Conditions: Acne Vulgaris
Keywords: Acne Dark skin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 50
Healthy volunteers: no

Brief summary:
This is a multicenter open-label, prospective study in subjects with dark skin from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American and with moderate to severe acne vulgaris on the face.

All eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo Forte/TactuPump Forte) once daily on whole face.

The purpose of this trial is to evaluate subject reported outcomes with the combination of Adapalene 0.3% - BPO 2.5%, Epiduo Forte / TactuPump Forte gel, after 16 weeks of treatment of moderate to severe acne in dark skin phototypes (IV to VI).

Detailed description:

Arms:
arm 1: Adapalene 0.3% / BPO 2.5% gel, once daily in the evening

Interventions: intervention 1: Adapalene 0.3% / BPO 2.5% gel
Intervention descriptions: intervention 1: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks

Protocol document:
Prot_SAP_000.pdf: 
Subject Reported Outcomes with use of Adapalene 0.3% - Benzoyl peroxide 2.5% in Moderate to Severe Acne in 
Dark Skin Phototype subjects
NCT Number: NCT02932267
Date: 23 March 2017


GALDERMA RESEARCH & DEVELOPMENT 
Protocol N° RD.03.SPR.110232 
Version 03 Final- dated on 23-MAR-2017 USA  
Page 1 of 72 CONFIDENTIAL 
CLINICAL TRIAL PROTOCOL 
PROTOCOL NUMBER: RD.03.SPR.110232 
CONFIDENTIAL 
This document contains confidential, proprietary information 
All the information provided to the Investigator and his/her staff and all data obtained through 
this GALDERMA R&D clinical trial protocol are confidential.  The Sponsor reserves all 
proprietary rights. No information may be disclosed to any third party without prior written 
consent from GALDERMA R&D. 


GALDERMA RESEARCH & DEVELOPMENT 
Protocol N° RD.03.SPR.110232 
Version 03 Final - dated on 23-MAR-2017 US  
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TITLE PAGE 
Title: 
Subject Reported Outcomes with use of Adapalene 0.3% - Benzoyl peroxide 2.5% in Moderate to Severe Acne in 
Dark Skin Phototype subjects 
Project Name:  
Project Number: 
Clinical Trial Phase: 
Epiduo® Forte gel / TactuPump Forte gel
816 
IV 
EUDRACT NUMBER: N/A 
IND NUMBER: IND067801 
Version Number: 03 
Sponsor Contact details: 
Name 
GALDERMA R&D 
Address 
Les Templiers 
2400, Route des Colles 
06410 Biot - France 
Tel 
+ 33 4 93 95 70 51 
Fax 
+ 33 4 92 95 23 80 


GALDERMA RESEARCH & DEVELOPMENT 
Protocol N° RD.03.SPR.110232 
Version 03 Final - dated on 23-MAR-2017 US  
Page 3 of 72 CONFIDENTIAL 
For any urgent medical questions, including safety reasons, please use the contact details 
provided in Section 8.2.2 
 
 
 
 
 
 
 
 
This clinical trial will be performed in compliance with applicable regulations, Good Clinical 
Practice (GCP) and the ethical principles that have their origin in the Declaration of Helsinki. 
This clinical trial Protocol follows guidelines outlined by the International Conference on 
Harmonization (ICH) and the GALDERMA R&D Phase IV department template. 


GALDERMA RESEARCH & DEVELOPMENT 
Protocol N° RD.03.SPR.110232 
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CLINICAL TRIAL ADMINISTRATIVE STRUCTURE  
The following table contains the details of GALDERMA R&D employees involved in the conduct 
of the trial. 
 
SPONSOR PERSONNEL 
Name/Title 
Affiliation/Address/Tel./Fax 
Responsibilities 
 
 
GALDERMA R&D SNC, 
 
 
 
  
Responsible for clinical management 
and monitoring of clinical trial and for 
overall coordination of clinical project 
 
 
GALDERMA R&D SNC, 
Same as above 
 
 
Responsible for 
administrative follow-up and 
management of Trial Master File 
 
  
GALDERMA R&D SNC,  
 
 
Responsible for medical 
management and safety surveillance 
 
 
GALDERMA R&D SNC, 
Same as above 
 
 
Responsible for the Phase IV group 
 
 
GALDERMA R&D SNC, 
Same as above 
 
 
Clinical Operation Manager for the 
Phase IV group 
 
 
GALDERMA R&D SNC, 
Same as above 
 
 
Responsible for the coordination of all 
data management activities 
 
 
GALDERMA R&D SNC, 
Same as above 
 
 
Responsible for the management of 
all statistical activities 
 
 
 
GALDERMA R&D SNC, 
Same as above 
 
 
Responsible for quality assurance 
and audits  
 
 
GALDERMA R&D SNC, 
Same as above 
 
 
Responsible for the management of 
all clinical supplies activities 
 
 
GALDERMA US Fort Worth 
 
 
Responsible for safety surveillance 
 


GALDERMA RESEARCH & DEVELOPMENT 
Protocol N° RD.03.SPR.110232 
Version 03 Final - dated on 23-MAR-2017 US  
Page 5 of 72 CONFIDENTIAL 
SIGNATURE PAGE 
Investigator’s Agreement 
I agree to: 
 Implement and conduct this clinical trial diligently and in strict compliance with the 
protocol, Good Clinical Practices and all applicable laws and regulations. 
 Accurately record all required data on each subject’s electronic Case Report Forms 
(eCRFs) in a timely manner on an ongoing basis. 
 Use the investigational product(s) for this clinical trial only. Maintain a complete and 
accurate inventory during and at the completion of the clinical trial. Maintain records of all 
investigational product units received, dispensed, returned by the subjects, and the number 
of product units returned to GALDERMA R&D. 
 Allow authorized representatives of GALDERMA R&D or regulatory authorities to conduct 
on-site visits to review, audit, and copy clinical trial documents. I will personally meet 
these representatives at mutually convenient times to answer any clinical trial-related 
questions. 
 Comply strictly with the agreement signed for the carrying out of my services within the 
scope of this protocol, especially with the provisions regarding confidentiality and 
intellectual property (results and publications). 
I have read this protocol in its entirety, including the above statement, and I agree to all aspects. 
 
SIGNATURE 
PRINCIPAL INVESTIGATOR 
 
PRINTED NAME: 
 
SIGNATURE DATE 
 
RETURN THE ORIGINAL SIGNED COPY TO GALDERMA R&D AND KEEP A COPY AT YOUR SITE 
 
SIGNATURE 
DATE 
GALDERMA R&D 
 
 
 
 
 
 
 
 
 
 
 
 


GALDERMA RESEARCH & DEVELOPMENT 
Protocol N° RD.03.SPR.110232 
Version 03 Final - dated on 23-MAR-2017 US  
Page 6 of 72 CONFIDENTIAL 
DISTRIBUTION 
Copy of the Protocol: 
All signatories and, 
 
, GALDERMA R&D 
 
 GALDERMA R&D 
 
, GALDERMA R&D 
 
 
, GALDERMA R&D 
 
, GALDERMA R&D 
 
, GALDERMA R&D, SNC 
 
 
, GALDERMA R&D 
 
, GALDERMA Fort Worth US 
 
, GALDERMA USA 
Ldta. 
 
 
 
 
 
 
 
, GALDERMA 
Singapore Private Ltd. 
 
 
 
 
 
 
 
, GALDERMA 
Mauritius 
 
, Medical Sciences Liaison 
GALDERMA Medical Affairs 
 
, GALDERMA International 
 
 
 GALDERMA International 
 
 
, GALDERMA Medical Affairs 
 
 
 
 
, 
GBU 
Prescription, 
GALDERMA International 
 
, GALDERMA R&D 
 
, Galderma Laboratories, L.P. USA 
 
, Regulatory Affairs, Galderma Laboratories, L.P. 
USA 


GALDERMA RESEARCH & DEVELOPMENT 
Protocol N° RD.03.SPR.110232 
Version 03 Final - dated on 23-MAR-2017 US  
Page 7 of 72 CONFIDENTIAL 
Copy of the Synopsis: 
 
 
, 
GALDERMA R&D 
 
 GALDERMA Marketing 
 
 
 
, GALDERMA International 
 
, GALDERMA R&D SNC 
Original Protocol: 
Archives (GALDERMA R&D Sophia Antipolis) 


GALDERMA RESEARCH & DEVELOPMENT 
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TABLE OF CONTENTS 
TITLE PAGE ............................................................................................................................................... 2 
CLINICAL TRIAL ADMINISTRATIVE STRUCTURE ........................................................................ 4 
SIGNATURE PAGE .................................................................................................................................... 5 
DISTRIBUTION .......................................................................................................................................... 6 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ......................................................... 12 
1. 
SYNOPSIS ........................................................................................................................................ 14 
2. 
BACKGROUND AND RATIONALE ........................................................................................... 17 
2.1. 
MEDICAL BACKGROUND AND SHORT RATIONALE FOR THE CLINICAL TRIAL ......................... 17 
2.2. 
INVESTIGATIONAL PRODUCT PROFILE ....................................................................................... 18 
2.3. 
RISK/BENEFIT ASSESSMENT ....................................................................................................... 18 
2.3.1. 
Risk-benefit statement related to the clinical trial products .............................................. 18 
2.3.2. 
Risk-benefit statement related to the clinical trial .............................................................. 19 
3. 
CLINICAL TRIAL OBJECTIVES AND CLINICAL HYPOTHESIS ...................................... 19 
3.1. 
CLINICAL TRIAL OBJECTIVES ..................................................................................................... 19 
3.2. 
CLINICAL HYPOTHESIS ............................................................................................................... 19 
4. 
SELECTION AND DISPOSITION OF CLINICAL TRIAL POPULATION ........................... 20 
4.1. 
NUMBER OF SUBJECTS ................................................................................................................. 20 
4.2. 
CLINICAL TRIAL POPULATION .................................................................................................... 20 
4.3. 
INCLUSION CRITERIA .................................................................................................................. 20 
4.4. 
EXCLUSION CRITERIA ................................................................................................................. 21 
4.5. 
PRIOR AND CONCOMITANT THERAPIES ..................................................................................... 23 
4.5.1. 
Definition ................................................................................................................................ 23 
4.5.2. 
Categories ............................................................................................................................... 23 
4.5.3. 
Recording ............................................................................................................................... 24 
4.5.4. 
Authorized therapies during the clinical trial ..................................................................... 24 
4.5.5. 
Prohibited therapies during the clinical trial ...................................................................... 25 
4.5.6. 
Procedures / reasons for discontinuation ............................................................................. 25 


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5. 
INVESTIGATIONAL PLAN.......................................................................................................... 26 
5.1. 
OVERALL CLINICAL TRIAL DESIGN ............................................................................................ 26 
5.2. 
DISCUSSION OF CLINICAL TRIAL DESIGN ................................................................................... 27 
5.3. 
CLINICAL TRIAL DURATION AND TERMINATION ....................................................................... 27 
5.4. 
CLINICAL TRIAL FLOW CHART ................................................................................................... 29 
5.5. 
CLINICAL TRIAL VISIT DESCRIPTION AND PROCEDURES .......................................................... 30 
5.5.1. 
Visit 1 – Baseline visit ............................................................................................................ 30 
5.5.2. 
Visit 2 (week 2) (±1 Day) ....................................................................................................... 31 
5.5.3. 
Visit 3 (week 8) (±3 Days) ...................................................................................................... 32 
5.5.4. 
Visit 4 (week 12) (±3 Days) .................................................................................................... 33 
5.5.5. 
Visit 5 (week 16) (±5 Days) .................................................................................................... 33 
5.5.6. 
Early termination visit .......................................................................................................... 34 
6. 
CLINICAL SUPPLIES ................................................................................................................... 34 
6.1. 
INVESTIGATIONAL PRODUCT IDENTIFICATION AND USE .......................................................... 34 
6.1.1. 
Product identity ..................................................................................................................... 34 
6.1.2. 
Method of treatment assignment .......................................................................................... 35 
6.1.3. 
IVR/IWR System ................................................................................................................... 36 
6.1.4. 
Subject Identification Number (SIN) ................................................................................... 36 
6.1.5. 
Instructions for use and administration .............................................................................. 36 
6.1.6. 
Non-investigational products ................................................................................................ 37 
6.2. 
INVESTIGATIONAL PRODUCT PACKAGING AND LABELLING ..................................................... 38 
6.3. 
INVESTIGATIONAL PRODUCT MANAGEMENT ............................................................................ 39 
6.3.1. 
Accountability ........................................................................................................................ 39 
6.3.2. 
Dispensing ............................................................................................................................... 39 
6.3.3. 
Investigational product compliance management and record ........................................... 39 
6.3.4. 
Storage of investigational product ....................................................................................... 40 
6.3.5. 
Return of investigational product ........................................................................................ 40 
6.3.6. 
Dose modification................................................................................................................... 41 


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6.4. 
BLINDING ..................................................................................................................................... 41 
6.4.1. 
Verification of blinding ......................................................................................................... 41 
6.4.2. 
Unblinding during the clinical trial ...................................................................................... 41 
7. 
SUBJECT REPORTED OUTCOME, EFFICACY AND SAFETY ASSESSMENT ................ 41 
7.1. 
SUBJECT REPORTED OUTCOMES ................................................................................................ 41 
7.1.1. 
Quality of Life Questionnaire ............................................................................................... 42 
7.1.2. 
Subject Satisfaction Questionnaire ...................................................................................... 42 
7.2. 
EFFICACY ASSESSMENTS ............................................................................................................. 42 
7.2.1. 
Investigator’s global assessment of acne severity (IGA) .................................................... 42 
7.2.2. 
Global Assessment of Improvement (GAI) ......................................................................... 43 
7.3. 
SAFETY ASSESSMENTS ................................................................................................................. 43 
7.3.1. 
Post inflammatory hyperpigmentation (PIH) ..................................................................... 43 
7.3.2. 
Local tolerance assessment ................................................................................................... 44 
7.3.3. 
Adverse Events ....................................................................................................................... 45 
7.4. 
OTHERS ........................................................................................................................................ 46 
7.4.1. 
Cosmetic acceptability Questionnaire .................................................................................. 46 
7.4.2. 
Photographs ........................................................................................................................... 46 
7.5. 
APPROPRIATENESS OF MEASUREMENTS .................................................................................... 46 
8. 
ADVERSE EVENT .......................................................................................................................... 47 
8.1. 
DEFINITIONS ................................................................................................................................ 47 
8.1.1. 
Adverse Events (AE).............................................................................................................. 47 
8.1.2. 
Serious Adverse Events (SAE) .............................................................................................. 48 
8.1.3. 
Unexpected adverse drug reaction ....................................................................................... 48 
8.1.4. 
Adverse event reporting period ............................................................................................ 49 
8.1.5. 
Severity ................................................................................................................................... 49 
8.1.6. 
Relationship to the trial product(s) and/or clinical trial procedure .................................. 49 
8.2. 
REPORTING PROCEDURES ........................................................................................................... 50 
8.2.1. 
Procedures for reporting adverse events ............................................................................. 50 


