A Clinical Study to Assess the Mildness of a Cosmetic Cleanser in Healthy Subjects Using the Forearm-Controlled Application Technique (FCAT)
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  An unpublished work subject to trade secret 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
207619

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CONFIDENTIAL
SUMMARY INFORMATION
Title:
A Clinical Study to Assess the Mildness of a Cosmetic 
Cleanser in Healthy Subjects Using the Forearm-
Controlled Application Technique (FCAT).
Protocol Number:
207619
Sponsor:
GlaxoSmithKline Consumer Healthcare (GSKCH)
Rua Hungria, 1240 4º andar, Jardim Europa
São Paulo/SP – Brazil, CEP 01455-000
Tel: 
Product Name:
Facial micellar cleanser
Development Phase:
N/A
Expert Advice Outside of Normal 
Working Hours:
Tel: 
 (US)
Key Protocol Authors:
PRIMARY CONTACT
Clinical Research Scientist:
, MSc
GlaxoSmithKline Consumer Healthcare 
(GSKCH)
St. Georges Avenue, Weybridge, Surrey, 
KT13 0DE. UK
Tel. 
PRIMARY CONTACT
Clinical Study Manager:
GlaxoSmithKline Consumer Healthcare 
(GSKCH)
Rua Hungria, 1240 4º andar, Jardim Europa
São Paulo/SP – Brazil, CEP 01455-000
Tel: 
Biostatistician:
Other Protocol Authors:
Clinical Supplies:
Data Manager:
Medical Expert:
, MD, Ph.D
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Principal Investigator:
Mariane Martins Mosca – Biologist
Study Site Name & Address:
ALLERGISA PESQUISA DERMATO-
COSMÉTICA LTDA. 
Av. Dr. Romeu Tórtima, 452/466 - Barão 
Geraldo – Campinas/SP – Brazil – CEP 
13084-791
Study Site Telephone Number:
Study Examiner(s):
Study examiner (s) will be assigned 
according to the site schedule (before 
First Subject First Visit) and documented 
in the site file.
Dermatologist:
Study Dermatologist will be assigned 
according to the site schedule (before 
First Subject First Visit) and documented 
in the site file.
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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.
Investigator Name:
Investigator Qualifications:
Investigator Signature:
Date of Signature/ Agreement:
DD/MMM/YYYY
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Table of Content
SUMMARY INFORMATION...............................................2
PRINCIPAL INVESTIGATOR PROTOCOL AGREEMENT 
PAGE ..............................................................................4
Table of Content......................................................................5
PROCESS FOR AMENDING THE PROTOCOL...............9
PROTOCOL AMENDMENT PAGE ....................................10
PROTOCOL SYNOPSIS FOR STUDY 207619 ...................14
1. INTRODUCTION...............................................................21
2. OBJECTIVE(S) AND ENDPOINT(S)...............................22
3. STUDY PLAN .....................................................................23
3.1. Study Design.......................................................................23
3.2. Subject Restrictions ...........................................................26
3.3. Type and Planned Number of Subjects ............................27
3.4. Study Design and Application Amount Justification.......28
4. SELECTION OF STUDY POPULATION AND 
WITHDRAWAL CRITERIA........................................32
4.1. Inclusion Criteria...............................................................33
4.2. Exclusion Criteria..............................................................34
4.3. Screening/ Baseline Failures..............................................36
4.4. Withdrawal/ Stopping Criteria .........................................36
4.5. Subject Replacement..........................................................37
4.6. Subject and Study Completion..........................................37
5. PRODUCT INFORMATION.............................................37
5.1. Study Product.....................................................................37
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5.2. Application Schedule .........................................................38
5.3. Product Assignment...........................................................38
5.3.1 Randomisation....................................................................39
5.3.2 Blinding...............................................................................39
5.3.3 Code Breaks........................................................................39
5.4. Packaging and Labelling ...................................................40
5.4.1. Accountability of Product.................................................41
5.4.2. Storage of Product ............................................................41
6. STUDY ASSESSMENTS AND PROCEDURES ..............41
6.1. Visit 1 - Screening Visit......................................................41
6.1.1 Telephone Screening ..........................................................41
6.1.2. Informed Consent .............................................................41
6.1.3. Demographics....................................................................42
6.1.4 Dermatologist Assessment .................................................42
6.1.5. Medical History and Concomitant Medication ...............42
6.1.6. Examiner Assessment of Redness and Dryness...............43
6.2. Visit 2 – Day 1 - Baseline Visit to Visit 6 (AM).................43
6.2.1. Examiner Assessment of Redness and Dryness...............43
6.2.2. Corneometry......................................................................44
6.2.3. Transepidermal Water Loss (TEWL)..............................45
6.2.4. FCAT Wash Procedure.....................................................45
6.3. Visit 6 - Day 5 (PM) and Study Conclusion......................47
6.3.1. Study Conclusion...............................................................47
7. SAFETY ASSESSMENTS..................................................48
7.1. Definitions of an Adverse Event and Serious Adverse 
Event.................................................................................48
7.1.1. Adverse Events..................................................................48
7.1.2. Serious Adverse Events.....................................................49
7.2. Recording Adverse Events and Serious Adverse Events.50
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7.3. Evaluating Adverse Events and Serious Adverse Events 51
7.4. Reporting Adverse Events and Serious Adverse Events..52
7.5. Follow-up of Adverse Events and Serious Adverse Events
..........................................................................................54
7.6. Collection of Pregnancy Information................................55
7.6.1. Time Period for Collecting of Pregnancy Information ...55
7.6.2. Action to be Taken if Pregnancy Occurs .........................55
8. DATA MANAGEMENT ....................................................56
8.1. Source Documents/ Data....................................................56
8.2. Electronic Case Report Form............................................57
8.3. Data Handling ....................................................................57
8.3.1. Data Queries......................................................................58
8.4. External Data .....................................................................58
9. STATISTICAL CONSIDERATIONS AND DATA 
ANALYSES ....................................................................58
9.1 Sample Size Determination.................................................58
9.2. General Considerations .....................................................59
9.2.1. Definition of Analysis Populations ...................................59
9.2.2. Exclusion of Data from Analysis ......................................59
9.2.3. Criteria for Evaluation .....................................................59
9.2.4. Criteria for Assessing Safety and Tolerability.................60
9.2.5. Handling of Dropouts and Missing Data .........................60
9.3. Statistical Methods and Analytical Plan...........................60
9.3.1. Demographic and Baseline Characteristics.....................60
9.3.2. Primary Analysis(es).........................................................60
9.3.3. Secondary Analysis(es) .....................................................61
9.3.4. Safety Analysis(es).............................................................62
10. STUDY GOVERNANCE CONSIDERATIONS.............62
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10.1. Posting of Information on Publicly Available Clinical 
Trials Registers................................................................62
10.2. Regulatory and Ethical Considerations, Including the 
Informed Consent............................................................62
10.3. Quality Control (Study Monitoring)...............................63
10.4. Quality Assurance............................................................63
10.5. Conditions for Terminating the Study............................64
10.6. Records Retention............................................................64
10.7. Provision of Study Results to Investigators, posting of 
Information on Publicly Available Clinical Trials 
Registers and Publication................................................66
11. REFERENCES..................................................................66
12. APPENDICES...................................................................67
12.1. Appendix 1 - Abbreviations and Trademarks................67
12.2. Appendix 2 – Forearm Grading Scale ............................68
12.3. Appendix 3 - Fitzpatrick Skin Type Grading.................69
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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 representative of 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 
appropriate IRB in accordance with local requirements, before the revised edition can 
be implemented. 
All non-substantial/ minor/ administrative amendments should be submitted to the 
IRB as 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 add text: 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.:
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
Signature:
Protocol 
Version 
No.:
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
Signature:
Protocol 
Version 
No.:
Substantial/ Major           
Date:
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SCHEDULE OF EVENTS
Screening
WASHOUT PERIOD (5-7 Days)
Treatment Period
                       Study Day  
Procedure/
Assessment
DAY -7
to 
DAY 0
VISIT 1
DAY 1
MON 
VISIT 2
DAY 2
TUE 
VISIT 3
DAY 3
WED 
VISIT 4
DAY 4
THU 
VISIT 5
DAY 5
FRI 
VISIT 6
Time of Day
-
AM
PM
AM
PM
AM
PM
AM
PM
AM
PM
Informed Consent
X
Demographics
X
Medical History
X
Current/Concomitant medication 
review 
X
X
X
X
X
X
Fitzpatrick Skin Type Assessment
X
Inclusion/Exclusion Criteria
X
X a b
Subject Eligibility
X
X
Examiner Visual Assessment of 
Dryness and Redness b
X c
X d
X e
X e
X e
X e
X
Dermatologist Assessment a
X
X
X
Continued Eligibility
X
X
X
X
X
Dispense standard soap 
X
Compliance Check for soap use
X
X
X
X
X
Acclimatisation
(for instrumental assessments)
X
X
Corneometry Assessment
X
X
TEWL Assessment
X
X
Controlled Product Application/Wash 
procedure (at study site) f
X
X
X
X
X
X
X
X
X
Return standard soap
X
Adverse Events g
X
X
X
X
X
X
X
X
X
X
X
Study Conclusion/Exit from Study
X
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a.
Inclusion criteria 3c Performed by a qualified dermatologist.
b. A trained (by a dermatologist) blinded examiner will perform visual assessments 
of dryness and redness of each volar forearm using the scoring system detailed in 
Appendix 2. (Inclusion Criteria 4b).
c.
Screening assessment of dryness and redness of each volar forearm, will be 
performed using the scoring system detailed in Appendix 2. For inclusion in the 
study each volar forearm dryness score should be zero and each volar forearm
redness score should be zero.
d. Baseline assessment of dryness and redness of each proposed test site on each
volar forearm, will be performed prior to any wash application (Day 1 (AM) Visit 
2) using the scoring system detailed in Appendix 2. For continuation in the study 
each site dryness score should be zero and each site redness score should be zero.
e.
Examiner visual examination of dryness and redness using the scoring system 
detailed in Appendix 2 will be prior to the PM wash procedure, Except Day 5 
(Visit 6) where the final examination will be 3 hours after the final AM wash 
procedure.
f.
Subjects will report to the study site for 5 days for the FCAT wash procedure, 18 
controlled wash applications of each product to each allocated test site in total
(one site will remain unwashed), two in the morning (AM) and two in the 
afternoon (PM) (except Day 5 where only the AM wash procedure will take 
place).  The first application will follow all Baseline assessments at Day 1 AM 
(Visit 2), the final application will be Day 5 AM (Visit 6). Each wash application 
(AM and PM) will be separated by at least 3 hours.
g. Subjects are asked to report any adverse events from use of the Standard soap and 
the use of any concomitant medications throughout the study.
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PROTOCOL SYNOPSIS FOR STUDY 207619
Brief Summary
A cosmetic product that is freely available to the consumer must be free from adverse 
reactions when applied under normal or reasonably foreseeable conditions of use. As
a general requirement, the safety and compatibility of a new formulation should be 
confirmed before it is commercialised (Guideline for the Safety Evaluation of 
Cosmetic Products; Agência Nacional de Vigilância Sanitária, ANVISA, 2012).
Mildness is a factor that contributes to consumer acceptance of a cleansing product, 
especially in those with dry or sensitive skin.  The relative mildness (or irritation 
potential) of personal cleansing products is ideally judged under conditions of actual
consumer use.  However, these may not present the best conditions for discriminating 
product mildness differences, since normal use conditions typically do not induce 
differentiable product skin effects (Ertel, 1995).
The Forearm Controlled Application Technique (FCAT) is a method that offers an 
efficient means to estimate the relative mildness of personal cleansers.  It provides
greater precision and sensitivity and also minimises confounding effects due to 
biological diversity (Ertel, 1995). 
Visual assessment of dryness and redness will be conducted by a trained blinded 
examiner at Baseline and on a daily basis throughout the 5-day FCAT wash 
procedure.
Instrumental assessments of skin barrier function measured by Transepidermal Water 
Loss (TEWL) (using a Tewameter) and skin moisturisation (using a Corneometer) 
will be performed at Baseline and after completion of the 5 day FCAT wash 
procedure.
The objective of this clinical study is to assess the relative mildness of a cosmetic 
facial cleanser in comparison to water through repeated application to the volar 
forearm using the FCAT wash procedure.
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Objective(s) and Endpoint(s)
Objective(s)
Endpoint(s)
Primary
To compare change from Baseline in 
examiner rating of dryness to 3 hours 
following last wash procedure on Day 5, 
for the test product versus water in the 
skin of healthy subjects.
Examiner assessment of dryness 
(Lukacovic, 1987) as per Appendix 2 at 
Day 5, 3 hours post last wash procedure.
Secondary
To compare change from Baseline in the 
examiner rating of redness to 3 hours
following last wash procedure on Day 5 
for the test product versus water in the 
skin of healthy subjects.
Examiner assessment of redness 
(Lukacovic, 1987) as per Appendix 2 at 
Day 5, 3 hours post last wash procedure.
To compare change from Baseline in the 
examiner rating of dryness and redness
each day for test product and the positive 
control versus water in the skin of 
healthy subjects.
Examiner assessment of redness and 
dryness (Lukacovic, 1987) as per 
Appendix 2 at Day 2, 3, 4 and 5, 3 hours 
post last wash procedure.
To assess change from Baseline in skin 
barrier function following the FCAT 
wash procedure for test product and 
positive control versus water.
TEWL measurements on Day 5, 3 hours 
post last wash procedure.
To assess change from Baseline skin 
moisturisation following the FCAT wash 
procedure for test product and positive
control versus water.
Corneometer measurements on Day 5, 3 
hours post last wash procedure.
To evaluate the general safety of the test 
product.
Assessment of frequency and severity of 
Adverse Events
Study Design
Overall Design
This is a test site randomised, examiner blinded, positive and negative-controlled, 
single-center; Forearm Controlled Application Technique clinical study in healthy 
subjects to assess the mildness potential of a cosmetic facial cleansing product.
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Subjects will give their written consent prior to any study procedures taking place.
Visual assessments of dryness and redness will be conducted (by a trained blinded 
examiner). Each subject should have a score of zero for dryness and zero for redness
on each volar forearm to be eligible for inclusion in the study. Eligible subjects will 
undergo a 5 to 7-day washout period, during which only the provided standard soap 
(Simple Soap®) will be used. This standard soap will also be used throughout the 
study in place of current cleansing product(s), but subjects should avoid using 
anything other than water on the volar forearms throughout the study, including the 
washout period.
A qualified dermatologist will assess subjects at Screening (Visit 1) for eligibility and 
again at Visit 2 for continued eligibility, to ensure the subjects are free of any 
clinically-relevant dermatological conditions.
At the Baseline Visit (Visit 2, Day 1) examiner assessment of the dryness and redness 
of each proposed test site on each volar forearm will be performed prior to any wash 
application using the scoring system detailed in Appendix 2. Each subject should 
have a score of zero for dryness and zero for redness to be considered eligible to 
continue in the study.
Prior to any wash procedure, subjects will be acclimatized to the environment of 
controlled temperature and humidity room and instrumental measurements of skin
barrier function (measured with a Tewameter) and skin moisturisation (measured with 
a Corneometer) will be performed at Baseline (Visit 2 (AM)) in addition to the 
Baseline examiner ratings of dryness and redness at each forearm test site.
This will be followed by 5 days of repeated FCAT wash procedure where subjects 
will be instructed to attend the site for two wash visits per day for the first 4 days 
(Visits 2-5, AM and PM) and one wash visit on Day 5 (Visit 6, AM only). The AM 
and PM wash procedures on any given day will be separated by a minimum of 3
hours. 
Visual assessment of dryness and redness will be conducted (by a trained, blinded 
examiner) prior to each PM wash procedure for Days 1-4 (Visits 2-5). The final 
examiner assessment of dryness and redness will be conducted on Day 5 (Visit 6), a 
minimum of 3 hours following the final Day 5 AM wash procedure.
A trained technician will perform each wash procedure to ensure consistency and 
                                               
