A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Moderate to Severe Atopic Dermatitis in Children and Adults
Phase: PHASE3
Conditions: Atopic Dermatitis
Sponsor: Organon and Co

Tapinarof 
Protocol No.: DMVT-505-3102, Amendment 3 
Dermavant Sciences, Inc. 
Clinical Study Protocol 
Confidentiality Statement 
The information contained in this document, particularly unpublished data, is the property or under control of Dermavant Sciences, 
Inc. and is provided to you in confidence as an investigator, potential investigator, or consultant, for review by you, your staff, and 
an applicable Institutional Review Board or Independent Ethics Committee.  The information is only to be used by you in 
connection with authorized clinical studies of the investigational drug described in the protocol.  You will not disclose any of the 
information to others without written authorization from Dermavant Sciences, Inc. except to the extent necessary to obtain informed 
consent from those persons to whom the drug may be administered. 
Confidential 
Page | 1 
Clinical Study Protocol 
Study Title: 
A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of 
Moderate to Severe Atopic Dermatitis in Children and Adults 
Sponsor: 
Dermavant Sciences, Inc. 
3300 Paramount Parkway, Suite 150 
Morrisville, NC, USA  27560 
Compound Name: 
tapinarof 
Protocol Number: 
DMVT-505-3102 
Indication: 
Atopic Dermatitis 
Development Phase: 
3 
IND Number: 
104601 
Current Version: 
4.0 
Approved/Effective Date 
Version 1.0, Approved: 24 Mar 2021 
Version 2.0, Amendment 1 Approved:16 Jun 2021 
Version 3.0, Amendment 2 Approved: 12 Aug 2021 
Version 4.0, Amendment 3 Approved: 09 Aug 2022 

Tapinarof 
Protocol No.: DMVT-505-3102, Amendment 3 
Dermavant Sciences, Inc. 
Clinical Study Protocol  
Confidential 
Page | 2 
 
 
Sponsor Signature Page 
 
 
Study Title: 
A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Moderate to 
Severe Atopic Dermatitis in Children and Adults 
Protocol Number: 
DMVT-505-3102 
Current Version: 
Version 4.0, Amendment 3 Approved: 09 Aug 2022 
 
 
 
 
This protocol has been approved by a representative of Dermavant Sciences, Inc.  The following signature 
documents this approval. 
 
 
 
 
 

Tapinarof 
Protocol No.: DMVT-505-3102, Amendment 3 
Dermavant Sciences, Inc. 
Clinical Study Protocol  
Confidential 
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Medical Monitor / Sponsor Information Page 
 
 

Tapinarof 
Protocol No.: DMVT-505-3102, Amendment 3 
Dermavant Sciences, Inc. 
Clinical Study Protocol  
Confidential 
Page | 4 
 
Investigator Statement 
 
 
Study Title: 
A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Moderate to 
Severe Atopic Dermatitis in Children and Adults 
Protocol Number: 
DMVT-505-3102 
Current Version:  
Version 4.0, Amendment 3 Approved: 09 Aug 2022 
 
• I confirm agreement to conduct the study in compliance with the protocol. 
• I acknowledge that I am responsible for overall study conduct.  I agree to personally conduct or 
supervise the described study. 
• I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study 
are informed about their obligations and comply with the study protocol.  Mechanisms are in place 
to ensure that site staff receives the appropriate information throughout the study. 
 
 
 
 
 
 
 
 
 
 

Tapinarof 
Protocol No.: DMVT-505-3102, Amendment 3 
Dermavant Sciences, Inc. 
Clinical Study Protocol  
Confidential 
Page | 5 
Table of Contents  
Synopsis     . ..................................................................................................................................................... 13 
1 
Introduction ................................................................................................................................... 23 
1.1 
Background Information and Study Rationale ............................................................................. 23 
1.1.1 
Background Information ............................................................................................................... 23 
1.1.2 
Study Rationale ............................................................................................................................. 24 
1.2 
Rationale for Study Design, Dose, and Control Groups ............................................................... 24 
1.3 
Potential Risks and Benefits ......................................................................................................... 26 
 
 
 
 
 
 
 
 
1.3.2 
Benefit Assessment ....................................................................................................................... 28 
1.3.3 
Overall Benefit Risk ..................................................................................................................... 28 
2 
Objectives and Endpoints ............................................................................................................. 29 
3 
Study Design ................................................................................................................................. 31 
3.1 
Overall Design .............................................................................................................................. 31 
3.2 
Treatment Groups and Duration ................................................................................................... 32 
3.3 
Definition of Study Completion and Eligibility for Open-Label, Long-Term Extension 
Study ............................................................................................................................................. 32 
4 
Study Population ........................................................................................................................... 33 
4.1 
Type and Number of Subjects ...................................................................................................... 33 
4.2 
Inclusion Criteria .......................................................................................................................... 33 
4.3 
Exclusion Criteria ......................................................................................................................... 34 
4.4 
Lifestyle Restrictions .................................................................................................................... 36 
4.5 
Screening/Baseline Failures.......................................................................................................... 36 
4.6 
Withdrawal Criteria ...................................................................................................................... 37 
4.6.1 
Reasons for Withdrawal from the Study ...................................................................................... 37 
4.6.2 
Withdrawal Procedures ................................................................................................................. 37 
4.7 
Lost to Follow-Up......................................................................................................................... 38 
5 
Study Treatment ............................................................................................................................ 39 
5.1 
Study Drug .................................................................................................................................... 39 
5.1.1 
Description, Packaging, and Labeling .......................................................................................... 39 
5.1.2 
Storage .......................................................................................................................................... 39 
5.1.3 
Handling and Disposal .................................................................................................................. 39 

Tapinarof 
Protocol No.: DMVT-505-3102, Amendment 3 
Dermavant Sciences, Inc. 
Clinical Study Protocol  
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6.3.6.2 
Subject (or Caregiver)-Assessed Local Tolerability Scale ........................................................... 49 
6.4 
Treatment of Study Drug Overdose .............................................................................................. 49 
6.5 
Pharmacokinetics .......................................................................................................................... 50 
6.6 
Virtual Assessments ...................................................................................................................... 50 
7 
Timing of Procedures and Assessments ....................................................................................... 52 
7.1 
Visit 1; Screening Period (Day -30 to Day -1) ............................................................................. 52 
7.2 
Visit 2; Baseline (Day 1) .............................................................................................................. 53 
7.3 
Visit 3; Week 1 (Day 8 ±2 Days) ................................................................................................. 54 
7.4 
Visit 4; Week 2 (Day 15 ±2 Days) ............................................................................................... 54 
7.5 
Visit 5; Week 4 (Day 29 ±2 Days) ............................................................................................... 55 
7.6 
Visit 6; Week 8 (Day 57 ±2 Days) ............................................................................................... 56 
7.7 
Phone Contact at Weeks 3 (Day 22 ±2 Days) and 6 (Day 43 ±2 Days) ....................................... 56 
7.8 
Follow-Up Visit 7; Week 9 (Day 64 ±2 Days) ............................................................................. 56 
7.9 
Early Termination Visit ................................................................................................................ 57 
7.10 
Unscheduled Visit ......................................................................................................................... 58 
7.11 
End of Study ................................................................................................................................. 58 
8 
Safety Monitoring and Reporting ................................................................................................. 59 
8.1 
Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest ..................... 59 
8.1.1 
Definition of Adverse Events ....................................................................................................... 59 
8.1.2 
Definition of Serious Adverse Event ............................................................................................ 60 
8.1.3 
Adverse Events of Special Interest ............................................................................................... 61 
8.2 
Classification of Adverse Events .................................................................................................. 62 
8.2.1 
Assigning Severity Rating for Adverse Events ............................................................................ 62 
8.2.1.1 
Criteria for Determining Adverse Event Severity ........................................................................ 62 
8.2.1.2 
Toxicity Management Criteria ...................................................................................................... 62 
8.2.1.2.1 
Grade 1 or Grade 2 Adverse Event ............................................................................................... 62 
8.2.1.2.2 
Grade 3 Adverse Event ................................................................................................................. 62 
8.2.1.2.3 
Grade 4 Adverse Event ................................................................................................................. 63 
8.2.1.2.4 
Folliculitis ..................................................................................................................................... 63 
8.2.1.2.5 
Other Management Criteria: ......................................................................................................... 63 
8.2.2 
Assigning Causal Relationship to Study Drug ............................................................................. 63 
8.3 
Time Period and Frequency for Event Assessment and Follow-Up ............................................. 64 
8.3.1 
Adverse Event Reporting .............................................................................................................. 64 
8.3.2 
Follow-Up of Adverse Events ...................................................................................................... 64 
8.4 
Reporting Procedures .................................................................................................................... 64 

Tapinarof 
Protocol No.: DMVT-505-3102, Amendment 3 
Dermavant Sciences, Inc. 
Clinical Study Protocol  
Confidential 
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8.4.1 
Serious Adverse Event Reporting ................................................................................................. 64 
8.4.2 
Regulatory Reporting Requirements for Serious Adverse Events ............................................... 65 
8.5 
Pregnancy Management and Reporting ........................................................................................ 65 
9 
Data Management ......................................................................................................................... 66 
10 
Statistical Considerations and Data Analyses ............................................................................... 67 
10.1 
General Considerations ................................................................................................................. 67 
10.2 
Determination of Sample Size ...................................................................................................... 67 
10.3 
Analysis Populations .................................................................................................................... 67 
10.3.1 
Safety ............................................................................................................................................ 67 
10.3.2 
Intent-To-Treat ............................................................................................................................. 67 
10.3.3 
Per-Protocol .................................................................................................................................. 67 
10.3.4 
Pharmacokinetic ........................................................................................................................... 67 
10.4 
Planned Analyses .......................................................................................................................... 67 
10.4.1 
Disposition and Demographics ..................................................................................................... 68 
10.4.2 
Efficacy Analyses ......................................................................................................................... 68 
10.4.2.1 
Primary Endpoint Analyses .......................................................................................................... 68 
10.4.2.2 
Secondary and Exploratory Efficacy Endpoint Analyses ............................................................. 68 
10.4.3 
Safety Analyses ............................................................................................................................ 70 
 