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8.2.2. 
Procedure for reporting a Serious Adverse Event .............................................................. 51 
8.2.3. 
Procedure for suspected allergic contact reaction .............................................................. 52 
9.1. 
STATISTICAL AND ANALYTICAL PLANS ...................................................................................... 56 
9.1.1. 
Variables to be statistically analyzed ................................................................................... 56 
9.1.2. 
Populations analysed, evaluability and limitations / evaluation of Bias ........................... 57 
9.1.3. 
Data presentation and graphics ............................................................................................ 57 
9.1.4. 
Statistical analyses ................................................................................................................. 58 
9.2. 
SAMPLE SIZE DETERMINATION ................................................................................................... 58 
10. 
TRAINING / MONITORING / DATA MANAGEMENT / QUALITY ASSURANCE ............ 58 
10.1. 
PERSONNEL TRAINING ................................................................................................................ 58 
10.2. 
CLINICAL MONITORING .............................................................................................................. 59 
10.3. 
DATA MANAGEMENT ................................................................................................................... 59 
10.4. 
QUALITY ASSURANCE / AUDIT / INSPECTION ............................................................................. 59 
11. 
ETHICS AND GENERAL CLINICAL TRIAL CONDUCT CONSIDERATIONS ................. 60 
11.1. 
INSTITUTIONAL REVIEW BOARD (IRB) OR ETHICS COMMITTEE (EC) .................................... 60 
11.2. 
ETHICAL CONDUCT OF THE CLINICAL TRIAL ............................................................................ 60 
11.3. 
SUBJECT INFORMATION SHEET / INFORMED CONSENT ............................................................. 60 
11.4. 
CONTRACTUAL REQUIREMENTS ................................................................................................. 61 
11.5. 
DATA COLLECTION AND ARCHIVING ......................................................................................... 61 
11.5.1. 
Data Collection ....................................................................................................................... 61 
11.5.2. 
Source documentation ........................................................................................................... 61 
11.5.3. 
Archives .................................................................................................................................. 62 
11.6. 
INSURANCE ................................................................................................................................... 62 
12. 
REFERENCE LIST ......................................................................................................................... 63 
13. 
ATTACHMENTS ............................................................................................................................ 65 
13.1. 
ATTACHMENT 1: QUALITY OF LIFE QUESTIONNAIRES ............................................................. 65 
13.2. 
ATTACHMENT 2: SUBJECT’S SATISFACTION QUESTIONNAIRE ................................................. 69 
13.3. 
ATTACHMENT 3: COSMETIC ACCEPTABILITY QUESTIONNAIRE ............................................. 71 


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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation 
Term 
AE 
Adverse Event 
APT 
All Subjects Treated (Safety Population) 
BPO 
Benzoyl peroxide 
CDMS 
Clinical Data Management System 
CPM 
Clinical Project Manager 
CRA 
Clinical Research Associate 
CRO 
Contract Research Organization 
CTD 
Clinical Trial Dossier 
DLQI 
Dermatology Life Quality Index questionnaire 
cDLQI 
Children’s Dermatology Life Quality Index questionnaire 
DMP 
Data Management Plan 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EU 
European Union 
FSI 
First Subject In (first subject who signs the Informed Consent Form) 
GAI 
Global Assessment of Improvement 
GBU 
Global Business Unit 
GCP 
Good Clinical Practice 
GMP 
Good Manufacturing Practice 
hCG 
Human chorionic gonadotropin 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
ICDRG 
International Contact Dermatitis Research Group 
i.e. 
That is (Latin: id est) 
IEC 
Independent Ethic Committee 


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Abbreviation 
Term 
IGA 
Investigator’s Global Assessment 
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
ISF 
Investigator Site File 
IUD 
Intra Uterine Device 
IU/L 
International Unit/Liter 
ITT 
Intent-To-Treat 
IVRS 
Interactive Voice Response System 
IWRS 
Interactive Web-based Response System 
LOCF 
Last Observation Carried Forward 
LSI 
Last Subject In (Last subject randomized/assigned to treatment) 
LSO 
Last Subject Out ( Last subject who completed its last clinical trial visit) 
MedDRA 
Medical Dictionary for Regulatory Activities 
N/A 
Not Applicable 
OTC 
Over-The-Counter 
PIH 
Post-Inflammatory Hyperpigmentation 
PRO 
Patient Reported Outcome 
R&D 
Research & Development 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SAS 
Statistical Analysis  System (SAS Institute Inc., Cary, NC) 
SIN 
Subject Identification Number 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
SPF 
Sun Protection Factor 
UPT 
Urine Pregnancy Test 
USA 
United State of America 
UV 
Ultraviolet 
W 
Week 


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1. SYNOPSIS 
Clinical trial title: 
Subject Reported Outcome with use of Adapalene 0.3% - benzoyl peroxide 2.5% in moderate to severe acne 
in Dark Skin Phototype subjects 
Short title (± acronym): 
Subject Reported Outcome in Dark Skin Phototype subjects with acne 
Project number: 
Clinical trial phase: 
Clinical trial period 
816 
IV 
Q1 2017 – Q4 2017 
Objective(s): 
The main objective of this trial is to evaluate subject reported outcomes 
with a fixed combination treatment containing Adapalene 0.3% - Benzoyl 
Peroxide (BPO) 2.5%, in the treatment of moderate to severe acne vulgaris 
in dark skin phototypes (IV to VI). 
The safety of the treatment will also be evaluated. 
Methodology: 
This is a multicenter open-label, prospective trial in subjects with dark skin 
from one of the 3 ethnic/race backgrounds: Asian, Latin American and 
Black/African-American and with moderate to severe acne vulgaris on the 
face. 
All eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo® 
Forte/TactuPumpForte) once daily on whole face. 
 
One third of subjects should have dark skin with Asian ethnic/race 
background. 
One third of subjects should have dark skin with Latin American 
ethnic/race background. 
One third of subjects should have dark skin with Black/African-American 
ethnic/race background 
 
In each ethnic/race backgrounds at least one third of subjects should have 
“Severe acne” severity (IGA 4) and two third “Moderate acne” severity 
(IGA 3). 
 
Total number of planned subjects:  
Approximately 60 subjects will be enrolled 
Total number of planned sites: 
4 sites  
Approximate number of 
subjects/site: 
Approximately 10 to 20 subjects per site 
Country(ies) involved: 
Mauritius, Singapore and USA 
Population and main inclusion 
criteria: 
Male or female subjects with moderate to severe acne vulgaris, aged at 
least 12 years old inclusive with dark skin phototypes IV to VI meeting 
specific inclusion/ exclusion criteria. 
Clinical trial duration per subject  
16 weeks, with 5 trial visits 
Number of visits: 
Baseline, W2, W8, W12 and W16 
Investigational product: 
 
Name: 
Epiduo® Forte / TactuPump Forte (CD0271 0.3% / CD1579 2.5%) 
Pharmaceutical form: 
Gel 
Dose/concentration: 
Adapalene 0.3% - BPO 2.5% 
Total daily dose: 
4 pea-sized amounts (to cover whole face, e.g. one on the forehead, one 
on the chin and one on each cheek), 
Mode and frequency of administration: 
Topical, once daily in the evening after washing 
Location of treated area: 
Whole face 
Duration of treatment: 
16 weeks 


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Clinical trial title: 
Subject Reported Outcome with use of Adapalene 0.3% - benzoyl peroxide 2.5% in moderate to severe acne 
in Dark Skin Phototype subjects 
Short title (± acronym): 
Subject Reported Outcome in Dark Skin Phototype subjects with acne 
Project number: 
Clinical trial phase: 
Clinical trial period 
816 
IV 
Q1 2017 – Q4 2017 
Non-investigational product to be 
provided for the clinical trial: 
Cetaphil® DermaControl Oil control Foam Wash twice daily in the 
morning and in the evening) 
 
Cetaphil® DermaControl Oil control Moisturizer SPF 30 once daily in the 
morning after washing (using Cetaphil® DermaControl Oil control Foam 
Wash) and to re-apply if sun exposure during the day. 
 
Both products are topical and will be used on the whole face for 16 weeks 
 
Measurement criteria 
Subject-reported outcomes 
 
Dermatology Life Quality Index questionnaire (DLQI) or Children’s 
Dermatology Life Quality Index (cDLQI) questionnaires at 
Baseline, Week 12 and at Week 16/Early termination 
 
Subject satisfaction questionnaire at Week 12 and Week 16/Early 
termination 
 
Efficacy  
 
Investigator’s Global Assessment (IGA): acne severity of the face 
on a scale from 0 (Clear) to 4 (Severe) at each visit 
 
Investigator’s Global Assessment of Improvement from baseline 
(GAI): improvement compared with baseline on a scale from 0 
(Excellent improvement) to 5 (Worse) at Week 12 and Week 
16/Early termination 
 
Safety 
 
Post-inflammatory hyper-pigmentation (PIH) severity at each visit 
(if present at Baseline) 
 
Local tolerance (erythema, scaling, dryness, stinging/ burning): 
severity score on a scale from 0 (None) to 3 (Severe) at each trial 
visit 
 
Adverse Events throughout the trial 
 
Other 
 
Photographs (visible light photos) at each visit 
 
Cosmetic acceptability questionnaire regarding the non-
investigational products, at Week 16/Early termination 


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Clinical trial title: 
Subject Reported Outcome with use of Adapalene 0.3% - benzoyl peroxide 2.5% in moderate to severe acne 
in Dark Skin Phototype subjects 
Short title (± acronym): 
Subject Reported Outcome in Dark Skin Phototype subjects with acne 
Project number: 
Clinical trial phase: 
Clinical trial period 
816 
IV 
Q1 2017 – Q4 2017 
Analysed variables 
Subject-reported outcomes  
 
DLQI/cDLQI at Baseline and at each evaluation time 
 
Subject satisfaction questionnaire at each evaluation time 
 
Efficacy variable 
 
IGA score: % of subjects across scores at each visit 
 
GAI score: % of subjects across scores at Week 12 and last visit 
 
Safety variables  
 
PIH severity: Raw value at each visit and % change from baseline 
at each post-baseline visit 
 
Local tolerance: Raw value at each visit and worst-score across 
visit, % of Subjects across scores at each post-baseline visit 
 
Incidence of adverse events 
 
Other 
 
Cosmetic acceptability questionnaire at Week 16/Early termination 
 
Principal statistical methods and 
sample size calculation: 
The Intent-to-Treat (ITT) population consists of all enrolled subjects. The 
safety population (APT) consists of the ITT population, after exclusion of 
subjects who never took the treatment. Population definitions will be 
decided before the database lock. 
 
The objective of this trial is to evaluate the subject reported outcome with 
Adapalene 0.3% - BPO 2.5% gel during 16 weeks of treatment.  
 
No inferential statistics will be performed. All variables will be descriptively 
summarized on ITT population and on APT population for the safety 
variables. The last observation carried forward (LOCF) method will be used 
to impute missing efficacy values. 
 
As no inferential statistics will be performed, no statistical rationale of 
sample size can be used. However, the subject reported outcomes (quality 
of life and satisfaction survey), can be evaluated with a total of 60 subjects. 
 


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2. BACKGROUND AND RATIONALE 
2.1. 
MEDICAL BACKGROUND AND SHORT RATIONALE FOR THE CLINICAL TRIAL 
Acne vulgaris is a chronic, inflammatory skin disease of the pilosebaceous unit, affecting 
approximately 80% of young adults and adolescents (Usatine R.P., 1998) (Leyden J J., 1995). 
Skin of color patients (typically Fitzpatrick skin types IV–VI) are no exception as shown in an 
epidemiological trial (Alexis A.F., 2007) that the diagnosis of visits from patients of different 
racial/ethnic backgrounds seen at a hospital-based dermatology practice in New York City were 
compared and acne was the most common reason for visits for both African American (28.4%) 
and Caucasian (21%) patients. It is the sequelae of the disease that are the distinguishing 
characteristics of acne in skin of color, namely Post Inflammatory Hyperpigmentation (PIH) or 
hypertrophic scarring. 
 
Currently, it is believed that acne in skin of color develops largely by the same pathogenesis that 
occurs in Caucasian patients. However, there is controversy over whether differences exist in 
certain biological characteristics of skin (such as sebum production and bacterial colonization) 
among various racial/ethnic groups. Several studies have been published evaluating racial/ethnic 
differences in sebaceous gland size and activity compared to Caucasians. (Kligman A.M., Shelley 
W.B. 1958) (Pochi P.E., Strauss JS. 1988). However, results have been contradictory. The trial 
evaluated 18 African-American and 19 Caucasian patients for differences in certain skin surface 
properties, such as sebum level, pH, moisture content, and barrier function and found no 
significant differences in sebum production between African-American and Caucasian patients. 
Another trial (Warrier A.G., 1996) examined facial skin microflora in 30 African-American and 
30 Caucasian women. The authors found a higher density of P. acnes in African-American 
patients compared to Caucasian patients; however, the results were not statistically significant. As 
acne is a chronic and relapsing disease normalizing follicular desquamation is then the key to 
achieve and maintain control of acne. Today it is established that retinoids such as Adapalene aid 
the differentiation and reduction of keratinocytes. 
 
Adapalene with Benzoyl Peroxide (BPO) is a unique antibiotic-free combination of Adapalene, a 
well-tolerated and efficacious topical retinoid, and BPO, a well-established antimicrobial agent. 
The complementary modes of action, efficacy and safety profiles of these two agents make 
Adapalene-BPO the most logical choice for once-daily treatment for all types of acne but the 
most severe. Adapalene possesses anti-comedogenic, comedolytic, and anti-inflammatory 
properties, whereas BPO, the most potent bactericidal agent, is more effective than topical 
antibiotics against P. acnes. (Brown J.M., Poston S.M. 1983) (Eady E.A., Cove J.H., Holland 
K.T., Cunliffe W.J. 1989) (Leyden J.J., 1983) (Lucky, A. W., 1987). 
 


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Adapalene 0.3% - BPO 2.5% gel is efficacious to treat moderate to severe acne with a trend of 
superiority compared to other topical preparations in subjects with severe acne (Stein Gold L., 
2010). This suggests that the combination Adapalene - BPO both prevents the formation of new 
acne by reducing the number of primary and secondary lesions. However, it is also important to 
assess the local tolerability in terms of skin irritation and other skin barrier impairments in dark 
skin phototypes that might be caused by the treatment or by acne it-self. 
Maintaining skin hydration and avoiding sun exposure is recommended as part of the skin care 
regimen in acne patients. Minimizing skin irritation and photo-protection can be achieved by the 
use of non-comedogenic moisturizers with appropriate SPF that hydrate and protect the skin from 
UV irradiation (Schorr E.S., 2012) (Whitney P., Bowe M.Da. 2014) (Del Rosso, J. Q., 2013) 
(Zeichner, J., 2011). Using an appropriate cleanser will reduce oil on the face and will not affect 
skin hydration or the skin barrier function. 
Acne can persist for years and may affect seriously the psychosocial development, resulting in 
emotional problems, withdrawal from society, and depression (Koo , J Y et Smith, L L. 1991).If 
not treated, acne may cause serious physical and emotional scarring and can significantly impact 
the quality of life of those affected by the disease (Brown J.M., Poston S.M. 1983) (Usatine, R.P., 
1998) Therefore this trial aims to evaluate acne medication for assessment of subject satisfaction 
and quality of life in the dark skin subjects known to be sensitive with topical retinoids. The local 
tolerance of the treatment regimen in terms of erythema, scaling, dryness, stinging/burning will 
also be evaluated. 
 
This clinical trial is designed to evaluate the patient reported outcome with use of Adapalene 
0.3% - BPO 2.5% gel (Epiduo® Forte/TactuPump Forte) in subjects with dark phototype with 
moderate to severe acne vulgaris and also to assess this sub-population which was not specifically 
evaluated during the clinical development of Adapalene 0.3% - BPO 2.5% gel. 
2.2. 
INVESTIGATIONAL PRODUCT PROFILE 
The product used in this clinical trial (Adapalene 0.3% - BPO 2.5% gel) is marketed under the 
name Epiduo® Forte in USA and TactuPump Forte in Canada. TactuPump Forte is used for 
for sites in Mauritius and Singapore. Adapalene 0.3% - BPO 2.5% gel is well tolerated in subjects 
with acne vulgaris. See product monograph for detailed safety information. 
2.3. 
RISK/BENEFIT ASSESSMENT 
2.3.1. Risk-benefit statement related to the clinical trial products 
Adapalene 0.3% - BPO 2.5% gel (marketed under the name Epiduo® Forte / TactuPump Forte) 
is a commercial product that will be used according to the approved indications and usage. 
Warnings and precautions with Adapalene 0.3% - BPO 2.5% gel are well known and documented 
in the product monograph. For more details regarding the clinical adverse reactions and/or the 
post-marketing experience, please refer to the product monograph. 