® Simple Soap is a registered trademark of Unilever.
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eliminate the risk of cross-contamination of the study test sites. The technician will 
wash each of the 4 designated sites with one of the randomly allocated products; test 
product, positive control (Imperial Leather bar soap), negative control (sterile water 
only) or unwashed. 
On Day 5, 3 hours after the last wash procedure, examiner ratings of dryness and 
redness and final instrumental measurements of skin barrier function and skin 
moisturisation will be performed. Additionally, a final clinical assessment by a 
qualified dermatologist will be performed to ensure that it is medically appropriate to 
discharge each subject from the study.
Visit 1 - Screening Visit (Day -7 to 0)
The following assessments will be conducted:
1. Subject Informed Consent taken
2. Subject demographics collected
3. Medical history details
4. Details of current and concomitant medication collected 
5. Fitzpatrick Skin Type Assessment (Appendix 3) 
6. Examiner assessment of dryness and redness (Inclusion criteria 4b)
7. Inclusion/Exclusion criteria 
8. Dermatologist assessment for eligibility to participate in the study (including 
visual examination of the volar forearm region)
9. Subject Eligibility
10. Dispense standard soap and instructions for use
11. Adverse events will be reported following first use of the Standard soap.
Visit 2 - Baseline Visit - Day 1 AM & PM (FCAT Wash Period)
The following assessments will be conducted:
1. Current/Concomitant Medications review (AM only)
2. Compliance Check (for standard soap use – AM only)
3. Continued eligibility check (AM only)
4. Test Site allocation on each volar forearm (AM only)
5. Examiner assessment of dryness and redness AM (prior to AM wash 
procedure) and PM (3 hours post AM wash procedure and prior to Day 1 PM 
wash procedure).
NOTE: To continue in the study subjects should have a dryness score 
of zero and a redness score of zero at each of the proposed test sites 
(Inclusion criteria 4b) at Baseline (AM only).
6. Inclusion criteria 3c and 4b review -  AM only
7. Dermatologist determination for continued eligibility to participate in the study 
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(AM only)
8. Subject acclimatised to standard room conditions (AM only)
9. Baseline TEWL and Corneometer assessments (AM only)
10. Randomisation (AM only)
11. Controlled wash procedure by trained technician (AM and PM)
1. Adverse event assessment
Visit 3 to Visit 5 / Day 2 to Day 4 AM & PM (FCAT Wash period)
The following assessments will be conducted:
1. Current/Concomitant Medications review (AM only)
2. Continued eligibility check (AM only)
3. Compliance Check (for standard soap use – AM only)
4. Examiner assessment of dryness and redness (PM only prior to PM wash 
procedure)
5. Controlled wash procedure by a trained technician (AM and PM)
6. Adverse event assessment
Visit 6 - Day 5 AM (Final Test Product Application)
The following assessments will be conducted:
1. Current/Concomitant Medications review
2. Continued eligibility check
3. Compliance Check (for standard soap use)
4. Controlled wash procedure by a trained technician
5. Adverse event assessment
Visit 6 - Day 5 PM (Final Assessments) Exit from Study
The following assessments will be conducted:
1. Examiner assessment of dryness and redness
2. Subject acclimatised to standard room conditions
3. TEWL and corneometry assessments
4. Return Standard soap
5. Adverse event assessment
6. Dermatologist final assessment
7. Study discharge from the study site following completion of all study 
procedures.
Type and Planned Number of Subjects
A sufficient number of subjects will be screened in order to randomise approximately 
45 subjects to ensure that at least 40 subjects complete the study. 
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Diagnosis and Main Criteria for Inclusion
Healthy male and female subjects aged 18 to 65 with no dermatological disorders, a 
Fitzpatrick skin phototype I-IV and a blinded trained evaluator score for redness and 
dryness of zero (at Screening and Baseline visits) will be enrolled into this study.
Product Information
Test Product
Positive Control
Reference Product
Product Name
Micellar Cleanser
Imperial Leather
Original Bar Soap
Baxter Sterile Water
Product 
Formulation 
Code (MFC)
N/A
Market Place product
N/A
Market Place product
Product 
Format
200ml Clear PET 
bottle
100g Bar
1000ml bottle
Application 
Quantity
0.09ml onto a 
Moistened Towel 
(with sterile water)
Moistened Towel 
(with sterile water)
rubbed onto bar soap for 
6 seconds to generate a 
lather
0.09ml onto a 
Moistened Towel 
(with sterile water)
Route of 
Administration
Topical dermal application
Application 
Instructions
Applied on-site by technician
Statistical Methods
The primary hypothesis is that the test product is not inferior to sterile water in the 
change from baseline in the examiner rating of dryness on Day 5. Assuming that the 
standard deviation of the within subject treatment difference in change from baseline 
in examiner rating of dryness is 0.25 (based on previous study; GSKCH Study: 
 
