Clinical trial NCT03915860
Conditions: Acne Vulgaris
Sponsor: Galderma R&D
Start date: 2019-03-27; Completion date: 2019-12-23
Enrollment: 47 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Participant Reported Outcomes with use of Trifarotene 50 μg/g Cream in participants with Moderate Facial and Truncal Acne Vulgaris

Detailed description:
There was no formal hypothesis to be tested. Approximately 50 subjects would be enrolled to evaluate the subject reported outcomes (quality of life and satisfaction survey). The sample size was not based on any formal hypothesis testing.

Arms: arm 1: Participants applied Trifarotene 50 μg/g topically once daily in the evening for 24 weeks.
Interventions: intervention 1: Trifarotene
Intervention descriptions: intervention 1: Topical Cream

Protocol documents:
Prot_000.pdf: 
GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 1 of 88 
CLINICAL TRIAL PROTOCOL 
PROTOCOL NUMBER: RD.06.SPR.118295 
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 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. 
NCT03915860


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GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 3 of 88 
This clinical trial will be performed in compliance with applicable regulatory requirements and 
Good Clinical Practice (GCP). This clinical trial protocol follows guidelines outlined by the 
International Conference on Harmonisation (ICH) and the Galderma template. 


GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 4 of 88 
Table of Contents 
TITLE PAGE ............................................................................................................................................... 2 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ........................................................ 16 
1 
BACKGROUND AND RATIONALE ........................................................................................... 18 
1.1 
Medical background and short rationale for the clinical trial ............................................... 18 
1.2 
Drug profile ................................................................................................................................ 19 
1.3 
Risk/benefit assessment ............................................................................................................. 19 
2 
CLINICAL TRIAL OBJECTIVES AND CLINICAL HYPOTHESIS ..................................... 20 
2.1 
Clinical trial objectives .............................................................................................................. 20 
2.2 
Clinical hypotheses ..................................................................................................................... 20 
3 
OVERALL CLINICAL TRIAL DESCRIPTION ........................................................................ 21 
3.1 
Efficacy assessment .................................................................................................................... 21 
3.2 
Safety Assessment ...................................................................................................................... 21 
3.3 
Application areas........................................................................................................................ 21 
4 
CLINICAL TRIAL DURATION AND TERMINATION .......................................................... 23 
5 
SELECTION AND DISPOSITION OF CLINICAL TRIAL POPULATION .......................... 23 
5.1 
Number of subjects .................................................................................................................... 23 
5.2 
Clinical trial population characteristics ................................................................................... 23 
5.3 
Inclusion criteria ........................................................................................................................ 23 
5.4 
Exclusion criteria ....................................................................................................................... 25 
5.5 
Previous and concomitant therapies......................................................................................... 28 
5.5.1 
Definition ............................................................................................................................... 28 
5.5.2 
Categories .............................................................................................................................. 28 
5.5.3 
Recording ............................................................................................................................... 28 
5.5.4 
Authorized concomitant therapies ...................................................................................... 29 
5.5.5 
Prohibited concomitant therapies........................................................................................ 29 
5.6 
Procedures/reasons for subject discontinuation ...................................................................... 30 
6 
CLINICAL SUPPLIES ................................................................................................................... 32 
6.1 
Clinical supply identification and use ...................................................................................... 32 


GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 5 of 88 
6.1.1 
Study drug description ......................................................................................................... 32 
6.1.2 
Subject identification number ............................................................................................. 33 
6.1.3 
Kit number ............................................................................................................................ 33 
6.1.4 
Instructions for use and application .................................................................................... 33 
6.1.5 
Other supplies........................................................................................................................ 34 
6.2 
Study drug packaging and labeling .......................................................................................... 35 
6.3 
Supplies management ................................................................................................................ 35 
6.3.1 
Accountability ....................................................................................................................... 35 
6.3.2 
Storage of clinical study drug .............................................................................................. 35 
6.3.3 
Dispensing and return .......................................................................................................... 36 
6.3.4 
Treatment compliance management and record ............................................................... 36 
6.4 
Dose modification ....................................................................................................................... 37 
7 
CLINICAL TRIAL ASSESSMENT .............................................................................................. 37 
7.1 
Efficacy assessments .................................................................................................................. 37 
7.1.1 
Efficacy measurements ......................................................................................................... 37 
7.1.2 
Efficacy endpoints ................................................................................................................. 40 
7.2 
Safety assessment ....................................................................................................................... 41 
7.2.1 
Local tolerability assessment (of face and of trunk) .......................................................... 41 
7.2.2 
Adverse events ....................................................................................................................... 42 
7.3 
Other assessments ...................................................................................................................... 51 
7.3.1 
Photographs ........................................................................................................................... 51 
7.3.2 
Dermatology Life Quality Index (DLQI) / Children’s Dermatology Life 
Quality Index (C-DLQI) ....................................................................................................... 52 
7.3.3 
CompAQ for Facial and Truncal Acne ............................................................................... 53 
7.3.4 
EuroQoL 5-Dimension (EQ-5D-5L) .................................................................................... 54 
7.3.5 
Subject satisfaction questionnaire ....................................................................................... 54 
7.3.6 
Study drug acceptability questionnaire .............................................................................. 54 
8 
CLINICAL TRIAL VISITS DESCRIPTIONS AND PROCEDURES ...................................... 54 
8.1 
Description of clinical trial visits .............................................................................................. 54 