 
10.4.5 
Pharmacokinetic Analyses ............................................................................................................ 70 
10.5 
Interim Analyses ........................................................................................................................... 71 
10.6 
Handling of Missing Data ............................................................................................................. 71 
11 
Responsibilities ............................................................................................................................. 72 
11.1 
Investigator Responsibilities ......................................................................................................... 72 
11.1.1 
Good Clinical Practice .................................................................................................................. 72 
11.1.2 
Institutional Review Board/Independent Ethics Committee Approval ........................................ 72 
11.1.3 
Informed Consent/Assent ............................................................................................................. 72 
11.1.4 
Confidentiality .............................................................................................................................. 73 
11.1.5 
Study Files and Retention of Records .......................................................................................... 73 
11.1.6 
Electronic Case Report Forms ...................................................................................................... 74 
11.1.7 
Drug Accountability ..................................................................................................................... 74 
11.1.8 
Inspections .................................................................................................................................... 74 
11.1.9 
Protocol Compliance .................................................................................................................... 75 
11.2 
Sponsor Responsibilities ............................................................................................................... 75 
11.2.1 
Protocol Modifications ................................................................................................................. 75 

Tapinarof 
Protocol No.: DMVT-505-3102, Amendment 3 
Dermavant Sciences, Inc. 
Clinical Study Protocol  
Confidential 
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Table of Tables  
Table 1: 
Schedule of Assessments .............................................................................................................. 20 
Table 2: 
Tapinarof and Vehicle Cream ....................................................................................................... 39 
Table 3: 
Validated Investigator Global Assessment Scale for Atopic Dermatitis ...................................... 45 
Table 4: 
Laboratory Tests ........................................................................................................................... 48 
Table 5: 
Criteria for Determining the Grade/Severity of Adverse Event Terms Not Specified by the 
National Cancer Institute CTCAE ................................................................................................ 62 
Table 6 
Primary Estimand Attributes ........................................................................................................ 68 
Table 7. 
Calculation of Percent Body Surface Area Affected .................................................................... 81 
Table 8. 
Calculation of Eczema Area and Severity Index Score for Ages 8 Years and Above ................. 83 
Table 9. 
Calculation of Eczema Area and Severity Index Score for Ages < 8 Years ................................ 84 
 
Table of Figures 
Figure 1: 
Treatment Success (IGA score) by Dosing Regimen in Study 203121 ........................................ 25 
Figure 2:  Study Schema ............................................................................................................................... 32 
 
 

Tapinarof 
Protocol No.: DMVT-505-3102, Amendment 3 
Dermavant Sciences, Inc. 
Clinical Study Protocol  
Confidential 
Page | 11 
Table of Abbreviations 
Term 
Full Description 
AD 
atopic dermatitis 
AE 
adverse event 
AESI 
adverse event of special interest 
AhR 
aryl hydrocarbon receptor 
ALT 
alanine aminotransferase 
ANCOVA 
analysis of covariance 
Anti-HBc 
anti-hepatitis B core antigen 
Anti-HBs 
anti-hepatitis B surface antigen 
AST 
aspartate aminotransferase 
BID 
twice daily 
BMI 
body mass index 
BSA 
body surface area 
%BSA 
percent of total body surface area 
BUN 
blood urea nitrogen 
CBP 
child-bearing potential 
 
 
CFR 
Code of Federal Regulations 
CMH 
Cochran-Mantel-Haenszel 
CRF 
case report form 
CTCAE 
Common Terminology Criteria for Adverse Events 
CV 
cardiovascular 
Dermavant 
Dermavant Sciences, Inc. 
 
  
 
 
EASI 
Eczema Area and Severity Index 
ECG 
electrocardiogram 
ET 
early termination 
FSH 
Follicle-stimulating hormone 
FU 
follow-up 
 
 
HBsAg 
hepatitis B surface antigen 
 
 
ICF 
informed consent form 
IEC 
Independent Ethics Committee 
IGA 
Investigator’s Global Assessment 
 
 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
LOCF 
last observation carried forward 
LTS 
Local Tolerability Scale 
MCH 
mean corpuscular hemoglobin 

Tapinarof 
Protocol No.: DMVT-505-3102, Amendment 3 
Dermavant Sciences, Inc. 
Clinical Study Protocol  
Confidential 
Page | 12 
Term 
Full Description 
MCHC 
mean corpuscular hemoglobin concentration 
MCV  
mean corpuscular volume 
MI 
Multiple Imputations 
NA 
not applicable 
 
 
OL-LTE 
Open-Label, Long-Term Extension study 
P/C 
phone contact 
PGA 
Physician’s Global Assessment 
PK 
Pharmacokinetic(s) 
 
 
PP 
per protocol 
PP-NRS 
Peak Pruritus-Numeric Rating Scale 
QD 
once daily 
RBC 
red blood cell(s) 
SAE 
serious adverse event 
SD 
standard deviation 
 
 
TEAE 
treatment emergent adverse event 
TF 
Treatment Failure 
ULN 
upper limit of normal 
US 
United States 
V 
visit 
vIGA-AD™ 
validated Investigator Global Assessment for Atopic Dermatitis 
WBC 
white blood cell(s) 
WOCBP 
women of child-bearing potential 
 
 
 
 

Tapinarof 
Protocol No.: DMVT-505-3102, Amendment 3 
Dermavant Sciences, Inc. 
Clinical Study Protocol  
Confidential 
Page | 13 
Synopsis       
Name of Sponsor/Company: 
Dermavant Sciences, Inc. 
Name of Investigational Product: 
DMVT-505 (tapinarof cream, 1%) 
Name of Active Ingredient:   
Tapinarof 
Protocol Number: 
DMVT-505-3102 
Phase: 
3 
Country: 
United States (US) and Canada 
Title of Study: 
A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Moderate to Severe Atopic Dermatitis in Children and 
Adults 
Study Sites(s): 
Up to approximately 60 sites in the US and Canada 
Objectives: 
Primary: 
• 
To evaluate the efficacy of tapinarof cream, 1% once daily (QD) compared with vehicle control in subjects with 
atopic dermatitis (AD) 
Secondary: 
• 
To further characterize the efficacy of tapinarof cream, 1% QD compared with vehicle control over time 
• 
To evaluate the safety and tolerability of tapinarof cream, 1% QD in subjects with AD 
• 
To describe the effect of tapinarof cream, 1% QD on AD symptom severity and the associated impact on daily 
activities and attitudes in subjects with AD 
• 
To evaluate plasma concentrations of tapinarof in subjects with AD 
Methodology: 
This is a double-blind, randomized, vehicle-controlled, Phase 3, multicenter study to evaluate the efficacy and safety of topical 
tapinarof cream, 1% compared with vehicle control cream in subjects ages 2 years and above with AD. 
Following a 30-day screening period, eligible subjects will be randomized at a 2:1 ratio to receive QD treatment with 
tapinarof cream, 1% or vehicle cream.  Subjects will return to the clinic at Weeks 1, 2, 4, and 8 for efficacy and safety 
assessments.  Subjects will be contacted by phone at Weeks 3 and 6 to assess AEs and concomitant medications, to review study 
drug administration instructions, and to confirm subject’s continued participation in this study. 
Study drug will be dispensed and applied during the clinic visits and will be administered at home between clinic visits as 
instructed by site personnel.  Subjects or their caregivers will be instructed to apply study drug QD to all affected areas, including 
newly appearing lesions and lesions/areas that improve during the study.  Subjects or caregivers will apply sufficient study drug to 
cover completely each lesion with a thin layer of study drug and will record the time of study drug application and daily itch score 
(Peak Pruritus-Numeric Rating Scale [PP-NRS]) in a daily diary provided by the study site.  (Note that subjects are allowed, but 
not required, to treat scalp lesions with study drug; however, efficacy analyses will not include assessment of AD in this area.)  
Subjects or caregivers will be advised to maintain the approximate dosing time chosen at the beginning of the study for their full 
study participation.  At the phone contacts at Weeks 3 and 6, subjects should be reminded to complete their daily diary and bring it 
with them to the next clinic visit. 
Study drug application instructions will be reviewed at all post-randomization clinic visits and during any planned study phone 
calls.  On clinic visit days, subjects will be instructed/reminded how to apply study drug (except during the final treatment/end-of-
study visits).  During the clinic visits, subjects or caregivers will apply the daily dose of study drug while on-site under the 
supervision of site personnel.  The time of the dose application and assessments will depend on the time of the clinic visit.  
Therefore, the timing of the clinic visit may lead to a change in the subject’s chosen dosing time for that day. 
At the end of the 8 weeks of treatment in this study, subjects will have the option to enroll in an Open-Label, Long-Term 
Extension (OL-LTE) study for an additional 48 weeks of treatment.  Subjects who choose not to participate in the OL-LTE study 
or who fail to qualify for participation in the OL-LTE study will complete a Follow-up Visit (Week 9 visit) approximately 1 week 
after the end of treatment in this study.  Subjects who withdraw from the study before Week 8 will complete an Early Termination 
Visit and are not eligible for the OL-LTE study. 