.
The primary endpoint will be tested for non-inferiority of the test product to water in 
change from baseline to Day 5 in examiner rating of dryness using treatment 
estimates derived from an ANCOVA with subject (random effect), treatment and site 
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as factors with baseline value as a covariate. The treatment difference (test product –
water) and upper one-sided 95% confidence limit will be presented. If this upper 
confidence limit is below 0.25, it will be concluded that the test product is not inferior 
to water in the examiner rating of dryness. 
This will be corroborated by using a one-sided 0.05 level of significance Wilcoxon sign 
rank test performed on the adjusted difference (within subject change from baseline
subtracted by 0.25) on Day 5 to test the hypothesis that the mean change from baseline 
for the test product is not greater than the change for water by 0.25 or more.
The same non-inferiority analyses will also be performed for the secondary endpoint
based on examiner rating of redness.
For secondary endpoints based on examiner rating of dryness and redness to compare 
positive control versus water, the same ANCOVA model as above will be used and 
the treatment difference (positive control – water), p-value and 95% confidence 
interval will be presented.
For the other secondary endpoints of dryness and redness each day, TEWL and 
corneometer, the change from baseline will be analysed using ANCOVA with 
subject (random effect) treatment and site as factors with baseline value as a 
covariate. The treatment differences (test product – water and positive control -
water), p-value and 95% confidence interval will be presented.
If data are sufficiently non-normal in distribution, the non-parametric Wilcoxon 
signed rank test will be used with median difference and 95% confidence intervals 
presented based on the Hodges-Lehmann method.
No interim or subgroup analyses are planned.
Adverse Events (AE) will be tabulated according to the current version of the 
Medical Dictionary for Regulatory Activities (MedDRA). Frequencies and 
percentages will be presented overall, for each system organ class, and for each 
preferred term. Summaries of treatment-emergent AE’s, treatment-related AE’s, and 
AE’s leading to discontinuation, and serious AE’s will be completed. For treatment-
related AE’s, these will also be presented by treatment/test site.
Detailed methodology for summary and statistical analyses of the data collected in 
this study will be documented in a Statistical Analysis Plan, which will be maintained 
and signed off prior to study unblinding.  
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1. INTRODUCTION
In recent years the cosmetic industry has grown considerably, along with its concern 
for developing safe and effective products.  This industry awareness, and consumer 
and regulatory agency requirements have led cosmetic manufacturers to adopt
procedures that provide them with a better understanding of their products.  This 
includes the conduct of clinical tests to assess safety and efficacy, which are often 
coordinated by dermatologists or other experts before marketing a product.  These 
procedures, which provide greater assurance of safety for the companies, increase 
credibility and confidence among consumers.
A cosmetic product that is freely available to the consumer must be safe when applied 
under normal or reasonably foreseeable conditions of use (ANVISA, 2012). Thus, the 
raw materials used in the product formulation must be of proven safety and with 
established use in the cosmetic industry.  As a general requirement, the safety of the 
final formulation must also be confirmed before it is marketed.
Cleansers are designed to remove dirt, sweat, sebum and oils from the skin. This is 
achieved through the use of surfactants that aid in the uplifting of dirt and 
solubilisation of oils. However the interaction of cleansers and the stratum corneum 
can be detrimental to the skin, causing tightness and dryness as well as barrier 
damage, erythema, irritation and itch. (Wihelm, 1994)
Mildness is a factor that contributes to consumer acceptance of a personal cleansing 
product, especially in dry skin.  The relative mildness (or irritation potential) of 
personal cleansing products is ideally judged under conditions of actual consumer 
use.  However, these may not present the best conditions for discriminating product 
mildness differences, since normal use conditions typically do not induce 
differentiable product skin effects (Ertel, 1995).
The Forearm Controlled Application Technique (FCAT) is an exposure method that 
offers an efficient means to estimate the relative mildness (irritation) of personal 
cleansers through repeated overuse.  It provides greater precision and sensitivity and 
minimises confounding effects due to biological diversity (Ertel, 1995). The FCAT is 
able to discriminate the relative mildness of personal cleansers in a wide variety of 
test conditions. Mildness can be defined by the parameters of skin redness and 
dryness (Lukacocvic, 1987). 
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Transepidermal water loss (TEWL) is the rate at which water permeates the stratum 
corneum and evaporates from the skin surface and qualifying TEWL can be used to 
support the examiner assessments. 
Corneometry is a standard measurement of skin moisturisation which uses an 
electrical capacitance method to model the water content of the skin (Eisner et al, 
1994). This assessment is included to provide an instrumental measurement of skin 
moisturisation to support the examiner assessments.
Clinical studies which are designed to evaluate the irritation and sensitisation 
potential of a product must take into account a number of variables including the
components used in the formulation and their concentration, absorption, amount 
applied, skin condition, application directions and frequency, as well as the 
cumulative effect (Dooms-Goossens, 1993).
The objective of this clinical study is to assess the relative mildness of a cosmetic 
facial cleanser in comparison to water through repeated application to the volar 
forearm using the FCAT wash procedure. A positive control has been included in the 
design to help validate the trial results. Specifically, Imperial Leather Original bar 
soap has been selected as the positive control as
 
. An 
area that will remain unwashed is also included in the study as a reference for the 
treated areas.
2. OBJECTIVE(S) AND ENDPOINT(S)
Objective(s)
Endpoint(s)
Primary
To compare change from Baseline in 
examiner rating of dryness to 3 hours 
following last wash procedure on Day 5, 
for the test product versus water in the 
skin of healthy subjects.
Examiner assessment of dryness 
(Lukacovic, 1987) as per Appendix 2 at 
Day 5, 3 hours post last wash procedure.
Secondary
To compare change from Baseline in the 
examiner rating of redness to 3 hours
following last wash procedure on Day 5 
for the test product versus water in the 
skin of healthy subjects.
Examiner assessment of redness 
(Lukacovic, 1987) as per Appendix 2 at 
Day 5, 3 hours post last wash procedure.
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To compare change from Baseline in the 
examiner rating of dryness and redness
each day for test product and the positive 
control versus water in the skin of 
healthy subjects.
Examiner assessment of redness and 
dryness (Lukacovic, 1987) as per 
Appendix 2 at Day 2, 3, 4 and 5, 3 hours 
post last wash procedure.
To assess change from Baseline in skin 
barrier function following the FCAT 
wash procedure for test product and 
positive control versus water.
TEWL measurements on Day 5, 3 hours 
post last wash procedure.
To assess change from Baseline skin 
moisturisation following the FCAT wash 
procedure for test product and positive 
control versus water.
Corneometer measurements on Day 5, 3 
hours post last wash procedure.
To evaluate the general safety of the test 
product.
Assessment of frequency and severity of 
Adverse Events
3. STUDY PLAN
3.1. Study Design
Overall Design
This is a test site randomised, examiner blinded, positive and negative-controlled, 
single-center; Forearm Controlled Application Technique clinical study in healthy 
subjects to assess the mildness potential of a cosmetic facial cleansing product.
Subjects will give their written consent prior to any study procedures taking place.
Visual assessments of dryness and redness will be conducted (by a trained blinded 
examiner). Each subject should have a score of zero for dryness and zero for redness
on each volar forearm to be eligible for inclusion in the study. Eligible subjects will 
undergo a 5 to 7-day washout period, during which only the provided standard soap 
(Simple Soap®) will be used. This standard soap will also be used throughout the 
study in place of current cleansing product(s), but subjects should avoid using 
anything other than water on the volar forearms throughout the study, including the 
washout period.
A qualified dermatologist will assess subjects at Screening (Visit 1) for eligibility and 
again at Visit 2 for continued eligibility, to ensure the subjects are free of any 
                                               