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GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 8 of 88 
List of Tables 
Table 1 
Clinical trial schematic ........................................................................................................... 13 
Table 2 
Schedule of assessments ......................................................................................................... 14 
Table 3 
Exit Form reasons for discontinuation .................................................................................... 31 
Table 4 
Description and usage of the study drug ................................................................................. 32 
Table 5 
Suspected sensitization - reaction grading .............................................................................. 49 
Table 6 
Suspected sensitization - conclusion ....................................................................................... 49 


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GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 16 of 88 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation Term 
°C 
Degrees Celsius 
°F 
Degrees Fahrenheit 
AE 
Adverse Event 
AESI 
Adverse Event of Special Interest 
CDLQI 
Children’s Dermatology Life Quality Index 
CDMS 
Clinical Data Management System 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CSO 
Clinical Safety Officer 
CSR 
DLQI 
Clinical Study Report 
Dermatology Life Quality Index 
DMP 
Data Management Plan  
EDC 
Electronic Data Capture 
e.g.
For Example (Latin: exempli gratia) 
ET
Early Termination  
etc.
Et cetera 
FDA
Food and Drug Administration 
FSI
First Subject In (first subject screened, i.e. who signs the Informed Consent Form) 
GCP
Good Clinical Practice 
HIPAA
Health Insurance Portability and Accountability Act of 1996 
IB
Investigator’s Brochure 
ICF 
ICH 
Informed Consent Form 
International Conference on Harmonization 
i.e.
That is (Latin: id est) 
IEC
Independent Ethics Committee  
IGA
Investigator’s Global Assessment 
IND
Investigational New Drug 
IRB
Institutional Review Board 
ITT
Intention-to-treat 
ITTT
Intent-to-treat on the Trunk  
IUD
Intrauterine Device 
LOAEL
Lowest-observed-adverse-effect level 


GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 17 of 88 
Abbreviation Term 
LOCF 
Last Observation Carried Forward 
LSI 
Last Subject In (Last subject enrolled/randomized) 
LSO 
Last Subject Out (Last subject who completed his/her last clinical trial visit) 
MI 
Multiple Imputation 
MD 
Medical Doctor 
MedDRA 
Medical Dictionary for Regulatory Activities 
mL 
Milliliter 
NOAEL 
no observed adverse effect level 
OTC 
Over-the-Counter 
PGA 
Physician Global Assessment 
PK 
Pharmacokinetics 
PP 
Per-Protocol 
PT 
Preferred term 
RAR 
Retinoic Acid Receptor 
RXR 
Retinoic X Receptor 
SAE 
Serious Adverse Event  
SAP 
Statistical Analysis Plan  
SAF 
Safety 
SAFT 
Safety Population on the Trunk 
SIN 
Subject Identification Number  
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
SPF 
Sun Protection Factor 
TEAE 
Treatment-Emergent Adverse Event 
UPT 
Urine Pregnancy Test  
USA 
United States of America 
UV 
Ultraviolet 


GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 18 of 88 
1 
BACKGROUND AND RATIONALE 
1.1 
Medical background and short rationale for the clinical trial 
Acne is one of the most common skin disorders treated by dermatologists. While acne is highly 
prevalent in youth with around 85% of teenagers affected at some point in time.1  In European 
populations over 70–80 % of all males will experience acne in some point of their lifetime. In the 
USA, acne has been reported to affect an estimated number of over 25 (17–45) million Americans.2 
As acne is a chronic and relapsing disease, normalizing follicular desquamation is then the key to 
achieve and maintain control of acne. It can persist for years and result in disfigurement and 
permanent scarring, and may have serious adverse effects on psychosocial development, resulting 
in emotional problems, withdrawal from society, and depression.3 Teenagers with even mild acne 
feel stigmatized and frustrated.4 Today it is established that retinoids acts in the pathology of acne 
vulgaris: it is a potent modulator of cellular differentiation and keratinisation. Topical retinoids 
have been the first-line treatment for most forms of acne vulgaris.5 
Acne is a multifactorial inflammatory disease affecting pilosebaceous follicles.6, 7, 2 Both clinically 
and pathophysiologically, truncal acne and facial acne are similar in terms of specific lesions (eg, 
closed comedones, open comedones, papules and pustules etc.). Further, the management of 
truncal acne vulgaris warrants an approach similar to what is used for the treatment of facial acne8. 
Truncal acne has been estimated to occur in over half the number of acne patients even if facial 
acne is the most common and often the most visible form of acne. In one study of patients referred 
to a dermatology clinic, it was found more than 60 percent of individuals had back acne 9. In 
another cohort of 696 patients, half of patients with facial acne were found to have coexistent 
truncal involvement. Approximately 50% of patients who presented with acne vulgaris 
demonstrated involvement on the chest and/or back, with more than 3% presenting with truncal 
acne lesions alone. Interestingly, approximately 1 out of 4 patients who presented with both facial 
and truncal acne involvement did not voluntarily mention the presence of truncal acne as part of 
their presenting complaint. In such cases, the presence of truncal acne lesions was detected by 
clinical examination. The majority of patients presenting with truncal acne vulgaris exhibited mild 
to moderate severity and more than 75% were interested in treatment for truncal acne lesions. 10 
Trifarotene, a new generation topical retinoid with its unique mechanism of action, binds to 
specific retinoic acid receptor (RAR-ɤ).11 Current evidence suggests that topical Trifarotene 
normalizes the differentiation of follicular epithelial cells resulting in decreased microcomedone 
formation. It may be an ideal topical agent with high selectivity towards gamma receptors, skin 
metabolism and with very low systemic absorption for management of acne treatment. Currently 
under clinical development with studies in acne vulgaris of face and trunk. However, it is also 
important in terms of patient-reported outcomes (PRO) to assess satisfaction that might be caused 
by the treatment or by acne itself and to also assess the local tolerability.  
Proper skin care is considered to be an important component of the total management plan for 
patients with acne vulgaris. There are several ways to mitigate adverse effect and prevent further 
worsening of skin tolerability. These include initiating patients on lower concentrations of topical 
retinoids, choosing cream or lotion (rather than gel). Trifarotene, being a highly selective RAR-ɤ 