Tapinarof 
Protocol No.: DMVT-505-3102, Amendment 3 
Dermavant Sciences, Inc. 
Clinical Study Protocol  
Confidential 
Page | 14 
Number of Subjects: 
Approximately 400 subjects ages 2 years and above will be enrolled in the study, randomized at a 2:1 ratio to receive tapinarof 
cream, 1% (approximately 267 subjects) or vehicle cream (approximately 133 subjects).  Subjects will be stratified so that a 
minimum of 10% will have severe disease (validated Investigator Global Assessment in Atopic Dermatitis [vIGA-AD™] = 4) and 
the remainder will have moderate disease (vIGA ADTM = 3).  A minimum of approximately 15% of subjects will be enrolled into 
each of the following age groups: 2-6 years, 7-11 years, 12-17 years, 18 years and above.  Adults 18 years and above will 
comprise a maximum of 20% of enrolled subjects. 
Diagnosis and Main Criteria for Inclusion: 
Inclusion Criteria: 
Each subject must meet all the following criteria to be eligible to participate in the study: 
1. Male and female subjects ages 2 years and above with clinical diagnosis of AD by Hanifin and Rajka criteria. 
2. Subjects with AD covering ≥ 5% and ≤ 35% of the body surface area (BSA).  Scalp should be excluded from the BSA 
calculation to determine eligibility during Screening and at Baseline, and for all efficacy assessments.  
NOTE: Subjects with disease only on palms and soles are not eligible. 
3. A vIGA-AD™ score of > 3 at Screening and Baseline (pre-randomization). 
4. An Eczema Area and Severity Index (EASI) score of > 6 at Screening and Baseline (pre-randomization). 
5. AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old, confirmed by prior 
medical documentation and/or according to the subject/caregiver report.   
6. Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use one 
of the following acceptable birth control methods while on study and for 4 weeks after the last exposure to study drug.   
• 
Acceptable contraception methods include intrauterine device, hormonal contraceptives, barrier method (e.g., 
condom or diaphragm), or surgical sterilization of male partner (vasectomy)  
• 
Subjects who claim abstinence as their method of contraception are allowed provided they agree to use a barrier 
method (e.g., condom or diaphragm) should they become sexually active from Screening to 4 weeks after the 
last dose of study drug 
Non-child-bearing potential is defined as:  
• 
premenarchal  
• 
pre-menopausal females with a documented bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or 
hysteroscopic sterilization 
• 
postmenopausal female with a cessation of menses for at least 12 months without an alternative medical cause; a 
blood sample with follicle stimulating hormone > 40 mIU/mL is confirmatory in questionable cases 
7. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine 
pregnancy test at Baseline (Day 1). 
8. Subject, subject’s parent(s), or legal representative must be capable of giving written informed consent/assent, which 
includes compliance with the requirements and restrictions listed in the consent/assent form; written informed consent 
must be obtained prior to any study related procedures. 
Exclusion Criteria: 
A subject who meets any of the following criteria will be excluded and considered ineligible for participation in the study:  
1. Concurrent conditions:  
a. 
Immunocompromised (e.g., lymphoma, acquired immunodeficiency syndrome) or or history or evidence of 
active or latent tuberculosis or human immunodeficiency virus antibody as documented by medical history 
and/or according to the subject/caregiver report..  
b. Chronic or acute systemic infection requiring treatment with antiparasitics or antiprotozoals, within 4 weeks 
prior to the Baseline visit.  
c. 
Chronic or acute systemic bacterial infection requiring treatment with systemic antibiotics within one week prior 
to the Baseline visit. 

Tapinarof 
Protocol No.: DMVT-505-3102, Amendment 3 
Dermavant Sciences, Inc. 
Clinical Study Protocol  
Confidential 
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d. Chronic or acute superficial fungal infection requiring treatment with systemic antifungals within one week prior 
to the Baseline visit. 
e. 
Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection within 1 week 
prior to the Baseline visit; the condition should be completely resolved one week prior to Baseline Visit. 
f. 
Significant dermatologic or inflammatory condition other than AD that, in the Investigator’s opinion, would 
make it difficult to interpret data or assessments during the study.  For example, subjects with an active skin 
condition such as Kaposi's varicelliform eruption, scabies, molluscum contagiosum, impetigo, psoriasis, severe 
acne, connective tissue disorder, or Netherton's syndrome, or any other concurrent active disease.  
g. Concurrent skin lesions in the treatment area or pruritus due to conditions other than AD that, in the opinion of 
the Investigator, would either interfere with study evaluations or affect the safety of the subject. 
2. Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.0 x the upper limit of normal (ULN).  
3. Screening total bilirubin > 1.5x ULN; total bilirubin > 1.5x ULN is acceptable if bilirubin is fractionated and direct 
bilirubin < 35%.  
4. Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert’s 
syndrome or asymptomatic gallstones), presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody 
test result, or presence of anti-hepatitis B core antigen (anti-HBc).  Subjects having a negative HBsAg and a positive 
anti-HBc may enroll if they have a positive anti-hepatitis B surface antigen demonstrating natural immunity.  Subjects 
with a history of hepatitis C virus infection who were medically cured and have an undetectable viral load are eligible to 
enroll.  Subjects with a history of stable non-alcoholic fatty liver disease without evidence of active inflammation 
(elevated ALT/AST ≥ 2.0x ULN) or cirrhosis are eligible to enroll. 
5. Current or a history of cancer within 5 years except for adequately treated skin basal cell carcinoma, cutaneous squamous 
cell carcinoma or carcinoma in situ of the cervix (surgical excision or electrodessication and curettage).  
6. Subjects who would not be considered suitable for topical therapy (e.g., those with extensive disease involvement over a 
large BSA who would be candidates for systemic therapy). 
7. Use of any prohibited medication or procedure within the indicated period before the Baseline visit.  
NOTE:  Prohibited concomitant medications, therapy, etc. during the defined period are as listed in the bullets below.  If 
a subject requires any of these medications throughout the study period, he/she may be excluded from or discontinued 
from the study, at the discretion of the Investigator and Medical Monitor.  
a. 
From 4 months prior to Baseline until the completion of the Follow-up visit or study discontinuation:  
o 
DUPIXENT® (dupilumab) injection.  
o 
Any monoclonal antibody product that becomes approved for AD during the course of the trial. 
b. From 28 days prior to Baseline until the completion of the Follow-up visit or discontinuation:  
o 
Oral, injectable, and suppository preparations of corticosteroids.  Eye drops and nasal preparations are 
allowed.  Inhaled preparations are allowed when used for a stable condition and stable dose for > 28 
days before Screening and are continued at the same dose throughout the study.  
o 
Oral preparations and injections of immunosuppressants (cyclosporine, methotrexate, azathioprine, 
tacrolimus, Janus kinase inhibitors, etc.). 
o 
Excessive sun exposure, tanning booth, other ultraviolet light source and phototherapy including 
psoralen and ultraviolet A therapy or is unwilling to minimize natural and artificial sunlight exposure.  
o 
Treatment with antivirals with the exception of short-term treatment for acute upper respiratory viral 
infections (i.e., influenza) or viral suppressive therapy for a history of recurrent herpes labialis or 
genital herpes. 
c. 
From 14 days prior to Baseline until the completion of the Follow-up visit or discontinuation:  
o 
EUCRISA® (crisaborole) and any other PDE4 inhibitor. 
o 
Tacrolimus ointment and pimecrolimus cream. 
o 
Topical corticosteroids that are classified as medium or high potency (e.g., fluocinonide, triamcinolone 
acetonide) or super-high potency (e.g., clobetasol propionate).  Eye drops and nasal preparations are 
allowed.  

Tapinarof 
Protocol No.: DMVT-505-3102, Amendment 3 
Dermavant Sciences, Inc. 
Clinical Study Protocol  
Confidential 
Page | 16 
o 
Coal tar products (on the body).  If subject chooses to treat scalp with study drug, then coal tar products 
are prohibited for use on the scalp.  
o 
Over the counter or herbal medicines for AD (topical and oral preparations).  If subjects are using 
emollients, they may continue to use the same emollient on nonlesional skin during the study.  
Emollients containing salicylic acid are prohibited during the study. 
d. From 7 days prior to Baseline until the completion of the Follow-up visit or discontinuation:  
o 
Topical corticosteroids that are classified as low potency (e.g., desonide, hydrocortisone).    
o 
Oral, injectable, or intravenous antibiotics or antifungal medications. 
o 
Topical doxepin, topical gentamicin, or topical neomycin sulfate. 
NOTE: Oral doxepin is allowed for treatment of depression if subject has been on a stable dose (4 
weeks) at Screening. 
o 
Topical products containing urea, except for the treatment of follicular events. 
o 
Antihistamines/antiallergics (oral, topical and injections):  diphenhydramine, chlorpheniramine 
maleate, hydroxyzine.  
NOTE:  The following antihistamines are allowed from Screening throughout the treatment period: 
loratadine, fexofenadine hydrochloride, cetirizine hydrochloride.  Subjects are allowed to switch from 
non-allowed antihistamines to allowed antihistamines during Screening but must be on a stable dose for 
7 days prior to Baseline.     
e. 
The subject has received an investigational product within the following time period prior to the first dosing day 
in the current study:  Minimum of 30 days or 5 half-lives of the investigational product (whichever is longer).  
8. A history of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator’s opinion, 
may interfere with the subject’s participation in the study, interpretation of results, safety of the subject or ability to 
understand and give informed consent.   
9. Pregnant females as determined by positive serum (Screening) or urine (Baseline) human chorionic gonadotropin test.  
10. Lactating females.  
11. History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the 
opinion of the Investigator or Medical Monitor, contraindicates their participation.  
12. Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001).  
Investigational Product, Dosage and Mode of Administration: 
Tapinarof cream, 1% 
 
is to be administered by the subject/caregiver QD via topical application of a thin layer to affected areas. 
Reference Therapy, Dosage and Mode of Administration: 
Vehicle cream 
 is to be administered by the subject/caregiver QD via 
topical application of a thin layer to affected areas. 
Duration of Treatment: 
• 
Subjects randomized to tapinarof cream, 1% will receive tapinarof for 8 weeks 
• 
Subjects randomized to vehicle cream will receive vehicle for 8 weeks 
The total study duration for subjects who complete this Phase 3 study and who fail to qualify for participation in the OL-LTE 
study, or who qualify to participate in the OL-LTE study but elect not to enroll in that study is up to 13 weeks in total (including 
up to 30 days screening, 8 weeks treatment, and a 1-week follow-up period). 

