee) must contact the Sponsor prior to breaking the 
blind.  The investigator must document the reason for breaking the code and sign and 
date the appropriate document.
The study blind must be returned to GSKCH at the end of the study.
5.9. Packaging and Labelling
The Washout/ Reference products (Simple Kind to Skin Moisturising Facial Wash 
and Sunmax Sensitive SPF 50) will be over-wrapped in opaquevinyl and any 
branding on the commercial products will be obscured. The Test Product (Physiogel 
Calming Relief SPF 20 Cream) will be supplied in plain white pumps and will not be 
overwrapped.
A new label will be created by the Clinical Supplies Department, GSKCH and 
applied to each product. The contents of the label will be in accordance with all 
applicable regulatory requirements and will be the responsibility of the Clinical 
Supplies Department, GSKCH. Each study label will contain, but not be limited to, 
protocol number, product code letter for Test Product only and directions for storage.
Care should be taken with the supplied products and their labels so that they are 
maintained in good condition.  It is important that all labels remain intact and legible 
for the duration of the study. Subjects should be instructed to not remove or deface 
any part of the study label.
5.9.1. Accountability of Product
All products supplied are for use only in this clinical study and should not be used for 
any other purpose.
 
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The investigator or designee will maintain a full record of study product 
accountability. A Product Dispensing Log must be kept current and will contain the 
following information:
1. The identification of the subject to whom the study product was dispensed.
2. The date(s) and quantity of the study product dispensed to the subject.
3. The date(s) and quantity of the study product returned by the subject (if 
applicable).
The inventory must be available for inspection by the study monitor during the study. 
At the end of the study, study product supplies will be verified by the monitor.  Study
 
product supplies will then be either collected by the study monitor or returned by the 
investigator or designee to theGSKCH Clinical Supplies Department or designated 
vendor.
5.9.2. Storage of Product
Study product supplies must be stored in compliance with the label requirements in a 
secure place with limited or controlled access.
 
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6. STUDY ASSESSMENTS AND PROCEDURES
This section lists the procedures and parameters of each planned study assessment.  
The exact timingof each assessmentat each scheduled visit is listed in the Schedule 
of Events section.
Adherence to the study design requirements, including all assessments and 
procedures are essential and required for study conduct.
6.1. Visit 1 –Screening/ WashoutVisit
6.1.1. Informed Consent
The investigator, or designee, must obtain written (signed and dated by the subject) 
informed consent from each subject participating in this study after adequate
explanation of the aims, methods, objectives, and potential hazards of the study.
The investigator, or designee, must also explain to the subjects that they are 
completely free to refuse to enter the study or to withdraw from it at any time.  
Appropriateforms for documenting a written consent will be provided by the 
investigator or by GSKCH.  The investigator, or designee, should sign and date the 
consent form to confirm that the consentprocess was completed correctly.  The 
subject will be provided witha copy of their signed and dated informed consentform
(ICF)and any other written information which they should be instructed to retain.
A list of the chemical entities present in all formulations will be provided to subjects 
so that they may evaluate the list for any known sensitivity or intolerance to the study 
materials. It will be made clear on the ICF that subjects who have a known sensitivity 
or intolerance to the study materials should not provide their consent to continue.
If, during a subject’sparticipation in the study, any new information becomes 
available that may affect the subject’s willingness to participate in the study, each 
ongoing subject should receive a copy of this new information and be re-consented 
into the study. Subjects shouldbe provided with a copy of the signed and dated 
amended consent form. The date of consent will be recorded on theeCRF.
Photographs (Image Capture –VISIA) are to be captured forboth clinical assessment 
and potential commercial exploitation. Subjects will be requested to provide their 
consent on the ICF. Subjects who do not provide consent for the potential commercial 
exploitation of their photographic data will still be considered eligible for the study. 
All subjects will have their photographs taken atthe scheduled time points to enable 
 
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the Evaluator to make an accurate assessment of global toleranceand cosmetic 
efficacy. 
6.1.2. Demographics
The following demographic parameters will be captured by the Investigator or 
designee and recorded on theeCRF: year of birth, raceandgender.
6.1.3. Medical History and Concomitant Medication
Medical history will be assessed as related to the inclusion/exclusion criteria by the 
Investigator or designee.  Details of any relevant medical or surgical history within 
the last year, including allergies or drug sensitivity, will be recorded on theeCRF.  
Any concomitant therapy taken in the 30 days prior tothe Screening Visit and 
throughout the study will also be recorded.
6.1.4.Fitzpatrick Skin Type Assessment
Fitzpatrick skin type assessment will be conducted by a trained, qualified technician
and recorded on theeCRFusing the scale below.
Type
Description
I
Always burns, never tans
II
usually burns, tans minimally
III
sometimes mild burn, tans uniformly (cream white; fair with any hair or 
eye color)
IV
burns minimally, always tans well (moderate brown)
V
very rarely burns, tans very easily (dark brown)
VI
Never burns, never tans (deeply pigmented dark brown to darkest 
brown)
6.1.5.Glogau Photoaging Type Assessment
Glogau photoaging type assessment will be conducted by a trained, qualified 
technician and recorded on theeCRFusing the scale below.
 
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Group Classification
Skin Characteristics
I
Mild
Early Photoaging: mild pigment changes, no keratosis, 
minimal wrinkles, minimal or no makeup
II
Moderate
Early to Moderate Photoaging: Early brown spots visible, 
keratosis palpable but not visible, parallel smile lines begin 
to appear, wears some foundation
III
Advanced
Advanced Photoaging: Obvious discolorations, visible 
capillaries (telangiectasias), visible keratosis, wears heavier 
foundation always
IV
Severe
Severe Photoaging: Yellow-gray skin color, prior skin 
malignancies, wrinkles throughout -no normal skin, cannot 
wear makeup because it cakes and cracks
6.1.6. Inclusion / Exclusion Criteria
Inclusion/exclusion criteria will be confirmed by the Investigator or medically 
qualified designee and recorded on theeCRF. Exclusion 3P will be assessed by a 
qualified ophthalmologist. At this point, exclusion criteria 9will not be evaluated 
until aftercompletion of the study material sensitivity test and corresponding 
Dermatologist and Subject self-assessment data. 
6.1.7. Subject Eligibility
Subjects meeting the inclusion and exclusion criteria, whom provide their informed 
consent and who are also considered eligible for enrollment in the studybythe 
Investigator or medically qualified designee will be enrolled into the study. 
Confirmation of whether a subject was enrolled, or not, will be recorded on the eCRF.
6.1.8. Study Material Sensitivity Test
This procedure isincluded to determine whether each subject is overly sensitive to 
the washout products and glycolic acid peel regimen.  A qualified dermatologist will 
dispense a thin layer of the 70% glycolic acid peel solution (approximately 0.5ml) to 
cover a demarcated 5 x 5 cm square areaon the volar surface of the forearmand, 
within a period ofapproximately30-60 seconds, will neutralize the 70% glycolic acid 
peel solution with the bicarbonate neutralizing agent thenrinse the skin thoroughly 
with water and pat dry with a soft towel. Once dry, the dermatologist will apply a thin 
layer of the Sunmax Sensitive SPF50 sunscreen to the forearm. Successful 
completion of this procedure will be recorded on the eCRF.
 
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6.1.9. Subject Self-Assessment of Sensitivity
The following assessments will be conducted by test subjects reflective of their skin 
condition at the 5 x 5 cm square area on the volar surface of the forearm at the time of 
evaluation and recorded on the eCRF.
Score
Pain
Stinging/ 
Burning
Itching
Tightness Redness
Dryness
0
None 
None 
None 
None 
None 
None
1
Mild 
Mild 
Mild 
Mild 
Mild 
Mild
2
Moderate Moderate Moderate Moderate Moderate Moderate
3
Severe 
Severe 
Severe 
Severe
Severe
Severe
6.1.10. Dermatologist Assessment of Sensitivity
The following assessments will be conducted by a dermatologist reflective of the 
subject’sskin condition at the 5 x 5 cm square area on the volar surface of the 
forearm at the time of the evaluation and recorded on theeCRF.  Whenever possible, 
it is preferable for the same dermatologist to evaluate the same subject through the 
entire study.
Erythema
Score
Description
0
None -No evidence of erythema present
1
Mild –Slight red coloration
2 
Moderate -Definite redness
3
Severe -Marked erythema, bright red to dusky dark red in color
Dryness
Score
Description
0
None -No dryness
1
Mild -Barely perceptible, fine scales or flakes present to limited areas of 
the test site
2
Moderate -Fine scales or flakes generalized to all areas of the test site
3
Severe -Scaling and peeling of skin over all areas of the test site
 
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Desquamation
Score
Description
0 
None -No evidence of desquamation/peeling
1
Mild -Barely perceptible scaling; evident only on scratching
2
Moderate -Minimal scaling, adherent to the skin
3
Severe -Moderate scaling, loosely adherent to the skin and easily 
removable
Edema
Score
Description
0
None -No edema present
1
Mild -Barely perceptible edema present
2
Moderate -Definite edema present
3
Severe -Marked/pronounced edema present
6.1.11. Exclusion Criteria 9
Dermatologist and Subject self-assessment data will be evaluated by the Investigator 
or designee. Any subject with a score of “Severe” for any of the Dermatologist 
(Erythema, Dryness, Desquamation, Edema) or Subject self-assessed (Pain, 
Stinging/Burning, Itching, Tightness, Redness, Dryness) parameters will be 
considered to be in violation of exclusion 9and will be discharged from the study. All 
other subjects will be considered eligible to continue in the study.
Any Dermatologist or Subject self-assessed score of “severe” will also be considered 
an adverse event and reported as per the procedures outlined in Section 7. 
Dermatologist or Subject self-assessed scores of “none”, “mild” and “moderate” will 
not be considered adverse events. 
6.1.12. Subject Eligibility
See 6.1.7.
6.1.13. Washout Products Weighing
The Investigator or designee will weigh the washout products using a calibrated mass 
balance to 2 decimal places (in grams) and will document the measured weight on the
eCRF.
 