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2.3.2.  Risk-benefit statement related to the clinical trial 
Adapalene 0.3% - BPO 2.5% gel is an established and widely used marketed product and 
considered standard of care by many physicians and expert bodies for the treatment of acne 
vulgaris. It is therefore considered that exposure to the treatment over 4 months is covered by 
long-term safety data for the products Adapalene 0.3% and the combination of Adapalene 0.1% - 
BPO 2.5% which have shown that the safety profile remains stable with a long-term use. 
 
Treatment-related adverse reactions typically associated with use of Epiduo® Forte / 
TactuPump Forte gel include mild to moderate application site reactions, such as skin irritation 
characterized by scaling, dryness, erythema, atopic dermatitis, eczema, and burning/stinging. 
These reactions usually occur early in the treatment, and tend to gradually lessen over time. 
 
Any subject is free to discontinue his/her participation in this clinical trial at any time and for 
whatever reason, specified or unspecified, and without any prejudice.  No constraints are to be 
imposed on the subject, and when appropriate, a subject may be treated with other conventional 
therapy when clinically indicated. 
 
No invasive method will be conducted during this trial. 
 
Subjects will be followed (especially for Adverse events) regularly during all the trial, 
approximately once a month for 4 months. 
 
Consequently, based on available safety data and the proposed trial design, no safety issues other 
than those reported by the labelling are expected following topical administration of Adapalene 
0.3% - BPO 2.5% gel. 
3. 
CLINICAL TRIAL OBJECTIVES AND CLINICAL HYPOTHESIS 
3.1. 
CLINICAL TRIAL OBJECTIVES 
The purpose of this trial is to evaluate subject reported outcomes with the combination of 
Adapalene 0.3% - BPO 2.5%, Epiduo® Forte / TactuPump Forte gel, after 16 weeks of 
treatment of moderate to severe acne in dark skin phototypes (IV to VI). 
3.2. 
CLINICAL HYPOTHESIS 
The trial hypothesis is that daily acne treatment with Epiduo® Forte / TactuPump Forte is well 
tolerated as a treatment in moderate to severe acne in dark phototypes and improves subject’s 
quality of life. 
This trial has been designed to provide evidence in support of this hypothesis. 


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4. 
SELECTION AND DISPOSITION OF CLINICAL TRIAL POPULATION 
4.1. 
NUMBER OF SUBJECTS 
Approximately 60 subjects presenting moderate to severe acne vulgaris with dark skin phototype 
will be enrolled at 1 site located in Mauritius, 2 sites in USA and 1 site in Singapore. 
 
One third of subjects should have dark skin with Asian ethnic/race background. 
One third of subjects should have dark skin with Latin American ethnic/race background. 
One third of subjects should have dark skin with Black/African-American ethnic/race 
background. 
In each ethnic/race backgrounds (Asian, Latin American and Black/African-American) 
approximately one third of subjects at least should have “Severe acne” and two third “Moderate 
acne”.  
4.2. 
CLINICAL TRIAL POPULATION 
Male or female subjects with a dark skin phototype of any ethnic background (Asian, Latin 
American and/or Black /African) with a diagnosis of moderate to severe acne vulgaris on the face 
and meeting the following specific eligibility criteria. 
4.3. 
INCLUSION CRITERIA 
1. Male or female subject of one of the 3 ethnic background (see Inclusion criterion # 4) of at 
least 12 years old inclusive, 
2. Subject with clinical diagnosis of moderate to severe facial acne vulgaris, defined by: 
a) Investigator’s Global Assessment (IGA) score of 3 (Moderate) OR 4 (Severe ); and 
b) A minimum of 25-100 inflammatory lesions (papules and pustules); and 
c) A minimum of 30-150 non-inflammatory lesions (open and closed comedones) in total 
(excluding the nose); and 
d) No more than two acne nodules (≥ 1 cm), 
3. Subject with skin phototype IV to VI (according to T.B. Fitzpatrick skin phototype [i.e IV- 
burns minimally; always tans well (moderate brown); V – rarely burns; tans profusely (dark 
brown; VI – never burns; deeply pigmented (black) tans profusely)]), 
4. Subjects from one of the 3 ethnic/race backgrounds: Asian, Latin American and 
Black/African-American, 


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5. Female subjects of childbearing potential must have a negative urine pregnancy test (UPT) at 
Baseline visit (Visit 1), 
6. Female subjects of childbearing potential must practice an effective method of contraception 
during the clinical trial and at least 1 month after the last clinical trial treatment application: 
medical contraception [combined oral contraceptives (estrogens and progesterone) or 
implanted or injectable contraceptives] with stable dose for 1 month prior to clinical trial 
entry, bilateral tubal ligation, hormonal Intra-Uterine Device (IUD) inserted at least 1 month 
prior to clinical trial entry, strict abstinence (1 month prior to trial entry and agrees to 
continue for the duration of the trial), condom with spermicide, vasectomized partner (for at 
least 3 months prior to clinical trial entry), 
7. Females of non-childbearing potential, e.g. Premenses, Post-menopausal (absence of 
menstrual bleeding for 1 year without any other medical reason), hysterectomy, or bilateral 
oophorectomy, 
8. Subject having read, understood and signed the approved Informed Consent Form (ICF) 
prior to any participation in the clinical trial. Subject under the age of 18 having signed an 
Assent Form to participate in the clinical trial and their parent(s) or legal representative 
having read and signed the informed consent form prior to any clinical trial related 
procedure, 
9. Subject willing and able to comply with the requirements of the trial protocol, in particular, 
subject must adhere to the visit schedule, concomitant therapy prohibitions, and must be 
compliant to the treatment, 
10. Subject must be willing to be photographed. Subject (and parents/guardian if subject is under 
18 years of age) must be willing to sign a Photography Release Consent Form, 
4.4. 
EXCLUSION CRITERIA 
Any subject who meets at least one of the following criteria will not be eligible for the trial. 
1. Subject with severe acne (IGA > 3) with more than 2 nodules, cysts, or extra-facial lesions, 
2. Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced 
acne, etc.), nodulo cystic acne, acne requiring systemic treatment, 
3. Subject with history of lupus, atopic dermatitis, perioral dermatitis, dermatomyositis, rosacea 
on the face 
4. Prior failure to treatment with Epiduo® Forte/TactuPump Forte gel (Adapalene 0.3% - 
BPO 2.5%), 


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5. Subject with damaged facial skin (e.g. tattoo, cuts, skin abrasion , eczema or sunburned 
skin), 
6. Subjects with skin phototype < IV, 
7. Female subject who is pregnant, lactating or planning a pregnancy during the trial, 
8. Female Taking Diane-35 or who is planning to change her contraceptive method or 
hormone replacement therapy during the trial, 
9. Subject with known impaired hepatic or renal functions, 
10. Subject with a wash-out period for topical treatment  or procedures on the face less than: 
Topical treatments: Corticosteroids, antibiotics, benzoyl peroxide, azelaic 
acid, dapsone, hydroxyacids, Zinc containing treatments, , antiseptics, other 
anti-inflammatory products or other acne treatments (for example salicylic 
acid treatments/ transdermal contraceptives are forbidden if used to treat 
acne) 
2 weeks 
Retinoids 
4 weeks 
Cosmetic/aesthetic procedures on the face (e.g., comedone extraction, 
desquamating, or abrasive agents, adhesive cleansing strips) 
1 week 
Wax epilation 
2 weeks 
Photodynamic therapy 
6 weeks 
Laser therapy, microdermabrasion, deep chemical peel, plastic surgery for 
acne 
3 months 
11. Subject with a wash-out period for systemic treatment less than: 
 Corticosteroids, (except locally acting corticosteroids such as inhaled or 
intrathecal or dermal application at distance from the face), tetracyclines, 
other antibiotics (except penicillin)  
1 month 
 Oral retinoids/isotretinoin/ anti-androgens / Cyproterone acetate / 
Chlormadinone acetate 
6 months 
 Spironolactone/ Drospirenone (except if at a stable dose for at least 3 
months for drospirenone) 
3 months 
 Immunomodulators 
3 months 
 Oral contraceptives/ oral dapsone for acne 
1 month 
12. Subjects with severe PIH (Score > 3 on PIH scale), 
13. Subject with active or chronic skin allergies, 


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14. Subject with known or suspected allergy to the investigational product (See Product 
Monograph for Epiduo® Forte / TactuPump Forte gel), 
15. Subject who has used tanning booths or lamps or had excessive ultraviolet (UV) radiation 
exposure within 1 month prior to clinical trial entry or foresees intensive UV exposure 
during the trial (mountain sports, sailing, sunbathing, etc.), 
16. Subject who is at risk in terms of precautions, warnings, and contraindications (see Product 
Monograph for Epiduo® Forte/TactuPump Forte gel), 
17. Subject with a beard or other facial hair that might interfere with trial assessments, 
18. Subject with an acute / chronic disease, uncontrolled systemic disease or a history of major 
medical or psychiatric condition or surgical interventions that, in the opinion of the 
investigator, might put the subject at risk, 
19. Subject under guardianship, hospitalized subject in a public or private institution for a 
reason other than the research, and subject deprived of his/her freedom, 
20. Subject who has participated in another investigational product or device research trial 
within 30 days prior to enrolment OR is in an exclusion period from a previous clinical trial, 
21. Subject who is unable to communicate or cooperate with the investigator due to language 
problems, poor mental development, or impaired cerebral function. 
4.5. 
PRIOR AND CONCOMITANT THERAPIES 
4.5.1. Definition 
Previous therapies (products and/or procedures) are defined as therapies that have been stopped 
within 6 months preceding baseline visit and prior to the first investigational product application 
that may have an impact on inclusion/exclusion criteria should be recorded in the eCRF.  
Concomitant therapies are defined as follows: 
 any existing therapies ongoing at the time of the baseline visit (ongoing at the time of the 
first investigational product application), or 
 any changes to existing therapies (such as changes in dose or formulation) during the 
course of the clinical trial, or 
any new therapies received by the subject since the baseline visit (first investigational 
product application). 
4.5.2. Categories 


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The following two categories will be considered for previous and concomitant therapies:  
 Products/therapies including, but not limited to, prescription, over-the-counter (OTC), birth 
control pills/patches/hormonal devices, vitamins, moisturizers, sunscreens, herbal 
medicines/supplements, and homeopathic preparations. 
 Medical and surgical procedures including, but not limited to, laser/radiation procedures, 
dermal fillers, X-rays, etc. 
4.5.3. Recording 
Previous and concomitant therapies will be recorded on the Drugs/Therapies Form (for 
drugs/therapies) and/or on the Medical and Surgical Procedures form (for medical/surgical 
procedures) in the electronic case report form (eCRF). 
Concomitant therapies will be recorded, reviewed, and updated at each trial visit. 
Any new concomitant therapy or modification of an existing therapy may be linked to an adverse 
event (AE). A corresponding Adverse Event Form must be completed to account for the change 
in therapy, except in some cases such as therapy used for prophylaxis, dose modification for a 
chronic condition, etc. 
4.5.4. Authorized therapies during the clinical trial 
Unless listed under the Exclusion Criteria above (see section 4.4, criteria 10 and 11) or in 
Prohibited Therapies (see section below 4.5.5), all therapies are authorized. 
 
Subject must use the provided moisturizer and cleanser as required for the symptomatic relief 
of skin dryness or irritation (use of moisturizer with sunscreen and cleanser other than the 
provided ones must be recorded in the eCRF as concomitant therapy). 
Oral vitamin A supplement (up to the recommended daily allowance) and plain penicillin are 
acceptable. 
Systemic anti-inflammatory medication up to 21 days of treatment in total is also acceptable; 
however, it should be avoided for 1 week prior to the final trial assessments. 
 
Also subjects should be instructed to avoid excessive sun-exposure wind and cold. Cosmetics are 
to be used minimally and not at all during evaluation visit or photography of the skin.


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4.5.5. Prohibited therapies during the clinical trial  
The following drugs/procedures are prohibited because they may interfere with the 
efficacy/safety assessment of the investigational product, or because they may interact with the 
metabolism of the investigational product: 
 
 All topical or systemic drugs/procedures listed in exclusion criteria (section 4.4, criteria 10 and 
11), 
 Any irritating topical products (medicated or abrasive soaps and cleansers, soaps and 
cosmetics that have strong skin-drying effect and products with high concentrations of 
alcohol, astringents, spices, or limes), 
 Any other drugs/procedures which at the investigator’s judgement are liable to interfere or 
interact with the efficacy and the safety of Epiduo® Forte / TactuPump Forte® gel. 
If prohibited therapies become a necessary treatment for the safety or best interest of the subject, 
GALDERMA R&D should be notified to discuss possible alternatives prior to administration of a 
prohibited therapy and to discuss the pertinence and the modalities for the subject to continue in 
the clinical trial. 
4.5.6. Procedures / reasons for discontinuation 
An Investigator may decide to discontinue a subject from the clinical trial for safety reasons. 
Although the importance of completing the entire clinical trial should be explained to the subject 
by the clinical trial personnel, any subject is free to discontinue his/her participation in this 
clinical trial at any time and for whatever reason, specified or unspecified, and without prejudice.  
Subjects who discontinue the clinical trial prematurely should be fully evaluated, whenever 
possible. The procedures corresponding to the next theoretical visit should be performed (e.g. if a 
subject discontinues after week 2, complete the week 8 visit procedures). Additional final 
procedures will be conducted for all premature discontinuation as indicated in the trial flow chart 
section 5.4. The appropriate eCRF pages should be completed. 
For all subjects who prematurely discontinue the clinical trial, the reason must be carefully 
documented by the investigator on the Exit Form, and, if applicable, on the Adverse Event Form 
for discontinuation due to an AE.  
A subject who has been enrolled and assigned a kit number cannot be replaced by another subject 
if he/she discontinues the clinical trial for any reason. 
In the case of early termination, the investigator should ensure that the subject receives 
appropriate therapy for his/her condition. 


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The sponsor may also decide to prematurely terminate or suspend the clinical trial or the 
participation of a subject in the clinical trial. 
All data gathered on the subject prior to termination will be made available to the sponsor. 
Reasons for clinical trial completion/discontinuation, as listed on the Exit Form of the eCRF are 
described below: 
Normal trial Completion 
Subject completes the clinical trial as planned in the protocol 
Pregnancy 
Withdraw the subject from the clinical trial following the procedure described in the 
protocol section 8.2.3.1 
Lack of efficacy 
Investigator judgment only: based on therapeutic/disease-state expectations. If subject 
opinion only, mark “withdrawal by subject” and document it in the comment section of 
the eCRF Exit Form 
Adverse Event 
Complete eCRF Adverse Event Form 
Withdrawal by subject 
Includes consent withdrawal, subject relocation, schedule conflicts, etc… Does not 
include AE. . Explain the reason for withdrawal in the comments section of the eCRF 
Exit Form. 
Protocol Violation 
Explain the violation in the comments section of the eCRF Exit Form 
Lost to Follow-up 
Confirm with 2 documented phone calls and a certified letter (delivery receipt 
requested) without response. Explain in the comments section of the eCRF Exit Form. 
Other 
This category is to be used for a subject who discontinues for a reason other than 
those specified in the predefined categories above. Explain the reason for 
discontinuation in the comments section of eCRF Exit Form. 
If reason for discontinuation is “withdrawal by subject” or “other”, the subject must be 
questioned to rule out the possibility of an AE; this should be documented in the eCRF. 
5. 
INVESTIGATIONAL PLAN 
5.1. 
OVERALL CLINICAL TRIAL DESIGN 
This clinical trial will be conducted as a multi-centre, open-label prospective trial involving 
subjects aged at least 12 years old inclusive with dark skin type phototype IV to VI from one of 
the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American with 
moderate to severe acne vulgaris on the face and meeting other specific eligibility criteria. 
 
Approximately 60 subjects will be enrolled in 4 sites located in Mauritius, USA and Singapore. 
20 subjects are planned from each site. 
 
One third of subjects should have dark skin with Asian ethnic/race background: 
One third of subjects should have dark skin with Latin American ethnic/race background: 
One third of subjects should have dark skin with Black/African-American ethnic/race 
background: 


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In each ethnic/race backgrounds (Asian, Latin American and Black/African-American) 
approximately one third of subjects should have “Severe acne” (IGA 4) and two third 
“Moderate acne” severity (IGA 3). 
 
All eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo® Forte / TactuPump 
Forte gel) once daily on the whole face. 
There will be 5 trial visits: at baseline, week 2 (± 1 day), week 8 (± 3 days), week 12 (± 3 days), 
and week 16 (±5 days).  
5.2. 
DISCUSSION OF CLINICAL TRIAL DESIGN 
This clinical trial will assess subject reported outcomes with a product marketed in USA under 
the name Epiduo® Forte gel and TactuPump Forte gel in Canada, used according to its labeling 
information (indication, selected population, dose regimen). Therefore, this trial will be classified 
as Phase IV study in USA. Meanwhile, as this product is not marketed in Mauritius and 
Singapore (CTD recently submitted) therefore this trial is classified as a Phase IIIb trial for 
Mauritius and Singapore. 
According to clinical studies performed with Epiduo® in acne, 3 months treatment is sufficient to 
treat acne. As this trial aims to treat moderate to severe acne consequently, treatment period is 
fixed to 4 months as a maximum in order to have a complete cure of acne. 
Since acne is a chronic and long-lasting skin condition which could affect seriously the 
psychosocial development resulting in emotional problems it is deemed important to evaluate 
subjects’ quality of life before and after treatment.  
For this subjects will complete DLQI or cDLQI for children, at baseline, Week 12 and at last trial 
visit. 
A satisfaction questionnaire on use of the investigational product will be completed by subjects at 
Week 12 and at end of the trial. 
An acceptability questionnaire on use of the non –investigational products will also be completed 
by subjects at end of the trial. 
This clinical trial should allow evaluation of subjects’ reported outcome after use of the 
investigational product Adapalene 0.3% - BPO 2.5%.  
5.3. 
CLINICAL TRIAL DURATION AND TERMINATION 
The average planned period for the clinical trial from First Subject In (FSI) to Last Subject Out 
(LSO)] is 11 months. The end date of the clinical trial will be the date of the last visit of the last 
subject who participates in the clinical trial. 


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The planned duration of recruitment (i.e. From FSI to Last Subject In (LSI)) is approximately 7 
months. 
The clinical trial may be terminated by the investigator at his/her clinical trial site at any time 
with appropriate notification to GALDERMA R&D. Likewise, GALDERMA R&D may terminate 
the clinical trial and/or the participation of the clinical trial site(s) with appropriate notification. 
The expected duration of subject participation is 16 weeks.


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5.4. 
CLINICAL TRIAL FLOW CHART 
PROCEDURES 
CLINICAL TRIAL VISITS 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Baseline 
Week 2 
(±1 d) 
Week 8 
(±3 d) 
Week 12 
(±3 d) 
Week 16 
(±5 d) 
Informed consent/Photography Consentb 
X 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
Demographics/ Relevant medical history/ 
Prior therapiesc 
X 
 
 
 
 
Urine Pregnancy test (UPT)d 
X 
 
X 
X 
X 
Investigator’s Global Assessment (IGA) 
X 
X 
X 
X 
X 
Global Assessment of Improvement 
 
 
 
X 
Xa 
PIH evaluatione 
X 
X 
X 
X 
X 
Local tolerance assessment 
X 
X 
X 
X 
X 
Photographsb 
Xh 
X 
X 
X 
X 
Concomitant therapies 
X 
X 
X 
X 
X 
Adverse eventsf 
X 
X 
X 
X 
X 
Dispensation of investigational products  
X 
 
X 
 
 
Dispensation of non-investigational 
products 
X 
 
X 
 
 
Return of investigational products  
 
 
X 
 
X 
Subject Diary/Complianceg 
 
X 
X 
X 
X 
DLQI-cDLQI questionnaire  
X 
 
 
X 
Xa 
Subject satisfaction questionnaire 
 
 
 
X 
Xa 
Cosmetic acceptability questionnaire 
 
 
 
 
Xa 
Exit form 
 
 
 
 
Xa 
 
a.  To be performed at Week 16 or before in case of early termination. 
b.  Photography consent and standardized photography (mandatory criteria for inclusion in the trial). 
c.  Only prior therapies that were stopped within 6 months of the baseline visit and that may have an impact on 
inclusion/exclusion criteria should be recorded. Treatment that continues after baseline should be recorded on 
the Concomitant Treatment Form of the CRF. 
d.  UPT will have sensitivity down to at least 25 IU/L for hCG. UPT is mandatory at baseline, week 8, week 12 
and week 16/early termination in female subjects  
e.  If PIH present at baseline visit. 
f.  Adverse event onsets after subject signature of the informed consent form should be recorded on the AE Form 
of the CRF. 
g.  Subject diary is a diary which will be given to the subject to report the treatment application 
h.  Sponsor Medical Expert will review the clinical evaluation of acne and give his confirmation for inclusion of 
subjects into the trial.


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5.5. 
CLINICAL TRIAL VISIT DESCRIPTION AND PROCEDURES 
5.5.1. Visit 1 – Baseline visit 
1. Explain the nature and the constraints of the clinical trial to the subject and to his/her 
parent(s) or guardian if the subject is under the age of 18, 
2. If a female subject of childbearing potential agrees to participate to the clinical trial, make 
sure she is using the required method(s) of contraception, 
3. Ensure the subject (and parent/guardian for subjects under the age of 18) has read, 
understood, dated and signed the approved Informed Consent Form (ICF), 
4. Give a dated and signed copy of the ICF to each subject and parent/guardian if applicable, 
5. Question the subject about demography (birthdate, race, skin phototype, gender), relevant 
medical history, prior therapies (stopped within 6 months of the baseline visit and that may 
have an impact on the inclusion/exclusion criteria) and concomitant therapies, 
6. Inform subject about authorized and prohibited concomitant therapies, 
7. Check inclusion/exclusion criteria (see sections 4.3 and 4.4), 
8. Log into the IVR/IWR System to check the inclusion rate in terms of balance in ethnic/race 
background and acne severity, 
9. Conduct a urine pregnancy test (UPT) for female subjects of childbearing potential, 
10. Log into the eCRF to get a Subject Identification Number (SIN), 
11. Perform an Investigator’s Global Assessment (IGA) of the whole face (see section 7.2.1), 
12. Assess the Post-Inflammatory Hyperpigmentation (PIH) severity if any (see section 7.3.1), 
13. Perform the baseline Local Tolerability Assessment (erythema, scaling dryness and 
stinging/burning; see section ), 
Note: Stinging/burning at the baseline visit should NOT be assessed at baseline, 
14. Take photographs of the face according to the provided procedure (subject and 
parent/guardian should accept through the approved ICF), 
15. Question the subject about the occurrence of any adverse events (AEs) by asking an open 
ended question taking care not to influence the subject’s answer, such as: “have you had any 
new symptoms, injuries, illness or side-effects or worsening of pre-existing conditions?” 
Record all events as appropriate on the corresponding AE eCRF pages, 
16. If the subject is eligible, assign a kit number (see specific section 0) (to be reported on the 
prescription form), 
17. Fill in a prescription form with the Subject’s Identification Number, 
18. The Product Dispenser (person in charge of products dispensation) will: 


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a. 
Dispense to the subject the baseline investigational product from the adequate subject 
kit according to the Prescription Form, 
b. Affix the tear-off portion of the label on the Product Dispensation Log, 
c. 
Dispense to the subject the associated non-investigational products with explanations 
how and when to use them, 
d. Dispense the subject participation card to the subject, 
e. 
Provide appropriate verbal and written instructions on how to properly use the 
investigational product. The first application of investigational product will be 
conducted by the subject under the direction of the Product Dispenser before leaving 
the investigational site, 
f. 
Remind the subject to not to apply the investigational product the first evening, 
g. Dispense a subject Diary and provide verbal instruction on how to complete the Diary 
after each product application, 
h. Emphasize the importance of complying with the given instructions and treatments, 
instruct the subject to bring back the subject’s diary at the next visit, 
i. 
For all female subjects, emphasize the guidelines about contraception and risks in 
case of pregnancy, 
19. Ask the subject to complete baseline DLQI/cDLQI questionnaire, 
20. Schedule the next follow up visit in two weeks ± 1 day. 
5.5.2. Visit 2 (week 2) (±1 Day) 
1. Question the subject about occurrence of adverse events (AEs) and record occurrence of any 
events and/or any changes in events that were ongoing at the previous clinical trial visit. 
Document all changes in the eCRF, 
2. Enquire whether any concomitant therapies have been added, stopped, or changed since the 
subject’s last visit. Document all changes in the eCRF, 
3. Perform an Investigator’s Global Assessment (IGA) of the whole face (see section 7.2.1). 
4. Assess the Post-Inflammatory Hyperpigmentation (PIH) severity if present at baseline (see 
section 7.3.1), 
5. Perform Local Tolerability Assessment (erythema, scaling dryness and stinging/burning; see 
Section 7.3.2), 
6. Take photographs of the face according to the provided procedure, 
7. The Product Dispenser will: 
a. Check the returned subject’s diary and interview the subject about compliance (number 
of missed trial product applications), 


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b. Emphasize again the importance of complying with the given instructions and 
treatments; instruct the subject to bring back the dispensed investigational product 
together with the subject’s diary at the next visit, 
c. 
For all female subjects, emphasize the guidelines about contraception and risks in 
case of pregnancy, 
8. Schedule the next follow up visit, visit 3 (week 8) 8 weeks after Baseline visit ± 3 days. 
5.5.3. Visit 3 (week 8) (±3 Days)  
1. Question the subject about occurrence of adverse events (AEs) and record occurrence of any 
events and/or any changes in events that were ongoing at the previous clinical trial visit. 
Document all changes in the eCRF, 
2. Enquire whether any concomitant therapies have been added, stopped, or changed since the 
subject’s last visit. Document all changes in the eCRF, 
3. Conduct a urine pregnancy test (UPT) for female subjects of childbearing potential. 
4. Perform an Investigator’s Global Assessment (IGA) of the whole face (see section 7.2.1). 
5. Assess the Post-Inflammatory Hyperpigmentation (PIH) severity if present at baseline (see 
section 7.3.1), 
6. Perform Local Tolerability Assessment (erythema, scaling dryness and stinging/burning; see 
section 7.3.2), 
7. Take photographs of the face according to the provided procedure, 
8. The Product Dispenser will: 
a. 
Check the returned investigational product, the subject’s diary and interview the 
subject about compliance (number of missed trial Products applications), 
b. Dispense from the subject kit the applicable visit treatment box, 
c. 
Affix the tear-off portion of the label on the Product Dispensation Log, 
d. Dispense to the subject the associated non-investigational clinical trial product with 
explanations how and when to use them, 
e. 
Emphasize again the importance of complying with the given instructions and 
treatments; instruct the subject to bring back the subject’s diary at the next visit, 
f. 
For all female subjects, emphasize the guidelines about contraception and risks in 
case of pregnancy, 
9. Schedule the next follow up Visit 4 (week 12), 12 weeks after Baseline visit ± 3 days. 


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5.5.4. Visit 4 (week 12) (±3 Days)  
1. Question the subject about occurrence of adverse events (AEs) and record occurrence of any 
events and/or any changes in events that were ongoing at the previous clinical trial visit. 
Document all changes in the eCRF, 
2. Enquire whether any concomitant therapies have been added, stopped, or changed since the 
subject’s last visit. Document all changes in the eCRF, 
3. Conduct a urine pregnancy test (UPT) for female subjects of childbearing potential, 
4. Perform an Investigator’s Global Assessment (IGA) of the whole face (see section 7.2.1). 
5. 
Evaluate Global Assessment of Improvement of acne versus baseline (see section7.2.2), 
6. Assess the Post-Inflammatory Hyperpigmentation (PIH) severity if present at baseline (see 
section7.3.1), 
7. Perform Local Tolerability Assessment (erythema, scaling dryness and stinging/burning; see 
Section7.3.2), 
8. Take photographs of the face according to the provided procedure, 
9. The Product Dispenser will: 
a. 
Check the subject’s diary and interview the subject about compliance (number of 
missed trial products applications), 
b. Emphasize again the importance of complying with the given instructions and 
treatments; instruct the subject to bring back the dispensed investigational product 
together with the subject’s diary at the next visit, 
c. 
For all female subjects, emphasize the guidelines about contraception and risks in 
case of pregnancy, 
10. Ask the subject to complete Week 12 DLQI/cDLQI questionnaire, 
11. Ask the subject to complete Subject Satisfaction questionnaire. 
5.5.5. Visit 5 (week 16) (±5 Days) 
1. Question the subject about occurrence of adverse events (AEs) and record occurrence of any 
events and/or any changes in events that were ongoing at the previous clinical trial visit. 
Document all changes in the eCRF, 
2. Enquire whether any concomitant therapies have been added, stopped, or changed since the 
subject’s last visit. Document all changes in the eCRF, 
3. Conduct a urine pregnancy test (UPT) for female subjects of childbearing potential. 
4. Perform an Investigator’s Global Assessment (IGA) of the whole face (see section 7.2.1), 
5. Evaluate Global Assessment of Improvement of acne versus baseline (see section 7.2.2), 


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6. Assess the Post-Inflammatory Hyperpigmentation (PIH) if present at baseline (see section 
7.3.1), 
7. Perform Local Tolerability Assessment (erythema, scaling dryness and stinging/burning; see 
Section 7.3.2), 
8. Take photographs of the face according to the provided procedure, 
9. The Product Dispenser will: 
a. 
Check the returned investigational product, the subject’s diary and interview the 
subject about compliance (number of missed trial Products applications), 
b. Ensure that the subject has returned all used/unused investigational products and the 
subject Diary. All missing investigational product units must be documented in the 
Product Dispensation Log comments section and on other accountability form. 
c. 
For all female subjects, reiterate the guidelines about contraception and risks in case 
of pregnancy during 1 month after the end of the trial. 
10. Ask the subject to complete the week 16/end of the trial DLQI/cDLQI questionnaire, 
11. Ask the subject to complete Subject Satisfaction and Cosmetic acceptability questionnaires, 
12. Complete the Exit Form in the eCRF and give the reason for clinical trial discontinuation 
(see section 4.5.6). 
5.5.6. Early termination visit 
In case of early termination, the procedures corresponding to the next theoretical visit should be 
performed (e.g. if a subject discontinues after week 2, complete the week 8 visit procedures). 
Additional final procedures will be conducted as indicated in the trial flow chart section 5.4. 
6. 
CLINICAL SUPPLIES 
Investigational product and supplies will be provided by the sponsor and shipped by the clinical 
supply unit or local depot. The investigational and non-investigational products used during this 
clinical trial are marketed products. 
6.1. 
INVESTIGATIONAL PRODUCT IDENTIFICATION AND USE 
6.1.1. Product identity 


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Investigational Product 
Trade Name 
Epiduo® Forte  
Name of Active Ingredient 
Adapalene - Benzoyl Peroxide 
Pharmaceutical Form 
Gel 
Dose or Concentration 
Adapalene 0.3% - BPO 2.5% 
Formula number 
534.0201 
Total Daily dose 
Four pea-sized amounts to cover whole face (e.g. one on the forehead, 
chin and each cheek) 
Mode and frequency of administration 
Topical, once daily in the evening 
Location of treated area 
Face 
Manufacturer 
(Name and address) 
Galderma Production Inc. (GPI) 
19400 Route Transcanadienne 
Baie d’Urfé, Québec 
Canada H9X 3S4 
Packaging type and size (primary) 
45g airless bottles with polypropylene pump system 
Storage Conditions 
Store at controlled room temperature 20°C to 25°C (68 °F to 77 °F). 
Excursions permitted be-tween 15 and 30°C (59°F et 86°F), 
 
 
Investigational Product 
Trade Name 
TactuPump Forte 
Name of Active Ingredient 
Adapalene - Benzoyl Peroxide 
Pharmaceutical Form 
Gel 
Dose or Concentration 
Adapalene 0.3% - BPO 2.5% 
Formula number 
534.0201 
Total Daily dose 
Four pea-sized amounts to cover whole face (e.g. one on the forehead, 
chin and each cheek) 
Mode and frequency of administration 
Topical, once daily in the evening 
Location of treated area 
Face 
Manufacturer 
(Name and address) 
Galderma Production Inc. (GPI) 
19400 Route Transcanadienne 
Baie d’Urfé, Québec 
Canada H9X 3S4 
Packaging type and size (primary) 
70g airless bottles with polypropylene pump system 
Storage Conditions 
Store at controlled room temperature 15°C to 25°C 
 
6.1.2. Method of treatment assignment 
This will be an open label trial and all subjects will be dispensed with the investigational product. 
The kit number, a unique number will be assigned to each eligible subject at baseline according 
to the Inclusion/Non-inclusion criteria. 
A subject kit will be composed of: 


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 Two visit boxes: One visit box will be dispensed to the subjects at Baseline (Dispensation 
1) and one at week 8 visit (Dispensation 2), 
One extra box to be dispensed in case if subjects loose or destroy trial treatment. 
Each box will contain:  
- Dispensation 1 (Baseline): 
 Two Epiduo® Forte / TactuPump Forte gel bottles 
- Dispensation 2 (Week 8):  
 Two Epiduo® Forte / TactuPump Forte gel bottles  
- Extra box:  
 One Epiduo® Forte / TactuPump Forte gel bottle 
At baseline visit, all eligible subjects will be dispensed a Baseline visit box from the subject kit in 
a chronological order of inclusion into the clinical trial, without omitting or skipping any number. 
If a number is omitted by mistake, the skipped kit number should be allocated to the next subject. 
 