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Criteria for Evaluation: 
Efficacy Assessments: 
• 
vIGA-AD™  
• 
EASI 
• 
Percentage of total body surface area (%BSA) affected 
Functional Outcomes 
and Quality of Life 
Assessments: 
• 
PP-NRS, for completion by subjects ages > 12 years and for completion by caregivers 
of subjects ages < 12 years 
• 
 
 
 
 
 
 
 
• 
 
• 
 
 
Pharmacokinetic 
Assessments: 
• 
Plasma concentrations of tapinarof 
Safety Assessments: 
• 
Adverse events (AEs) 
• 
Vital signs 
• 
Physical examinations 
• 
Clinical laboratory tests 
• 
Electrocardiograms (ECGs) 
• 
Investigator-assessed Local Tolerability Scale (LTS) 
• 
Subject (or caregiver)-assessed LTS 
Study Endpoints: 
Primary: 
• 
Proportion of subjects who have a vIGA-AD™ score of clear or almost clear (0 or 1) and at least a 2-grade 
reduction from Baseline at Week 8.   
Secondary: 
• 
Proportion of subjects with ≥ 75% improvement in EASI from Baseline at Week 8 
• 
Mean change in %BSA affected from Baseline at Week 8 
• 
Proportion of subjects with ≥ 90% improvement in EASI from Baseline at Week 8 
• 
Proportion of subjects > 12 years old with a Baseline PP-NRS score > 4 who achieve ≥ 4-point reduction in the 
PP-NRS from Baseline at Week 8 
Exploratory: 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 

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1 Introduction  
1.1 Background Information and Study Rationale  
1.1.1 Background Information  
Atopic dermatitis (AD) (also called atopic eczema) is an intensely pruritic, chronic, relapsing, inflammatory 
skin disease [Bieber, 2008].  The characteristic signs and symptoms of AD include sensations of pruritis and 
burning, xerosis, erythematous papules and plaques, exudation, crusting, and lichenification.  Quality of life is 
affected through sleep deprivation due to the intense and constant itching, as well as the stigma associated 
with having a visible skin disease [Carroll, 2005; Lewis-Jones, 2006].  Up to 30% of children may be affected 
by AD at some point, and 2% to 10% of adults have AD [Bieber, 2008].  Currently there is no curative 
therapy.  Stabilizing the disease and reducing the number and severity of flares are the primary goals of 
treatment.  Topical treatments directed at skin inflammation are a key factor in disease management, as is 
symptomatic relief of itching.  Although multiple topical treatment options are available, there remains a need 
for a topical treatment that combines a high level of efficacy with an acceptable safety profile that permits 
application to a large body surface area (BSA) without restrictions on duration of treatment. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.1.2 Study Rationale  
This pivotal Phase 3 study is being conducted as part of a clinical development program to evaluate the 
efficacy and safety of tapinarof cream, 1% for the topical treatment of AD in adults and children ages 2 years 
and above.  The results of this study are intended to support product registration in the United States and 
Canada. 
1.2 Rationale for Study Design, Dose, and Control Groups  
This study is an 8-week double-blind, vehicle-controlled treatment study in which subjects will be 
randomized to receive tapinarof cream, 1% or vehicle cream QD for 8 weeks.  The study will be conducted at 
multiple study sites in more than one country to enhance the possibility of inclusion of a wider range of 
population groups and to increase generalizability of the results. 
This randomized, double-blind, vehicle-controlled study design will minimize the potential for subjective bias 
related to possible identification of which subjects are receiving active treatment and will minimize selection 
and allocation bias by balancing potential prognostic factors.  A vehicle control group is included to provide a 

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control for comparison and to ensure study sensitivity for characterization of the safety and efficacy profile of 
tapinarof cream, 1%. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.3 Potential Risks and Benefits  
To assess any potential impact on subject eligibility with regard to safety, the Investigator must refer to the 
current version of the tapinarof Investigator’s Brochure for detailed information regarding warnings, 
precautions, contraindications, AEs, and other significant data pertaining to the study drug being used in this 
study. 

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1.3.2 Benefit Assessment  
Subjects may experience improvements in their AD during the course of the study and may benefit from the 
additional safety assessments conducted as part of the study (e.g., physical examination, laboratory tests).  
Subjects in the study will also contribute to the process of developing a novel anti-inflammatory agent for the 
topical treatment of AD. 
1.3.3 Overall Benefit Risk  
Taking into account the measures taken to minimize risk to subjects in this study, the potential risks identified 
in association with tapinarof are justified by the anticipated benefits that may be afforded to subjects with AD. 

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2 Objectives and Endpoints  
The objectives and associated endpoints of the study are as follows: 
Objectives 
Associated Endpoint 
Primary 
• To evaluate the efficacy of 
tapinarof cream, 1% QD 
compared with vehicle 
control in subjects with AD 
1. 
Proportion of subjects who have a validated Investigator Global 
Assessment in Atopic Dermatitis (vIGA-AD™) score of clear or almost clear (0 or 1) ) and at 
least a 2-grade reduction from Baseline at Week 8 
Secondary/Exploratory 
Secondary: 
• To further characterize the 
efficacy of tapinarof cream, 
1% QD compared with 
vehicle control over time 
• Proportion of subjects with ≥ 75% improvement in EASI from Baseline at Week 8 
• Mean change in %BSA affected from Baseline at Week 8 
• Proportion of subjects with ≥ 90% improvement in EASI from Baseline at Week 8 
• Proportion of subjects > 12 years old with a Baseline Peak Pruritus-Numeric Rating Scale 
(PP-NRS) score > 4 who achieve ≥ 4-point reduction in the PP-NRS from Baseline at 
Week 8 
Exploratory: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
• To evaluate the safety and 
tolerability of tapinarof 
cream, 1% QD in subjects 
with AD 
• Incidence, frequency, and duration of TEAEs and serious adverse events (SAEs) 
• Change from Baseline in laboratory values 
• Change from Baseline in ECG parameters  
• Change from Baseline in vital signs 
• Mean Investigator-assessed local tolerability scale (LTS) scores by visit (overall and 
sensitive areas) 
• Mean subject (or caregiver)-assessed LTS scores by visit 
• To describe the effect of 
tapinarof cream, 1% QD on 
AD symptom severity and 
the associated impact on 
daily activities and attitudes 
in subjects with AD 
• 
 
 
 
 
 
• 
 
  
• 
 
 

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Objectives 
Associated Endpoint 
• 
 
 
• 
 
• To evaluate plasma 
concentrations of tapinarof 
in subjects with AD  
• Plasma concentration of tapinarof at Weeks 4 and 8 

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3 Study Design  
3.1 Overall Design  
This is a double-blind, randomized, vehicle-controlled, Phase 3, multicenter study to evaluate the efficacy and 
safety of topical tapinarof cream, 1% compared with vehicle cream in children and adult subjects with AD.   
Following a 30-day screening period, eligible subjects will be randomized at a 2:1 ratio to receive QD 
treatment with tapinarof cream, 1% or vehicle cream for 8 weeks.  Subjects will return to the clinic at Weeks 
1, 2, 4, and 8 for efficacy and safety assessments.  Additionally, subjects will be contacted by phone at Weeks 
3 and 6 to assess AEs and concomitant medications, to review study drug administration instructions, and to 
confirm subject’s continued participation in this study. 
Study drug will be dispensed and applied during the clinic visits and will be administered at home between 
clinic visits as instructed by site personnel.  Subjects or their caregivers will be instructed to apply study drug 
QD to all affected areas, including newly appearing lesions and lesions/areas that improve during the study.  
Subjects or their caregivers will apply sufficient study drug to cover completely each lesion with a thin layer 
of study drug and will record the time of study drug application and daily itch score (PP-NRS) in a daily diary 
provided by the study site.  Subjects are allowed, but not required, to treat scalp lesions with study drug; 
however, efficacy analyses will not include assessment of AD in this area.  Subjects and/or caregivers will be 
advised to maintain the approximate dosing time chosen at the beginning of the study for their full study 
participation.  Nonmedicated emollients that do not contain salicylic acid may be used on nonlesional skin but 
the subject (or caregiver) should wait at least 30 minutes after applying study drug before applying 
nonmedicated emollients; emollients should not be applied to lesional skin during treatment.  The same 
emollient should be used throughout the subject’s participation in the study.  At the phone contacts at Weeks 
3 and 6, subjects or caregivers should be reminded to complete their daily diary and bring it with them to the 
next clinic visit. 
Study drug application instructions will be reviewed at all post-randomization clinic visits and during any 
planned study phone calls.  On clinic visit days, subjects and/or caregivers will be instructed/reminded on how 
to apply study drug (except during the final treatment/end-of-study visits).  During the clinic visits, subjects or 
their caregivers will apply the daily dose of study drug while on-site under the supervision of site personnel 
after efficacy and safety assessments have been completed, with the exception of the LTS at some visits (as 
outlined in the Schedule of Assessments [Table 1]).  The time of the dose application and assessments will 
depend on the time of the clinic visit.  Therefore, the timing of the clinic visit may lead to a change in the 
subject’s chosen dosing time for that day.  
At the end of the 8 weeks of assessments in this study, subjects will have the option to enroll in an Open-
Label, Long-Term Extension (OL-LTE) study for an additional 48 weeks.  Subjects who complete Visit 
6/Week 8 but choose not to participate in the OL-LTE study or who fail to qualify for participation in the 
OL-LTE study will complete a Follow-up Visit (Visit 7/Week 9 visit) approximately 1 week after the end of 
treatment in this study.  Subjects who withdraw from the study before Visit 6/Week 8 will complete an Early 
Termination Visit as their final visit and are not eligible for the OL-LTE study. The subjects who complete 
the Early Termination Visit must not complete a Follow-Up Visit.   
Study duration for subjects who complete this Phase 3 study and who fail to qualify for participation in the 
OL-LTE study, or who qualify to participate in the OL-LTE study but elect not to enroll in that study is 