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6.1.14. Washout Products and Washout Diary Dispensing
Dispensing of washout products andwashoutdiary to subjectsto standardize skin 
care regimen and usage instructionswill be recorded on theeCRF.
6.2. Visit 2 –1 day after Visit 1
6.2.1. Current / Concomitant Medication
Any concomitant therapy taken since the last visitand throughout the study will be 
recorded on the eCRF by the Investigator or designee.
6.2.2. Adverse Events
Adverse events will be assessed by the Investigator or designee and recorded on the 
eCRF, as per the process detailed in Section 7.
As per Section 7.1, the following does not meet the definition of anadverse event:
“Any clinically significant abnormal laboratory findings (if applicable) or other 
abnormal safety assessments which are associated with the underlying disease, unless 
judged by the investigator to be more severe than expected for the subject’s 
condition.” Therefore, the Dermatologist (erythema, edema, dryness, and 
desquamation) and Subject-self assessment (pain, stinging/burning, itching, tightness, 
redness, and dryness) grades will only be considered adverse events if they are scored 
as “Severe”, or if the investigator judges them to be more severe than expected in 
context of the Glycolic Acid treatment procedure. 
6.2.3. Continued Subject Eligibility
The Investigator or designee will ascertain whether there have been any deviations 
from the protocol since the last visit, whether the subject has adhered to the lifestyle 
restrictions since the last visit and whether, in their opinion, the subject is eligible to 
continue in the study. Subject Continued Subject Eligibilitywill be recorded on the 
eCRF.
6.2.4. Compliance (Diary Review)
Subject diaries will be reviewed by the Investigator or their designee. Subjects who 
apply the washout products more or less frequently than twice a day will be 
considered to have deviated from the protocol and additional/missed applications will 
recorded on the Deviations Log. The total number of product applications and total 
number of missed product applications will be recorded on the eCRF.
 
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6.2.5. Washout Products Weighing
The Investigator or designee will weigh the washout products using a calibrated mass 
balance to 2 decimal places (in grams) and will document the measured weight on the 
eCRF.
6.2.6. Subject Self-Assessment of Sensitivity
Assessments to be taken as per 6.1.9, 24±4 hours after completion of the study 
material sensitivity test.
6.2.7.Dermatologist Assessment of Sensitivity
Assessments to be taken as per 6.1.10, 24±4 hours after completion of the study 
material sensitivity test.
6.2.8. Exclusion Criteria
The exclusion criteria described in Appendix 4 will be confirmed by the Investigator 
or medically qualified designee and recorded on theeCRF.
Any subject with a score of “Severe” for any of the Dermatologist (Erythema, 
Dryness, Desquamation, Edema) or Subject self-assessed (Pain, Stinging/Burning, 
Itching, Tightness, Redness, Dryness) parameters will be considered to be in violation 
of exclusioncriteria9and will be discharged from the study. All other subjects will 
be considered eligible to continue in the study.
Any Dermatologist or Subject self-assessed score of “severe” will also be considered 
an adverse event and reported as per the procedures outlined in Section 7. 
Dermatologist or Subject self-assessed scores of “none”, “mild” and “moderate” will 
not be considered adverse events. 
6.2.9. Subject Eligibility
See 6.1.7.
6.3. Visit 3–Day of Procedure-6 days after Visit 2
6.3.1. Current / Concomitant Medication
Any concomitant therapy taken since the last visitand throughout the study will be 
recorded on theeCRFby the Investigator or designee.
 
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6.3.2. Adverse Events
Adverse events will be assessed by the Investigator or designee and recorded on the
eCRF, as per the process detailed in Section 7.
As per Section 7.1, the followingdoes not meet the definition of an adverse event:
“Any clinically significant abnormal laboratory findings (if applicable) or other 
abnormal safety assessments which are associated with the underlying disease, unless 
judged by the investigator to be more severe than expected for the subject’s 
condition.” Therefore, the Dermatologist (erythema, edema, dryness, and 
desquamation) and Subject-self assessment (pain, stinging/burning, itching, tightness, 
redness, and dryness) grades will only be considered adverse events if they are scored 
as “Severe”, or if the investigator judges them to be more severe than expected in 
context of the Glycolic Acid treatment procedure. 
6.3.3. Continued Subject Eligibility
The Investigator or designee will ascertain whether there have been any deviations 
from the protocol since the last visit, whether the subject has adhered to the lifestyle 
restrictions since the last visit and whether, in their opinion, the subject is eligible to 
continue in the study. Subject Continued Subject Eligibilitywill be recorded on the 
eCRF.
6.3.4. Compliance (Diary Review)
Subject diaries will be reviewed by the Investigator or their designee. Subjects who 
apply the washout product more or less frequently than twice a day will be considered 
to havedeviated from the protocol and additional/missed applications will recorded 
on the Deviations Log. The total number of product applications and total number of 
missed product applications will be recorded on the eCRF. 
6.3.5. Washout Product Weighing
TheInvestigator or designee will weigh the washout products using a calibrated mass 
balance to 2 decimal places (in grams) and will document the measured weight on the 
eCRF. 
6.3.6. Subject Self-Assessment of Sensitivity
Assessments to be taken as per 6.1.9, 7 days after completion of the study material 
sensitivity test.
6.3.7. Dermatologist Assessment of Sensitivity
Assessments to betaken as per 6.1.10, 7 days after completion of the study material 
sensitivity test.
 
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6.3.8.Exclusion Criteria
Exclusion criteria detailed in Appendix 4 will be assessed by the Investigator or
medically qualified designee to confirm subject eligibility and recorded on theeCRF. 
Subjects who trigger any of the exclusion criteria will be discharged from the study.
Any subject with a score of “Severe” for any of the Dermatologist (Erythema, 
Dryness, Desquamation, Edema) or Subject self-assessed (Pain, Stinging/Burning, 
Itching, Tightness, Redness, Dryness) parameters will be considered to be in violation 
of exclusion criteria 9and will be discharged from the study. All other subjects will 
be considered eligible to continue in the study.
Any Dermatologist or Subject self-assessed score of “severe” will also be considered 
an adverse event and reported as per the procedures outlined in Section 7. 
Dermatologist or Subject self-assessed scores of “none”, “mild” and “moderate” will 
not be considered adverse events. 
6.3.9. Subject Eligibility
See 6.1.7.Note, to be considered compliant eligible to continue in the study, a subject 
must not have missed more than 5 applications of either the washout cleanser or 
sunscreen. Subjects failing to meet this criteria will be considered to have deviated 
from the protocol and will be discharged from the study.
6.3.10. Subject Randomisation
Subject randomisation will be conducted as per the process detailed in Section 5.8.1 
and documented on theeCRF.
6.3.11. Instrumental Measurements Pre-Procedure
Instrumental measurements of Transepidermal Water Loss and skin hydration will be 
conducted by the Investigator or designee and recorded on the eCRF. Subjects will 
acclimatize to the controlled room temperature (21±1 ºC) and humidity (50±10%) for 
at least 30 minutes prior to instrumental assessment. 
Instrumental Measurement of Transepidermal Water Loss
TEWL measurement will be performed by evaporimetry with a Tewameter TM 300 
(Courage & Khazaka, Cologne, Germany) following the European Expert Group on 
Efficacy Measurement of Cosmetics and Other Topical Products (EEMCO) Guidance 
for the Assessment of Transepidermal Water Loss in Cosmetic Sciences. [Rogiers]  
Measurements will be taken in triplicate on the left cheek (below the cheekbone, 
between the nose and ear) with units of g/m
2/hr.TEWL measurements will be taken 
 
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with the subject lying horizontally
, on their back, so that the chimney of the 
Tewameter probe is aligned vertically.
Instrumental Measurementof Moisturisation
Measurement of stratum corneum hydration will be performed by the electrical 
capacitance method with a Corneometer CM 865 (Courage & Khazaka, Cologne, 
Germany) following the EEMCO Guidance for the Assessment of Stratum Corneum 
Hydration. [Berardesca]Corneometer measurements will be taken in triplicate at the 
left cheek (below the cheekbone, between the nose and earand not overlapping with 
the site previously used for TEWL measurements) with the subject lying horizontally
, 
on their back. Instrumental data will be reported in Corneometer Units
6.3.12. Image Capture (VISIA)Pre-Procedure
VISIA CR®high resolution photographs of the front, leftand right sides of subject’s 
faces will be taken using polarised and non-polarised lighting and documented on the 
eCRF. Jewelry will be removed and hair loosely tied back and covered with a black 
veil so that it does not interfere with the photograph. Subjects will be asked to 
maintain a relaxed, neutral expression with their eyes closed. Photographic images of 
subjects are considered personal identifiable information (PII) and will be transferred 
securely from the site to GSK. Subjects who did not provideconsent for the 
commercial exploitation of their photographic data will not have their photographs 
taken.
6.3.13. Subject Self-Assessment Pre-Procedure
The following assessments will be conducted by test subjects reflective of their facial 
skin conditionat the time of evaluation and recorded on the eCRF.
Score
Pain
Stinging/ 
Burning
Itching
Tightness Redness
Dryness
0
None 
None 
None 
None 
None 
None
1
Mild 
Mild 
Mild 
Mild 
Mild 
Mild
2
Moderate Moderate Moderate Moderate Moderate Moderate
3
Severe 
Severe 
Severe 
Severe 
Severe 
Severe
6.3.14. Dermatologist AssessmentPre-Procedure
The following assessments will be conducted by a dermatologist reflective of the 
subject’s facial skin condition at the time of the evaluation and recorded on theeCRF.  
 