6.1.3. IVR/IWR System  
Once a Subject has fulfilled inclusion/exclusion criteria and is qualified to enter into the trial, the 
site will call/connect to the IVR/IWR System to check trial inclusion rate as per ethnic/race 
background and acne severity stratifications and assign the Subject kit number. The IVR/IWR 
System acts as an automatic central recruitment center.  
The IVR/IWR System requires at least the Subject identification number (SIN) and Site number 
to provide proper treatment assignment number by linking the SIN to ethnic/race backgrounds 
and acne severity of the included subjects in the eCRF. 
6.1.4. Subject Identification Number (SIN) 
Upon signature of the informed consent, a subject meeting all inclusion/exclusion criteria will be 
allocated a unique subject identification number (SIN). This SIN number will be automatically 
generated by the eCRF.  
During the whole clinical trial, the subject will only be identified using the SIN for all 
documentation and discussion. 
6.1.5. Instructions for use and administration 
The Product Dispenser will give each subject verbal and written instructions on how to use the 
investigational product and non-investigational products. A specific focus on risks in case of 
pregnancy will be made for female subjects.  
 


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In addition, at the baseline visit the Product Dispenser will show the subject how to apply the 
investigational product on the face and how to record these applications in the subject diary. This 
procedure will be thoroughly discussed and reviewed at each trial visit. 
 
All subjects will apply the investigational product in the evening after washing their face, for 16 
weeks, as described in the instructions for use provided to the subjects. The procedure is as 
follows: 
1. Wash hands, 
2. Wash the entire face using the provided Cetaphil® DermaControl™ Oil Control Foam 
Wash, 
3. Blot dry the face with a soft towel. Do not rub the face, 
4. Apply a thin film of gel on the whole face avoiding eyes, lips and mucous membranes. 
DO NOT SPOT APPLY. Four pea-sized amounts should be enough to cover the whole 
face (e.g. one on the forehead, chin and each cheek), 
5. Wash hands, 
6. Complete the given subject Diary after each product application. 
 
Investigational Product 
Concentration 
Adapalene 0.3% - BPO 2.5% 
Dose regimen 
Once daily 
Period of administration 
Evening 
Route of administration 
Topical 
6.1.6. Non-investigational products 
Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control 
Moisturizer SPF 30 and Urine Pregnancy Tests (UPT) will be provided by the sponsor (or 
designee). 
Subjects should use the provided Cetaphil® DermaControl™ Oil Control Foam Wash twice daily 
(once in the morning and once in the evening) in order to gently wash their face. Face should 
thereafter be blotted dry with a soft towel. 
 
Subjects should use Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 once daily in the 
morning after washing their face, and they may use it as needed during the day (in case of sun 
exposure for instance). 
 
Both products are topical and will be used on the whole face for 16 weeks. 
 
No specific labels will be used. Subjects will not return these products to the site. No 
accountability will be conducted on these products. 


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6.2. 
INVESTIGATIONAL PRODUCT PACKAGING AND LABELLING 
All investigational products will be supplied in the subject’s kit containing 2 visit boxes (one per 
dispensing visit) plus an extra box. 
 
The subject kit label will be comprised of a single panel fixed label, while the visit box labels will 
be comprised of a double-panel label with an affixed and a tear-off portion for accountability. 
 
The labels will be printed in the local language. The text of the label will detail the information 
requested by Good Manufacturing Practice and Good Clinical Practice and local regulations. 
For treatment documentation, the affixed portion of the label will remain on the appropriate 
packaging. The tear-off portion of the label will be removed at the time of dispensation and 
attached to the corresponding product Dispensation Log. 


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6.3. 
INVESTIGATIONAL PRODUCT MANAGEMENT 
6.3.1. Accountability 
Upon receipt of the clinical supplies at the site, the investigational product Dispenser will conduct 
a complete inventory of all investigational products and assume responsibility for their storage, 
accountability and dispensation. 
The Investigator or designee will sign the original “Receipt of Clinical Supplies” Form (or any 
acknowledgment of receipt) upon receipt and inspection of the supplies, fax the signed copy to 
GALDERMA R&D and retain the receipt in the Investigator Site File (ISF). 
All supplies sent to the investigator site will be accounted for and in no case used in any 
unauthorized situation.  
All used and unused investigational product will be appropriately inventoried by GALDERMA 
R&D /CRO representative and returned to GALDERMA R&D /designated contractor for further 
reconciliation and destruction. 
6.3.2. Dispensing 
All investigational and non-investigational products will be provided only to subjects enrolled 
into the clinical trial, at no cost and in accordance with the conditions specified in the protocol. 
 
Dispensation will be appropriately documented on the Product Dispensation Log by the Product 
Dispenser at each visit. 
 
It is important that no subject runs out of clinical trial supplies between visits.  
Each subject will receive a new visit box containing two bottles of investigational product at 
baseline and at post-baseline visit week 8. 
 
Treatment kits will be dispensed in ascending sequential order according to the chronological 
order of enrolment of subjects into the clinical trial. 
6.3.3. Investigational product compliance management and record 
Each subject will be instructed by the Product Dispenser about the importance of being compliant 
with clinical trial treatment(s) throughout the clinical trial as well as the importance of returning 
their investigational product (used and/or not used) at week 8 and week 16 (or at the end of the 
trial in case of early termination) visits. 


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The investigational products will be collected, counted and documented on the Product  
Dispensation Log or other accountability document as applicable, at post-baseline visits (week 8 
and week 16), by the Product Dispenser. 
 
In this trial product compliance will be assessed using a subject diary. 
At Baseline visit, subjects will be provided with a subject diary to record on a daily basis the 
frequency of applications of investigational product (Epiduo® Forte / Tactupump Forte gel) and 
non-investigational products on the face and to record their compliance with the instructed 
application procedures. Subjects should return the diary at each post-baseline visit for review by 
the Product Dispenser. At the end of the trial week 16/early termination subjects should return the 
diary. 
The return of investigational products should be appropriately documented on the Product 
Dispensation Log by the trial Product Dispenser. All subject kits will be collected at the week 16 
visit at the latest, if not done before, or at Early Termination. 
Subjects will also be questioned regarding the application technique, intake, frequency and 
missed doses of investigational product and the use of any other additional topical, systemic 
product as well as OTC product. 
During the data review meeting, investigational product compliance for all subjects will be 
determined and reviewed by the sponsor’s clinical team. 
6.3.4. Storage of investigational product 
The investigator has to agree to keep all investigational products in a safe, temperature controlled 
and secure area with restricted access, in accordance with applicable regulatory requirements 
(e.g., in the site pharmacy, if applicable). 
Investigational products should be stored at appropriate storage conditions specified by 
GALDERMA R&D (see section 6.1.1). 
6.3.5. Return of investigational product 
The Product Dispenser will inform each subject about the importance of returning their 
investigational products (used and/or not used) at week 8 and week 16 at the latest, if not done 
before, or at Early Termination. 
In the event of early termination/suspension of the clinical trial for safety reasons, a rapid recall 
of the trial product(s) will be initiated.  The investigator or designee must immediately instruct all 
subjects to stop the clinical trial treatment regimen and return the investigational products to the 
clinical trial site. 
As a general procedure, GALDERMA R&D will provide the investigator with a detailed list of 
units being recalled so that any of the units remaining on site can be put immediately into 
quarantine. 


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6.3.6. Dose modification 
Local cutaneous reactions including erythema, scaling, dryness, and stinging/burning may be 
experienced with use of Adapalene 0.3% - BPO 2.5%. All these adverse reactions are easily 
managed depending upon the severity of these adverse reactions. 
 
Subjects should be instructed to use a moisturizer (the provided one for this trial) and if needed, 
investigators may reduce temporarily the frequency of the application of Adapalene 0.3% - BPO 
2.5% (eg. every other day), or temporarily discontinue use.  
 
These are most likely to occur during the first four weeks of treatment but are mostly mild to 
moderate in intensity, and usually improve with continued use of the medication. 
All dose modifications should be documented in the subject’s source data and reported in the 
eCRF (treatment compliance page). 
6.4. 
BLINDING 
6.4.1. Verification of blinding 
The trial design is considered as open label trial so blinding is not applicable for this trial. 
6.4.2. Unblinding during the clinical trial 
Not applicable for this open label trial. 
7. 
SUBJECT REPORTED OUTCOME, EFFICACY AND SAFETY ASSESSMENT 
7.1. 
SUBJECT REPORTED OUTCOMES 
The following Subject Reported Outcome (PRO) questionnaires should be filled out by the 
subjects. The investigator or delegate should check all questions of the PRO questionnaires for 
completeness prior to the subject leaving the office.  


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7.1.1. Quality of Life Questionnaire 
At baseline before application of the investigational product, at Week 12 and at Week 16/Early 
termination subjects will complete a Dermatology Life Quality Index questionnaire (DLQI) or 
Children Dermatology Life Quality Index questionnaire (cDLQI) (for children age of ≤16 years) 
(see Attachment 1). 
DLQI and cDLQI questionnaires will be used in local language. 
7.1.2. Subject Satisfaction Questionnaire 
At Week 12 and Week 16/Early termination, subjects will complete a satisfaction questionnaire 
regarding use of investigational product they used in this trial (see Attachment 2). 
Subject satisfaction questionnaire will be translated in local language. 
7.2. 
EFFICACY ASSESSMENTS 
Clinical evaluations should be performed by the same evaluator (investigator or designee) 
throughout the clinical trial. If it is not possible to use the same evaluator to follow a subject, then 
evaluations should overlap for at least one visit in order to examine the subject together and 
discuss findings and this should be documented in the source documents. At least for the baseline 
assessments and the final assessments (Week 16/Early termination), the evaluator should be the 
same person. 
 
The evaluated areas must be examined under the same conditions of light exposure at each visit 
(same angle to avoid shadow and same light source, i.e. artificial or daylight). 
7.2.1. Investigator’s global assessment of acne severity (IGA) 
The evaluator will assess the severity of acne for the whole face of the subject using the scale 
described below. The evaluator will assess subject’s acne severity at each visit by performing a 
static (“snapshot”) evaluation of acne. The evaluator should make no reference to baseline or 
other previous visit when evaluating the subject’s acne.  


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Category 
Score 
Description 
Clear 
0 
Clear skin with no inflammatory or non-inflammatory lesions 
Almost Clear 
1 
A few scattered comedones and a few small papules 
Mild 
2 
Easily recognizable; less than half of the face is involved. Some 
comedones and some papules and pustules. 
Moderate 
3 
More than half of the face is involved. Many comedones, papules 
and pustules. One small nodule may be present. 
Severe 
4 
Entire face is involved. Covered with comedones, numerous 
papules and pustules. Few nodules may or may not be present. 
 
For the inclusion criterion (subjects should have an IGA of 3 or 4). 
7.2.2. Global Assessment of Improvement (GAI) 
At Week 12 and Week 16/Early termination, the evaluator will evaluate the degree of acne 
improvement versus baseline using the Global Assessment of Improvement score as follows: 
Category 
Score 
Description 
Excellent 
improvement 
0 
All or nearly all signs and symptoms cleared (around and more than 
90% improvement from Baseline). Whether no, or only minimal 
residual signs and symptoms remain 
Very good 
Improvement 
1 
Majority of the signs and symptoms have resolved 
(about 75% improvement from Baseline) 
Good 
Improvement 
2 
Significant improvement, but many signs and symptoms remain 
(about 50% improvement from Baseline) 
Minimal 
Improvement 
3 
Slight overall improvement, but not clinically significant 
(about 25% improvement from Baseline) 
No Change 
4 
Overall severity similar to Baseline 
Worse 
5 
Worse than Baseline 
7.3. 
SAFETY ASSESSMENTS 
Safety assessments will be conducted for all subjects at the baseline visit (after the ICF has been 
signed) and every subsequent visit. The safety parameters include adverse events (AEs) and 
increase in Post inflammatory hyperpigmentation (PIH) and local tolerance severity. 
7.3.1. Post inflammatory hyperpigmentation (PIH) 
Post inflammatory hyperpigmentation (PIH) is mostly seen in subjects with skin phototypes IV to 
VI (according to T.B. Fitzpatrick’s definitions). PIH lesions may represent the sequel of various 


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cutaneous disorders as well as therapeutic interventions. The shapes of these lesions closely 
follow the contours of the original inflammatory dermatosis. Severity of PIH of the treated areas 
on the face will be evaluated by the evaluator at each visit as follows: 
Category 
Score 
Description 
None 
0 
No post inflammatory hyperpigmentation 
Very mild 
1 
Few areas of post inflammatory hyperpigmentation, very small in size 
and only very slightly darker than the surrounding skin 
Mild 
2 
Several areas of post inflammatory hyperpigmentation; small in size 
and slightly darker than the surrounding skin 
Moderate 
3 
Many areas of post inflammatory hyperpigmentation; medium in size 
and much darker than the surrounding skin 
Severe 
4 
Large number of areas of post inflammatory hyperpigmentation; large 
in size and markedly darker than the surrounding skin. 
Any increase of PIH score during the trial is to be reported as an Adverse Event. 
7.3.2. Local tolerance assessment 
Local cutaneous signs and symptoms (erythema, scaling, dryness and/or stinging/ burning) are 
possible during treatment with Adapalene 0.3% - BPO 2.5%. 
 
The investigator will evaluate erythema, scaling, dryness and/or stinging/burning at each visit. 
The investigator will record stinging/burning after discussion with the subject regarding the 
previous application days. The investigator will ask an open-ended question, taking care not to 
influence the subject’s answer, such as: “Have you experienced any sensations immediately 
following product application (within 5 minutes)?” 
 
Erythema, scaling, dryness will be evaluated by the investigator, and stinging/burning will be 
recorded by the investigator after discussion with the subject. The four signs and symptoms will 
be graded at each follow up visit as follows: 


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Erythema – abnormal redness of the skin 
None 
0 
No erythema 
Mild 
1 
Slight pinkness present 
Moderate 
2 
Definite redness, easily recognized 
Severe 
3 
Intense redness 
Scaling – abnormal shedding of the stratum corneum 
None 
0 
No scaling 
Mild 
1 
Barely perceptible shedding, noticeable only on light scratching or rubbing 
Moderate 
2 
Obvious but not profuse shedding 
Severe 
3 
Heavy scale production 
Dryness – brittle and/or tight sensation 
None 
0 
No dryness 
Mild 
1 
Slight but definite roughness 
Moderate 
2 
Moderate roughness 
Severe 
3 
Marked roughness 
Stinging/Burning – pricking pain sensation immediately after dosing (within 5 minutes)  
None 
0 
No stinging/burning 
Mild 
1 
Slight warm, tingling/stinging sensation; not really bothersome 
Moderate 
2 
Definite warm, tingling/stinging sensation that is somewhat bothersome 
Severe 
3 
Hot, tingling/stinging sensation that has caused definite discomfort 
 
Note: Stinging/Burning should NOT be assessed at the baseline visit 
 
An Adverse Event will be recorded if the severity of the signs and symptoms is such that: 
 The subject’s participation in the trial is interrupted at his/her request or at the 
investigator’s request after the first four weeks of treatment. 
 The subject permanently discontinues the treatment at his/her request or at the 
investigator’s request. 
 The subject requires concomitant prescription or OTC therapy (other than moisturizers). 
 