® Simple Soap is a registered trademark of Unilever.
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clinically-relevant dermatological conditions.
At the Baseline Visit (Visit 2, Day 1) examiner assessment of the dryness and redness 
of each proposed test site on each volar forearm will be performed prior to any wash 
application using the scoring system detailed in Appendix 2. Each subject should 
have a score of zero for dryness and zero for redness to be considered eligible to 
continue in the study.
Prior to any wash procedure, subjects will be acclimatized to the environment of 
controlled temperature and humidity room and instrumental measurements of skin 
barrier function (measured with a Tewameter) and skin moisturisation (measured with 
a Corneometer) will be performed at Baseline (Visit 2 (AM)) in addition to the 
Baseline examiner ratings of dryness and redness at each forearm test site.
This will be followed by 5 days of repeated FCAT wash procedure where subjects 
will be instructed to attend the site for two wash visits per day for the first 4 days 
(Visits 2-5, AM and PM) and one wash visit on Day 5 (Visit 6, AM only). The AM 
and PM wash procedures on any given day will be separated by a minimum of 3
hours. 
Visual assessment of dryness and redness will be conducted (by a trained, blinded 
examiner) prior to each PM wash procedure for Days 1-4 (Visits 2-5). The final 
examiner assessment of dryness and redness will be conducted on Day 5 (Visit 6), a 
minimum of 3 hours following the final Day 5 AM wash procedure.
A trained technician will perform each wash procedure to ensure consistency and 
eliminate the risk of cross-contamination of the study test sites.  The technician will 
wash each of the 4 designated sites with one of the randomly allocated products; test 
product, positive control (Imperial Leather bar soap), negative control (sterile water 
only) or unwashed. 
On Day 5, 3 hours after the last wash procedure, examiner ratings of dryness and 
redness and final instrumental measurements of skin barrier function and skin 
moisturisation will be performed. Additionally, a final clinical assessment by a 
qualified dermatologist will be performed to ensure that it is medically appropriate to 
discharge each subject from the study.
Visit 1 - Screening Visit (Day -7 to 0)
The following assessments will be conducted:
1. Subject Informed Consent taken
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2. Subject demographics collected
3. Medical history details
4. Details of current and concomitant medication collected 
5. Fitzpatrick Skin Type Assessment (Appendix 3) 
6. Examiner assessment of dryness and redness (Inclusion criteria 4b)
7. Inclusion/Exclusion criteria 
8. Dermatologist assessment for eligibility to participate in the study (including 
visual examination of the volar forearm region)
9. Subject Eligibility
10. Dispense standard soap and instructions for use
11. Adverse events will be reported following first use of the Standard soap.
Visit 2 - Baseline Visit - Day 1 AM & PM (FCAT Wash Period)
The following assessments will be conducted:
12. Current/Concomitant Medications review (AM only)
13. Compliance Check (for standard soap use – AM only)
14. Continued eligibility check (AM only)
15. Test Site allocation on each volar forearm (AM only)
16. Examiner assessment of dryness and redness AM (prior to AM wash 
procedure) and PM (3 hours post AM wash procedure and prior to Day 1 PM 
wash procedure).
NOTE: To continue in the study subjects should have a dryness score 
of zero and a redness score of zero at each of the proposed test sites 
(Inclusion criteria 4b) at Baseline (AM only).
17. Inclusion criteria 3c and 4b review -  AM only
18. Dermatologist determination for continued eligibility to participate in the study 
(AM only)
19. Subject acclimatised to standard room conditions (AM only)
20. Baseline TEWL and Corneometer assessments (AM only)
21. Randomisation (AM only)
22. Controlled wash procedure by trained technician (AM and PM)
23. Adverse event assessment
Visit 3 to Visit 5 / Day 2 to Day 4 AM & PM (FCAT Wash period)
The following assessments will be conducted:
1. Current/Concomitant Medications review (AM only)
2. Continued eligibility check (AM only)
3. Compliance Check (for standard soap use – AM only)
4. Examiner assessment of dryness and redness (PM only prior to PM wash 
procedure)
5. Controlled wash procedure by a trained technician (AM and PM)
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1. Adverse event assessment
Visit 6 - Day 5 AM (Final Test Product Application)
The following assessments will be conducted:
1. Current/Concomitant Medications review
2. Continued eligibility check
3. Compliance Check (for standard soap use)
4. Controlled wash procedure by a trained technician
5. Adverse event assessment
Visit 6 - Day 5 PM (Final Assessments) Exit from Study
The following assessments will be conducted:
1. Examiner assessment of dryness and redness
2. Subject acclimatised to standard room conditions
3. TEWL and corneometry assessments
4. Return Standard soap
5. Adverse event assessment
6. Dermatologist final assessment
7. Study discharge from the study site following completion of all study 
procedures.
3.2. Subject Restrictions
Lifestyle/ Dietary
During the entire study (Screening – Last Subject Last Visit (LSLV)) the following 
should be avoided:
1. Applying any product to the forearms (other than water during bathing) except 
during the wash procedure.
2. Changing any cosmetic habits, including personal hygiene.
3. Changing dietary habits.
4. Wearing tight or restrictive clothing that could cause friction or cause redness
to the forearms.
5. Exposure to artificial ultraviolet (UV) light or cosmetic procedures (includes 
tanning beds, Intense Pulsed Light (IPL), etc.) on the test areas.
6. Introduction of new products during the study including but not limited to; 
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soap, laundry detergent, or fabric softener.
7. Use of self-tanning products 2 weeks prior to screening and for the duration of 
the study
8. Crossing or folding of arms throughout the duration of each of the visits (AM 
and PM) in order to reduce the risk of product cross-contamination.
9. Contact between clothing and the test sites during a Visit period (AM and PM) 
(sleeves rolled up if required).
Medications and Treatments
During the entire study (Screening –LSLV) the following medications and treatments 
should be avoided:
1. Having any body aesthetic or dermatological treatments performed.
2. Changing hormone treatment.
3. Changing contraceptive method.
4. Use of the following medications:
a) Systemic or topical corticosteroids
b) Systemic or topical immunosuppressive drugs
c) Systemic or topical antihistamines, Vitamin A acid and its derivatives, 
or non-steroidal anti-inflammatory drugs 
d) Concomitant topical treatment at test sites
3.3. Type and Planned Number of Subjects
A sufficient number of healthy male and female volunteers aged 18 to 65 with no 
dermatological disorders, with Fitzpatrick skin phototype I to IV and a trained 
blinded examiner assessment of dryness score of zero and redness score of zero will 
be screened in order to randomise approximately 45 subjects to ensure that at least 40 
subjects complete the study.
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3.4. Study Design and Application Amount Justification
This will be a single centre, randomised, positive and negative-controlled, examiner-
blinded study in healthy subjects aged 18-65 years. Subjects will be exposed to a 
repeated wash procedure method which will be conducted for the test product, a 
positive control (Imperial Leather bar soap), and a negative control (sterile water) for 
5 days. A fourth unwashed site will be included as a reference. 
The study will be conducted under the supervision of a qualified dermatologist.  
Prospective subjects will be assessed by the dermatologist as a prerequisite to 
enrollment, and again at study end.
During screening subjects will sign an informed consent document and then a 
dermatological assessment will be conducted to ensure subjects have no 
dermatological conditions on their forearms that might impact subject safety or study 
results and to ensure subjects are classified as Fitzpatrick Phototype I to IV. A 
trained, blinded examiner will assess the dryness and redness of each volar forearm 
and only subjects with a score of zero for dryness and zero for redness will be 
enrolled into the study. Each subject’s medical and medication history will be 
reviewed, in addition to the inclusion/exclusion criteria. Subsequently, site staff will 
review lifestyle guidelines and directions with eligible subjects.
A standard soap to be used in place of subjects’ normal cleansers will be provided for 
use during the washout period and study treatment phase. Subjects will be instructed 
to avoid using any products, including the supplied cleanser, on their forearms 
throughout the washout and study treatment phase. 
Consented eligible subjects will undergo a one-week washout period (5-7 days) prior 
to first wash procedure, during which the use of any skin cleansing products, 
including the standard soap, and any other topical products on the forearms will be 
prohibited. 
On Day 1 (Visit 2, AM), eligible subjects will return to the study site and another 
dermatological assessment will be conducted, as will a review of any concomitant 
medications used since screening to ensure subject continued eligibility. Compliance 
concerning correct use of the standard soap will also be checked.
Each subject will have two test sites (3x3 cm) marked out on each volar forearm. The 
distance between the two sites should be at least 1 cm to prevent either the test 
product, positive control product (Imperial Leather Original bar soap) or negative 
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control (sterile water) applications from spreading over and influencing neighbouring 
test sites. A trained, blinded examiner assessment (Baseline; Day 1 - AM) of dryness 
and redness will be conducted at each marked site to ensure the dryness score is zero 
and the redness score is zero for each site for continued eligibility. The site on each 
forearm for each wash procedure (or unwashed) will be determined according to the 
provided randomisation schedule. The randomisation schedule will determine the 
allocation of the 4 test sites for the test product, positive control and negative control 
wash applications and the site to be left unwashed. A trained technician will perform 
product application to ensure consistency and eliminate the risk of cross-
contamination of the study test sites.  
Subjects will be acclimatised to the environment of a temperature (20-22ºC) and 
humidity (40-60% RH) controlled room for a period of at least 30 minutes before
instrumental measurements of TEWL and corneometry at Baseline (Day 1 - AM) are 
taken, prior to any wash procedures and additionally at the final visit (Day 5 - PM) 
following the final wash procedure (Day 5 – AM). (EEMCO, 1997).
The treatment period will consist of 5 days of FCAT wash procedure where subjects 
will be instructed to come to the site for two wash procedures per day for the first 4 
days (AM and PM) and one wash procedure on Day 5 (AM only). Each wash 
procedure will consist of two washings of each test site AM and PM. The AM and 
PM wash procedures on any given day will be separated by a minimum of 3 hours. 
Further visual assessments of dryness and redness will be performed prior to each PM 
wash procedure on Days 1 to 4 and again at Day 5 (PM) following the final Day 5 
AM wash procedure (Appendix 2). The visual assessments of dryness and redness 
will be performed prior to subject acclimatisation, TEWL and corneometry 
measurements on Day 1 and Day 5.
The FCAT generally produces only mild to moderate skin irritation, however, if any
site reaches a dryness or redness score of ≥5.0 at any time during the study, treatment 
of all sites on that subject will be immediately discontinued, all test sites will be 
scored and these will be recorded as an Adverse Event and the subject will be 
withdrawn from the study.
FCAT Wash Procedure:
The wash procedure has been derived from consumer habit and general use practices 
and is therefore considered to be reflective of realistic conditions of product exposure. 
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Generally, people will use a cleanser once or twice a day for between 6 and 10 
seconds (Lukacovic, 1987).
Each subject will have 2 test sites (3x3 cm) marked out on each volar forearm (Figure 
1). The distance between sites will be at least 1 cm to prevent products from 
spreading over and influencing neighbouring test sites.  
The randomisation schedule will identify the test sites for the test product, positive 
control and water (negative control) wash applications and the unwashed site. 
Figure 1.
All washings will be performed at the study site by a trained technician to ensure 
consistent washing and correct product usage. The technician will adhere to the 
following instructions: 
1. Wet the forearm liberally with warm (32-37ºC) tap water.
2. Soak a piece of Masslinn® (or equivalent non-woven towel) with sterile water, 
and then squeeze to remove excess water.
a.
For the test product: Dispense 0.09ml of the test product via pipette 
onto the moistened towel.
                                               