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Whenever possible, it is preferable for the same dermatologist to evaluate the same 
subject through the entire study.
Erythema
Score
Description
0
None -No evidence of erythema present
1
Mild –Slight red coloration
2 
Moderate -Definite redness
3
Severe - Marked erythema, bright red to dusky dark red in color
Dryness
Score
Description
0
None -No dryness
1
Mild -Barely perceptible, fine scales or flakes present to limited areas of 
the face
2
Moderate -Fine scales or flakes generalized to all areas of the face
3
Severe -Scaling and peeling of skin over all areas of the face
Desquamation
Score
Description
0 
None -No evidence of desquamation/peeling
1
Mild -Barely perceptible scaling; evident only on scratching
2
Moderate -Minimal scaling, adherent to the skin
3
Severe -Moderate scaling, loosely adherent to the skin and easily 
removable
Edema
Score
Description
0
None -No edema present
1
Mild -Barely perceptible edema present
2
Moderate -Definite edema present
3
Severe -Marked/pronounced edema present
 
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6.3.15. Dermatological Procedure (Facial Peel)
The 70% Glycolic Acid facial peel procedure will be conducted by a medically 
qualified professional with hands-on experience administering peels of this nature. 
The site will source 70% Glycolic Acid treatment (SM Emprendimentos 
Farmacêuticos (Fagron)) and Sodium Bicarbonate neutralizing solution (Labsynth 
Produtos para Laboratórios (Synth)) from MagisPharma and will retain a copy of the 
purchase orderand certificate of analysis,which will be stored in the Trial Master 
File (TMF).
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
.
6.3.16.Dermatologist Assessment Post-Procedure, Pre-Treatment 
(BASELINE)
Assessments to be taken and recorded as per 6.3.14, 60±15 minutes after completion 
of the facial peel procedure.
 
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59
6.3.17. Instrumental Measurements Post-Procedure, Pre-Treatment 
(BASELINE)
Assessments to betaken and recorded as per 6.3.11, 60±15 minutesafter completion 
of the facial peel procedure.
6.3.18. Image Capture (VISIA)Post-Procedure, Pre-Treatment 
(BASELINE)
Assessments to betaken and recorded as per 6.3.12, 60±15 minutes after completion 
of the facial peel procedure.
6.3.19. Subject Self-Assessment Post-Procedure, Pre-Treatment 
(BASELINE)
Assessments to be taken and recorded as per 6.3.13, 60±15 minutesafter completion 
of thefacial peel procedure.
6.3.20. Test Product Weighing
The Investigator or designee will weigh the test and washout productsusing a 
calibrated mass balance to 2 decimal places(in grams)and will document the 
measured weight on theeCRF. 
6.3.21. Test Productand Test DiaryDispensing. Washout Diary 
Collection.
The time and dateof test productdispensing will be documented on theeCRF.Test 
product diary will be dispensed and washout diary collected.  Subjects randomised to 
test product will be dispensed a different diary than subjects who are not randomised 
to test product. The Investigator or designee involved in test product and test diary 
dispensing must not be involved in any assessments in order to protect the blind.
6.3.22. Supervised Test Product ApplicationPost-Procedure
Subjects randomized to test product (Group I) will be instructed to apply the test 
product as per the labelled usage instructions immediately afterthe post-procedure, 
pre-treatment (baseline) assessments are complete. The Investigator or designee will 
oversee this initial product application. Group II will not apply any test product. 
Product application will be recorded on theeCRFand subject diaryand must happen 
at least 30 minutes prior to any further instrumental measurements. The Investigator 
or designee involved in this step must not be involved in any assessments in order to 
protect the blind.
 
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6.3.23. Instrumental Measurements Post-Procedure, Post-Treatment
Measurements to be taken and recorded as per 6.3.11, 180±15 and 360±15 minutes 
after completion of the facial peel procedure.
6.3.24. Subject Self-Assessment Post-Procedure, Post-Treatment
Assessments to be taken and recorded as per 6.3.13, 180±15 minutesafter completion 
of the facial peel procedure.
6.3.25. Evaluator (Dermatologist) Assessment Post-Procedure, Post-
Treatment
Assessments to be taken and recorded as per 6.3.14, 180±15 minutes after completion 
of the facial peel procedure.
Subjects will remain at site until at least 5:00 PM to prevent exposure to intense 
sunlight.
6.4. Visit4–1 day after Visit 3 
Subjects will be instructed to arrive at the site prior to 9:00 AM to minimize exposure 
to intense sunlight. 
6.4.1. Current / Concomitant Medication
Any concomitant therapy taken since the last visitand throughout the study will be 
recorded on theeCRFby the Investigator or designee.
6.4.2. Adverse Events
Adverse events will be assessed by the Investigator or designee and recorded on the
eCRF, as per the process detailed in Section 7.
As per Section 7.1, the following does not meet the definition of an adverse event:
“Any clinically significant abnormal laboratory findings (if applicable) or other 
abnormal safety assessments which are associated with the underlying disease, unless 
judged by the investigator to be more severe than expected for the subject’s 
condition.” Therefore, the Dermatologist (erythema, edema, dryness, and 
desquamation) and Subject-self assessment (pain, stinging/burning, itching, tightness, 
redness, and dryness) grades will only be considered adverse events if they are scored 
 
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as “Severe”, or if the investigator judges them to be more severe than expected in 
context of the Glycolic Acid treatment procedure. 
6.4.3. Continued Subject Eligibility
The Investigator or designee will ascertain whether there have been any deviations 
from the protocol since the last visit, whether the subject has adhered to the lifestyle 
restrictions since the last visit and whether, in their opinion, the subject is eligible to 
continue in the study. Subject Continued Subject Eligibilitywill be recorded on the 
eCRF.
6.4.4. Compliance (Diary Review)
Subject diaries will be reviewed by the Investigator or their designee. Subjects who 
apply the washout products (All subjects) and test product (Group I, only) more or 
less frequently than twice a day will be considered to have deviated from the protocol 
and additional/missed applications will recorded on the Deviations Log. The total 
number of product applications and total number of missed product applications will 
be recorded on the eCRF.
6.4.5. Washout Products Weighing
The Investigator or designee will weigh the washout products using a calibrated mass 
balance to 2 decimal places (in grams) and will document the measuredweighton the
eCRF.
6.4.6. Test Product Weighing
The Investigator or designee will weigh the test product using a calibrated mass 
balance to 2 decimal places and will document the measuredweighton theeCRF. 
6.4.7. Instrumental Measurements Post-Procedure, Post-Treatment (24±4 
hours after Facial Peel)
Measurementsto be taken and recorded as per 6.3.11, 24±4 hoursafter completion of 
the facial peel procedure.
6.4.8. Image Capture (VISIA)Post-Procedure, Post-Treatment (24±4 
hours after Facial Peel)
Assessments to be taken and recorded as per 6.3.12, 24±4 hoursafter completion of 
the facial peel procedure.
 
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6.4.9. Subject Self-Assessment Post-Procedure, Post-Treatment (24±4 
hours after Facial Peel)
Assessments to be taken and recorded as per 6.3.13, 24±4 hoursafter completion of 
the facial peel procedure.
6.4.10. Dermatologist Assessment Post-Procedure, Post-Treatement (24±4 
hours after Facial Peel)
Assessments to be taken and recorded as per 6.3.14, 24±4hoursafter completion of 
the facial peel procedure.
6.4.11.Supervised Test Product Application
Only subjects in Group I will undergo supervised test product application. The 
Investigator or designee will oversee application of the test product. Product 
application will be recorded on theeCRFand subject diary. The Investigator or 
designee involved in this step must not be involved in any assessments in order to 
protect the blind.
6.4.12. Supervised Sunscreen Application
All subjects will undergo supervised sunscreen application. The Investigator or 
designee will oversee application of the SPF 50sunscreen. Product application will 
be recorded on theeCRFand subject diary. 
6.5. Visit 5–1 day after Visit 4  
Subjects will be instructed to arrive at the site prior to 9:00 AM to minimize exposure 
to intense sunlight. 
6.5.1. Current / Concomitant Medication
Any concomitant therapy taken since the last visitand throughout the study will be 
recorded on the eCRF by the Investigator or designee.
6.5.2. Adverse Events
Adverse events will be assessed by the Investigator or designee and recorded on the 
eCRF, as per the process detailed in Section 7.
As per Section 7.1, the following does not meet the definition of an adverse event:
“Any clinically significant abnormal laboratory findings (if applicable) or other 
abnormal safety assessments which are associated with the underlying disease, unless 
judged by the investigator to be more severe than expected forthe subject’s 
 