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4 Study Population  
4.1 Type and Number of Subjects  
Approximately 400 adult and pediatric subjects ages 2 years and above with AD will be enrolled in the study 
at approximately 60 study sites in the US and Canada.  A minimum of approximately 15% of subjects will be 
enrolled into each of the following age groups:  2-6 years, 7-11 years, 12-17 years, 18 years and above.  
Adults 18 years and above will comprise a maximum of 20% of enrolled subjects. 
Protocol violations from inclusion and exclusion criteria are prohibited because ineligible study subjects can 
potentially jeopardize the scientific integrity of the study, regulatory acceptability, or subject safety.  
Therefore, adherence to the criteria as specified in the protocol is essential. 
4.2 Inclusion Criteria  
Each subject must meet all of the following criteria to be eligible to participate in the study: 
1. Male and female subjects ages 2 years and above with clinical diagnosis of AD by Hanifin and Rajka 
criteria [Hanifin, 1980] (see Appendix 1). 
2. Subjects with AD covering ≥ 5% and ≤ 35% of the BSA.  Scalp should be excluded from the BSA 
calculation to determine eligibility during Screening and at Baseline, and for all efficacy assessments.  
NOTE: Subjects with disease only on palms and soles are not eligible. 
3. A vIGA-AD™ score of > 3 at Screening and Baseline (pre-randomization). 
4. An EASI score of > 6 at Screening and Baseline (pre-randomization). 
5. AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old, 
confirmed by prior medical documentation and/or according to the subject/caregiver report. 
6. Female subjects of childbearing potential who are engaging in sexual activity that could lead to 
pregnancy should use one of the following acceptable birth control methods while on study and for 4 
weeks after the last exposure to study drug.   
• Acceptable contraception methods include intrauterine device, hormonal contraceptives, barrier 
method (e.g., condom or diaphragm), or surgical sterilization of male partner (vasectomy)  
• Subjects who claim abstinence as their method of contraception are allowed provided they agree to 
use a barrier method (e.g., condom or diaphragm) should they become sexually active from 
Screening to 4 weeks after the last dose of study drug 
Non-child-bearing potential is defined as:  
• premenarchal  
• pre-menopausal females with a documented bilateral tubal ligation, bilateral oophorectomy, 
hysterectomy, or hysteroscopic sterilization 
• postmenopausal female with a cessation of menses for at least 12 months without an alternative 
medical cause; a blood sample with follicle stimulating hormone > 40 mIU/mL is confirmatory in 
questionable cases 
7. Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and 
a negative urine pregnancy test at Baseline (Day 1). 

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8. Subject, subject’s parent(s), or legal representative must be capable of giving written informed 
consent/assent, which includes compliance with the requirements and restrictions listed in the 
consent/assent form; written informed consent must be obtained prior to any study related procedures. 
4.3 Exclusion Criteria  
A subject who meets any of the following criteria will be excluded and considered ineligible for participation 
in the study: 
1. Concurrent conditions:  
a. Immunocompromised (e.g., lymphoma, acquired immunodeficiency syndrome) or or history or 
evidence of active or latent tuberculosis or human immunodeficiency virus antibody as 
documented by medical history and/or according to the subject/caregiver report.  
b. Chronic or acute systemic infection requiring treatment with antiparasitics, or antiprotozoals, 
within 4 weeks prior to the Baseline visit.  
c. Chronic or acute systemic bacterial infection requiring treatment with systemic antibiotics within 
one week prior to the Baseline visit. 
d. Chronic or acute superficial fungal infection requiring treatment with systemic antifungals within 
one week prior to the Baseline visit  
e. Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection 
within 1 week prior to the Baseline visit; the condition should be completely resolved one week 
prior to Baseline Visit 
f. Significant dermatologic or inflammatory condition other than AD that, in the Investigator’s 
opinion, would make it difficult to interpret data or assessments during the study.  For example, 
subjects with an active skin condition such as Kaposi's varicelliform eruption, scabies, molluscum 
contagiosum, impetigo, psoriasis, severe acne, connective tissue disorder, or Netherton's 
syndrome, or any other concurrent active disease. 
g. Concurrent skin lesions in the treatment area or pruritus due to conditions other than AD that, in 
the opinion of the Investigator, would either interfere with study evaluations or affect the safety of 
the subject. 
2. Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.0 x the upper limit 
of normal (ULN).  
3. Screening total bilirubin > 1.5x ULN; total bilirubin > 1.5x ULN is acceptable if bilirubin is 
fractionated and direct bilirubin < 35%.  
4. Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception 
of Gilbert’s syndrome or asymptomatic gallstones), presence of hepatitis B surface antigen (HBsAg), 
or positive hepatitis C antibody test result, or presence of anti-hepatitis B core antigen (anti-HBc).  
Subjects having a negative HBsAg and a positive anti-HBc may enroll if they have a positive anti-
hepatitis B surface antigen demonstrating natural immunity.  Subjects with a history of hepatitis C 
virus infection who were medically cured and have an undetectable viral load are eligible to enroll.  
Subjects with a history of stable non-alcoholic fatty liver disease without evidence of active 
inflammation (elevated ALT/AST ≥ 2.0 x ULN) or cirrhosis are eligible to enroll. 

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5. Current or a history of cancer within 5 years except for adequately treated cutaneous basal cell 
carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix (surgical excision or 
electrodessication and curettage).  
6. Subjects who would not be considered suitable for topical therapy (e.g., those with extensive disease 
involvement over a large BSA who would be candidates for systemic therapy). 
7. Use of any prohibited medication or procedure within the indicated period before the Baseline visit.  
NOTE:  Prohibited concomitant medications, therapy, etc. during the defined period are as listed in the 
bullets below.  If a subject requires any of these medications throughout the study period, he/she may 
be excluded from or discontinued from the study, at the discretion of the Investigator and Medical 
Monitor.  
a. From 4 months prior to Baseline until the completion of the Follow-up visit or study 
discontinuation:  
− DUPIXENT® (dupilumab) injection. 
− Any monoclonal antibody product that becomes approved for AD during the course of the trial. 
b. From 28 days prior to Baseline until the completion of the Follow-up visit or discontinuation:  
− Oral, injectable, and suppository preparations of corticosteroids.  Eye drops and nasal 
preparations are allowed.  Inhaled preparations are allowed when used for a stable condition 
and stable dose for > 28 days before Screening and are continued at the same dose throughout 
the study.  
− Oral preparations and injections of immunosuppressants (cyclosporine, methotrexate, 
azathioprine, tacrolimus, Janus kinase inhibitors, etc.). 
− Excessive sun exposure, tanning booth, other ultraviolet light source and phototherapy 
including psoralen and ultraviolet A therapy or is unwilling to minimize natural and artificial 
sunlight exposure.  
− Treatment with antivirals with the exception of short-term treatment for acute upper respiratory 
viral infections (i.e., influenza) or viral suppressive therapy for a history of recurrent herpes 
labialis or genital herpes. 
c. From 14 days prior to Baseline until the completion of the Follow-up visit or discontinuation:  
− EUCRISA® (crisaborole) and any other PDE4 inhibitor. 
− Tacrolimus ointment and pimecrolimus cream. 
− Topical corticosteroids that are classified as medium or high potency (e.g., fluocinonide, 
triamcinolone acetonide) or super-high potency (e.g., clobetasol propionate).  Eye drops and 
nasal preparations are allowed.  
− Coal tar products (on the body).  If subject chooses to treat scalp with study drug, then coal tar 
products are prohibited for use on the scalp. 
− Over the counter or herbal medicines for AD (topical and oral preparations).  If subjects are 
using emollients, they may continue to use the same emollient on nonlesional skin during the 
study.  Emollients containing salicylic acid are prohibited during the study. 
d. From 7 days prior to Baseline until the completion of the Follow-up visit or discontinuation:  