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GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 31 of 88 
Table 3 
Exit Form reasons for discontinuation 
Pregnancy: 
Withdraw the Subject from the clinical trial and follow the procedure described in 
Section 7.2.2.2.5. 
Lack of Efficacy: 
Investigator judgment only: based on therapeutic/disease-state expectations. If subject 
opinion only, mark “subject request” and document it in the comment section of the Exit 
Form. 
Adverse Event: 
Complete an Adverse Event Form. 
Subject Requesta: 
Includes consent withdrawal, subject relocation, schedule conflicts. Explain the reason for 
withdrawal in the comment section of the Exit Form. If a subject withdraws consent 
because of an adverse event, the reason for discontinuation should be Adverse Event 
Protocol Violation: 
Explain the violation in the comment section of the Exit Form. 
Lost to Follow-up: 
Confirmed with two documented phone calls and a certified letter (delivery receipt 
requested) without answer. Explain in the comment section of the Exit Form. 
Othera: 
This category is to be used for a subject who discontinues due to a reason other than as 
specified in the predefined categories above. Explain the reason for discontinuation in the 
comment section of the Exit Form. 
a) If reason for discontinuation is “subject request” or “other”, the subject will be questioned to rule out the possibility of an AE (this
should be documented in the comment section of the Exit Form). 


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GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 43 of 88 
 
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 any clinically significant worsening of an existing sign, 
symptom or disease compared to the condition at the first visit (including disease treated), should 
be considered as an AE. Lack of efficacy is not considered as an AE. 
Each new episode of a chronic disease (e.g., hay fever, allergy, etc.) 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 is not to be considered as an AE; however, is an important medical event that must 
be monitored as described in Section 7.2.2.2.5. 
7.2.2.1.2 
Serious Adverse events  
A serious adverse event (SAE) is any untoward medical occurrence that at any dose: 
 Results in death, 
 Is life-threatening, 
 Requires inpatient hospitalization or prolongation of existing hospitalization, 
 Results in persistent or significant disability/incapacity, or 
 Is a congenital anomaly/birth defect. 
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. 


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GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 45 of 88 
 
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 may not appear until a 
medication has been discontinued. 
7.2.2.1.6 
Severity 
Severity is a clinical determination of the intensity of an AE and not of a disease. 
The Investigator is to 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 signs or symptom, but easily tolerated. 
Moderate 
Discomfort, enough to cause interference with usual activity 
Severe 
Incapacitating with inability to work or perform usual activity 
7.2.2.1.7 
Relationship to the study drug 
The Investigator is to determine whether there is a reasonable causal relationship between the study 
drug and the AE. Medical judgment should be used to determine the relationship, considering all 
relevant factors including the pattern of reaction, temporal relationships, positive challenge or 
rechallenge, relevant medical history, and confounding factors such as co-medication or 
concurrent diseases. 
The expression “reasonable causal relationship” is meant to convey in general that there are facts 
or arguments to suggest a causal relationship (ICH E2A, Section IIIA 1). 
The relationship assessment for an AE is to be completed using the following definitions as a 
guideline for all AEs occurring during clinical trials conducted or sponsored by 
GALDERMA R&D: 
Reasonable possibility: 
 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 study drug (investigational product and the AE),  
 The clinical trial protocol procedure (such as blood test) and the AE. 


GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 46 of 88 
 
No reasonable possibility: 
No suggestive evidence or arguments can be identified regarding a causal relationship between the 
study drug or the clinical trial protocol procedure and the AE. 
7.2.2.2 
Reporting procedures 
7.2.2.2.1 
Procedures for reporting adverse events 
The collection of AEs is from the time that a subject signs the ICF to their final visit. 
At each post-enrollment visit, the Investigator (or sub-Investigator) will question the subject about 
AEs using an open non-persuasive question to elicit reporting of AEs, for example: “Have you 
noticed any change in your health since the last visit?” Directed questioning and examination will 
then be performed, as appropriate.  
Any AE occurring during the AE reporting period, whether it is related to the study drug or not, 
will be recorded immediately in the source document, and described on the Adverse Event Form 
along with the date of onset, severity, relationship to the study drug, and outcome, without omitting 
any requested and known information. Additional information may be requested under certain 
circumstances. Adverse Events 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. 
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 7.2.2.2.2), 
AESIs 
(see 
Section 7.2.2.2.3), 
and 
pregnancies 
(see Section 7.2.2.2.5), the CSO is to be informed immediately by fax or email. The event must be 
reported by facsimile or scan and sent by e-mail to the CSO within 24 hours of knowledge of the 
event (contact details in Section 7.2.2.2.2). 
7.2.2.2.2 
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 the subject is the 
first priority. 
2. 
Immediately inform the CSO of the event by fax or email and discuss further actions to be 
taken. 


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GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 53 of 88 
 
summing the scores of each question, resulting in a maximum of 30 and a minimum of 0. A 
lower score on the DLQI indicated increased QOL; therefore, negative changes from Baseline 
indicate improvement. The meaning of the DLQI total scores were interpreted as: no effect (0-1), 
small effect (2-5), moderate effect (6-10), very large effect (11-20), or extremely large effect (21-
30). 
For the cDLQI: 
The meaning of the DLQI total scores were interpreted as: no effect (0-1), small effect (2-6), 
moderate effect (7-12), very large effect (13-18),or extremely large effect (19-30). 
 
The higher the score, the more quality of life is impaired. For instructions of use and scoring: 
http://sites.cardiff.ac.uk/dermatology/quality-of-life/dermatology-quality-of-life-index-dlqi/dlqi-
instructions-for-use-and-scoring 
The questionnaires completed will be considered as source data and the answers will be entered 
into the CRF by the site. 
7.3.3 
CompAQ for Facial and Truncal Acne 
It will be collected at baseline, week 12 and 24/ early termination. The Investigator or designee 
should provide the subject (16 years of age and older) with the comprehensive QoL measure 
inclusive of facial and truncal form and instruct the subject to read and answer all 20 quality of life 
questions. The questionnaire will measure the impact of facial and torso acne on health-related 
quality of life.  
The 20 questions consists of 5 domains that assess a variety of psychosocial and physical impacts 
of acne: Psychological/Emotional, Social (Judgement From Others), Social Interactions, 
Treatment Concerns, Physical Symptoms. The score on the CompAQ has a possible range of 0 to 
160. The higher the score, the more quality of life is impaired. For instructions of use and scoring 
( Chelsea McLellan, Marc P. Frey, Diane Thiboutot, Alison Layton, Mary-Margaret Chren, Jerry 
Tan, Development of a Comprehensive Quality-of-Life Measure for Facial and Torso Acne.  
Journal 
of 
Cutaneous 
Medicine and Surgery First Published January 31, 2018 
https://doi.org/10.1177/1203475418756379)  
 
An anchor question is added in order to detect responsivity with intervention and for Minimal 
Clinically Important Difference (MCID). 
Higher scores indicate greater adverse impact 
•The response range for each question is from 0–8 with higher numbers indicating greater adverse 
impact. 
•For each domain, response range is from 0–32. 
•For the long form questionnaire, response range is from 0–160 
•For the short form questionnaire, response range is from 0–40 
The investigator or delegate will then check all questions of the questionnaire for completeness 
prior to the subject leaving the office. 


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GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 64 of 88 
 
Subject disposition, demographics and baseline characteristics, previous therapies, and 
concomitant therapies will be summarized by descriptive statistics based on the ITT Population. 
Treatment exposure and compliance data will be summarized based on the Safety Population. 
For statistical analysis purposes, previous therapies/procedures are defined as those ending at 
Baseline or before; and concomitant therapies/procedures are defined as those ongoing at the 
Baseline visit or starting after the Baseline visit. 
Treatment-emergent Adverse Events (TEAEs) are defined as AEs with onset on or after first dose 
of study drug; or those AEs with onset prior to first dose of study drug but worsened during 
treatment.  
TEAEs will be tabulated in frequency tables by System Organ Class (SOC) and Preferred Term 
(PT) based on the Medical Dictionary for Regulatory Activities (MedDRA). Additional summary 
tables will be provided for SAEs, AEs considered related to the study drug, severe AEs, AESIs, 
and AEs leading to discontinuation. For a given AE, a subject will be counted once even if he/she 
has experienced multiple episodes of that particular AE.  
In addition, non TEAEs will be summarized or listed separately. 
For local tolerability (erythema, scaling, dryness, stinging/burning), data will be summarized for 
worst score over treatment period, the final score during treatment, as well as scores for each visit. 
The quality of life indices, EQ-5D-5L, COMPAQ (including the anchor question), C-DLQI, and 
DLQI will be summarized descriptively. 
Subgroup analyses will be explored by analysis center, age (<18 years, ≥18 years), gender and race 
if appropriate for efficacy endpoint, and safety endpoints (TEAEs and Local tolerability).  
Further details will be provided in the SAP. 
9.1.3.1 
Imputation of missing data 
The last observation carried forward (LOCF) will be used to impute efficacy endpoints, where 
applicable. Non-responder analysis will also be carried out for Binary endpoints.  
Further details will be provided in the SAP. 
9.1.3.2 
Statistical hypothesis testing and multiplicity adjustment 
Analysis of Efficacy Endpoint 
All efficacy and patient reported endpoints will be summarized with point estimate and 95% 
confidence intervals.  
Further details will be provided in SAP.  