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condition.” Therefore, the Dermatologist (erythema, edema, dryness, and 
desquamation) and Subject-self assessment (pain, stinging/burning, itching, tightness, 
redness, and dryness) grades will only be considered adverse events if they are scored 
as “Severe”, or if the investigator judges them to be more severe than expected in 
context of the Glycolic Acid treatment procedure. 
6.5.3. Continued Subject Eligibility
The Investigator or designee will ascertain whether there have been any deviations 
from the protocol since the last visit, whether the subject has adhered to the lifestyle 
restrictions since the last visit and whether, in their opinion, the subject is eligible to 
continue in the study. Subject Continued Subject Eligibility will be recorded on the 
eCRF.
6.5.4. Compliance (Diary Review)
Subject diaries will be reviewed by the Investigator or their designee. Subjects who 
apply the washout products (All subjects) and test product (Group I, only) more or 
less frequently than twice a day will be considered to have deviated from the protocol 
and additional/missed applications will recorded on the Deviations Log. The total 
number of product applications and total number of missed product applications will 
be recorded on the eCRF. 
6.5.5. Washout Products Weighing
The Investigator or designee will weigh the washout products using a calibrated mass 
balance to 2 decimal places (in grams) and will document the measured weighton the 
eCRF.
6.5.6. Test Product Weighing
The Investigator or designee will weigh the test product using a calibrated mass 
balance to 2 decimal places and will document the measured weighton the eCRF. 
6.5.7. Instrumental Measurements Post-Procedure, Post-Treatment (48±4 
hours after Facial Peel)
Measurementsto be taken and recorded as per 6.3.11, 48±4 hoursafter completion of 
the facial peel procedure.
6.5.8. Subject Self-Assessment Post-Procedure, Post-Treatment (48±4 
hours after Facial Peel)
Assessments to be taken and recorded as per 6.3.13, 48±4 hoursafter completion of 
the facial peel procedure.
 
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6.5.9. Dermatologist Assessment Post-Procedure, Post-Treatement (48±4 
hours after Facial Peel)
Assessments to be taken and recorded as per 6.3.14, 48±4hoursafter completion of 
the facial peel procedure.
6.5.10.Supervised Test Product Application
Only subjects in Group I will undergo supervised test product application. The 
Investigator or designee will oversee application of the test product. Product 
application will be recorded on the eCRF and subject diary. The Investigator or 
designee involved in this step must not be involved in any assessments in order to 
protect the blind.
6.5.11. Supervised Sunscreen Application
All subjects will undergo supervised sunscreen application. The Investigator or 
designee will oversee application of the SPF 50 sunscreen. Product application will 
be recorded on the eCRF and subject diary. 
6.6. Visit 6–1 day after Visit 5  
Subjects will be instructed to arrive at the site prior to 9:00 AM to minimize exposure 
to intense sunlight. 
6.6.1. Current / Concomitant Medication
Any concomitant therapy taken since the last visitand throughout the study will be 
recorded on the eCRF by the Investigator or designee.
6.6.2. Adverse Events
Adverse events will be assessed by the Investigator or designee and recorded on the 
eCRF, as per the process detailed in Section 7.
As per Section 7.1, the following does not meet the definition of an adverse event:
“Any clinically significant abnormal laboratory findings (if applicable) or other 
abnormal safety assessments which are associated with the underlying disease, unless 
judged by the investigator to be more severe than expected for the subject’s 
condition.” Therefore, the Dermatologist (erythema, edema, dryness, and 
desquamation) and Subject-self assessment (pain, stinging/burning, itching, tightness, 
redness, and dryness) grades will only be considered adverse events if they are scored 
as “Severe”, or if the investigator judges them to be more severe than expected in 
context of the Glycolic Acid treatment procedure. 
 
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6.6.3. Continued Subject Eligibility
The Investigator or designee will ascertain whether there have been any deviations 
from the protocol since the last visit, whether the subject has adhered to the lifestyle 
restrictions since the last visit and whether, in their opinion, the subject is eligible to 
continue in the study. Subject Continued Subject Eligibility will be recorded on the 
eCRF.
6.6.4. Compliance (Diary Review)
Subject diaries will be reviewed by the Investigator or their designee. Subjects who 
apply the washout products (All subjects) and test product (Group I, only) more or 
less frequently than twice a day will be considered to have deviated from the protocol 
and additional/missed applications will recorded on the Deviations Log. The total 
number of product applications and total number of missed product applications will 
be recorded on the eCRF. 
6.6.5. Washout Products Weighing
The Investigator or designee will weigh the washout products using a calibrated mass 
balance to 2 decimal places (in grams) and will document the measured weight on the 
eCRF.
6.6.6. Test Product Weighing
The Investigator or designee will weigh the test product using a calibrated mass 
balance to 2 decimal places and will document the measured weight on the eCRF. 
6.6.7. Instrumental Measurements Post-Procedure, Post-Treatment (72±4 
hours after Facial Peel)
Measurementsto be taken and recorded as per 6.3.11, 72±4 hoursafter completion of 
the facial peel procedure.
6.6.8. Subject Self-Assessment Post-Procedure, Post-Treatment (72±4 
hours after Facial Peel)
Assessments to be taken and recorded as per 6.3.13, 72±4 hoursafter completion of 
the facial peel procedure.
6.6.9. Dermatologist Assessment Post-Procedure, Post-Treatement (72±4 
hours after Facial Peel)
Assessments to be taken and recorded as per 6.3.14, 72±4hoursafter completion of 
the facial peel procedure.
 
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6.6.10.Supervised Test Product Application
Only subjects in Group I will undergo supervised test product application. The 
Investigator or designee will oversee application of the test product. Product 
application will be recorded on the eCRF and subject diary. The Investigator or 
designee involved in this step must not be involved in any assessments in order to 
protect the blind.
6.6.11. Supervised Sunscreen Application
All subjects will undergo supervised sunscreen application. The Investigator or 
designee will overseeapplication of the SPF 50 sunscreen. Product application will 
be recorded on the eCRF and subject diary. 
6.7. Visit 7–4 days after Visit 6 
Subjects will be instructed to arrive at the site prior to 9:00 AM to minimize exposure 
to intense sunlight. 
6.7.1. Current / Concomitant Medication
Any concomitant therapy taken since the last visitand throughout the study will be 
recorded on the eCRF by the Investigator or designee.
6.7.2. Adverse Events
Adverse events will be assessed by the Investigator ordesignee and recorded on the 
eCRF, as per the process detailed in Section 7.
As per Section 7.1, the following does not meet the definition of an adverse event:
“Any clinically significant abnormal laboratory findings (if applicable) or other 
abnormal safety assessments which are associated with the underlying disease, unless 
judged by the investigator to be more severe than expected for the subject’s 
condition.” Therefore, the Dermatologist (erythema, edema, dryness, and 
desquamation) and Subject-self assessment (pain, stinging/burning, itching, tightness, 
redness, and dryness) grades will only be considered adverse events if they are scored 
as “Severe”, or if the investigator judges them to be more severe than expected in 
context of the Glycolic Acid treatment procedure. 
6.7.3. Continued Subject Eligibility
The Investigator or designee will ascertain whether there have been any deviations 
from the protocol since the last visit, whether the subject has adhered to the lifestyle 
restrictions since the last visit and whether, in their opinion, the subject is eligible to 
continue in the study. Subject Continued Subject Eligibility will be recorded on the 
eCRF.
 
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6.7.4. Compliance (Diary Review)
Subject diaries will be reviewed by the Investigator or their designee. Subjects who 
apply the washout products (All subjects) and test product (Group I, only) more or 
less frequently than twice a day will be considered to have deviated from the protocol 
and additional/missed applications will recorded on the DeviationsLog. The total 
number of product applications and total number of missed product applications will 
be recorded on the eCRF. 
6.7.5. Washout Products Weighing
The Investigator or designee will weigh the washout products using a calibrated mass 
balance to 2 decimal places (in grams) and will document the measured weight on the 
eCRF.
6.7.6. Test Product Weighing
The Investigator or designee will weigh the test product using a calibrated mass 
balance to 2 decimal places and will document the measured weighton the eCRF. 
6.7.7. Instrumental Measurements Post-Procedure, Post-Treatment 
(168±4 hours after Facial Peel)
Measurementsto be taken and recorded as per 6.3.11, 168±4 hoursafter completion 
of the facial peel procedure.
6.7.8. Subject Self-Assessment Post-Procedure, Post-Treatment (168±4 
hours after Facial Peel)
Assessments to be taken and recorded as per 6.3.13, 168±4 hoursafter completion of 
the facial peel procedure.
6.7.9. DermatologistAssessment Post-Procedure, Post-Treatement (168±4 
hours after Facial Peel)
Assessments to be taken and recorded as per 6.3.14, 168±4hoursafter completion of 
the facial peel procedure.
6.7.10.Supervised Test Product Application
Only subjects in Group Iwill undergo supervised test product application. The 
Investigator or designee will oversee application of the test product. Product 
application will be recorded on the eCRF and subject diary. The Investigator or 
designee involved in this step must not beinvolved in any assessments in order to 
protect the blind.
 