® Masslinn Towel is a registered trademark of Chicopee Mills, New Brunswick
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b. For the positive control: Rub the moistened towel in a circular motion 
on the Imperial Leather Original soap bar for 6 seconds to generate a 
lather.
c.
For the negative control: Dispense 0.09ml of sterile water onto the 
moistened towel.
d. For the un-washed site: no further action.
3. Rub the towel in a circular motion on the allocated site for 10 seconds. 
4. Wait 90 seconds.
5. Rinse the application site with warm (32-37ºC) tap water for 15 seconds and 
pat dry.
6. Repeat this procedure for each test applicable product application.
7. After each forearm has been washed once with test product, positive control,
and sterile water, and is patted dry, repeat this procedure a second time - i.e. 
each test site is to be washed twice at the AM and PM time points. 
During the study, each subject will have the wash procedure completed four times 
daily at each application site as per the randomisation schedule, two wash procedures 
in the morning (AM) and two wash procedures in the afternoon (PM) on Days 1, 2, 3 
and 4.  On Day 5, each subject will have the wash procedure performed twice only in 
the morning (AM). 
This study aims to determine whether the test product is no more drying to the skin 
than water. The study design is based on the published FCAT method (Ertel, 1995) 
which was developed to assess the cutaneous compatibility of personal cleansers.
Assessments:
The same experienced trained blinded examiner will assess the dryness and redness of
all test sites for the duration of the study according to the scoring scale (Appendix 2).
A Baseline assessment will be carried out at Visit 2, prior to any wash procedure. 
Baseline scores of dryness and redness must be zero for each proposed test 
application site on each forearm for subjects to be considered eligible to continue in 
the study.
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Additionally, dryness and redness assessments will be performed for each test site 
prior to each PM wash procedure on Days 1 to 4 and following the final AM wash 
procedure on Day 5 (Final assessment).
Transepidermal water loss (TEWL) is the rate at which water permeates the stratum 
corneum and evaporates from the skin surface and qualifying TEWL can be used to 
support the examiner assessments. TEWL measurements will be taken at baseline 
(Day 1) and on Day 5 PM, 3 hours post AM application.
Corneometry is a standard measurement of skin moisturisation which uses an 
electrical capacitance method to model the water content of the skin (Eisner et al, 
1994). This assessment is included to provide an instrumental measurement of skin 
moisturisation to support the examiner assessments. Corneometer measurements will 
be taken at baseline (Day 1) and on Day 5 PM, 3 hours post AM application.
Application Quantity Justification:
The application regimen and study duration are consistent with the methodology
published by Ertel (Ertel, 1995).  The application quantity of study product has been 
selected based on the assumption that, typically, 4ml of a cleansing product will be 
applied to a facial area of approximately 400cm2, as consistent with the average 
amount of non-lathering cleanser reported in the literature (Loretz, 2008). This 
equates to 0.09ml on a 9cm2 area of the volar forearm.
A positive control has been included in the design to help validate the trial results. 
Specifically, Imperial Leather Original bar soap has been selected as the positive 
control
 