Note: Need for increased moisturizer use does NOT constitute an AE. 
 
Any new sign or symptom, which is not included in the scheduled evaluation of tolerability, 
should be recorded as an Adverse Event, including those of mild intensity. 
7.3.3. Adverse Events 
Adverse Events will be recorded monitored throughout the course of the clinical trial.  All clinical 
medical events, whether observed by the investigator or reported by the subject and whether or 
not thought to be product or trial procedure-related will be considered adverse events and 


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recorded on the appropriate adverse event form of the eCRF with complete information as 
required.  If AEs occur, the main concern will be the safety of the subjects. At the time of the ICF 
signature, each subject must be provided with the name and phone number of clinical trial site 
personnel for reporting AEs and medical emergencies. 
7.4. 
OTHERS 
7.4.1. Cosmetic acceptability Questionnaire 
At Week 16/Early termination, subjects will complete an acceptability questionnaire regarding 
the non-investigational product they have been using in this trial (see Attachment 3). 
Subject cosmetic acceptability questionnaire will be translated in local language. 
7.4.2. Photographs 
Standardized digital photographs of the whole face (front, right and left) will be taken using a 
Canfield Scientific stereostatic device (Visia CR®) or equivalent. Detailed procedures will be 
provided. Subjects will be photographed at baseline and at each post-baseline visit.  
At Baseline visit subjects’ photograph will be used to confirm the severity of acne (moderate or 
severe) for inclusion of subjects into the trial. Sponsor Medical Expert will review the clinical 
evaluation of acne and give his confirmation for inclusion of subjects into the trial. 
7.5. 
APPROPRIATENESS OF MEASUREMENTS 
Efficacy is evaluated by assessing severity of acne by the investigator (IGA) and the degree of 
acne improvement versus baseline using the Global Assessment of Improvement (GAI) scores 
which are current and non-invasive techniques for assessing efficacy of acne treatment.  
Post inflammatory hyperpigmentation (PIH) is mostly seen in subjects with skin phototypes IV to 
VI (according to T.B. Fitzpatrick’s definitions). PIH lesions may represent the sequel of various 
cutaneous disorders as well as therapeutic interventions. Severity of PIH of the treated areas on 
the face will be evaluated by the the evaluator at each visit. 
Acne can persist for years and may affect seriously the psychosocial development, resulting in 
emotional problems, withdrawal from society, and depression (Koo , J Y., et Smith, L L. 1991). If 
not treated, acne may cause serious physical and emotional scarring and can significantly impact 
the quality of life of those affected by the disease (Brown J.M., Poston S.M. 1983) (Usatine, RP., 
Quan, MA et Strick, R. 1998). 
Therefore impact of trial treatments on subjects’ quality of life will be assessed using quality of 
life and satisfaction questionnaires in dark skin subjects known to be sensitive with topical 
retinoids. For this, subjects will complete the DLQI / cDLQI at baseline, Week 12 and at the end 
of the trial. A satisfaction questionnaire will also be completed by all subjects at Week 12 and at 
the end of the trial Week 16/Early termination. 


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To collect specifically subject’s feed-back on the associated non-investigational products used in 
the trial, a subject cosmetic acceptability questionnaire will be completed at the end of the trial 
Week 16/Early termination. 
Safety will be assessed through the reporting of adverse events and local tolerability assessment 
on an ongoing basis as a well-established process in clinical trials. 
8. 
ADVERSE EVENT 
8.1. 
DEFINITIONS 
8.1.1. Adverse Events (AE) 
According to ICH E2A, an AE is any untoward medical occurrence in a subject or clinical 
investigation subject administered a pharmaceutical product and which does not necessarily have 
a causal relationship with this treatment.  An AE can therefore be any unfavorable and 
unintended sign (including an abnormal laboratory value), symptom, or disease temporally 
associated with the use of a medicinal (investigational) product, whether or not related to the 
medicinal (investigational) product. 
Thus any new sign, symptom or disease, or clinically significant increase in the intensity of an 
existing sign, symptom or disease since the first visit (including the disease being treated), should 
be considered as an adverse event. Lack of efficacy should not be considered as an AE. 
Each new episode of a chronic disease (e.g., hay fever, allergy, etc.) from the screening visit 
should be reported as a new AE. 
Notes: 
 Any new sign or symptom reported by the subject that appears after accidental or intentional 
overdose or misuse should also be reported as an AE. 
 There should be an attempt to report a diagnosis rather than the signs, symptoms or abnormal 
laboratory values associated with the report of an AE.  However, a diagnosis should be 
reported only if, in the Investigator’s judgment, it is relatively certain.  Otherwise, symptoms, 
signs, or laboratory values should be used to describe the AE. 
 Pregnancy should not be considered as an adverse event but must be followed up as described 
in section 8.2.3.1. 
 For an AE of irritation, the “date of onset” should be the date that the first symptom occurred. 
There may be side effects during treatment with the investigational product, as described in the 
product monograph for Epiduo® Forte / TactuPump Forte gel and in this protocol (mild to 
moderate application site reactions, such as skin irritation characterized by scaling, dryness, 
erythema, and burning/stinging). 


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The course of these expected events will be assessed and reported on the Local Tolerability 
Assessment Forms.  An Adverse Event Form will be completed only if the severity of the 
expected signs and symptoms is such that an interruption (after the first 4 weeks of 
treatment)/discontinuation of the subject’s participation in the clinical trial, at his/her request or at 
the investigator’s, occurred and/or if a concomitant medication is prescribed to treat the 
sign/symptom(s). 
8.1.2. Serious Adverse Events (SAE) 
A serious adverse event is any untoward medical occurrence that at any dose:  
 results in death, 
 is life-threatening, 
 requires hospitalization or prolongation of existing hospitalization, 
 results in persistent or significant disability/incapacity, or 
 is a congenital anomaly/birth defect. 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical judgment, they 
may jeopardize the safety of the subject, and may require medical or surgical intervention to 
prevent one of the outcomes listed in this definition. Examples of such events are intensive 
treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasia, or 
convulsions that do not result in hospitalization. 
Note: 
 The term “life-threatening” 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 was more severe. 
 Inpatient hospitalization is considered to have occurred if the subject has had to stay in 
hospital overnight. The criterion for the prolongation of hospitalization is also defined as an 
extra night at the hospital. Hospitalization may not constitute sufficient grounds to be 
considered as an hospitalization if it is solely for the purpose of diagnostic tests, (even if 
related to an AE), elective hospitalization for an intervention which was already planned 
before subject enrolment in the clinical trial, admission to a day-care facility, social admission 
(e.g., if the subject has no place to sleep), or administrative admission (e.g., for a yearly 
examination). 
8.1.3. Unexpected adverse drug reaction 
According to ICH E6, an unexpected adverse Product reaction is defined as an adverse reaction, 
the nature or severity of which is not consistent with the applicable trial product information (in 
this clinical trial: the approved Canadian product monograph at the time of AE occurrence). 


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8.1.4. Adverse event reporting period 
The clinical trial period during which AEs must be reported is the period from when the subject 
signs the Informed Consent Form to the end of the subject’s participation. 
The sponsor should be informed if the investigator becomes aware of any unusual safety 
information or any safety information that appears to be drug-related involving a subject who has 
participated in a clinical trial, even after a subject has completed the clinical trial. The 
investigator should be diligent in looking for possible latent safety effects that do not appear until 
a medication has been discontinued. 
8.1.5. Severity 
Severity is a clinical determination of the intensity of an AE and not of a disease. 
The investigator will classify the intensity of AEs using the following definitions as a guideline 
for all AEs occurring during clinical trials conducted or sponsored by GALDERMA. For this 
classification, the investigator will take into account the possible range of the intensity of the 
event and report the grade of intensity which is the most appropriate according  his medical 
judgment. 
Mild 
Awareness of sign or symptom, but easily tolerated 
Moderate 
Discomfort, enough to cause interference with usual activity 
Severe 
Incapacitating with inability to work or perform usual activity 
8.1.6. Relationship to the trial product(s) and/or clinical trial procedure 
The investigator is to determine whether there is a reasonable causal relationship between the 
occurrence of the AE and exposure to the trial product(s) and/or clinical trial procedure required 
by the protocol, such as moisturizer use. AE reporting for moisturizer use should be detailed, 
taking into account whether moisturizer use is recommended or mandatory. 
 
Medical judgment should be used to determine the relationship, considering all relevant factors, 
including pattern of reaction, temporal relationship, positive dechallenge or rechallenge, relevant 
medical history, and confounding factors such as co-medication or co-concurrent diseases. 
The expression “reasonable causal relationship” is meant to convey in general that there are facts 
or arguments to suggest a causal relationship (International Conference on Harmonization (ICH) 
E2A, section IIIA 1). 
The relationship assessment for an AE is to be completed using the following definitions as a 
guideline for all adverse events occurring during clinical trials conducted or sponsored by 
GALDERMA: 
Reasonable possibility: 


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According to the reporting investigator, there is a reasonable possibility (i.e. suggestive evidence 
or arguments) that there is a causal relationship irrespective of the dose administered between: 
 The trial product (investigational product, active comparator, or vehicle, etc.) and the AE,  
 The clinical trial protocol procedure (e.g., UV-induction, biopsy, xylocaine injection, blood 
test or intraocular pressure measurement, ancillary products provided by the sponsor, such 
as moisturizers, etc.) and the AE. 
The Investigator has to complete these 2 causality assessments on the AE form. 
No Reasonable Possibility: 
No suggestive evidence or arguments can be identified regarding a causal relationship between 
the investigational product or the clinical trial protocol procedure and the AE. 
8.2. 
REPORTING PROCEDURES  
8.2.1. Procedures for reporting adverse events 
The collection of AEs is from the time that a subject signs the ICF to their final trial visit. 
At each post-baseline visit, the investigator (or sub-investigator) will enquire about adverse 
events using an open question taking care not to influence the subject’s answer (e.g., “Have you 
noticed any change in your health since the last visit?”). Direct questioning and examination will 
then be performed as appropriate. 
Any AE occurring during the AE reporting period, whether it is related to the trial product or not, 
will be recorded immediately in the source document, and described in the Adverse Event Form 
of the eCRF along with the date of onset, severity, relationship to the trial product, and outcome, 
without omitting any requested and known information.  Additional information will be requested 
under certain circumstances. Adverse Events (AEs) assessed as related to the treatment will be 
monitored until they are completely or satisfactorily resolved. Other AEs will be monitored until 
the last visit if they are not resolved or satisfactorily resolved. 
Adverse events assessed as related to the treatment or trial procedure will be monitored until they 
have resolved or reached a stable condition. Other AEs will be monitored until the last visit if 
they have not resolved or reached a stable condition. The investigator will obtain and maintain in 
the subject’s files all pertinent medical records, information and medical judgment from 
colleagues who assisted in the treatment and follow-up of the subject. If necessary, the 
investigator will contact the subject’s personal physician or hospital staff to obtain further details. 
For SAEs (see section 8.2.2) and pregnancies (see section 8.2.3.1), the Sponsor is to be informed 
immediately by e-mail/fax.  The event must be reported by fax or sent by e-mail to the Sponsor 
within 24 hours of receipt of the information (contact details in section 8.2.2). 


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8.2.2. Procedure for reporting a Serious Adverse Event 
For an SAE occurring during the period of the clinical trial, regardless of whether it is related to 
the treatment or not, and of whether it is expected or not, the investigator must do the following: 
1. 
Take prompt and appropriate medical action, if necessary. The safety of subject is the 
first priority. 
2. 
Ensure that the event is classified as an SAE. Immediately (no later than 24 hours) 
inform the Sponsor of the event by email/ fax/, and discuss further actions  to be taken: 
 
GALDERMA R&D 
Name 
 
Title 
 
Address 
 
 
 
Tel. during office hours 
 
Tel. Outside office hours 
 
Fax  
 
Email 
pharmacovigilance@galderma.com 
3. 
Complete the SAE form provided by the CRA (Clinical Research Associate) at the start of 
the clinical trial (it is also available in the eCRF system as PDF document). Fax or send by 
email the completed form, accompanied by demographics, medical history and 
drugs/therapies forms (if any), and adverse event pages of the eCRF, and any other relevant 
information (e.g., test results) within 24 hours of receipt of the information to the Sponsor 
(see contact details above) 
4. 
Print and complete the Serious Adverse Event form (available in the EDC system as PDF 
document). Fax or send by email the completed form, accompanied any other relevant 
information or anonymized medical records (e.g., laboratory test results) within 24 hours of 
receipt of this information to the sponsor (see contact details above). The demographics, 
medical history, drugs/therapies forms, and adverse event pages of the eCRF must be 
completed and available for review in the EDC system at the time of the report. 
5. 
Monitor and record the progress of the event until it resolves or reaches a clinically 
stable outcome, with or without sequelae. For all additional follow-up evaluations, fax or 
send by e-mail all additional follow-up information on the SAE to the sponsor (see contact 
details above) within 24 hours of receipt of the updated information.  SAEs will be 
monitored until the Investigator and Sponsor agree that the event is satisfactorily resolved. 
6. 
Obtain and maintain in his/her files all pertinent medical records, information, and medical 
judgments from colleagues who assisted in the treatment and follow-up of the subject.  If 
necessary, contact the subject’s personal physician or hospital staff to obtain further details 


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7. 
Inform the sponsor of the final outcome of the event. Send a revised or updated SAE 
form and AE form, if appropriate. 
8. 
Prompt notification of SAEs by the investigator to GALDERMA is essential so that legal 
obligations and ethical responsibilities towards the safety of subjects are met. GALDERMA 
has a legal responsibility to notify both the local regulatory authority and other regulatory 
agencies about the safety of a product under clinical investigation. GALDERMA will 
comply with country specific regulatory requirements relating to safety reporting to 
regulatory authorities, IRBs/IECs and investigators. Investigator safety reports are prepared 
for Suspected Unexpected Serious Adverse Reactions (SUSARs) according to local 
regulatory requirements and GALDERMA policy and are forwarded to investigators as 
necessary. An investigator who receives an investigator safety report describing an SAE(s) 
or other specific safety information (e.g., summary or listing of SAEs) from GALDERMA 
will file it with the Investigator’s Brochure (IB) and will notify the IRB/IEC, if appropriate 
according to local requirements. 
9. 
Comply with the applicable regulatory requirements related to the reporting of SAEs 
to your IRB/EC. 
8.2.3. Procedure for suspected allergic contact reaction 
This is a general procedure and further details can be discussed with the sponsor. 
 Stop the trial product 
 Take a picture of the affected area and the non-affected surrounding skin  
 Document the event and report it immediately to the sponsor by email/fax, within 24 hours of 
receipt of the information as described in section 8.2.2. 
In case of suspicion of allergic contact dermatitis  
1. 
After all signs and symptoms have resolved and after a minimum of two weeks from last 
dose application, a re-challenge test with the assigned trial product will be performed.  
2. 
Ensure the subject has not been under any treatment with corticosteroids or antihistamines, 
regardless of the route of administration, the week before testing. 
3. 
Ensure that the skin on the back has not been exposed to the sun or artificial ultraviolet 
sources the week before testing. 
4. 
Apply an appropriate quantity of the assigned trial product to fill the cupule of the test 
chamber on the skin of the upper back on either the right or left side of the center line (or 
the inner forearm if the back cannot be tested). If no test chamber is available on-site, patch 
test units will be provided. It may be preferable to perform the test under semi-occlusive 
conditions depending on the irritant potential of the trial product and the intensity of the 
reaction that was observed. The method to be used will be discussed with the sponsor.  
5. 
Choose a skin site that was not previously involved in the inflammatory skin reaction. 
6. 
Cover it for 48 hours with a hypoallergenic tape. 