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− Topical corticosteroids that are classified as low potency (e.g., desonide, hydrocortisone).    
− Oral, injectable, or intravenous antibiotics or antifungal medications.  
− Topical doxepin, topical gentamicin, or topical neomycin sulfate. 
NOTE: Oral doxepin is allowed for treatment of depression if subject has been on a stable dose 
(4 weeks) at Screening. 
− Topical products containing urea, except for the treatment of follicular events 
− Antihistamines/antiallergics (oral, topical and injections):  diphenhydramine, chlorpheniramine 
maleate, hydroxyzine.  
NOTE:  The following antihistamines are allowed from Screening throughout the treatment 
period: loratadine, fexofenadine hydrochloride, cetirizine hydrochloride.  Subjects are allowed 
to switch from non-allowed antihistamines to allowed antihistamines during Screening but 
must be on a stable dose for 7 days prior to Baseline. 
e. The subject has received an investigational product within the following time period prior to the 
first dosing day in the current study:  30 days or 5 half-lives of the investigational product 
(whichever is longer). 
8. A history of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the 
Investigator’s opinion, may interfere with the subject’s participation in the study, interpretation of 
results, or ability to understand and give informed consent.  
9. Pregnant females as determined by positive serum (Screening) or urine (Baseline) human chorionic 
gonadotropin test. 
10. Lactating females. 
11. History of sensitivity to the study medications, or components thereof or a history of drug or other 
allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation. 
12. Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 
and WBI-1001). 
4.4 Lifestyle Restrictions  
Subjects must avoid ultraviolet light, phototherapy, and excessive sun exposure throughout the study.  When 
prolonged exposure cannot be avoided, use of sunscreen products (except on AD lesions) and protective 
apparel are recommended. 
4.5 Screening/Baseline Failures  
To determine subject eligibility at Screening and Baseline, a single repeat of tests or procedures may be 
allowed during the screening period at the discretion of the Investigator; the Medical Monitor should be 
consulted if needed.    
Screen failures are defined as subjects who consent to participate in the clinical study but are not subsequently 
randomized within the screening time period.  A minimal set of screen failure information is required to 
ensure transparent reporting of screen failure subjects to meet the Consolidated Standards of Reporting Trials 
publishing requirements and to respond to queries from regulatory authorities.  Minimal information includes 
demography, screen failure details, eligibility criteria, and any AEs/SAEs. 

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A subject who screen fails may be allowed to re-screen one time at the discretion of the Investigator; the 
Medical Monitor should be consulted if needed. 
4.6 Withdrawal Criteria  
A subject may voluntarily discontinue treatment and/or withdraw from participation in this study at any time 
at his/her own request or may be discontinued from study treatment at any time at the discretion of the 
Investigator for safety, behavioral, compliance, or administrative reasons.  Subjects withdrawn from the study 
will not be replaced. 
4.6.1 Reasons for Withdrawal from the Study  
Study drug will be discontinued and the subject withdrawn from the study for any of the following reasons: 
• Subject has an AE that is considered to be related to study drug or procedures AND is severe 
enough to warrant treatment discontinuation, as determined by the Investigator (Section 8.1). 
• Pregnancy 
• Any Grade 3 or 4 AE, based on Cancer Institute Common Terminology Criteria for Adverse 
Events (CTCAE) criteria, considered causally related to study drug (Section 8.2.2) 
Study drug may be discontinued and the subject withdrawn from the study for any of the following reasons: 
• Subject requires concurrent prohibited medication during the study (Section 5.6.2).  Nonmedicated 
emollients that do not contain salicylic acid may be used on nonlesional skin but the subject (or 
caregiver) should wait at least 30 minutes after applying study drug before applying nonmedicated 
emollients; emollients should not be applied to lesional skin during treatment.  The same emollient 
should be used throughout the subject’s participation in the study. 
NOTE: If, in the opinion of the Investigator and the study Medical Monitor, such medication will 
not interfere with the conduct or interpretation of the study or compromise the safety of the 
subject, then the subject may continue to receive study drug.  If the subject is permanently 
discontinued from study drug, they may remain in the study for safety assessments as needed, at 
the discretion of the Investigator and Medical Monitor, but they are not eligible to enroll in the 
OL-LTE. 
• Subject noncompliance 
• Investigator noncompliance 
• Discontinuation of the study at the request of the Sponsor, regulatory agency, or an Institutional 
Review Board (IRB)/Independent Ethics Committee (IEC). 
If a subject meets a withdrawal criterion during treatment, an Early Termination visit will be required 
(Section 7.9). 
4.6.2 Withdrawal Procedures  
The primary reason for the discontinuation of study drug and/or withdrawal from study must be recorded in 
the source document and on the case report form (CRF).  If a subject is prematurely discontinued from study 
drug, the Investigator must make every effort to perform an Early Termination Visit (Section 7.9) and 
document the primary reason for withdrawal. 

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4.7 Lost to Follow-Up  
A subject is considered lost to follow-up if he/she repeatedly fails to return to the study site for scheduled 
visits and is unable to be contacted by the study site.  The following actions must be taken if a subject fails to 
return to the clinic for a required study visit: 
• The site must attempt to contact the subject or caregiver and reschedule the missed visit as soon as 
possible, counsel the subject on the importance of maintaining the assigned visit schedule, and 
ascertain whether or not the subject wishes to and/or should continue in the study. 
• Before a subject is deemed lost to follow-up, the Investigator or designee must make every effort 
to regain contact with the subject or caregiver (where possible, 3 telephone calls and, if necessary, 
a certified letter to the subject’s last known mailing address or local equivalent methods).  These 
contact attempts should be documented in the subject’s medical record.  
• Should the subject or caregiver continue to be unreachable, he/she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up.  In this case, the 
discontinuation date will be listed as the date the certified letter was mailed to the subject. 

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• QD application to affected areas; subjects or their caregivers are advised to choose the application 
time they prefer and to apply the study drug at that approximate time each day of study 
participation.  Subjects should avoid dosing around midnight to avoid potentially dosing twice in 
one calendar day. 
• If a subject misses a daily dose, it will be recorded as a protocol deviation.  The subject should 
continue dosing the next day and should not apply more than once daily to make up for the missed 
dose on the previous day.  If a dose is missed, the missed dose and the reason for the missed dose 
should be recorded in the daily diary as such.  Itch rating can still be recorded in the diary even if a 
daily dose was missed. 
• Study drug should be applied to dry, clean skin. 
• Study drug may be applied to skin around the eye but avoid direct contact with the eye – study 
drug is not for ophthalmic use. 
• Wash hands after application, unless treating lesions on the hands. 
• Study drug should be applied to all lesions, including newly appearing lesions and lesions that 
have improved or resolved during the study.  A body diagram identifying locations of lesions may 
be provided to the subject and/or caregiver.  
• Subjects are allowed, but not required, to treat scalp lesions with study drug; however, efficacy 
analyses will not include assessment of AD in this area.   
• If there is residual cream visible on the disease-affected lesional skin, then the subject or caregiver 
should be instructed to continue to lightly rub the cream into the skin until it is no longer visible. 
• If study drug is applied to the subject by another person, that person should thoroughly wash 
his/her hands after application. 
• When dosing at home subjects or caregiver should record the time of study drug application in the 
daily diary.  Itch rating should also be recorded in the diary. 
• On clinic visit days, study drug should be applied in the clinic under the supervision of site 
personnel and after safety and efficacy assessments have been completed (except for subject and 
Investigator LTS at Weeks 1, 2 and 4). 
NOTE:  The time of the dose and assessments on clinic visit days will depend on the time of the 
clinic visit.  Therefore, the timing of the clinic visit may differ from the subject’s chosen dosing 
time.  The intention is to allow flexibility to accommodate subjects’ schedules. 
• Nonmedicated emollients that do not contain salicylic acid may be used on nonlesional skin but 
the subject (or caregiver) should wait at least 30 minutes after applying study drug before applying 
nonmedicated emollients; emollients should not be applied to lesional skin during treatment.  The 
same emollient should be used throughout the subject’s participation in the study. 
Subjects and/or caregivers will be instructed/reminded on how to apply study drug at each clinic visit (except 
during the final treatment visit). 
5.1.6 
  
 

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5.2 Randomization/Treatment Assignment  
For the double-blind, vehicle-controlled phase of the study, subjects will be randomized at a ratio of 2:1 to 
receive tapinarof cream, 1% or vehicle cream as follows: 
Randomization in Double-Blind, Vehicle-Controlled Phase 
Regimen 
Number of Subjects 
Tapinarof cream, 1% QD for 8 weeks 
Approximately 267 Subjects 
Vehicle cream QD for 8 weeks 
Approximately 133 Subjects 
QD = once daily 
Randomization will be stratified by Baseline vIGA-AD™ score so that subjects with severe AD (vIGA-AD™ 
score of 4) will be limited to approximately 10% each of the total randomized population, and the majority of 
the enrolled subjects (approximately 90%) will have a vIGA-AD™ score of 3, signifying moderate disease.   
Randomization will also be stratified by age so that a minimum of approximately 15% of subjects will be 
enrolled into each of the following age groups:  2-6 years, 7-11 years, 12-17 years, 18 years and above.  
Adults 18 years and above will comprise a maximum of 20% of enrolled subjects. 
The randomization lists will be generated using a validated system, which involves a pseudo-random number 
generator so that the resulting treatment will be both reproducible and non-predictable.  Access to the codes 
will be controlled and documented.  
5.3 Blinding  
The Investigator, study site staff, subject, and Sponsor will be blinded to treatment assignment. 
The study blind should not be broken except in medical emergencies when the appropriate management of the 
subject requires knowledge of the study drug the subject received.  The following conditions will apply for 
breaking the blind: 
• The Investigator or treating physician may unblind a subject’s treatment assignment only in the 
case of an emergency OR in the event of a serious medical condition when knowledge of the 
study drug is essential for the appropriate clinical management or welfare of the subject as judged 
by the Investigator. 
• Investigators will contact the Medical Monitor, who will have direct access to the system for 
unblinding an individual study subject. 
• The Investigator should discuss options with the Medical Monitor or appropriate study personnel 
before making the decision to unblind the subject’s treatment assignment. 