An area that will remain unwashed is also 
included in the study as a reference for the treated areas.
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 Safety 
Statement.
Deviations from inclusion and exclusion criteria are not allowed because they can 
potentially jeopardize the scientific integrity of the study, regulatory acceptability or 
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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 18 and 65 years inclusive.
3. GENERAL HEALTH
a.) 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.
b.) Intact skin at the proposed application site; volar forearm.
c.) Clinical assessment for eligibility by a dermatologist to ensure subject is free 
of clinically relevant dermatological conditions (Visit 1 and Visit 2(AM)).
4. SKIN TYPE
a) Fitzpatrick phototype I to IV (see Appendix 3).
b) Trained examiner scores of zero for dryness and redness for each volar 
forearm at Screening visit (Visit 1) and each allocated test site on each 
forearm at Baseline visit (Visit 2, AM).
5. COMPLIANCE 
Agreement to comply with the procedures and requirements of the study and to attend 
the scheduled assessment visits.
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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) Any history of significant dermatological diseases or conditions or medical 
conditions known to alter skin appearance or physiologic response (e.g. 
diabetes,) which could, in the opinion of the Investigator, preclude topical 
application of the investigational products and/or interfere with the evaluation 
of the test site reaction. 
b) Presence of open sores, pimples, or cysts at the application site. 
c) Active dermatosis (local or disseminated) that might interfere with the results 
of the study.
d) Considered immune compromised. 
e) History of diseases aggravated or triggered by ultraviolet radiation.
f)
History of atopic dermatitis.
g) Participants with dermatographism.
h) Currently using any medication which in the opinion of the investigator, may 
affect the evaluation of the study product, or place the subject at undue risk.
i)
Use of the following topical or systemic medications: immunosuppressants, 
antihistamines, non-hormonal anti-inflammatory drugs, and corticosteroids up 
to 2 weeks before screening visit.
j)
Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 
month before the screening visit.
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k) Intention of being vaccinated during the study period or has been vaccinated 
within 3 weeks of the screening visit.
l)
Currently receiving allergy injections, or received an allergy injection within 7 
days prior to Visit 1, or expects to begin injections during study participation
4. ALLERGY/ INTOLERANCE
a) Previous history of atopy, allergic reactions, irritation or intense discomfort 
feelings to topical-use products, cosmetics or medication.
b) Known or suspected intolerance or hypersensitivity to the study materials (or
closely related compounds) or any of their stated ingredients
5. CLINICAL STUDY/ EXPERIMENTAL PRODUCT
a) Participation in another clinical study (including cosmetic studies) or receipt 
of an investigational drug within 30 days 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.
7. DIAGNOSTIC ASSESSMENTS AND OTHER CRITERIA
a) Intense sunlight exposure or sun tanning sessions, including use of self-
tanning products on the test areas up to 14 days before the Screening 
evaluation.
b) Intention of bathing (in the sea or pool), sauna, water sports, or activities that 
lead to intense sweating.
c) Any Subject who, in the judgment of the Investigator and Dermatologist, 
should not participate in the study.
d) Any skin marks on the test site that might interfere with the evaluation of 
possible skin reactions (e.g. pigmentation disorders, vascular malformations, 
scars, tattoos, excessive hair, numerous freckles).
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e) Prisoner or involuntary incarcerated subject.
f)
Subject from an indigenous tribe.
8. PERSONNEL
An employee of the sponsor or the study site or members of their immediate family.
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. Re-screening of subjects considered previous screen failures will not be 
allowed in this study.
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 (CRF).  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:
1. The site must attempt to contact the subject and re-schedule the missed 
visit as soon as possible. 
2. The site must counsel the subject on the importance of maintaining the 
assigned visit 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 
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regain contact with the subject (where possible, at least 2 telephone calls). 
The contact attempt should be documented in the subject’s record. 
3. 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 to Follow-up”.
4.5. Subject Replacement
Subjects who withdraw from the study post-randomisation will not be replaced.
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.
5. PRODUCT INFORMATION
5.1. Study Product
The following study products will be supplied by the Clinical Supplies Department, 
GSKCH:
Test Product
Positive Control
Reference Product
Product Name
Micellar Cleanser
Imperial Leather
Original Bar Soap
Baxter Sterile Water
Product 
Formulation 
Code (MFC)
N/A
Market Place product
N/A
Market Place product
Product 
Format
200ml Clear PET 
bottle
100g Bar
1000ml bottle
Application 
Quantity
0.09ml onto a 
Moistened Towel 
(with sterile water)
Moistened Towel (with 
sterile water) rubbed 
onto soap for 6 seconds 
to generate a lather
0.09ml onto a 
Moistened Towel 
(with sterile water)
Route of 
Administration
Topical dermal application
Application 
Instructions
Applied on-site by technician
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Other items to be supplied by the Clinical Supplies Department, GSKCH:
Name of Item
Purpose
Simple Soap
Standard soap for use as during the washout period 
and for standard use at home during the study 
period.
Soap holder
To contain the subject standard soap between uses. 
Additional soap holders for use at the study site as 
require.
Baxter Sterile Water
Additional supplies for general use during the 
wash procedure to moisten the non-woven towels
5.2. Application Schedule
Each subject will have four test sites; two test sites (3x3 cm) marked out on each 
volar forearm (Figure 1, Section 3.4). The distance between different application sites
must be at least 1 cm to prevent either the test product, positive control (Imperial 
Leather bar soap) or negative control (sterile water) wash from spreading over and 
influencing neighbouring test sites. The site on each forearm for each wash 
application (or unwashed) will be determined according to the provided
randomisation schedule. The randomisation schedule will identify the test sites for the 
test product, positive control and water (negative control) wash applications, and the 
unwashed site. 
A trained technician will wash each marked site with the appropriate product. 
All wash procedures will be performed at the study site by a technician to ensure 
consistent wash application and correct product usage.
During the study, subjects will have the wash procedure completed four times daily at
each allocated site, two wash applications in the morning (AM) and two wash 
applications in the afternoon (PM) on Days 1, 2, 3 and 4.  On Day 5, subjects will 
have the wash procedure completed twice in the morning (AM) only. Each AM and 
PM wash procedure will be separated by a minimum of 3 hours.
5.3. Product Assignment
Each subject will have the test product, positive control (Imperial Leather Original 
bar soap), negative control (sterile water) and an unwashed site randomly assigned to 
sites on each volar forearm. The specific site locations will be assigned to subjects in 
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accordance with the randomisation schedule generated prior to the start of the study,
using validated software.
5.3.1 Randomisation
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 randomisation schedule, which will be 
prepared to achieve balance between each forearm and upper and lower forearm.
Randomisation numbers will be assigned in ascending numerical order as each 
subject is determined to be fully eligible.
The study site will receive two versions of the randomisation schedule, each in a 
sealed envelope and clearly marked as either “For Dispensing” or “Emergency Use 
Only”. The “For Dispensing” schedule will contain the list of randomisation numbers
and the test site location (1 to 4) a letter code A, B, C or D will be used to determine 
which product is to be applied to which site.
The ‘Emergency Use Only’ randomisation schedule will only be removed from the 
sealed envelope in an emergency situation. This schedule will have a randomisation
number followed by the letter. The schedule will have a footnote with a key for the 
letters identifying the treatments.
However, to maintain the blinding of the study as much as possible, all treatment 
allocations for all randomisation numbers on this randomisation schedule will be 
masked with scratch-off panels. Only the panels required for the unblinding the 
particular subject should be removed
5.3.2 Blinding
The study statistician and other employees of the Sponsor who may influence study 
outcomes are blinded to the product allocation/test site location. Site staff dispensing 
and carrying out the wash procedures will be aware of each subject’s test location and 
must not divulge information to other study staff or the examiners. The examiners
performing the measures of dryness and redness will be blinded to wash procedure
and locations.
5.3.3 Code 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 
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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.
5.4. Packaging and Labelling
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.
The test product; facial micellar cleanser (
) will be supplied in 200 ml
bottles which will have a study label affixed by the Sponsor. Each study label will 
contain, but not be limited to, protocol number, product code letter and directions for 
storage.
The positive control product; Imperial Leather Original bar soap will be supplied in 
market place packaging in a labelled soap holder. Each study label will contain, but 
not be limited to, protocol number, product code letter and directions for storage.
The negative control product; Baxter sterile water will be supplied in market place 
packaging. Each study label will contain, but not be limited to, protocol number, 
product code letter and directions for storage. 
Additional sterile water will be supplied for use to moisten the non-woven towels for 
product wash procedures. This will also be supplied in market place packaging. Each 
study label will contain, but not be limited to, protocol number, and directions for 
storage.  
The standard soap (Simple) will be supplied in a market place packaging in a labelled 
soap holder. Each study label will contain, but not be limited to, protocol number 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 on the standard soap. 
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5.4.1. Accountability of Product
All products supplied are for use only in this clinical study and should not be used for 
any other purpose.
The investigator or designee will maintain a full record of study product 
accountability. 
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 the GSKCH Clinical Supplies Department or designated 
vendor.
5.4.2. Storage of Product
Study product supplies must be stored in compliance with the label requirements in a 
secure place with limited or controlled access.
6. STUDY ASSESSMENTS AND PROCEDURES
This section lists the procedures and parameters of each planned study assessment.  
The exact timing of each assessment 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 Visit
6.1.1 Telephone Screening
Prior to the screening visit, telephone screening of interested subjects may be 
conducted using a telephone script. This will be conducted by the site recruitment 
staff or designee.  
6.1.2. Informed Consent
The investigator, or designee, must obtain 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.  
Appropriate forms for documenting a signed and dated consent will be provided by 
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the investigator or by GSKCH.  The investigator, or designee, should sign and date 
the consent form to confirm that the consent process was completed correctly after 
the subject has signed.  The subject will be provided with a copy of their signed and 
dated consent form and any other written information which they will be instructed to 
retain.
If, during a subject’s participation 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 should be provided with a copy of the signed and dated 
amended consent form. The date of consent will be recorded on the CRF.
After signing the Informed Consent Form (ICF), subjects will undergo all the 
screening assessments to confirm that they meet all the inclusion criteria and none of 
the exclusion criteria. If the subject is considered eligible by the Investigator (or 
designee) to participate they are considered enrolled in the study.
6.1.3. Demographics
The following demographic parameters will be captured by the Investigator or 
designee and recorded on the CRF: year of birth, Fitzpatrick skin type (skin phototype 
classification, according to the Fitzpatrick classification, per Appendix 3), gender and 
race.
6.1.4 Dermatologist Assessment
For products with specific safety appeals, the study must be followed up by a 
specialist (ANVISA, 2012). A qualified dermatologist will assess overall subject 
eligibility at the Screening Visit (Visit 1) and their continued eligibility at Baseline 
(Visit 2) to ensure that the subject is free of any pre-existing dermatological 
conditions. Additionally, a final assessment at Visit 6 by a qualified dermatologist 
will be performed to confirm whether it is medically appropriate to exit the subject 
from the study (Edward & Robillard, 2008).
6.1.5. Medical History and Concomitant Medication
Medical history will be assessed as related to the inclusion/exclusion criteria by the 
Investigator or medically qualified designee.  Details of any relevant medical or 
surgical history (within the last year), including allergies or drug sensitivity, will be 
recorded on the CRF.  Any concomitant therapy taken in the 30 days prior to the 
Screening Visit and throughout the study will also be recorded.
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All eligible subjects will be provided with a standard soap to use for the washout 
period and during the study. However, no products other than water (for bathing) 
should be applied to the forearms from completion of the Screening visit.
6.1.6. Examiner Assessment of Redness and Dryness
Mildness is defined by the parameters of skin dryness and redness (Lukacocvic, 
1987). An experienced, trained and blinded examiner will assess the dryness and 
redness according to the scale defined in Appendix 2. To be considered eligible to 
join the study, the volar forearm of each subject must have overall dryness and 
redness scores of zero.
6.2. Visit 2 – Day 1 - Baseline Visit to Visit 6 (AM)
At Visit 2, any current and concomitant therapy taken will be reviewed and the 
eligibility of each subject to continue in the study will be checked by a qualified 
dermatologist prior to randomisation. Continued eligibility will be reviewed at each 
subsequent visit by a member of study staff. Subject adherence to correct usage of the 
standard soap will be checked at all visits.
6.2.1. Examiner Assessment of Redness and Dryness
An experienced, trained and blinded examiner will assess the redness and dryness of 
all skin sites for the duration of the study according to the scoring scale defined in 
Appendix 2. A Baseline assessment will be carried out at Visit 2 prior to any wash 
procedure. The dryness and redness scores of each proposed test application site on 
each volar forearm must be zero for dryness and redness for the subject to continue in 
the study. 
Additionally, redness and dryness assessments will be performed at each test site 
prior to each PM wash procedure on Days 1-4 and following the final wash procedure 
on Day 5 (Final assessment). The examiner visual assessments of dryness and redness 
will be performed prior to subject acclimatisation and TEWL and corneometry 
assessments on Day 1 and Day 5.
The FCAT procedure generally produces only mild to moderate skin irritation,
however, if any test site reaches a dryness or redness score of ≥5.0 at any time during 
the study, treatment of all sites on that subject will be immediately discontinued, all 
test sites will be scored and these will be recorded as an Adverse Event and the 
subject will be withdrawn from the study.
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The examiner visual grading of dryness and redness will be performed prior to 
subject acclimatisation and TEWL and corneometry assessments on Day 1 and Day 5.
6.2.2. Corneometry
Corneometry is a standard measurement of skin moisturisation which uses an
electrical capacitance method to model the water content of the skin (Eisner, et al, 
1994). Corneometer measurements are included to provide support for examiner 
assessments. Corneometry will be initially measured at Baseline visit (Visit 2) prior to 
any study product application on both volar forearms at each designated test site. It 
will then be measured at the final visit (Day 5 - PM), at least 3 hours following the 
final wash procedure completed at that AM visit. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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6.2.3. Transepidermal Water Loss (TEWL)
TEWL is a non-invasive method to measure the integrity of stratum corneum barrier
function. This measurement has been included to provide support for the examiner 
assessments. TEWL will be initially measured at the Baseline visit (Visit 2) prior to 
any study product application on both forearms at all the designated sites. It will then 
be measured again at the final visit (Day 5 – PM), at least 3 hours following the final 
wash procedure completed at that AM visit. 
 