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7. 
Subject should be informed about avoiding exercise, showers, application of toiletries 
products, etc. to keep the test system dry 
8. 
After 48 hours, remove the tests and evaluate the site: 
- At approximately 30 minutes after patch test removal (1st reading) and, 
- 24 to 48 hours later (i.e. 72 or 96 hours after application) (2nd reading). 
- A facultative 3rd reading may be performed 96 to 120 hours later (i.e. 6 to 7 days after 
application of the patch) if the overall assessment so far equivocal or if asked by the 
sponsor. 
- Pictures of the tested areas will be taken systematically at each reading and properly 
documented. 
 
Duration 
of 
trial 
product application 
1st Reading 
2nd  Reading 
3rd reading  
(optional) 
48 hours 
48 hours after trial 
product application (30 
minutes 
after 
patch 
test 
removal) 
 72 to 96 hours after 
trial 
product 
application (24 to  48 
hours after patch test 
removal) 
6 or 7 days after trial 
product application (96 
to 120 hours after patch 
removal) 
 
9. 
Refer to the scoring system (Spiewak R., 2008) used by the International Contact 
Dermatitis Research Group (ICDRG) to assign a score at each reading:  
 
Score Morphology 
Interpretation 
- 
No skin changes in the tested area 
Negative 
? 
Faint, non-palpable erythema  
Doubtful reaction 
+ 
Palpable erythema (moderate edema or infiltrate), 
papules not present or scarce, vesicles not present  
Weak positive reaction 
++ Strong infiltrate, numerous papules, vesicles 
present 
Strong positive reaction 
+++ Erythema, infiltration, confluent vesicles, bullae or 
ulceration 
Extreme positive reaction 
ir 
Inflammation sharply limited to the exposed area, 
lack of infiltrate, small petechiae, pustules, and 
efflorescences other than papules and vesicles 
Irritant reaction 
Nt 
 
Not tested 
 
10. 
At last reading, the investigator will provide an assessment regarding a possible 
sensitization reaction using the following scale: 


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Sensitization Reaction 
0 
Negative (absence of reaction or might be irritant reaction) 
1 
Equivocal 
2 
Positive 
 
11. 
Report the results from the re-challenge test as directed by the sponsor and document with 
photographs. 
12. 
In case of absence of reaction, the subject may resume treatment if appropriate 
13. 
If the re-challenge is positive or equivocal, notify the sponsor immediately. Except specific 
situations, a new series of patch test will be initiated as directed by the sponsor (with 
individual ingredients at different concentrations if applicable, and possibly negative and 
positive controls) after a minimum of additional two weeks (but not later than 6 months) 
and after all signs and symptoms have resolved. The patch tests will be placed on the 
subject’s back (or the inner forearm if the back cannot be tested) distant from the site of the 
re-challenge test (e.g., the left upper back skin if the re-challenge test was done on the right 
side). Follow the same procedure for the patch test as for the re-challenge.  
14. 
In case of suspicion of immediate contact skin reaction (such as urticaria) 
A case by case approach will be applied and the procedure to follow will be discussed with the 
sponsor. 
8.2.3.1 
Procedures for reporting pregnancies 
Any pregnancy occurring during clinical trials, where the foetus could have been exposed to the 
investigational product(s), must be followed-up until outcome in order to ensure the complete 
collection of safety data on GALDERMA product. 
If a subject becomes pregnant, the Investigator is to do the following: 
1. 
Withdraw the subject from the clinical trial  
2. 
Complete all appropriate visit evaluations and eCRF pages. 
Immediately (no later than 24 hours) contact the Sponsor to inform them of the pregnancy 
occurrence and discuss further steps to be taken: 
 
GALDERMA R&D 
Name 
 
Title 
 
Address 
 
 
 


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3. 
Complete, as fully as possible, the pregnancy surveillance form – Part I: History and 
start of pregnancy - provided by the CRA at the beginning of the clinical trial (it is also 
available in the eCRF system as pdf document), as fully as possible. Fax or send by email 
this pregnancy form along with the Exit form within 24 hours of receipt of the information 
to the Sponsor. 
4. 
Monitor and record the progress of the pregnancy until its outcome.  Contact the subject’s 
regular physician (general practitioner or gynecologist) or hospital staff to obtain further 
details and ask regular follow-up information. 
5. 
Inform the Sponsor of the progress by tri-monthly updates up to the final outcome of 
the pregnancy. For all the additional follow-up evaluations, fax or send by e-mail the 
additional follow-up information to the sponsor within 24 hours of receipt of the 
information.  If the subject can no longer be reached (lost to follow-up), documentation of 
the non-response/contact with two phone calls and a letter (certified with return receipt) is 
required. 
6. 
At outcome of pregnancy, complete as fully as possible the pregnancy surveillance 
form – Part II: Course and outcome of pregnancy, as full as possible. Inform the Sponsor 
by email/ fax, then fax or send by e-mail this pregnancy form to the Sponsor within 
24 hours of receipt of the information. 
7. 
If the pregnancy leads to an abortion (voluntary abortion, spontaneous abortion or 
therapeutic abortion), in utero death or congenital anomaly, follow the procedure for 
declaration of an SAE (see Section 8.2.2). 
8. 
If the investigator is informed of a developmental abnormality of the baby, even a long time 
after the end of the clinical trial, he/she must inform the sponsor and follow the procedure 
for declaration of an SAE (see section 8.2.2) 
Tel. during office hours 
 
Tel. Outside office hours 
 
Fax  
 
Email 
pharmacovigilance@galderma.com 


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9. 
STATISTICAL METHODS PLANNED 
9.1. 
STATISTICAL AND ANALYTICAL PLANS 
A Statistical Analysis Plan (SAP) will be developed as a separate document. The SAP will 
contain a more detailed and technical description of specific data conventions, calculations and of 
statistical procedures for executing the analyses that are specified in the sections of the clinical 
trial protocol below.  The SAP will be finalized prior to database lock. 
Any change made to the finalized SAP will be documented in the clinical trial report. 
The purpose of the trial is to evaluate subject reported outcomes with the combination of 
Adapalene 0.3% - BPO 2.5%, Epiduo® Forte / TactuPump Forte gel, after 16 weeks of 
treatment of moderate to severe acne in dark skin phototypes (IV to VI). 
9.1.1. Variables to be statistically analyzed 
The following variables will be analyzed: 
Subject reported outcome variable 
 DLQI/cDLQI at Baseline, Week 12 and last visit 
 Subject satisfaction questionnaire at Week 12 and last visit 
 
Efficacy variables 
 IGA score: % of subjects across scores at each visit 
 GAI score: % of subjects across scores at Week 12 and last visit 
 
Safety variables on safety population 
 PIH: Raw value at each visit and % change from baseline at each post-baseline visit 
 Local tolerance: Raw value at each visit and worst-score across visit, % of Subjects across 
scores at each post-baseline visit 
 Incidence of adverse events 
 Incidence of serious adverse events 


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Other variables 
 Cosmetic acceptability questionnaire at last visit 
9.1.2. Populations analysed, evaluability and limitations / evaluation of Bias 
The statistical analyses will be performed based on the following subject populations. The 
definition of the populations will be finalized after a data review meeting. 
9.1.2.1 The Intent-to-Treat efficacy population (ITT) 
This population will consist of the entire population enrolled (i.e. assigned a kit number). The 
ITT population will be used for all variables except the safety variables. 
9.1.2.2 The Safety population (All subject treated [APT]) 
This population will consist of the Intent-to-Treat population, after exclusion of subjects who 
never used the treatment with certainty based on monitoring report. The APT population will be 
only used for the safety variables (AEs). 
9.1.2.3 Missing values 
The last observation carried forward (LOCF) method will be used to impute missing values of 
global assessment scores (GAI and IGA). If no post-baseline data are available, baseline will be 
carried forward. Thus, the number of subjects will not vary at each visit. The other missing values 
will not be replaced (observed data). 
9.1.3. Data presentation and graphics 
All continuous data will be summarized using usual statistics: number of values, mean, median, 
standard deviation, minimum and maximum, and by frequency distribution (n, %) for qualitative 
data. For ordinal data, both frequency distribution and usual statistics will be presented. All tables 
will be presented by clinical trial treatment and by visit (when applicable).  
Therapies that have been stopped before the baseline visit will be presented as prior therapies. 
Those reported at screening or starting between screening and baseline visits and still continuing 
after baseline will be classified as concomitant therapies. 
The adverse events will be descriptively summarized (n, %) for the safety population (APT). The 
adverse events will be descriptively summarized (n, %) by relationship to clinical trial treatments 
within System Organ Class (SOC) and preferred term (MedDRA). Subjects will be descriptively 
summarized (n, %) by intensity (i.e. mild, moderate and severe) of adverse events, SOC and 
preferred terms. Deaths and serious adverse events will be reported as well as withdrawals due to 
adverse events. A subject will be counted only once per System Organ Class (SOC) and only 


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once per preferred term even if more than one occurrence of an event was reported within a SOC 
or preferred term. In the summary by categories of intensity, the adverse event with the highest 
intensity will be used. The subject will be counted only once per SOC (highest intensity whatever 
the AE within the SOC) and once per preferred term (highest intensity whatever the AE within 
the preferred term).  
9.1.4. Statistical analyses 
No inferential statistics will be performed. All variables will be descriptively summarized on ITT 
population and on APT population for the safety variables. The last observation carried forward 
(LOCF) method will be used to impute missing efficacy values. 
 
Any changes of the statistical analyses decided after the database lock will be justified and 
documented. 
9.2. 
SAMPLE SIZE DETERMINATION 
As no inferential statistics will be performed, no statistical rationale of sample size can be used. 
However, a total of 60 subjects to evaluate the subject reported outcomes (quality of life and 
satisfaction survey), can be considered as sufficient. 
10. 
TRAINING / MONITORING / DATA MANAGEMENT / QUALITY ASSURANCE 
A contract research organization (CRO) will be responsible for monitoring the clinical trial and 
the sponsor may perform co-monitoring visits at selected sites. 
10.1. PERSONNEL TRAINING 
Clinical Research Associates (CRA) will be trained prior to clinical trial initiation. During this 
training, an overview of the disease of interest and treatment will be presented. Specific 
monitoring guidelines and procedures to be followed during monitoring visits will be discussed. 
Initiation visits will be conducted with all Principal Investigators and site teams. During these 
visits, an extensive review and discussion of the protocol, procedures and eCRF will be 
conducted. Evaluation scales will also be reviewed. 
A trial reference monitoring manual will be provided to each CRA as an additional reference tool.  
An eCRF completion guideline will be provided to each CRA and site. These guidelines will 
contain instructions on how to fill-in the eCRF with some examples in order to standardize the 
eCRF completion as much as possible. 
A trial reference manual will be provided to each site as an additional reference tool. These 
guidelines will contain key CRO and Sponsor contacts and phone numbers and specific 


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instructions for site in order to standardize as much as possible the assessments performed during 
the clinical trial.  
During the Investigator meeting/Initiation visit this document will be discussed and reviewed 
thoroughly. 
10.2. CLINICAL MONITORING  
The conduct of the clinical trial will be closely monitored by representatives of 
CRO/GALDERMA R&D to verify the adherence to the clinical trial protocol, ICH-GCP 
regulations, applicable standard operating procedures (SOPs), guidelines, and all local 
regulations.  
The investigator will allow representatives of GALDERMA R&D/CRO to have direct access to all 
clinical trial records, eCRFs, corresponding subject medical records, investigational product 
dispensing records and investigational product storage area, site facilities and any other 
documents considered as source documentation. 
The investigator also agrees to assist the GALDERMA R&D/ CRO representatives, if required. 
10.3. DATA MANAGEMENT 
A CRO will be responsible for data management in connection with the sponsor’s data manager. 
All data management procedures will be detailed in the Data Management Plan (DMP).  
The DMP will describe the Clinical Data Management System (CDMS) that will be used to 
collect and validate data. Computerized edit checks and review processes will be performed on an 
ongoing basis as outlined in the DMP until all data discrepancies are resolved. 
After all data discrepancies are resolved, coding is approved, and subject evaluability has been 
determined, the data will be exported to SAS datasets and will be locked. 
At the end of the trial the locked SAS database will be used to generate subject listings, 
tabulations and analyses.  
The data may be audited by the sponsor and/or CRO Quality Assurance department before or 
after the first statistical analysis results on the primary criteria. 
10.4. QUALITY ASSURANCE / AUDIT / INSPECTION 
The clinical trial will be conducted under the sponsorship of GALDERMA R&D in compliance 
with all appropriate local and local regulations as well as ICH guidelines and in accordance with 
the SOPs for clinical trial conduct and monitoring from GALDERMA R&D and/or the Contract 
Research Organization (CRO). 


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Audits of clinical trial sites may be conducted by the Sponsor/CRO representatives, and 
inspection may be performed by Regulatory Authority inspectorates or IRBs/ECs before, during, 
or after the clinical trial.   
The investigator will allow and assist the CRO/Sponsor’s representatives, IRBs/ECs and any 
regulatory agency to have direct access to all requested clinical trial-related records. 
For the audits performed by, or on behalf of, GALDERMA R&D auditors, audit certificate(s) will 
be provided by Quality Assurance. 
11. 
ETHICS AND GENERAL CLINICAL TRIAL CONDUCT CONSIDERATIONS 
11.1. INSTITUTIONAL REVIEW BOARD (IRB) OR ETHICS COMMITTEE (EC) 
This clinical trial protocol will be reviewed and approved by IRBs/ECs prior to clinical trial 
initiation. 
This protocol may be modified at any time for ethical, medical or scientific reasons. Such 
modifications will be documented by a clinical protocol amendment and, if deemed necessary, an 
amended protocol will be issued. 
Before implementation, the amendment should be submitted and approved by applicable 
IRBs/ECs and, if required by the Regulatory Authority(ies). 
No amendment will be required for modification(s) due to a change in logistical or administrative 
aspects of the clinical trial (e.g., change in monitors, change of telephone numbers). In such a 
case, the appropriate institution(s) and/or person(s) will be directly notified of the changes. 
11.2. ETHICAL CONDUCT OF THE CLINICAL TRIAL 
This clinical trial will be conducted in accordance with the ethical principles originating from the 
Declaration of HELSINKI declaration (1964) and subsequent amendments, the International 
Conference on Harmonization (ICH), Good Clinical Practice (GCP) and in compliance with local 
regulatory requirements. 
11.3. SUBJECT INFORMATION SHEET / INFORMED CONSENT 
All subjects who participate in this trial will have to be fully informed about the clinical trial in 
accordance with the applicable regulations and GCP guidelines and in accordance with local legal 
requirements.  


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The Informed Consent Form (including appropriate Assent Form for children (aged 12 to 17) and 
as applicable, photograph release form) approved by an IRB/EC, will be fully explained to the 
subject and parent/guardian if applicable. 
 
Prior to any clinical trial procedures, the subject and parent/guardian will sign and date the 
informed consent form(s) which is written in the local language. A copy of the signed and dated 
form(s) will be given to the subject and parent/guardian. The investigator is responsible for 
maintaining each subject’s consent form(s) in the investigator’s site file (ISF) and providing each 
subject and parent/guardian with a copy of the consent form. 
The informed consent form including photograph release form approved by an IRB/EC will be 
fully explained to the subject and parent/guardian. 
11.4. CONTRACTUAL REQUIREMENTS  
A 
contractual 
agreement 
will 
be 
signed 
between 
the 
CRO/Sponsor 
and 
each 
Investigator/Institution.  This document will contain supplementary information, including 
financial terms, confidentiality, the clinical trial schedule, third party responsibility, and 
publication rights. 
11.5. DATA COLLECTION AND ARCHIVING 
11.5.1. Data Collection 
The investigator must maintain required records on all clinical trial subjects.  
Data for this clinical trial will be recorded in the subject’s source documents and in the eCRF, the 
product Dispensation Logs and the subjects’ diary provided by GALDERMA R&D.  
All data recorded in the documents described above should be recorded completely, promptly, 
and legibly using black ink.  
The appropriate pages will be collected upon clinical trial completion or at any other time 
specified by CRO/CRA/sponsor.  
A complete set of trial documents copies (when applicable) will remain at the investigational site. 
11.5.2. Source documentation 
Investigators must keep accurate separate records (other than the eCRF) of all subjects’ visits, 
and all procedures done, being sure to include all pertinent clinical trial related information from 
which eCRF data will be recorded.  