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6.7.11. Supervised Sunscreen Application
All subjects will undergo supervised sunscreen application. The Investigator or 
designee will oversee application of the SPF 50 sunscreen. Product application will 
be recorded on the eCRF and subject diary. 
6.8. Visit 8–7 days after Visit 7  
Subjects will be instructed to arrive at the site prior to 9:00 AM to minimize exposure 
to intense sunlight. 
6.8.1. Current / Concomitant Medication
Any concomitant therapy taken since the last visitand throughout the study will be 
recorded on theeCRFby the Investigator or designee.
6.8.2. Adverse Events
Adverse events will be assessed by the Investigator or designee and recorded on the
eCRF, as per the process detailed in Section 7.
As per Section 7.1, the following does not meet the definition of an adverse event:
“Any clinically significant abnormal laboratory findings (if applicable) or other 
abnormal safety assessments which are associated with the underlying disease, unless 
judged by the investigator to be more severe than expected for the subject’s 
condition.” Therefore, the Dermatologist (erythema, edema, dryness, and 
desquamation) and Subject-self assessment (pain, stinging/burning, itching, tightness, 
redness, and dryness) grades will only be considered adverse events if they are scored 
as “Severe”, or if the investigator judges them to be more severe than expected in 
context of the Glycolic Acid treatment procedure. 
6.8.3. Continued Subject Eligibility
The Investigator or designee will ascertain whether there have been any deviations 
from the protocol since the last visit, whether the subject has adhered to the lifestyle 
restrictions since the last visit and whether, in their opinion, the subject is eligible to 
continue in the study. Subject Continued Subject Eligibilitywill be recorded on the 
eCRF.
6.8.4. Compliance (Diary Review)
Subject diaries will be reviewed by the Investigator or their designee. Subjects who 
apply the washout products (All subjects) and test product (Group I, only) more or 
less frequently than twice a day will be considered to have deviated from the protocol 
and additional/missed applications will recorded on the Deviations Log. The total 
 
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number of product applications and total number of missed product applications will 
be recorded on the eCRF. 
6.8.5. Washout Products Weighing
The Investigator or designee will weigh the washout products using a calibrated mass 
balance to 2 decimal places (in grams) and will document the measured weight on the
eCRF.
6.8.6. Test Product Weighing
The Investigator or designee will weigh the test product using a calibrated mass 
balance to 2 decimal places and will document the measured weighton theeCRF. 
6.8.7. Instrumental Measurements Post-Procedure, Post-Treatment 
(336±4 hours after Facial Peel)
Measurementsto be taken and recorded as per 6.3.11, 336±4 hours after completion 
of the facial peel procedure.
6.8.8. Image Capture (VISIA) Post-Procedure, Post-Treatment (336±4 
hours after Facial Peel)
Assessments to be taken and recorded as per 6.3.12, 336±4 hours after completion of 
the facial peel procedure.
6.8.9. Subject Self-Assessment Post-Procedure, Post-Treatment (336±4 
hours after Facial Peel)
Assessments to be taken and recorded as per 6.3.13, 336±4hoursafter completion of 
the facial peel procedure.
6.8.10. Subject Global Self-Assessment
Test subjects will rate the level of satisfaction with the post-procedure skin care 
regimen to which they were randomized using scale below. These data will be 
recorded on the eCRF.
Score
Description
0
Very Satisfied
1
Satisfied
2
Poorly Satisfied
3
Not at all Satisfied
 
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6.8.11. Dermatologist Assesment Post-Procedure, Post-Treatment (336±4 
hours after Facial Peel)
Assessments to be taken and recorded as per 6.3.14, 336±4 hours after completion of 
the facial peel procedure.
6.8.12. Dermatologist Global Assessment
The Dermatologist will assess the local tolerance of the post-procedure skincare 
regimen in context of the expected effects of the procedure for each subject using the 
scale belowand document the score on the eCRF. To make this assessment, the 
Dermatologist will draw on the total set of clinical and subject self-assessment data 
for each subject. The Dermatologist must be unaware of whether a subject was 
randomized to test product to protect the blind.  
Rating
Description
0 -Product Regimen 
was Well Tolerated
No clinically significant worsening of the expected 
signs/symptoms of the procedure. No new signs/symptoms 
manifest during product use.
1 -Product Regimen 
was Not Well Tolerated
Clear, clinically relevantworsening of the severity or 
frequency of expected signs/symptoms of the procedure 
and/or anyoccurrence of new, unexpectedsigns/symptoms 
during product use. 
6.8.13. Products and Test Diary Return
Washout products, test product and testdiary will be returned to the Investigator or 
designee and documented on theeCRF. 
6.8.14. Discharge from Study
Subjects will be evaluated to determine if they completed all study procedures or if 
they were discontinued from the study early.  If the subject discontinued at any point 
during the study, the primary reason for withdrawal should be recorded on the Study 
Conclusion page of theeCRFby selecting one of the options below.
1.
Subject did not meet study criteria
2.
Adverse Event
3.
Lost to Follow Up
4.
Protocol Violation
5.
Withdrawal of Consent
6.
Other
 
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7. SAFETY ASSESSMENTS
7.1. Definitions of an Adverse Event and Serious Adverse Event 
7.1.1. Adverse Events
The investigator or site staff will be responsible for detecting, documenting and 
reporting events that meet the definition of an AE or SAE.
Adverse Event Definition:
1. An AE is any untoward medical occurrence in a subjector clinical 
investigation subject, temporally associated with the use of an investigational 
or washout product, whether or not considered related to the investigational or 
washout product.
2. NOTE: An AE can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding), symptom, or disease (new or 
exacerbated) temporally associated with the use of an investigational or 
washout product.
Events meeting AE definition include:
1. Any abnormal laboratory test results (if applicable) or other safety 
assessments, including those that worsen from baseline, and felt to be 
clinically significant in the medical and scientific judgment of the 
investigator.
2. Exacerbation of a chronic or intermittent pre-existingcondition including 
either an increase in frequency and/or intensity of the condition.
3. New condition(s) detected or diagnosed after study product administration 
even though it may have been present prior to the start of the study.
4. Signs, symptoms, or the clinical sequelae of a suspected interaction.
5. Signs, symptoms, or the clinical sequelae of a suspected overdose of either 
study product or a concomitant medication (overdose per se will not be 
reported as an AE/SAE).
Events NOT meeting definition of an AE include:
1. Any clinically significant abnormal laboratory findings (if applicable) or other 
abnormal safety assessments which are associated with the underlying disease, 
unless judged by the investigator to be more severe than expected for the 
subject’s condition. 
2. The disease/disorder/ condition being studied or expected progression, signs, 
or symptoms of the disease/disorder being studied, unless more severe than 
expected for the subject’s condition.. 
3. Medical or surgical procedure (e.g., endoscopy, appendectomy): the condition 
that leads to the procedure is an AE.
 
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4. Situations where an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).
5. Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s)
present or detected at the start of the study that do not worsen.
7.1.2. Serious Adverse Events
Serious Adverse Event is defined as any untoward medical occurrence that, at 
any dose:
A. Results in death
B. Is life-threatening
NOTE: The term 
'life-threatening
' in the definition of 
'serious
' 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, which hypothetically might have caused death, if it were 
more severe.
C. Requires hospitalization or prolongation of existing hospitalization
NOTE: In general, hospitalization signifies that the subject has been detained 
(usually involving at least an overnight stay) at the hospital or emergency 
ward for observation and/or treatment that would not have been appropriate in 
the physician’s office or out-subjectsetting.  Complications that occur during 
hospitalization are AEs.  If a complication prolongs hospitalization or fulfills 
any other serious criteria, the event is serious.  When in doubt as to whether 
“hospitalization” occurred or was necessary, the AE should be considered 
serious.
Hospitalization for elective treatment of a pre-existing condition that did not 
worsen from baseline is not considered an AE.
D. Results in disability/incapacity
NOTE: The term disability means a substantial disruption of a person’s ability 
to conduct normal life functions.
This definition is not intended to include experiences of relatively minor 
medical significance such as uncomplicated headache, nausea, vomiting, 
diarrhea, influenza, and accidental trauma (e.g. sprained ankle) which may 
interfere or prevent everyday life functions but do not constitute a substantial 
disruption.
E. Is a congenital anomaly/birth defect
F. Other Situations
1. Medical or scientific judgment should be exercised in deciding 
whether reporting is appropriate in other situations, such as important 
medical events that may not be immediately life-threateningor result 
in death or hospitalization but may jeopardize the subject or may 
require medical or surgical intervention to prevent one of the other 
outcomes listed in the above definition. These should also be 
 
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considered serious.
2. Examples of such events are invasive or malignant cancers, intensive 
treatment in an emergency room or at home for allergic bronchospasm, 
blood dyscrasias or convulsions that do not result in hospitalization or 
development of drug dependency or drug abuse or reports of 
spontaneous abortion.
7.2. RecordingAdverse Eventsand Serious Adverse Events
Recording of adverse events and serious adverse events:
1. The investigator or site staff will be responsible for detecting, documenting 
and reporting events that meet the definition of an AE or SAE. 
2. The investigator or site staff will then record all relevant information 
regarding an AE/SAE in theeCRF.
3. There may be instances when copies of medical records for certain cases are 
requested by GSK.  In this instance, all subject identifiers, with the exception 
of the subject number, will be blinded on the copies of the medical records 
prior to submissionto GSK.
4. The investigator will attempt to establish a diagnosis of the eventbased on 
signs, symptoms, and/or other clinical information.  In such cases, the 
diagnosis will be documented as the AE/SAE and not the individual 
signs/symptoms. Clinical AEs will be described by diagnosis and not by 
symptoms when possible (e.g., upper respiratory tract infection, seasonal 
allergy, etc. instead of runny nose).
5. AEs will be collected from the start of the study material sensitivity test at 
Visit 1and until 5 daysfollowing last administration of the study product.
6. SAEs will be collected over the same time period as stated above for AEs.  
However, any SAEs assessed as relatedto study participation (e.g., 
investigational product, protocol mandated procedures, invasive tests, or 
change in existing therapy) or related to a GSK concomitant medication will 
be recorded from the time a subject consents to participate in the study up to 
and including any follow-up contact.  
7. Medical conditions reported prior to the time period for reporting AEs/SAEs 
should be recorded as part of the subject’s medical history.
7.3. Evaluating Adverse Eventsand Serious Adverse Events
Assessment of Intensity:
The investigator or designee will make an assessment of intensity for each AE and 
SAE reported during the study and will assign it to one of the following categories:
1. Mild:  An event that is easily tolerated by the subject, causing minimal 
discomfort and not interfering with everyday activities.
2. Moderate:  An event that is sufficiently discomforting to interfere with normal 
 