 
 
 
 
 
 
 
 
 
 
6.2.4. FCAT Wash Procedure
The wash procedure has been derived from consumer habit and general use practices 
and is therefore considered to be reflective of realistic conditions of product exposure. 
Generally, people will use a cleanser once or twice a day for between 6 and 10 
seconds (Lukacovic, 1987).
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Each subject will have 2 test sites (3x3 cm) marked out on each volar forearm (Figure 
1). The distance between sites will be at least 1 cm to prevent products from 
spreading over and influencing neighboring test sites.  
The randomisation schedule will identify the test sites for the test product, positive 
control and water (negative control) wash applications and the unwashed site. 
Figure 1.
All washings will be performed at the study site by a trained technician to ensure 
consistent washing and correct product usage. The technician will adhere to the 
following instructions: 
1. Wet the forearm liberally with warm (32-37ºC) tap water.
2. Wet a piece of Masslinn® (or equivalent non-woven towel) with sterile water, 
then squeeze to remove excess water.
a.
For the test product: Dispense 0.09ml of the test product via pipette 
onto the moistened towel.
b. For the positive control: Rub the moistened towel in a circular motion 
on the Imperial Leather Original soap bar for 6 seconds to generate a 
lather.
                                               
® Masslinn Towel is a registered trademark of Chicopee Mills, New Brunswick
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c.
For the negative control: Dispense 0.09ml of sterile water onto the 
moistened towel.
d. For the un-washed site: no further action.
3. Rub the towel in a circular motion on the allocated site for 10 seconds. 
4. Wait 90 seconds.
5. Rinse the application site with warm (32-37ºC) tap water for 15 seconds and 
pat dry.
6. Repeat this procedure for each test applicable product application.
7. After each forearm has been washed once with test product, positive control,
and sterile water, and is patted dry, repeat this procedure a second time - i.e. 
each test site is to be washed twice at the AM and PM time points. 
During the study, each subject will have the wash procedure completed four times 
daily at each application site as per the randomisation schedule, two wash procedures 
in the morning (AM) and two wash procedures in the afternoon (PM) on Days 1, 2, 3 
and 4.  On Day 5, each subject will have the wash procedure performed twice only in 
the morning (AM). 
6.3. Visit 6 - Day 5 (PM) and Study Conclusion
Subjects will return to the study site on the final day (Day 5, Visit 6) and will undergo 
the FCAT wash procedure at the AM visit as per Section 6.2.4. A minimum of 3 
hours following the final wash procedure, final examiner assessments of redness and 
dryness (per Section 6.2.1) and final instrumental measures of corneometry (per 
Section 6.2.2) and TEWL (per Section 6.2.3) will be performed.
6.3.1. Study Conclusion
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 the CRF by selecting one of the options below.
1.
Subject did not meet study criteria
2.
Adverse Event
3.
Lost to Follow Up
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4.
Protocol Violation
5.
Withdrawal of Consent
6.
Other
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 patient or 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-existing condition 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).
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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.
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.
6. The FCAT generally produces only mild to moderate skin irritation; however, if a 
treated site reaches a dryness or redness score of ≥ 5.0 at any time during the 
study, treatment of all sites on that subject will be immediately discontinued and 
all test sites will be scored and these will be recorded as an Adverse Event.
Subjects will be discontinued.
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-patient setting. Complications that occur during 
hospitalization are AEs.  If a complication prolongs hospitalization or fulfills 
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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
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-threatening or 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 considered serious.
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. Recording Adverse Events and 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 the CRF.
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 
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submission to GSK.
4. The investigator will attempt to establish a diagnosis of the event based 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 use of the washout soap product and 
until 5 days following 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 related to 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 Events and 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 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.
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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 Investigator Brochure (IB) and/or 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) or CRF that he/she has reviewed the AE/SAE and has provided an 
assessment of 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 Events and Serious Adverse Events
AE Reporting to GSKCH:
1. AEs will be recorded in the AE section of the CRF. 
2. Medical conditions recorded by the subject on a diary card or similar document 
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that meet the definition of an AE must also be recorded in the AE section of the 
CRF, 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 the CRF.  The investigator or designee must 
ask the subject the following question during each visit including any follow-up 
visits: “Have you felt unwell, experienced any symptoms or taken any 
medication (since your last visit) (today) (since your last application) (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 the CRF. 
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 8.3)
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 soon as possible, but 
not later than 24 hours after study site personnel learn of the event. The GSKCH 
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Study Manager should be notified of the situation by telephone or email.
Serious Adverse Events to:
Brazil Clinical Study Manager 
Tel: 
E-mail: 
Pharmacovigilance (Brazil) Fax Number: 
The GSKCH Study Manager will 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.
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 Events and 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:
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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, IRB and investigators.
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 GSKCH 
will file it with the Investigator Brochure (or safety statement) and will notify the 
IRB, if appropriate according to local requirements.
7.6. Collection of Pregnancy Information
7.6.1. Time Period for Collecting of Pregnancy Information
Collection of Pregnancy Information:
Pregnancy information will be collected on all pregnancies reported following 
administration of any investigational product (or washout product). Information on 
pregnancy identified during the screening phase and prior to investigational product 
(or washout product) administration does not need to be collected.
7.6.2. Action to be Taken if Pregnancy 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 investigational 
product (or washout product). The investigator will 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 
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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 
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 CRF.
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 the CRF should be 
specified in the Source Document Designation Form.  In some cases, the CRF can 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.
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8.2. Electronic Case Report Form
A CRF is a printed, optical, or electronic 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, CRF 
must be completed and signed by the Principal Investigator (or authorized designee) 
to certify that 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 
(PII) (including the subject's name or initials or birth date) is to be recorded in the 
CRF or as part of the query text.
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.  
Subject data will be entered into GSKCH defined CRFs and transmitted electronically 
to GSKCH in a validated (21 CFR Part 11 compliant) web-based electronic data 
capture system (InFormTM).
All CRF pages should be completed during a subject assessment when the CRF has 
been designated as the source.  Data that is sourced elsewhere should be entered into 
the CRF in an agreed upon timeframe between the Investigator and Sponsor.  
The CRFs (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 
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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 the CRF data, 
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 the CRFs 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 the CRFs, to raise 
manual queries as needed for site clarification or correction
8.4. External Data
External Data are subject data obtained externally to the CRF. These data are 
generated from laboratory instruments, computers or other sources and then 
transcribed into a file and format agreed upon by GSKCH to identify the subject and 
time point referenced in the CRF and/or protocol. 
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/DVD 
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.
9. STATISTICAL CONSIDERATIONS AND DATA 
ANALYSES
9.1 Sample Size Determination
The primary hypothesis is that the test product is not inferior to water in the change 
from baseline in the examiner rating of dryness on Day 5. Assuming that the standard 
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deviation of the within subject treatment difference in change from baseline in 
examiner rating of dryness is 0.25 (based on previous study 
), a 
 