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• If the Sponsor personnel are not contacted before the unblinding, the Investigator must notify the 
Sponsor as soon as possible after unblinding, but without revealing the treatment assignment of the 
unblinded subject, unless that information is important for the safety of subjects currently in the 
study. 
• The date and reason for the unblinding must be fully documented in the CRF. 
• A subject will be withdrawn if the subject’s treatment code is unblinded by the Investigator or 
treating physician.  The primary reason for discontinuation (the event or condition which led to the 
unblinding) will be recorded in the source documents and CRF. 
• The Sponsor or their designee may unblind the treatment assignment for any subject with an SAE.  
If the SAE requires that an expedited regulatory report be sent to one or more regulatory agencies, 
a copy of the report, identifying the subject’s treatment assignment, may be sent to Investigators in 
accordance with local regulations. 
5.4 Compliance with Study Drug Administration  
At Baseline, study staff will provide the subject or caregiver with detailed instructions concerning protocol 
requirements and use of study drug.  Additionally, subjects or caregivers will be asked to complete a daily 
diary with the time of each application of study drug, except on study visit days.  At each post-Baseline study 
visit, study staff will review use of study drug, as applicable, with the subject or caregiver.  Subject 
compliance will be assessed via study diary completion. 
When subjects are dosed at the site, they and/or their caregiver will apply the study drug under supervision of 
the study staff.  The date and time of each dose administered in the clinic will be recorded in the source 
documents.  The study drug and study subject identification should be confirmed at the time of dosing by a 
member of the study site staff other than the person dispensing the study drug. 
At the time of dispensing study drug to each subject, site personnel will weigh the tubes to be dispensed with 
the cap on and will record the weight of all tubes dispensed at each visit in the drug accountability logs.  
Subjects and/or caregivers will be instructed to bring all used and unused tubes with them to each study visit.  
Site personnel will weigh the returned tubes (used and unused) with the cap on and record the weight in the 
drug accountability logs.  If a tube has been lost, discarded, or forgotten by the subject, then the site personnel 
will make a notation of this on the drug accountability logs.  Forgotten tubes should be returned by the subject 
at the next study visit.  Tubes of study medication dispensed at the most recent prior visit which remain 
unopened (the foil cap on the tube remains fully intact/undisturbed) may be re-dispensed to study subjects at 
the current visit.  Unopened tubes may only be re-dispensed once.  Opened, partially used tubes or tubes with 
foil overlay removed are not to be re-dispensed to study subjects.  If there is any question as to 
re-dispensation, sites should issue new tubes of study medication to the subject(s). 
5.5 Treatment after the End of the Study  
Subjects will not receive any additional treatment with the study drug from the Sponsor after completion of 
the study (with the exception of eligible subjects who enroll in the OL-LTE study) because the indication 
being studied is not life threatening or seriously debilitating and other treatment options are available. 
The Investigator is responsible for ensuring that consideration has been given to the post-study care of the 
subject’s medical condition, whether or not the Sponsor is providing specific post-study drug. 

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5.6 Prior and Concomitant Therapy  
Any medication (including over the counter or prescription medication, vitamins and/or herbal supplements) 
administered to the subject up to 30 days before the Screening visit, at the time of enrollment, and during the 
study must be recorded in the CRF along with the reason for use.  The information to be recorded must also 
include name of the medication (generic name, as a general rule), dose, frequency, administration routes, and 
dates of the first and last dose, as applicable. 
The Medical Monitor should be contacted if there are any questions regarding concomitant or prior therapy. 
5.6.1 Permitted Medications and Nondrug Therapies  
Concomitant medications for medical treatment of other conditions are allowed under the condition that the 
dosage and administration of these treatments is not planned to change from the Baseline visit to the 
completion of the treatment phase (Week 8) and that the medication is not a prohibited medication as 
described in the Exclusion Criteria (Section 4.3). 
In the event of skin infection, topical antibacterial agents with the exception of gentamicin and neomycin 
sulfate can be applied to the infected area; however, study drug must not be applied to the area until the skin 
infection is healed. 
Nonmedicated emollients that do not contain salicylic acid may be used on nonlesional skin but the subject 
(or caregiver) should wait at least 30 minutes after applying study drug before applying nonmedicated 
emollients; emollients should not be applied to lesional skin during treatment.  The same emollient should be 
used throughout the subject’s participation in the study.  
NOTE:  Any emollient used during the study must be recorded as a concomitant medication.   
5.6.2 Prohibited Medications and Nondrug Therapies  
Medications and nondrug therapies that are prohibited throughout the study duration are described in the 
Exclusion Criteria (Section 4.3).  A list of prohibited medications, emollients and nondrug therapies may be 
provided as a separate document.   
If a subject chooses to treat scalp with study drug, then medicated shampoos that contain coal tar, salicylic 
acid, or hydrocortisone are prohibited for use. 
Emollients containing salicylic acid are prohibited. 
 

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6 Study Assessments and Procedures  
Study procedures and assessments are summarized in the Schedule of Assessments and in Section 7.  
Adherence to the study design requirements, including those specified in the Schedule of Assessments (Table 
1) are essential and required for study conduct.  Protocol waivers or exemptions are not allowed, except for 
immediate safety concerns. 
6.1 Demography, Medical History, and Baseline Characteristics  
6.1.1 Demographics  
Demographic information collected will include age, sex, race, ethnicity, and Fitzpatrick skin type. 
Information on Fitzpatrick skin type can be found in Appendix 2. 
6.1.2 Medical History  
Medical history will be collected to ensure subjects are eligible for participation in the study (per inclusion 
Section 4.2 and exclusion Section 4.3 criteria). 
Data collected will include year of AD diagnosis, allergic conditions, cardiovascular (CV) medical history and 
risk factors (including height, weight, blood pressure, medical conditions, and family history of premature CV 
disease), and family history of liver disease. 
As part of the subject’s medical history, all systemic (oral and injectable) medications used by the subject for 
treatment of AD prior to 30 days before the Screening visit will be collected.  
If a subject has previously tested positive for COVID-19 or has previously received a COVID-19 vaccine, it 
should be documented in the subject’s medical history. 
6.2 Efficacy Assessments  
To minimize inter-observer variability, Investigators and evaluators/raters will be trained on each of the 
required assessments during an Investigator meeting, site initiation visit, and/or utilizing online assessments 
before enrolling subjects at their study site.  Only trained evaluators/raters are permitted to perform the 
efficacy assessments.  To the fullest extent possible, the same Investigator (or designated evaluator/rater) will 
perform all efficacy assessments for an individual subject throughout the study.  If it is not possible for the 
same evaluator/rater to continue performing assessments, it is recommended that the primary and subsequent 
evaluator/rater both examine and discuss their respective scoring during at least 1 visit. 
6.2.1 Assessments Completed by Investigator  
6.2.1.1 
Validated Investigator Global Assessment of Atopic Dermatitis  
The vIGA-AD™ of disease severity will be assessed at every clinic visit.  The vIGA-AD™ is a global 
assessment of the current state of the disease.  It is a 5-point morphological assessment of overall disease 
severity (scalp excluded) and will be determined according to the categories described in Table 3 and 
Appendix 3.  To be eligible, subjects must have a vIGA-AD™ score of 3 or 4 at Screening and the Baseline 
visit (Day 1).  Eli Lilly and Company developed the vIGA-AD™ scale for use in clinical trials. 
 
 
 

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6.2.2.3 
Peak Pruritus-Numeric Rating Scale  
The PP-NRS is a scale used to quickly assess itch/pruritus severity over a 24-hour period.  The subject or 
caregiver will utilize the scale to assess peak pruritus QD and record the results in their daily diaries.  The itch 
rating can be done before or after study drug administration since it should reflect the past 24 hours.  On clinic 
visit days, the PP-NRS will be assessed in the clinic. For subjects ages 2 to < 12 years, the PP-NRS will be 
completed by the caregiver.  For subjects ages > 12 years, the PP-NRS will be completed by the subject. 
An example of the PP-NRS is provided in Appendix 11. 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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6.2.3 Optional Clinical Photography  
Clinical photography may be performed in a subgroup of subjects at selected study sites.  Informed 
consent/assent and photographic release will be required.  The photographs may not be referred to by the 
Investigator at any subsequent study visit for the purposes of grading. 
Photographs will be taken of a representative area of the subject’s disease area at the time points specified in 
the Schedule of Assessments (Table 1).  Photographs of the selected skin area will be taken in a standardized 
fashion (i.e., same camera, angle, background, distance).   
6.3 Safety Assessments  
6.3.1 Adverse Events  
All AEs and SAEs will be collected from the time the subject signs the informed consent form (ICF) until the 
final visit/contact with the subject.  Additional safety information, including the definition of an AE and the 
methods for recording, evaluating, and assessing causality of AEs and the procedures for completing and 
transmitting SAE reports are provided in Section 8. 
6.3.2 Brief Physical Examination  
A brief physical examination will include, at a minimum, assessments of the skin, lungs, CV system, and 
abdomen (liver and spleen).  Assess for changes in onset of menses (female participants) or sexual activity 
(male or female participants). Determine if there is a need for contraception or barrier use. Height and weight 
will be measured at Screening only.  Investigators should pay special attention to clinical signs related to 
previous serious illness. 