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everyday activities
3. Severe:  An event that prevents normal everyday activities. -an AE that is 
assessed as severe will not be confused with an SAE. Severity is a category 
utilized for rating the intensity of an event; and both AEs and SAEs can be 
assessed as severe.
Note: An event is defined as ‘serious’ when it meets at least one of the pre-defined 
outcomes as described in the definition of an SAE.
Assessment of Causality:
1. The investigator is obligated to assess the relationship between study product 
and the occurrence of each AE/SAE.
2. A "reasonable possibility" is meant to convey that there are facts/evidence or 
arguments to suggest a causal relationship, rather than a relationship cannot be 
ruled out.
3. The investigator will use clinical judgment to determine the relationship.
4. Alternative causes, such as natural history of the underlying diseases, 
concomitant therapy, other risk factors, and the temporal relationship of the 
event to the study product will be considered and investigated.
5. The investigator will also consult the Product Information, for marketed 
products, in the determination of his/her assessment.
6. For each AE/SAE the investigator must document in the medical notes 
(source document) oreCRFthat he/she has reviewed the AE/SAE and has 
provided an assessmentof causality.
7. There may be situations when an SAE has occurred and the investigator has 
minimal information to include in the initial report to GSK.  However, it is 
very important that the investigator always make an assessment of 
causality for every event prior to the initial transmission of the SAE data 
to GSK.
8. The investigator may change his/her opinion of causality in light of follow-up 
information, amending the SAE data collection tool accordingly.
9. The causality assessment is one of the criteria used when determining 
regulatory reporting requirements.
7.4. Reporting Adverse Eventsand Serious Adverse Events
AE Reporting to GSKCH:
1. AEs will be recorded in the AE section of theeCRF. 
2. Medical conditions recorded by the subject on a diary
 card or similar 
document that meet the definition of an AE must also be recorded in the AE 
section of theeCRF, if not previously well-characterized by the investigator in 
the subject’s medical history. 
3. AEs elicited by the investigator in a standard manner at the study visits should 
also be recorded in the AE section of theeCRF.  The investigator or designee 
must ask the subject the following question during each visit including any 
 
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follow-up visits:  “Have you felt unwell, experienced any symptoms or taken 
any medication (since your last visit) (today) (sinceyour last dose) (since the 
last session)?”
4. The medically qualified investigator should review adverse events in a timely 
manner; this review should be documented in writing in the source document 
or in theeCRF. 
5. After the study is completed at a given site, and the site has received their 
study data on Compact Discs (CDs), the electronic data collection tool will be 
removed from the internet to prevent the entry of new data or changes to 
existing data.
SAE Reporting to GSKCH:
A paper copy of the SAE form provided in the investigator study master file should 
be completed as fully as possible. 
It is essential to enter the following information: 
1. Protocol and subject identifiers
2. Subject’s demography
3. Description of events, with diagnosis if available
4. Investigator opinion of relationship to study product (see section 7.3)
5. Criterion for seriousness.
The following are desirable and are of particular relevance for investigator and 
GSKCH assessment of the SAE report:
1. Date of onset of AE 
2. Date AE stopped, if relevant
3. Study product start date
4. Study product end date if relevant
5. Action taken on study product
6. Outcome if known
The SAE form, completed as fully as possible, and SAE fax cover sheet must be 
faxed or e-mailed to the appropriate GSKCH Study Manager as soonas possible, but 
not later than 24 hoursafter study site personnel learn of the event. The GSKCH 
Study Manager should be notified of the situation by telephone or email.
Fax Serious Adverse Events to:
US: 
The GSKCH SAE Coordinatorwill be responsible for forwarding the SAE form to 
the Case Management Group, Global Clinical Safety and Pharmacovigilance, the 
Medical Director responsible for the study and other GSKCH personnel as 
appropriate via email.
Brazil SAE Coordinator (Rafaela Ross):
 
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Tel: 
E-mail: 
Brazil backup contact (
):
Tel: 
The initial report will be followed up with more information as relevant, or as 
requested by the GSKCH study manager.
7.5. Follow-up of Adverse Eventsand Serious Adverse Events
Follow-up of AEs and SAEs:
1. After the initial report, the investigator is required to proactively follow up 
with each subject and provide further information on the subject’s condition.
2. All AEs/SAEs will be followed until resolution, until the condition stabilizes, 
until the event is otherwise explained, or until the subject is lost to follow-up.  
3. The investigator is obligated to perform or arrange for the conduct of 
supplemental measurements and/or evaluations as may be indicated or as 
requested by GSK to elucidate as fully as possible the nature and/or causality 
of the AE or SAE.
4. Investigators are not obliged to actively seek AEs or SAEs in former subjects.  
However, if the investigator learns of any SAE, including the death, at any 
time after a subject has been discharged from the study, and considers the 
event reasonably related to the investigational product or study participation, 
the investigator will promptly notify GSKCH.
5. The investigator will submit any updated SAE data to GSK within the 
designated reporting time frames.
Regulatory and ethics reporting requirements for SAEs:
1. The investigator will promptly report all SAEs to GSKCH within the 
designated reporting timeframes (within 24 hours of learning of the event).  
GSKCH has a legal responsibility to notify, as appropriate, the local 
regulatory authority and other regulatory authorities about the safety of a 
product under clinical investigation.  Prompt notification of SAEs by the 
investigator to GSKCH is essential so that legal obligations and ethical 
responsibilities towards the safety of subjects are met.
2. GSKCH will comply with country specific regulatory requirements relating to 
safety reporting to the regulatory authority, IECandinvestigators.
3. Investigator safety reports are prepared according to GSKCH policy and are 
forwarded to investigators as necessary.  An investigator safety report is 
prepared for a SAE(s) that is both attributable to investigational product and 
unexpected.  The purpose of the report is to fulfill specific regulatory and 
GCP requirements, regarding the product under investigation.
4. An investigator who receives an investigator safety report describing a SAE(s) 
or other specific safety information (e.g., summary of listing of SAEs) from 
 
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GSKCH will file it with the Investigator Brochure (or safety statement) and 
will notify the IEC, if appropriateaccording to local requirements.
7.6. Collection of Pregnancy Information
7.6.1. Time Period for Collectingof Pregnancy Information
Collection of Pregnancy Information:
1. Pregnancy information will be collected on all pregnancies reported following 
administration of any washout product. Information on pregnancy identified 
during the screening phase and prior to investigational (test product) and 
washout productsadministration does not need to be collected.
7.6.2. Action to be Taken ifPregnancy Occurs
Action to be Taken:
1. The investigator will collect pregnancy information on any subject who 
becomes pregnant while participating in the study after administration of the 
washout product. The investigatorwill record pregnancy information on the 
appropriate form and submit it to GSKCH within 2 weeks of learning of the 
subject becoming pregnant. The subject will be followed to determine the 
outcome of the pregnancy. Information on the status of the mother and infant / 
neonate (including concomitant medications taken by the mother during the 
pregnancy) will be forwarded to GSKCH. Generally, follow-up will be no 
longer than 6 to 8 weeks following the estimated delivery date. Any 
termination of the pregnancy will be reported.
2. While pregnancy itself is not considered to be an AE, any pregnancy 
complication or elective termination for medical reasons will be recorded as 
an AE or SAE.
3. A spontaneous abortion is always considered to be an SAE and will be 
reported as such. An SAE occurring in association with a pregnancy, brought 
to the investigator’s attention after the subject completed the study and 
considered by the investigator as possibly related to the investigational 
product, must be promptly forwarded to GSK.
4. While the investigator is not obliged to actively seek this information in 
former study participants, he or she may learn of an SAE through spontaneous 
reporting.
5. If the subject becomes pregnant during the study they should be withdrawn 
from the study and this should be recorded in the appropriate section of the
eCRF.
 
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8. DATA MANAGEMENT
For this study subject data will be entered into an electronic case report form, using a 
GSKCH validated data system.
8.1. Source Documents/ Data
The source documents (e.g. hospital records, clinical and office charts, laboratory 
notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing 
records, recorded data from automated instruments, microfiches, photographic 
negatives, microfilm or magnetic media, x-rays, subject files and records kept at the 
pharmacy, at the laboratory and at the medico-technical departments involved in the 
clinical study) which contain the source of data recorded in theeCRFshould be 
specified in the Source Document Designation Form.  In some cases theeCRFcan be 
used as a source document.
Each subject will be assigned and identified by a unique Screening Number. Any 
reference made to an individual subject within the study must be done using the 
unique Screening Number.
8.2. Electronic Case Report Form
An eCRFis anelectronic document designed to record all of the protocol required 
information to be reported to the sponsor on each trial subject.
For each subject who has given informed consent/assent and has been screened, 
eCRFsmust be completed and signed by the Principal Investigator (or authorized 
designee) to certifythat the data are complete and correct.  
Management of clinical data will be performed in accordance with applicable 
GSKCH standards and data cleaning procedures to ensure the integrity of the data e.g. 
removing errors and inconsistencies in the data. 
In order to protect the privacy of subjects, no Personally Identifiable Information
(including the subject
's name or initials or birth date) is to be recorded in theeCRFor 
as part of the query text.Photographs will be collected of subject’s who providetheir 
consent to do so. These photographs are considered PII and will be transferred 
securely to GSK. All photographs will be anonymized.
Adverse events and concomitant medications terms (if applicable) will be coded 
using MedDRA (Medical Dictionary for Regulatory Activities) and an internal 
validated medication dictionary, GSKDrug.  
 