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A statement should be made on subject’s medical notes indicating that the subject has been 
enrolled in GALDERMA R&D protocol RD.03.SPR.110232 and has provided dated and 
signed informed consent and assent if appropriate. 
All adverse events with the associated concomitant therapies must be thoroughly documented. 
Results of any diagnostic tests conducted during the clinical trial will be included in the source 
documentation. 
Telephone conversations with the subjects and/or CRO/ GALDERMA R&D concerning the 
clinical trial may be recorded and kept on file. 
At the end of the trial a copy of photographs of all subjects will be burned on a CD and archived 
within trial files. 
11.5.3. Archives 
All pertinent data, samples, photos, questionnaires, correspondence, original or amended 
protocol, all reports and all other material relating to the clinical trial will be maintained securely 
in GALDERMA R&D / Investigator/Institution archives for the legally-required duration of 
archiving. 
If the investigator retires, relocates, or for any other reason withdraws from the responsibility of 
keeping the clinical trial records, custody must be transferred to a person who will accept the 
responsibility. The sponsor must be notified in writing of the name and address of the new 
custodian. 
11.6. INSURANCE 
A certificate attesting third party coverage of CRO/GALDERMA R&D will be provided upon 
request.


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12. 
REFERENCE LIST 
1. Alexis A.F., Sergay A.B., Taylor S.C. 2007. Common dermatologic disorders in skin of 
color: a comparative practice survey. Cutis. 2007, Vol. 80. 
2. Brown J.M., Poston S.M. 1983. Resistance of propionibacteria to antibiotics used in the 
treatment of acne. . J. Med. Microbiol . 1983. 
3. Del Rosso, J. Q. 2013. The role of skin care as an integral component in the management 
of acne vulgaris: Part 1: The importance of cleanser and moisturizer ingredients, design, 
and product selection. J Clin Aesthet Dermatol. 2013. 
4. Eady E.A., Cove J.H., Holland K.T., Cunliffe W.J. 1989. Erythromycin resistant 
propionibacteria in antibiotic treated acne patients: association with therapeutic failure . 
Brit. J. Dermatol. 1989. 
5. Grimes P., Edison B.L., Green B.A., et al. 2004. 8. Grimes P., Edison B.L., Green B.A., et 
al. Evaluation of inherent differences between African American and white skin surface 
properties using subjective and objective measures. Cutis. 2004. 
6. Kligman A.M., Shelley W.B. 1958. An investigation of the biology of the sebaceous 
gland. J Invest Dermatol. 1958. 
7. Koo , J Y et Smith, L L. 1991. Psychologic aspects of acne. Pediatr Dermatol. 1991, Vol. 
8, 3, pp. 185-188. 
8. Leyden J.J., Mc Ginley K.J., Cavalieri S., Webster G.F., Mills O.H. and Kligman A.M. 
1983. Propionibacterium Acnes Resistance to Antibiotics in Acne Patients. J. Am. Acad. 
Dermatol. 1983. 
9. Leyden, J J. 1995. New understandings of the pathogenesis of acne. J Am Acad Dermatol. 
1995, Vol. 32, pp. S15-S25. 
10. Lucky, A. W. 1987. Update on Acne Vulgaris. Pediatric Annals. 1987. 
11. Pochi P.E., Strauss JS. 1988. Sebaceous gland activity in black skin. Dermatol Clin. . 
1988. 
12. Schorr E.S., Sidou F., Kerrouche N. 2012. Adjunctive use of a facial moisturizer SPF 30 
containing ceramide precursor improves tolerability of topical tretinoin 0.05%: a 
randomized, investigator-blinded, split-face trial. J s Dermatol. 2012. 
13. Spiewak, R. 2008. Patch Testing for Contact Allergy and Allergic Contact Dermatitis. 
The Open Allergy Journal. 2008, Vol. 1, pp. 42-51. 


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14. Stein Gold L, Cruz A, Eichenfield L, et al. 2010. Effective and safe combination therapy 
for severe acne vulgaris: A randomized, vehicle-controlled, double-blind trial of 
Adapalene 0.1%-Benzoyl Peroxide 2.5% fixed-dose combination gel with doxycycline 
hyclate. Cutis. 2010. 
15. Usatine, RP, Quan, MA et Strick, R. 1998. Acne vulgaris: a treatment update. Hosp Pract. 
1998, Vol. 33, pp. 111-127. 
16. Warrier A.G., Kligman A.M., Harper R.A., et al. 1996. A comparison of black and white 
skin using noninvasive methods. J Soc Cosmet Chem. . 1996. 
17. Whitney P., Bowe M.Da and Leon H., Kircik M.Db. 2014. The importance of 
Photoprotection and moisturization in treating Acne Vulgaris. Drugs Dermatol. 2014. 
18. Zeichner, J. 2011. Strategies to minimize Irritation and potential iatrogenic post-
inflammatory pigmentation when treating acne patients with skin of color. J Drug 
Dermatol. 2011.


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13. 
ATTACHMENTS 
13.1. ATTACHMENT 1: QUALITY OF LIFE QUESTIONNAIRES 
DERMATOLOGY LIFE QUALITY INDEX (DLQI) &  
CHILDREN’S DERMATOLOGY LIFE QUALITY INDEX (C-DLQI) QUESTIONNAIRES 
 
DERMATOLOGY LIFE QUALITY INDEX QUESTIONNAIRE (DLQI) : 
 
At the beginning and end of the trial, subjects of 17 years old and over will answer the 10-item DLQI 
questionnaire. 
 
The aim of this questionnaire is to measure how much your skin problem has affected your life OVER 
THE LAST WEEK. Please tick  one box for each question 
 
1. 
Over the last week, how itchy, sore,  
 
painful or stinging has your skin been? 
 Very much 
 
 
 
 
 
 
 
 
 
A lot 
 
 
 
 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
Not at all 
 
 
2. 
Over the last week, how embarrassed or  
 
self-conscious have you been because of  
 
your skin? 
 Very much 
 
 
 
 
 
 
 
 
 
A lot 
 
 
 
 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
Not at all 
 
3. 
Over the last week, how much has your  
 
skin interfered with you going shopping or  
 
Very much 
 
 
looking after your home or garden? 
 
 
A lot 
 
 
 
 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
Not at all 
 
Not relevant 
 
4. 
Over the last week, how much has your  
 
skin influenced the clothes you wear? 
 
 
Very much 
 
 
 
 
 
 
 
 
 
A lot 
 
 
 
 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
Not at all 
 
Not relevant 
 
5. 
Over the last week, how much has your  
 
skin affected any social or leisure activities? 
 
Very much 
 
 
 
 
 
 
 
 
 
A lot 
 
 
 
 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
Not at all 
 
Not relevant 
 
 
 


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6. 
Over the last week, how much has your  
 
skin made it difficult for you to do any sport? 
 
Very much 
 
 
 
 
 
 
 
 
 
A lot 
 
 
 
 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
Not at all 
 
Not relevant 
 
 
7.  
Over the last week, has your skin prevented  
 
you from working or studying?  
 
 
Yes 
 
 
 
 
 
 
 
 
 
 
No 
 
 
Not relevant 
 
 
If "No", over the last week how much has  
 
your skin been a problem at work or studying?  
A lot 
 
 
 
 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
Not at all 
 
 
8. 
Over the last week, how much has your   
 
 
skin created problems with your partner or 
 
Very much 
 
  
any of your close friends or relatives?  
 
A lot 
 
 
 
 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
Not at all 
 
Not relevant 
 
 
9. 
Over the last week, how much has your  
 
skin caused any sexual difficulties? 
 
 
Very much 
 
 
 
 
 
 
 
 
 
A lot 
 
 
 
 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
Not at all 
 
Not relevant 
 
 
10. 
Over the last week, how much of a  
 
 
Very much 
 
 
problem has the treatment for your skin  
 
A lot 
 
 
 
been, for example by making your home  
 
A little  
 
 
messy, or by taking up time? 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
Not relevant 
 
 
Please check you have answered EVERY question. Thank you. 
®AY Finlay, GK Khan, April 1992 www.dermatology.org.uk, this must not be copied without the 
permission of the authors.



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CHILDREN’S DERMATOLOGY LIFE QUALITY INDEX QUESTIONNAIRE (cDLQI) : 
 
At the beginning and end of the trial, subjects of 12 to 16 years old included will answer the 10-item 
Children’s DLQI questionnaire.  
 
The aim of this questionnaire is to measure how much your skin problem has affected you OVER THE 
LAST WEEK. Please tick one box for each question. 
 
1. 
Over the last week, how itchy, "scratchy", 
 
 
Very much 
 
 
sore or painful has your skin been? 
 
 
  
Quite a lot 
 
 
 
  
 
 
 
 
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
2. 
Over the last week, how embarrassed  
 
 
Very much 
 
 
or self-conscious, upset or sad have you  
 
 
Quite a lot 
 
 
been because of your skin? 
 
  
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
3. 
Over the last week, how much has your   
 
 
Very much 
 
 
skin affected your friendships?   
 
 
 
Quite a lot 
 
 
 
 
 
 
 
 
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
4. 
Over the last week, how much have you changed 
 
Very much 
 
 
or worn different or special clothes/shoes 
 
 
Quite a lot 
 
 
because of your skin? 
 
 
 
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
5. 
Over the last week, how much has your   
 
 
Very much 
 
 
skin trouble affected going out, playing, 
 
 
Quite a lot 
 
 
or doing hobbies? 
 
 
 
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
6. 
Over the last week, how much have you   
 
 
Very much 
 
 
avoided swimming or other sports because 
 
 
Quite a lot 
 
 
of your skin trouble? 
 
 
 
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
7. 
Last week, 
  
 
If school time: Over the 
Prevented School 
 
was it  
 last week, how much did 
Very much 
 
 
school time?    
        
your skin affect your 
 
Quite a lot 
 
 
 
 
 
 
school work?  
 
Only a little 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
OR 
 
was it 
holiday time?  
 
If holiday time: How much 
Very much 
 
 
 
 
 
 
over the last week, has your 
Quite a lot 
 
 
 
 
 
 
skin problem interfered with 
Only a little 
 
 
 
 
 
 
your enjoyment of the holiday? Not at all 
 


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8. 
Over the last week, how much trouble   
 
 
Very much 
 
 
have you had because of your skin with  
 
 
Quite a lot 
 
 
other people calling you names, teasing, 
 
 
Only a little 
 
 
bullying, asking questions or avoiding you? 
 
 
Not at all 
 
 
 
9. 
Over the last week, how much has your sleep  
 
 
Very much 
 
 
been affected by your skin problem? 
 
 
 
Quite a lot 
 
 
 
 
 
 
 
 
 
 
Only a little 
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
10. 
Over the last week, how much of a  
 
 
 
Very much 
 
 
problem has the treatment for your  
 
 
 
Quite a lot 
 
 
skin been? 
 
 
 
 
 
 
Only a little 
 
 
 
 
 
 
 
 
 
  
Not at all 
 
 
 
 
 
Please check that you have answered EVERY question. Thank you. 
 
®M.S. Lewis-Jones, A.Y. Finlay, May 1993, this must not be copied without the permission of the 
authors. 
 
 
 
 


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13.2. ATTACHMENT 2: SUBJECT’S SATISFACTION QUESTIONNAIRE 
Please complete one questionnaire regarding the trial treatments you have been using in this trial. 
Please use a pen (not a pencil) to complete this questionnaire. Please give only ONE answer per 
question. There are no “Right” or “Wrong” answers. If you are unsure how to answer a question, 
please give the best answer you can. If you need to make a change, draw a line through the 
answer you would like to change, and then record your next response with a checkmark, put your 
initial and a date next to your correction. 
 
Your answers will not affect your participation in the trial and no prejudice will be shown 
towards you for completing this document. 
 
Questions about the acne treatment applied every evening: 
 
Whole face 
1. How bothered were you by the treatment side effects? 
Not bothered at all 
[  ] 
Bothered somewhat 
[  ] 
Bothered 
[  ] 
Bothered a great deal 
[  ] 
 
2. How satisfied were you with the time it took for treatment to work? 
Very satisfied 
[  ] 
Satisfied 
[  ] 
Somewhat satisfied 
[  ] 
Not satisfied 
[  ] 
 
3. How satisfied were you with the effectiveness of the treatment? 
Very satisfied 
[  ] 
Satisfied 
[  ] 
Somewhat satisfied 
[  ] 
Not satisfied 
[  ] 
 
4. How do you measure the improvement of the disease? 
Complete improvement 
[  ] 
Excellent improvement 
[  ] 
Good Improvement 
[  ] 
Minimal Improvement 
[  ] 
No Change 
[  ] 
Worse 
[  ] 
 
5. Overall, are you satisfied with the treatment? 
Very satisfied 
[  ] 
Satisfied 
[  ] 
Somewhat satisfied 
[  ] 
Not satisfied 
[  ] 
 


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6. Would you consider using this treatment again? 
Yes 
[  ] 
No 
[  ] 
 
7. Did you use the provided moisturizing lotion?  
Yes 
[  ] 
No 
[  ] 
 
If yes, would you say (check as many answers as you wish) 
[  ] The moisturizer helped to reduce stinging / burning sensations 
[  ] The moisturizer helped you to be adherent to trial treatments 
[  ] The moisturizer helped to reduce feeling of skin dryness 
[  ] The moisturizer was pleasant to use 
[  ] None of the above 
 
 


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13.3. ATTACHMENT 3: COSMETIC ACCEPTABILITY QUESTIONNAIRE 
 
MOISTURIZER: Cetaphil® DermaControlTM Oil control Moisturizer SPF 30 
 
1. Did you use the provided moisturizer? 
 
 
 
 
 
2. Would you say the moisturizer helps you to continue with the treatment? 
 
 
 
 
 
3. For each of the characteristics below, please tell us whether you agree or disagree: 
 
The moisturizer: 
Strongly 
disagree Disagree 
Agree 
Strongly 
agree 
Makes skin soft and smooth 
 
 
 
 
Is pleasant to use 
 
 
 
 
Is gentle enough 
 
 
 
 
Provides immediate hydration 
 
 
 
 
Is absorbed quickly by the skin 
 
 
 
 
Provides long lasting hydration 
 
 
 
 
Reduces skin dryness 
 
 
 
 
Relieves itchy skin 
 
 
 
 
Maintains skin health 
 
 
 
 
Reduces irritation 
 
 
 
 
Does not make my skin feel oily 
 
 
 
 
I feel this is needed as part of my acne 
treatment 
 
 
 
 
 


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FACIAL WASH: Cetaphil® DermaControlTM Oil control Foam Wash 
 
1. Did you use the provided facial cleanser? 
 
 
  
 
2. Would you say the facial cleanser helps you to continue with the treatment? 
 
 
 
  
 
3. For each of the characteristics below, please tell us whether you agree or disagree: 
 
The facial cleaning: 
Strongly 
disagree Disagree 
Agree 
Strongly 
agree 
Leaves my skin feeling clean 
 
 
 
 
Leaves my skin feeling relieved 
 
 
 
 
Makes my skin soft and smooth 
 
 
 
 
Does not leave my skin feeling tight 
 
 
 
 
Spread easily 
 
 
 
 
Is gentle enough 
 
 
 
 
Is pleasant to use 
 
 
 
 
Increases  my skin’s luminosity 
 
 
 
 
Does not dry my skin 
 
 
 
 
Increases  my overall skin appearance 
 
 
 
 
Helps prepare my skin for treatment 
 
 
 
 
I feel this is needed as part of my acne 
treatment