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GALDERMA R&D 
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The Investigator will allow the CRO / Sponsor’s representatives, to have direct access to all clinical 
trial records, CRFs, corresponding subject medical records, study drug dispensing records, study 
drug storage area, clinical trial facilities, and any other documents considered source 
documentation.  
The Investigator also agrees to assist the representative if required. 
10.3 
Data management 
The designated CRO will be responsible for activities associated with the data management of this 
study. 
 
This will include, but not limited to, setting up a relevant database and data transfer mechanisms, 
along with appropriate validation of data and resolution of queries. 
 
Study sites will enter data directly into an electronic data capture (EDC) system by completing the 
CRF via a secure internet connection. Data entered into the CRF must be verifiable against source 
documents at the study center. Data to be recorded directly on the CRF will be identified and the 
CRF will be considered the source document. Any changes to the data entered into the EDC system 
will be recorded in the audit trail. 
 
All data management activities will be detailed in a Data Management Plan (DMP). 
10.4 
Quality assurance / audit / inspection 
The clinical trial is conducted under the sponsorship of GALDERMA R&D in compliance with 
the applicable international and local regulatory requirements as well as applicable ICH guidelines 
and in accordance with the SOPs for clinical trial conduct and monitoring from GALDERMA 
and/or the CRO. 
At the completion of the study, digital images will be forwarded to the Sponsor according to 
individual testing facility SOPs.  
 
Audits of clinical trial centers may be conducted by the Sponsor/CRO representatives, and 
inspection may be performed by Regulatory Authority inspectorates or IRBs/IECs before, during, 
or after the clinical trial.  
The Investigator will allow and assist the CRO /Sponsor’s representatives, IRBs/IECs 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 auditors, audit certificate(s) will be 
provided by Quality Assurance. 
10.5 
Changes in clinical trial conduct / amendments 


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10.5.1 
Clinical trial conduct 
With the exception of eliminating an immediate hazard to a subject, the Investigator should not 
deviate from the clinical trial protocol or implement any changes without written approval from 
the Sponsor and prior review and documented approval/favorable opinion from the IRB/IEC of a 
protocol amendment. 
Changes that involve only logistical or administrative changes to the clinical trial protocol are 
authorized. The Investigator should document and explain any deviation from the clinical trial 
protocol. 
10.5.2 
Amendments 
The Sponsor may modify the clinical trial protocol at any time for ethical, medical, or scientific 
reasons. 
10.5.3 
Attrition 
Clinical studies may experience attrition. Subjects will be made aware that they are free to 
withdraw from the study at any time for any reason, without prejudice. Otherwise, every effort will 
be made to have subjects complete the study as stated in this protocol, ensuring subject safety and 
following the provisions of the ICF. Reasons for subject withdrawal may include an AE, SAE, 
subject’s request, protocol violation, lost to follow-up, and other reasons. Subjects lost from the 
study will be documented on a screening/enrollment log.   
 
If a subject fails to return for a scheduled examination, a representative of clinical site (site 
representative/study coordinator) will attempt to contact the subject and determine whether the 
subject has continued to follow study instructions and intends to continue participation in the study.  
If so, then the subject will be rescheduled to come into the clinic as soon as possible.  
 
If a rescheduled visit is outside of the specified time frame window, this will be recorded in the 
screening/enrollment log and as a deviation.  
 
If a subject cannot reschedule in an acceptable time frame and completely misses 1 study visit, the 
subject may be allowed to continue study participation at the discretion of the Investigator and the 
Sponsor, provided that the subject has continued to comply with study instructions. If the subject 
is allowed to continue, the missed visit will be noted in the screening/enrollment log and recorded 
as a protocol deviation. Subjects will not be allowed to miss the week 12 visit. 
 