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Subject data will be entered into GSKCH definedeCRFs and transmitted 
electronically to GSKCH in a validated (21 CFR Part 11 compliant) web-based 
electronic data capture system (InForm
TM).
AlleCRFpages should be completed during a subject self-assessment when theeCRF
has been designated as the source.  Data that is sourced elsewhere should be entered 
into theeCRFin an agreed upon timeframe between the Investigator and Sponsor.  
TheeCRFs (including queries, query responses and audit trails) will be retained by 
GSKCH. Site data archived compact discs (CD(s)) prepared by a third party will be 
sent to the investigator to maintain as the investigator copy following the 
decommissioning of the study.
8.3. Data Handling
Documentation of all data management activities should allow step-by-step 
retrospective assessment of data quality and study performance. Any changes or 
corrections to data will be performed in the Electronic Data Capture (EDC) System, 
and it will include rationale for changes. The EDC system has an audit trail, which 
will provide a complete record of the changes and corrections endorsed by the 
Investigator.
8.3.1. Data Queries
Programmed edit checks will be generated automatically, as the data is being entered 
into the system. Data Management will also run reports and listings on theeCRFdata, 
in addition to the queries already programmed and generated by the system, to raise 
manual queries as needed for site clarification or correction. The Clinical Dictionary 
Development and Management Group will raise queries as needed on safety data to 
code the terms (Adverse Events and Drugs) are reported appropriately. 
The study monitor at the study site will review theeCRFs in accordance with the 
monitoring plan, and any queries will be generated in the EDC System to the 
Investigator or designee, enabling the errors to be addressed in parallel with Data 
Management review. Monitor can also run reports and listings on theeCRFs, to raise 
manual queries as needed for site clarification or correction
8.4. External Data
External Data are subject data obtained externally to theeCRF. These data are 
generated from laboratory instruments, computers, photographic cameras or other 
sources and then transcribed into a file and format agreed upon by GSKCH to identify 
the subject and time point referenced in theeCRFand/or protocol. In this study, 
VISEA photographs are considered external data. 
 
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An agreed upon quality control process is performed against the transcribed data to 
the source to ensure the accuracy of the transcription. The transcribed data is 
transmitted in an agreed upon format to GSKCH via secured web portal or CD via 
mail carrier with tracking capabilities. 
Proper reconciliation will be performed between the transcribed data and the clinical 
database to ensure subject and time point referenced in the Clinical Database match 
before Clinical Database Freeze (locking of the database) can occur.
 
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9. STATISTICAL CONSIDERATIONS AND DATA 
ANALYSES
9.1 Sample Size Determination
Approximately 130 healthy females within the ages of 30 and 60 years with 
Fitzpatrick Skin Classification II-IV and moderate to advanced photo-damaged skin 
will be screened to randomize 80 subjects to ensure approximately 60 subjects (30 
subjects per group) successfully complete the study. The sample size is based on 
clinical considerations and literature precedent [Narurkar, Schalka, Sulimovic, Kim].
With 30 subjects per treatment group, a change from baseline in TEWL at least half 
the magnitude of the standard deviation (
 
) can be detected at two-sided 
alpha=0.05 with 80% power.
9.2.General Considerations
9.2.1.Definition of Analysis Populations
All randomized subjects will be included in the intent-to-treat (ITT) population. All 
subjects with at least one application of product in the test phase (i.e. test product for 
subjects in Group I or sunscreen for subjects in Group II) will be included in the 
Safety population. 
Subjects will be considered eligible for a Per Protocol (PP) population if they were 
randomized, received at least one application of test product, had at least one post-
procedure, post-treatment assessment available and were compliant with both testand 
washout products post-procedure. Other considerations for eligibility for the PP 
population including but not limited to use of concomitant medications will be 
detailed in the Statistical Analysis Plan prior to database unblinding.
9.2.2.Exclusion of Data from Analysis
No data will be excluded from any analyses.
9.2.3.Criteria for Evaluation
The primary evaluation of tolerance will be based on the Dermatologist global 
assessment. The trial will be considered a success if the majority (i.e. more than 50%) 
of subjects in the test product group have a favorable Dermatologist global 
assessment score.
 
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9.2.4.Criteria for Assessing Efficacy
Efficacy measurementsin this study will be based on changes from baseline in 
TEWL and Corneometer values at each visit. The baseline for these measurements 
will be defined as the measurements made 60±15 minutes after the facial peel 
procedure, before any test product application. Differences between product groups 
will also be explored.
9.2.5.Criteria for Assessing Local Tolerance
Secondary assessments of local tolerance will be based onDermatologist and Subject 
self-assessment scores at each visit and reported adverse events. The baseline for 
these assessments will be defined as the assessments made 60±15 minutes after the 
facial peel procedure, before any test product application. 
9.2.6.Handling of Dropouts and Missing Data
Missing data will not be imputed. All data available for dropouts will be considered 
in analyses.
9.3. Statistical Methods and Analytical Plan
Additional details of the proposed statistical analysis will be documented in the 
statistical analysis plan (SAP), which will be written following finalization of the 
protocol and prior to study unblinding / analysis (as appropriate).
9.3.1.Demographic and Baseline Characteristics
Age will be summarized descriptively for each product group using means, medians 
and standard deviations. Race, gender,Fitzpatrick phototype andGlogau photoaging 
type will be summarized by productgroup using frequency counts and percentages. 
9.3.2.Primary Analysis(es)
Descriptive statistics (N, %, 95% confidence intervals) will be used to summarize the 
proportion of subjects in each product group with a favorable Evaluator global 
assessment of tolerance. The proportions may also be compared between product 
groups using Chi-square test, and difference in proportion and 95% confidence 
interval.
9.3.3.Secondary Analysis(es)
Changes from baseline in the Evaluator, Subject self-assessmentand instrumental 
endpoints will be tabulated by productgroup and summarized descriptively using 
means, standard deviations and 95% confidence intervals and assessed for 
significance (different from zero) using t-tests or Wilcoxon signed rank tests 
dependent upon the distribution of the data. 
 
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Differences between product groups in the mean changes from baseline in Evaluator, 
Subject self-assessment and instrumental endpoints will also be explored using t-tests 
or Wilcoxon rank sum tests and summarised using 95% confidence intervals. 
9.3.4.Safety Analysis(es)
Adverse eventswill be tabulated by productgroup and listed for inspection.
10. STUDY GOVERNANCE CONSIDERATIONS
10.1.Posting of Information on Publicly Available Clinical Trials 
Registers
Study information from this protocol will be posted on publicly available clinical trial 
registers before enrollment of subjects begins.
10.2.Regulatory and Ethical Considerations, Including the Informed 
Consent
The study will be conducted in accordance with all applicable regulatory 
requirements, and with GSK policy.
The study will also be conducted in accordance with ICH Good Clinical Practice 
(GCP), all applicable subject privacy requirements, and the guiding principles of the 
current version of the Declaration of Helsinki.  This includes, but is not limited to, the 
following:
Before initiating a trial, the investigator/institution should have written and 
dated approval/favorable opinion from the IECforthe trial protocol (including 
amendments), written informed consent form, consent form updates, subject 
recruitment procedures (e.g., advertisements), investigator brochure/ safety 
statement (including any updates) and any other written information to be 
provided to subjects. A letter or certificate of approval will be sent by the 
investigator to the sponsor prior to initiation of the study, and also when 
subsequent amendments to the protocol are made.
Signed informed consent  to be obtained for each subject before participation 
in the study (and for amendments as applicable)
Investigator reporting requirements (e.g. reporting of AEs/SAEs/protocol 
deviations to IEC)
GSK will provide full details of the above procedures, either verbally, in 
writing, or both.
 
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10.3.Quality Control (Study Monitoring)
In accordance with applicable regulations including GCP, and GSK procedures, GSK 
or designee (i.e. third party vendor) monitors will contact the site prior to the start of 
the study to review with the site staff the protocol, study requirements, and their 
responsibilities to satisfy regulatory, ethical, and GSK requirements.
When reviewing data collection procedures, the discussion will include identification, 
agreement and documentation of data items for which theeCRFwill serve as the 
source document.
GSK or designee will monitor the study and site activity to verify that the:
Data are authentic, accurate, and complete.
Safety and rights of subjects are being protected.
Study is conducted in accordance with the currently approved protocol and 
any other study agreements, GCP, and all applicable regulatory requirements.
The extent and nature of monitoring will be described in a written monitoring plan on 
file at GSKCH. The investigator (or designee) agrees to allow the monitor direct 
access to all relevant documents and agrees to co-operate with the monitor to ensure 
that any problems detected in the course of these monitoring visits are resolved.
10.4.Quality Assurance
To ensure compliance with GCP and all applicable regulatory requirements, GSK 
may conduct a quality assurance assessment and/or audit of the site records, and the 
regulatory agencies may conduct a regulatory inspection at any time during or after 
completion of the study. 
In the event of an assessment, audit orinspection, the investigator (and institution) 
must agree to grant the advisor(s), auditor(s) and inspector(s) direct access to all 
relevant documents and to allocate their time and the time of their staff to discuss the 
conduct of the study, any findings/relevant issues and to implement any corrective 
and/or preventative actions to address any findings/issues identified.
The sponsor will be available to help investigators prepare for an inspection.
10.5.Conditions for Terminating the Study
Upon completion or premature discontinuation of the study, the GSKCH monitor will 
conduct site closure activities with the investigator or site staff, as appropriate, in 
accordance with applicable regulations including GCP, and GSKCH Standard 
Operating Procedures.
 