 
Sufficient number of subjects will be screened in order to randomise 45 subjects and 
to ensure that at least 40 subjects complete the study. 
9.2. General Considerations
The test for non-inferiority between test product versus water in the examiner rating 
of dryness and redness will be one-sided at the 0.05 level of significance. All other 
statistical tests will be done at a two-sided 0.05 level of significance.
9.2.1. Definition of Analysis Populations
The ‘Intent-to-treat’ (ITT) population will include all subjects who are randomized, 
receive at least one wash procedure, including sterile water, and have at least one 
post-baseline clinical assessment available. The ITT population will be the primary 
population for all clinical assessed analyses, including dryness and redness. 
The Safety population will include all subjects who have received at least one wash 
procedure.  All safety analysis will be performed using the Safety population. 
9.2.2. Exclusion of Data from Analysis
No data will be excluded from any analysis. 
9.2.3. Criteria for Evaluation
The primary endpoint will be tested for non-inferiority of the test product to water in 
examiner rating of dryness.  The test will be carried out as follows: within subject 
treatment difference (test to water) in change from Baseline to 3 hr following last 
application on Day 5 will be estimated. To test the hypothesis that the difference has a 
mean 0.25 or greater at 0.05 level of significance, a one-sided upper 95% confidence 
limit will be estimated for the test product to water mean difference. If the upper 95% 
confidence limit is below 0.25, it will be concluded that the test product is not inferior 
to water in the examiner rating of dryness. 
The criteria for non-inferiority of 0.25 on mean dryness score is considered clinically 
relevant after consideration of mean differences seen between positive control (bar 
soap) and water in previous studies (Ertel, 1995 and GSK Clinical Study 
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9.2.4. Criteria for Assessing Safety and Tolerability
Adverse events will be tabulated according to the version of the Medical Dictionary 
for Regulatory Activities (MedDRA) that is current at the time of analysis.
9.2.5. Handling of Dropouts and Missing Data
Missing data will not be replaced or imputed. Dropouts will be included in analyses 
up to the point of discontinuation. Sensitivity analyses may be conducted if 
substantial number of subjects have discontinued from the study.
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.
Selected raw data may be listed as defined in the SAP
9.3.1. Demographic and Baseline Characteristics
Age will be summarised using descriptive statistics such as the number of non-
missing observations, mean, and standard deviation, median, minimum, and 
maximum.  Gender, race and Fitzpatrick skin type will be summarized using
frequency counts and percentages.
9.3.2. Primary Analysis(es)
The primary endpoint will be tested for non-inferiority of the test product to water in 
change from baseline on Day 5 in examiner rating of dryness, using treatment 
estimates derived from an ANCOVA with subject (random effect), treatment and site 
as factors with baseline value as a covariate. The LSMeans will be presented for each 
treatment. The treatment difference (test product to water) and upper one-sided 95% 
confidence limit will be presented. If this upper confidence limit is below 0.25, it will 
be concluded that the test product is not inferior to water in the examiner rating of 
dryness. 
This will be corroborated by using a one-sided 0.05 level of significance Wilcoxon 
sign rank test performed on the adjusted difference (within subject change from 
Baseline subtracted by 0.25) on Day 5 to test the hypothesis that the mean change 
from baseline for the test product is not greater than the change for water by 0.25 or 
more. The interpretation of this analysis will be assessed with caution as the non-
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inferiority margin of 0.25 is based on mean dryness score with assumption of normal 
rather than discreet distribution. 
For individual subjects an increase in dryness score from baseline of 1 or more with 
treatment is considered as a clinically relevant irritation response, so additional 
analysis will be performed based on subjects with this response, with more details 
provided in the SAP.
9.3.3. Secondary Analysis(es)
The non-inferiority analyses performed for primary endpoint will also be performed 
for the secondary endpoint based on examiner rating of redness on Day 5.
For secondary endpoints based on examiner rating of dryness and redness on Day 5 to 
compare positive control versus water, the same ANCOVA model as above will be 
used and the treatment difference (positive control to water), p-value and 95% 
confidence interval will be presented. Also for information, the treatment difference 
(positive control to test product) and treatment difference (water to unwashed), p-
value, and 95% confidence interval will be presented.
For the other secondary endpoints of redness and dryness each day, TEWL and 
corneometer, the change from baseline will be analysed using ANCOVA with 
subject (random effect), treatment and site as factors with baseline value as a 
covariate. LSMeans for each treatment will be presented. The treatment differences
(test product to water and positive control to water), p-value and 95% confidence 
intervals will be presented. Also for information, the treatment difference (positive 
control to test product) and treatment difference (water to unwashed), p-value, and 
95% confidence interval will be presented.
If data are sufficiently non-normal in distribution, the non-parametric Wilcoxon 
signed ranks test will be used with median differences and 95% confidence interval 
presented based on the Hodges-Lehmann method.
Redness and dryness scores, TEWL and corneometer measurements at each time 
point and change from baseline in these scores and measurements at each time point 
will also summarized for test product, water, positive control and unwashed site using 
descriptive statistics such as the number of non-missing observations, mean, standard 
deviation, median, minimum, and maximum.
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No adjustment will be made for multiplicity testing for the secondary endpoints, 
however consistency of effects will be taken into consideration in interpreting the 
results.
9.3.4. Safety Analysis(es)
Adverse Events (AE) will be tabulated according to the current version of the 
Medical Dictionary for Regulatory Activities (MedDRA). Frequencies and 
percentages will be presented overall, for each system organ class, and for each 
preferred term. Summaries of treatment-emergent AE’s, treatment-related AE’s, and 
AE’s leading to discontinuation, and serious AE’s will be completed. For treatment-
related AE’s, these will also be presented by treatment/test site.
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:
1. Before initiating a trial, the investigator/institution should have written and 
dated approval/favorable opinion from the IRB for the 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.
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2. Signed informed consent to be obtained for each subject before 
participation in the study (and for amendments as applicable).
3. Investigator reporting requirements (e.g. reporting of AEs/SAEs/protocol 
deviations to IRB).
4. GSK will provide full details of the above procedures, either verbally, in 
writing, or both.
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 the CRF will serve as the 
source document.
GSK or designee will monitor the study and site activity to verify that the:
1. Data are authentic, accurate, and complete.
2. Safety and rights of subjects are being protected.
3. 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 or inspection, 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 
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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.
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 IRB, and should provide the sponsor and the IRB a detailed written 
explanation of the termination or suspension.
2. If the GSKCH terminates or suspends a trial, the investigator should 
promptly inform the IRB and provide the IRB a detailed written 
explanation of the termination or suspension. 
3. If the IRB terminates or suspends its approval/favorable opinion of a trial, 
the investigator should promptly notify 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.  
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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.
The investigator must assure that the subject’s anonymity will be maintained.  On 
CRFs 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 for 10 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 destroyed 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.
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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 if the 
results provide important scientific or medical knowledge.
11. REFERENCES
ANVISA, Guideline for the Safety Evaluation of Cosmetics Products, 2012
ANVISA; Resolution 79/00, Annex XXI and its updates
Dooms-Goossens A. Cosmetics as causes of allergic contact dermatitis. Cutis 1993; 
52: 316-320.
Edward, M. Jackson, and FMT Robillard Norman. "The controlled use test in a 
cosmetic product safety substantiation program." Journal of Toxicology: Cutaneous 
and Ocular Toxicology 1.2 (1982): 117-132.
EEMCO guidance for the assessment of dry skin (xerosis) and ichthyosis: evaluation 
by stratum corneum shippings. Skin Research and Technology, 1996: 0909-752X
Ertel KD, Keswick BH, and Bryant PB. A forearm controlled application technique 
for estimating the relative mildness of personal cleansing products. J. Soc. Cosmet. 
Chem., 46, 67-76 (March/April 1995).
Fitzpatrick TB, Pathak M, Parrish JA. Protection of human skin against the effects of 
the sunburn ultraviolet (290-320 nm). In: Fitzpatrick TB et al. (eds). Sunlight and 
man, normal and abnormal photobiological responses. Tokyo, p. 751-755.
Food and Drug Administration. ICH Topic E6: Guideline for Good Clinical Practice.  
Fed Reg 1997; 62(90): 25691-709.
Heinrich U, Koop U. et.al Multicentre comparison of skin hydration in terms of
physical-, physiological- and product dependent parameters by the capacitative 
method (Corneometer CM 825). International Journal of Cosmetic Science 2003; 25, 
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Heinrich U, Multicentre comparison of skin hydration in terms of physical, 
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(Corneometer CM 825), International Journal of Cosmetic Science, 2003 0142-5463
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12. APPENDICES
12.1. Appendix 1 - Abbreviations and Trademarks
Abbreviations
µl
Microliters
AE
Adverse Event
ANCOVA
Analysis of Covariance
aq
Aqueous 
AUC
Area under Curve
CD
Compact Disc
cm2
Centimetre squared
CRF
Case Report Form
DVD
Digital Versatile Disc
EDC
Electronic Data Capture
EEMCO
European Group for Efficacy Measurements on Cosmetics and Other 
Topical Products
FSFV
First Subject First Visit
g
Gram
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GCP
Good Clinical Practice
GSK
GlaxoSmithKline
GSKCH
GlaxoSmithKline Consumer Healthcare
hr
Hour(s)
ICF
Informed Consent Form
ICH
International Conference on Harmonization of Technical Requirements 
for Registration of Pharmaceuticals for Human Use
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ITT
Intention to Treat
LSLV
Last Subject Last Visit
m2
Square metre
MedDRA
Medical Dictionary for Regulatory Activities
mg
Milligrams
min
Minute
ml
Milliliters
nm
Nanometers
PII
Personally Identifiable Information
PP
Per Protocol
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SC
Stratum Corneum
SLS
Sodium Lauryl Sulphate
TEWL
Transepidermal Water Loss
w/w
Weight by Weight
12.2. Appendix 2 –
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SIGNATURE PAGE 
 
  
 
Date 
Signed By
 
Justification 
 
 
 
Date 
Signed By
 
Justification 
 
 
 
Date 
Signed By
 
Justification 
 
 
 
Date 
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Justification 
 
 
 
Date 
Signed By
 
 
Justification 
 
 
 
Date 
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Justification 
 
 
 
27-Feb-2017 10:56:57
Biostatistics Approval
06-Mar-2017 07:09:00
Approved
24-Feb-2017 11:59:29
Approved
Approved
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