11 
ETHICS AND GENERAL CLINICAL TRIAL CONDUCT CONSIDERATIONS 


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11.1 
Institutional Review Board or Independent Ethics Committee  
This study (protocol, ICF and all addenda) will be reviewed and approved by IntegReview IRB.  
The study will not be activated and subjects will not be consented, receive any study products, or 
participate in any study procedures until such time as the IRB has approved the protocol and the 
ICF. In addition, the IRB will review the study before any significant change in the protocol is 
initiated.  After each review, the IRB's approval will be documented in a letter to the Investigator 
and a copy of the IRB approval letter will be forwarded to the Sponsor.  
11.2 
Ethical conduct of the clinical trial 
This clinical trial will be conducted in accordance with the protocol, the HELSINKI declaration 
(1964) and subsequent amendments, and the ICH GCP, and in compliance with applicable 
regulatory requirements.  
11.3 
Subject information and consent 
All subjects who participate in this clinical trial are required to be fully informed about the clinical 
trial in accordance with GCPs guidelines, federal regulations, HIPAA (if in the US), or applicable 
local privacy act if in other countries, and guidelines and in accordance with local requirements. 
The ICF, Assent Form, HIPAA or other applicable local privacy act), and Photo Consent Form, 
approved by an IRB/IEC, will be fully explained to the subject. 
Prior to enrolment into the clinical trial, the subject and as needed, the subject’s parent/legal 
representative will sign and date the consent form(s), including assent.  The Investigator is 
responsible for maintaining each subject’s consent form(s) in the Investigator’s site file and 
providing each subject, and his/her parent legal representative with a copy of the signed and dated 
consent form(s) including assent. 
11.4 
Contractual requirements 
A 
contractual 
agreement 
will 
be 
signed 
between 
the 
Sponsor/CRO 
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 


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Page 69 of 88 
The Investigator must maintain all required records for all subjects. Data for this clinical trial will 
be recorded in the subject’s source documents, subject photographs and on the CRFs provided by 
the Sponsor. All data should be recorded on the CRFs completely and promptly. 
11.5.2 
Source documentation 
The Investigator must keep accurate separate records (other than the CRFs) of all subject visits, 
being sure to include all pertinent clinical trial-related information. A statement should be made 
indicating that the subjects have been included in this clinical trial and have provided signed 
written Informed Consent and Assent as applicable. All AEs must be thoroughly documented. 
Results of any diagnostic tests conducted during the clinical trial should also be included in the 
source documentation.  
11.5.3 
Archives 
All pertinent data, samples, photographs, correspondence, and reports, the original or amended 
clinical trial protocol, and all other material relating to the clinical trial will be maintained securely 
in Sponsor/CRO Investigator/Institution archives for the legally required duration for archiving. 
The Investigator/Institution should maintain the essential clinical trial documents as specified in 
Section 8 of ICH-GCP, and according to the applicable regulatory requirements. 
The Investigator/Institution should take measures to prevent accidental or premature destruction 
of these documents. 
If the Principal Investigator retires, relocates, or withdraws from the responsibility of keeping the 
clinical trial records for any other reasons, custody must be transferred to a person who will accept 
the responsibility. The Sponsor/CRO must be notified in writing of the name and address of the 
new custodian. 
11.6 
Insurance 
A certificate attesting Third Party coverage of Sponsor/CRO will be provided upon request. 
12 
LITERATURE REFERENCE LIST 
1. Canavan TN, Chen E, Elewski BE. Optimizing non-antibiotic treatments for patients with
acne: a review. Dermatol Ther. 2016;6(4):1-24.
2. Tsatsou F, Zouboulis CC. Anatomy of the sebaceous gland. In: Zouboulis C, Katsambas
A, Kligman, A, eds. Pathogenesis and Treatment of Acne and Rosacea. London, UK:
Springer; 2014:27-31.


GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 70 of 88 
3. Koo JY, et al. Psychologic aspects of acne. Pediatr Dermatol. 1991; 8:185-8.
4. Osterweil N, ed. Frustrated adults told acne was adolescent disease, survey says. Dermatol
Times. 1993;14(suppl):S5-S6.
5. Bayramgurler D, Pelin Kartal S, Altunel, C. Use of topical retinoids in acne. In: Pelin
Kartal, ed.Acne  and Acneiform Eruptions. London, UK: IntechOpen;  2017: 118-127.
6. Dreno B. Pathophysiology of acne. Presse Medicale. 2005 Apr 9;34(7):537-9.
7. Gollnick H. Current concepts of the pathogenesis of acne: implications for drug treatment.
2003;63(15):1579-1596.
8. Del Rosso JQ. Management of truncal acne vulgaris: current perspectives on treatment.
Cutis. 2006 May;77(5):285-9.
9. Joseph Bikowski. Managing Two Challenging Presentations of Acne. Practical
Dermatology, March 2011 : 63-65
10. Del Rosso JQ, Bikowski JB, Baum E, Smith J, Hawkes S, Benes V, Bhatia N. A closer
look at truncal acne vulgaris: prevalence, severity, and clinical significance. J Drugs
Dermatol. 2007 Jun;6(6):597-600.
11. Thoreau E, Arlabosse JM, Bouix-Peter C, Chambon S, Chantalat L, Daver S, et al.
Structure-based design of Trifarotene (CD5789), a potent and selective RARgamma
agonist for the treatment of acne. Bioorg Med Chem Lett. 2018;28(10):1736-41.
12. Del Rosso JQ. 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;6(12):19-27.
13. Davis EC, Callender VD. A review of acne in ethnic skin: pathogenesis, clinical
manifestations, and management strategies. Jour Clin Aesthet Dermatol., 2010 Apr;
3(4):24-38.
14. Schorr ES, Sidou F, Kerrouche N. Adjunctive use of a facial moisturizer SPF 30 containing
ceramide precursor improves tolerability of topical tretinoin 0.05%: a randomized,
investigator-blinded, split-face study. J Drugs Dermatol. 2012;11(9):1104-1107.
15. Bowe WP, Kircik LH. Importance of photoprotection and moisturization in treating acne
vulgaris . J Drugs Dermatol. 2014 Aug;13(8): s89-94.
16. Del Rosso JQ, Brandt S. The role of skin care as an integral component in the management
of acne vulgaris. Part 2: Tolerability and performance of a designated skin care regimen
using a foam wash and moisturizer SPF 30 in patients with acne vulgaris undergoing active
treatment. J Clin Aesthet Dermatol. 2013;6(12):28-36.
17. Usatine R, Quan M, Strick R. Acne vulgaris:a treatment update. Hosp Prac 1998;Feb
15:111-127.
18. Pawin H., Beylot C., Chivot M. et al., Physiopathology of acne vulgaris: recent data, new
understanding of the treatments. Eur J Dermatol. 2004 Jan Feb;14(1):4 12.