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Both GSKCH and the Investigator reserve the right to temporarily suspend or 
prematurely discontinue this study at any time for reasons including, but not limited 
to, safety or ethical issues or severe non-compliance. For multicenter studies (if 
applicable), this can occur at one or more or at all sites.  
If the trial is prematurely terminated or suspended for any reason, the investigator site 
should promptly inform the trial subjects and should assure appropriate therapy/ 
follow-up for the subjects. Where required by the applicable regulatory requirements, 
GSKCH should inform the regulatory authority(ies). 
In addition: 
1. If the investigator terminates or suspends a trial without prior agreement of 
GSKCH, the investigator site should promptly inform the sponsor and the 
IEC, and should provide the sponsor and the IECa detailed written 
explanation of the termination or suspension.
2. If the GSKCH terminates or suspends a trial, the investigator should promptly 
inform the IECand provide the IECa detailed written explanation of the 
termination or suspension. 
3. If the IECterminates or suspends its approval/favorable opinion of a trial, the 
investigator should promptly notify the GSKCH and provide GSKCH with a 
detailed written explanation of the termination or suspension.
10.6.Records Retention
Following closure of the study, the investigator must maintain all site study records 
(except for those required by local regulations to be maintained elsewhere), in a safe 
and secure location.  
The records (study/ site master file) must be maintained to allow easy and timely 
retrieval, when needed (e.g., for a GSK audit or regulatory inspection) and must be 
available for review in conjunction with assessment of the facility, supporting 
systems, and relevant site staff.
Where permitted by local laws/regulations or institutional policy, some or all of these 
records can be maintained in a format other than hard copy (e.g., microfiche, scanned, 
electronic); however, caution needs to be exercised before such action is taken. 
The investigator must ensure that all reproductions are legible and are a true and 
accurate copy of the original and meet accessibility and retrieval standards, including 
re-generating a hard copy, if required.  Furthermore, the investigator must ensure 
there is an acceptable back-up of these reproductions and that an acceptable quality 
control process exists for making these reproductions.
 
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The investigator must assure that the subject’s anonymity will be maintained.  On
eCRFs or other documents submitted to GSKCH, subjects should not be identified by 
their names or initials, but by an identification code. The investigator should keep a 
separate log of subjects’ codes, names and addresses.  Documents not for submission 
to GSKCH, e.g. subjects’ written consent forms, should be maintained by the 
investigator in strict confidence.
GSK will inform the investigator of the time period for retaining these records to 
comply with all applicable regulatory requirements (GSKCH recommends that 
documents be kept for10 years). The investigator is also required to keep subject 
identification codes on file for at least 15 years after completion or discontinuation of 
the study. The minimum retention time will meet the strictest standard applicable to 
that site for the study, as dictated by any institutional requirements or local laws or 
regulations, GSK standards/procedures, and/or institutional requirements.  
No study document should be destroy
ed without a prior written agreement between 
GSKCH and the investigator. The investigator must notify GSK of any changes in the 
archival arrangements, including, but not limited to, archival at an off-site facility or 
transfer of ownership of the records in the event the investigator is no longer 
associated with the site.
10.7.Provision of Study Results to Investigators, posting of 
Information on Publicly Available Clinical Trials Registers and 
Publication
Where required by applicable regulatory requirements, an investigator signatory will 
be identified for the approval of the clinical study report.  The investigator will be 
provided reasonable access to statistical tables, figures, and relevant reports and will 
have the opportunity to review the complete study results at a GSK site or other 
mutually-agreeable location.
GSK will also provide the investigator with the full summary of the study results.  
The investigator is encouraged to share the summary results with the study subjects, 
as appropriate.
The procedures and timing for public disclosure of the results summary and for 
development of a manuscript for publication will be in accordance with GSK Policy.
A manuscript will be progressed for publication in the scientific literature ifthe 
results provide important scientific or medical knowledge.
 
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11. REFERENCES
Hatcher RA, Trussell J, Nelson AL, Cates W Jr, Stewart F, Kowal D, editors. 
Contraceptive Technology. 19th edition. New York: Ardent Media, 2007(b):28
ICH Topic 6 Guideline for Good Clinical Practice CPMP/ICH/135/95 17th July 1996
World Medical Association Declaration of Helsinki, 59th General Assembly, Seoul 
2008
Sulimovic L, Licu D, Ledo E, Naeyaert JM, Pigatto P, Tzermias C, Vasquez Doval J, 
Dupuy P, DermatolSurg.,2002; 28(5):415-418
Schalka S, Agelune CM, Nogueira AT, Abreu FF, Surg Cosmet Dermatol., 
2013;5(4):337-343
Narurkar VA, Beer LR, Cohen JL, Journal of Cosmetic and Laser Therapy, 
2010;12:288–295
Kim JM, Kim WI, Ko HC, Kim M, Kim BS, Journal of the European Academy of 
Dermatology and Venereology,2016. DOI:10.1111/jdv.13750
Minimally Invasive Procedures for Facial Rejuvenation, Giuseppe Guerriero and 
Laura Del Regno,  October, 2014 (OMICS Group eBooks)
Sharad J. Clinical, Cosmetic and Investigational Dermatology2013;6:281–288
Perić S, Bubanj M, Bubanj S, Jančić S. J Basic Med Sci.2011;11(1):52–57
Vishal B, Rao SS, Pavithra S, Shenoy MM. J Cutan Aesthet Surg.2012;5(1):58–59
Rogiers V, Skin Pharmacol Appl Skin Physiol 2001;14:117–128
Berardesca E, Skin Research and Technology 1997;3(2):126-132
 
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12. APPENDICES
12.1. Appendix 1 -Abbreviations and Trademarks
Abbreviations
AE
Adverse Event
AHA
Alpha Hydroxy Acid
ANVISA
Agência Nacional de Vigilância Sanitária
CD
Compact Disc
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
EEMCO
Efficacy Measurement of Cosmetics and Other Topical Products
g
Grams
GA
Glycolic Acid
GCP
Good Clinical Practice
GSKCH
GlaxoSmithKline Consumer Healthcare
h
Hours
ICH
International Conference on Harmonization of Technical Requirements 
for Registration of Pharmaceuticals for Human Use
ICF
Informed Consent Form
IEC
Independent Ethics Committee
ITT
Intention to Treat
LSLV
Last-Subject, Last Visit
MedDRA
Medical Dictionary for Regulatory Activities
min
Minutes
OTC
Over the Counter
PII
Personally Identifiable Information
PP
Per Protocol
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SPF
Sun Protection Factor
TEWL
Transepidermal Water Loss
TMF
Trial Master File
UV
Ultraviolet
Trademark Information
Trademarks of the GlaxoSmithKline group of companies:
Physiogel
SunMax
 
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Trademarks not owned by the GlaxoSmithKline group of companies:
Simple
12.2. Appendix 2-Fitzpatrick Skin Type
Type
Description
I
Always burns, never tans
II
usually burns, tans minimally
III
sometimes mild burn, tans uniformly (cream white; fair with any hair or 
eye color)
IV
burns minimally, always tans well (moderate brown)
V
very rarely burns, tans veryeasily (dark brown)
VI
Never burns, never tans (deeply pigmented dark brown to darkest 
brown)
12.3. Appendix 3-Glogau Photoaging Scale
Group Classification
Skin Characteristics
I
Mild
Early Photoaging: mild pigment changes, no keratosis, 
minimal wrinkles, minimal or no makeup
II
Moderate
Early to Moderate Photoaging: Early brown spots visible, 
keratosis palpable but not visible, parallel smile lines begin 
to appear, wears some foundation
III
Advanced
Advanced Photoaging: Obvious discolorations, visible 
capillaries (telangiectasias), visible keratosis, wears heavier 
foundation always
IV
Severe
Severe Photoaging: Yellow-gray skin color, prior skin 
malignancies, wrinkles throughout -no normal skin, cannot 
wear makeup because it cakes and cracks
12.4. Appendix 4-Exclusion Criteria for Review at Visit2 and3
1. PREGNANCY
Women who are known to be pregnant or who are intending to become pregnant over 
the duration of the study.
2. BREAST-FEEDING
Women who are breast-feeding.
 
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3. CONCURRENT MEDICATION/ MEDICAL HISTORY 
A. Active skin disease or open wound in the test area.
E. Moles, tattoos, scars, irritated skin, hairs, etc. at the test area that could 
influence the investigation. 
9. STUDY MATERIAL SENSITIVITY TEST
A score of “Severe” for any Dermatologist or Subject Self-Assessed endpoint at any 
time for the study material sensitivity test. 
 
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SIGNATURE PAGE 
 
  
 
Date 
Signed By
 
Justification 
 
 
 
Date 
Signed By
 
Justification 
 
 
 
Date 
Signed By
 
Justification 
 
 
 
Date 
Signed By
 
 
Justification 
 
 
 
Date 
Signed By
 
 
Justification 
 
 
 
Date 
Signed By
 
 
Justification 
 
 
07-Jun-2017 01:32:23
 
Clinical Operations Approval
Approved
02-Jun-2017 13:45:45
Biostatistics Approval
Protocol 207213 SPF 20 Day Cream.doc
02-Jun-2017 10:50:00
 
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PPD
PPD
PPD