GALDERMA R&D 
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19. Leyden J.J. Topical treatment of acne vulgaris: Retinoids and cutaneous irritation. J Am 
Acad Dermatol. 1998 Apr; 38(4):S1 4.  
20. Rizer, RL, Mills, OH, Trookman, NS. The assessment of acne: a re-evaluation of grading 
strategies. Scientific Poster, Annual Meeting of the American Academy of Dermatology 
(2001). 
21. Dreno B, Bissonnette R, Gagne-Henley A, et al. Prevention and Reduction of Atrophic Acne Scars 
with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial 
Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual 
Comparison. Am J Clin Dermatol. 2018;19(2):275-286.  
 
22. Cook CH, Centner RC, Michaels SE.  An acne grading method using photographic 
standards. Arch Dermatol. 1979;115:571-575. 
 
 


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GALDERMA R&D 
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13.3 
Dermatology Life Quality Index (DLQI) 
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,  
 
 
Very much 
 
 
 
painful or stinging has your skin    
 
 
A lot 
 
 
 
 
been?   
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
2. 
Over the last week, how embarrassed 
 
 
Very much 
 
 
 
or self-conscious have you been because  
 
 
A lot 
 
 
 
 
of your skin? 
 
  
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
3. 
Over the last week, how much has your  
 
 
Very much 
 
 
 
skin interfered with you going 
 
 
 
A lot 
 
 
 
 
shopping or looking after your home or  
 
 
A little  
 
 
 
garden?  
 
 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant  
 
 
 
4. 
Over the last week, how much has your  
 
 
Very much 
 
 
 
skin influenced the clothes  
 
 
 
A lot 
 
 
 
 
you wear? 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant 
 
 
 
5. 
Over the last week, how much has your  
 
 
Very much 
 
 
 
skin affected any social or  
 
 
 
A lot 
 
 
 
 
leisure activities? 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant 
 
 
 
6. 
Over the last week, how much has your  
 
 
Very much 
 
 
 
skin made it difficult for   
 
 
 
A lot 
 
 
 
 
you to do any sport? 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant  
 
 
 
7. 
Over the last week, has your skin prevented  
 
Yes 
 
 
 
 
you from working or studying? 
 
 
 
No 
 
 
 
 
 
 
 
 
 
 
 
Not relevant 
 
 
 
 
 
If “No”, over the last week how much has   
 
A lot 
 
 
 
 
your skin been a problem at  
 
 
 
A little  
 
 
 
work or studying? 
 
 
 
 
Not at all 
 
 
 
8. 
Over the last week, how much has your  
 
 
Very much 
 
 
 
skin created problems with your  
 
 
 
A lot 
 
 
 
 
partner or any of your close friends 
 
 
A little  
 
 
 
or relatives?  
 
 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant  
 
 


GALDERMA R&D 
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9.
Over the last week, how much has your
Very much 
 
skin caused any sexual difficulties?
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
A lot 
 
skin been, for example by making
A little 
 
your home messy, or by taking up time?
Not at all 
 
Not relevant 
 
Please check that you have answered EVERY question. Thank you.  
AY Finlay, GK Khan, April 1992, This must not be copied without the permission of the authors. 


GALDERMA R&D 
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13.4 
Children’s Dermatology Life Quality Index (C-DLQI) 
 
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 
 
 
 
OR 
 
 
 
 
 
 
 
Not at all 
 
 
 
 
was it 
 
 
If holiday time: How much 
 
Very much 
 
 
 
holiday time? 
 
over the last week, has your 
 
Quite a lot 
 
 
 
 
 
 
skin problem interfered with 
 
Only a little 
 
 
 
 
 
 
your enjoyment of the holiday? 
 
Not at all 
 
 
 
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 
 
 
 


GALDERMA R&D 
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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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13.5 
QOL Questionnaire for Face and Trunk Acne (16 years of age and older) 
CompAQ Measure (Long Form) 
We define acne as pimples, zits, or breakouts. We do not mean holes, dark spots, or red spots left 
by acne. 
Thinking about the last 7 days, please answer the following questions about acne on your 
[face/torso (eg, chest, back, shoulders)] using the following scale: 
0 
1 
2 
3 
4 
5 
6 
7 
8 
Never 
Rarely 
Sometimes 
Often 
All the time 
Items, split by domain 
Response Choices 
0 
1 
2 
3 
4 
5 
6 
7 
8 
A.
Psychological/Emotional
Because of my acne…. 
1.
I feel depressed, sad, or upset.
2.
I feel embarrassed.
3.
I feel self-conscious.
4.
I feel less confident.
B.
Social (Judgment from others)
Because of my acne… 
5.
I feel that people stare at me.
6.
I feel like people judge me.
7.
People treat me differently.
8.
People think less of me.
C.
Social Interactions
Because of my acne… 
9.
I avoid social interactions.
10. I spend less time with my friends.
11. I am concerned about meeting new people.
12. I am uncomfortable showing affection to others.
D.
Treatment Concerns
Because of my acne… 
13. I spend a lot time taking care of my skin (at home remedies,
treatments, cleansing).
14. I spend time looking at my skin.
15. I am concerned that my skin will never be clear.
16. I am concerned about side effects from treatment.
E.
Physical Symptoms
      Because of my acne… 


GALDERMA R&D 
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17. My skin feels bumpy or uneven. 
18. My skin feels dirty. 
19. My skin is red. 
20. My skin causes me discomfort or pain. 
Since your baseline visit in this study, has there been any change in overall quality of life 
related to your acne? 
RESPONSE RANGE:  
Patient instructions: Please circle the number that best describes your response where -7 indicates 
a great deal WORSE and +7 indicates a great deal BETTER 
 
 
-7 (a great deal WORSE)   -6     -5     -4     -3     -2     -1       0  (No change)   +1     +2     +3     +4     
+5     +6     +7 (a great deal BETTER) 
 
The above is based on this section of the paper for MCID determination for DLQI GRCQ 
The GRCQ [4], used as an anchor, allows patients to give a self-assessment of the change since 
baseline assessment in, for example, overall QoL or severity of skin condition, whether it has 
improved, remained the same or deteriorated. It has a 15-point scoring system with responses 
ranging from a very great deal better (+7) to no change (0) to a very great deal worse (-7). The 
GRCQ with a 15-point scoring system was chosen to maximize the sensitivity of the responses. 
Respondents with scores of 0, -1 or 1 are classified as unchanged or having a small but unimportant 
change. Respondents whose scores are 2, 3, -2 or -3 are considered to have experienced a small 
change equivalent to the minimal important difference. Those with scores of 4, 5, -4 or -5 are 
considered to have experienced a moderate change, and those with scores of 6, 7, -6 or -7 are 
considered to have experienced a large change [3,4]. The question posed was: ‘Since your first 
clinic visit, has there been any change in overall quality of life related to your skin disease?' 
REF: Basra M, K, A, Salek M, S, Camilleri L, Sturkey R, Finlay A, Y: Determining the Minimal 
Clinically Important Difference and Responsiveness of the Dermatology Life Quality Index 
(DLQI): Further Data. Dermatology 2015;230:27-33. doi: 10.1159/000365390 
 
 
 


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13.6 
EuroQoL 5-Dimension (EQ-5D-5L) 


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13.7 
Fitzpatrick Skin Classification 
The Fitzpatrick skin classification is based on the skin’s unprotected response to the first 30 to 45 
minutes of sun exposure after a winter season without sun exposure. The categories of skin types 
are as follows: 
I 
White; very fair; red or blonde hair; blue eyes; freckles 
Always burns easily; never tans 
II 
White; fair; red or blonde hair; blue, hazel, or green eyes 
Always burns easily; tans minimally 
III Cream white; fair with any eye or hair color; very common 
Burns moderately; tans gradually 
IV Brown; typical Mediterranean white skin 
Burns minimally; always tans well 
V 
Dark brown; mid-eastern skin types, black hair, olive skin 
Rarely burns; tans profusely 
VI Black; black hair, black eyes, black skin 
Never burns; deeply pigmented 


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GALDERMA R&D 
RD.06.SPR.118295 Protocol V02 04Jun2019 
Page 88 of 88 
Protocol Signature Page 
I agree to conduct the trial in compliance: 
•
With the protocol, or any applicable amendment(s), agreed to by the sponsor, regulatory
authority and which was given a favorable opinion by the IRB/IEC
•
With Good Clinical Practices
•
With applicable local and international laws and regulations
•
With the instructions I received about
−ethic principles and subjects protection
−data collection and reporting
−study drug(s) and material(s) use and management
−clinical trial monitoring, audit and inspection
I have read this protocol in its entirety, including the above statement, and I agree to all aspects. 
Investigator (first name/last name)
    Signature         
Date: 

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