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6.3.3 Vital Signs  
Vital signs will be measured before blood collection for clinical laboratory assessments and PK analysis 
(where applicable) and will include measurements of systolic and diastolic blood pressure, pulse rate, and 
body temperature.  Subjects should be in a seated position for at least 5 minutes before vital signs 
measurement. 
6.3.4 Clinical Safety Laboratory Assessments  
All protocol-required laboratory assessments must be conducted in accordance with the Study Reference 
Manual or Laboratory Manual and the protocol Schedule of Assessments (Table 1).  Laboratory requisition 
forms must be completed, and samples must be clearly labeled with the subject number, protocol number, site 
number, and visit date.  Details for the preparation and shipment of samples will be provided by the laboratory 
and are detailed in the Study Reference Manual or the Laboratory Manual.  Reference ranges for all safety 
parameters will be provided to the site by the laboratory responsible for the assessments. 
A list of clinical laboratory tests and parameters is provided in Table 4. 
All laboratory tests with values that are considered clinically significantly abnormal during participation in the 
study should be repeated until the values return to normal or baseline.  If such values do not return to normal 
within a period judged reasonable by the Investigator, the etiology should be identified, if possible, and the 
Sponsor and Medical Monitor notified. 
Table 4: 
Laboratory Tests  
Diagnostic Screening Tests 
• HBsAg 
• Hepatitis C antibody 
• Anti-HBc 
• Anti-HBsa 
• Pregnancy tests: (serum at Screening and urine at other visits when performed; 
women of CBP only)b 
• FSH (as needed in women of non-CBP only) 
• At the Investigator’s discretion, subjects may be screened for alcohol and illicit 
drug use. 
Serum Chemistry 
• BUN 
• Creatinine 
• Glucose (fasting not required) 
• Sodium 
• Potassium 
• Chloride 
• Total carbon dioxide 
• Calcium 
• AST 
• ALT 
• Alkaline phosphatase 
• Uric acid 
• Total bilirubin (+fractionated if 
required) 
• Total protein 
• Albumin 
Hematology 
• Platelet count 
• RBC count 
• WBC count (absolute) 
• Hemoglobin 
• Hematocrit 
• RBC Indices: 
• MCV 
• MCH 
• MCHC 
• Reticulocyte percentage 
• WBC Differential: 
• Neutrophils 
• Lymphocytes 
• Monocytes 
• Eosinophils 
• Basophils 
Urinalysis 
• Specific gravity 
• Microscopic examination (if blood or protein is abnormal  
• Dipstick:  pH, Glucose, Protein, 
Blood Ketones 
a. Reflex test: a negative HBsAg and a positive anti-HBc may enroll if there is a positive anti-HBs demonstrating natural immunity 
b. Pregnancy tests should be administered based on CBP, which may change after the start of the study (e.g. a premenarchal female 
subject experiences menarche or a female subject ceases to meet the criteria of CBP) 

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ALT = alanine aminotransferase; Anti-HBc = anti-hepatitis B core antigen; Anti-HBs = anti-hepatitis B surface antigen; 
AST = aspartate aminotransferase; BUN = blood urea nitrogen; CBP = child-bearing potential; FSH = follicle-stimulating hormone; 
HBsAg = hepatitis B surface antigen; MCH = mean corpuscular hemoglobin; MCHC = mean corpuscular hemoglobin 
concentration; MCV = mean corpuscular volume; RBC = red blood cell(s); WBC = white blood cell(s). 
6.3.5 Electrocardiograms  
Single 12-lead ECGs will be obtained at a subset of sites in a subset of subjects at timepoints indicated in the 
Schedule of Assessments (Table 1) and Section 7 using an ECG machine that automatically calculates the 
heart rate and measures PR, QRS, QT, and QTc intervals.  Subjects should be in a supine or semi-supine 
position for at least 5 minutes before ECG is measured.  In case of an abnormal ECG or excess artifact, the 
ECG may be repeated two additional times over several minutes (triplicate in total), to allow further 
evaluation and averaging of interval measurements as necessary.   Abnormal ECGs should be characterized as 
clinically or non-clinically significant by the investigator.  In the event of a clinically significant change from 
baseline in the ECG for which the etiology cannot be identified, the Medical Monitor should be contacted. 
6.3.6 Local Tolerability Scale  
6.3.6.1 
Investigator-Assessed Local Tolerability Scale  
At each specified study visit, the Investigator (or qualified evaluator) will assess the presence and overall 
degree of irritation at the application sites, according to a 5-point LTS.  The score will ideally represent an 
“average” across all application sites.  To the fullest extent possible, the same Investigator (or designated 
evaluator) will perform all tolerability assessments for an individual subject throughout the study.  If the 
subject is applying study drug to “sensitive areas”, a separate LTS will be used to assess the degree of 
irritation for each of these areas where study drug is applied.  The sensitive areas that will be assessed are 
face, neck, skin folds, axilla, inframammary, anal crux, and genitalia.  An example of the Investigator-
assessed LTS is shown in Appendix 15.  The LTS should be completed pre-dose at Baseline and within 2 
hours post-dose at Weeks 1, 2 and 4. At Week 8 and the ET visit, when study drug is not being applied at that 
visit, the LTS should be completed when other assessments are completed.  Other than at the Baseline visit, 
the Investigator-assessed LTS should only completed when the subject is currently receiving study drug (i.e. 
has applied at least one application in the last 48 hours). 
6.3.6.2 
Subject (or Caregiver)-Assessed Local Tolerability Scale  
At each specified study visit, the subject or caregiver will separately assess the presence and degree of 
burning/stinging and itching at the application sites, each according to a 5-point LTS.  The subject or 
caregiver will not score each sensitive area individually but provide one overall score that will ideally 
represent an “average” across all application sites.  An example of the subject (or caregiver)-assessed LTS is 
shown in Appendix 16.  The subject (or caregiver)-assessed LTS should be completed pre-dose at Baseline 
and within 2 hours post-dose at Weeks 1, 2 and 4. At Week 8, when study drug is not being applied at that 
visit, the LTS should be completed when other assessments are completed.   Other than at the Baseline visit, 
the subject (or caregiver)-assessed LTS should only completed when the subject is currently receiving study 
drug (i.e. has applied at least one application in the last 48 hours).  For subjects ages < 12 years, the LTS will 
be completed by the caregiver.  For subjects ages > 12 years, the LTS will be completed by the subject. 
6.4 Treatment of Study Drug Overdose  
For this study, accidental or intentional oral ingestion of drug product will be considered an overdose.  
Ingestion of a 30-gram tube of tapinarof cream, 1% would result in an oral dose of 300 mg. 

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The Sponsor does not recommend specific treatment for an overdose; however, in the event of an overdose, 
the Investigator (or treating physician) should do the following: 
• Contact Medical Monitor to discuss the event 
• Closely monitor the subject for AEs/SAEs and laboratory abnormalities 
• Provide general symptomatic treatment as necessary 
• Document the quantity of the excess dose as well as the duration of the overdosing. 
• If the Medical Monitor requests a plasma sample for PK analysis, then a blood sample for PK 
should be obtained within 2 days from the date of the last dose of study drug. 
Decisions regarding dose interruptions or modifications following an overdose will be made by the 
Investigator in consultation with the Medical Monitor based on the clinical evaluation of the subject. 
6.5 Pharmacokinetics  
Blood samples for PK analysis of tapinarof concentration will be collected at a subset of sites in a subset of 
subjects at timepoints indicated in the Schedule of Assessments (Table 1) and Section 7.  The actual date and 
time of each blood sample collection will be recorded as well as the date and time of the last dose of study 
drug prior to sample collection.  Collection, processing, storage, and shipping procedures are provided in the 
Study Reference Manual or the Laboratory Manual. 
Concentrations of tapinarof will be determined in plasma samples using a validated bioanalytical method.  
Raw data will be archived at the bioanalytical site.   
Informed consent/assent for collection of PK samples will be required. 
6.6 Virtual Assessments  
In the event that a subject cannot attend their regularly scheduled study visits in person due to a COVID-19-
like situation necessitating a limit on in-person contact, the Investigator may perform safety and efficacy 
assessments by phone or video.  Source documentation should note if the visit was performed by phone or by 
video.  The Investigator may use the technology platform that is currently available to them.  Suggested 
platforms include Apple FaceTime, Zoom for Healthcare, Facebook Messenger video chat, Microsoft Teams, 
Google Hangouts video, and Skype.  Additional details of the visit should be included in source 
documentation, as detailed in the Study Reference Manual. 
If the subject can only be contacted by phone, the following should be assessed or performed: 
• AEs 
• Concomitant Medications 
• Reminder to complete diary 
• Instruction not to discard empty tubes of study drug 
If the subject has video capabilities, the following items should be assessed or performed: 
• AEs 
• Concomitant Medications  
• vIGA-AD™ assessment (excluding subject’s scalp) 

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• %BSA affected calculation (excluding subject’s scalp) 
• EASI assessment (excluding subject’s scalp) 
• Investigator-assessed LTS 
• Subject (or caregiver)-assessed LTS 
• Application of study drug by the subject 
• Completion of the PP-NRS (the subject or caregiver [as applicable] can verbally indicate the 
answer which the study coordinator will document in the source document) 
• Reminder to complete diary 
• Instruction not to discard empty tubes of study drug 
The reason that assessments cannot be completed during a virtual assessment (i.e., labs, vital signs, physical 
exams, etc.) must be noted (e.g., COVID-19) and the missed assessments will be recorded as protocol 
deviations. 

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7 Timing of Procedures and Assessments  
This section lists the procedures and assessment to be performed at scheduled timepoints during the study as 
outlined in the Schedule of Assessments (Table 1).  Information on study procedures and assessments is 
provided in Section 6. 
• Any change in timing or any addition of a timepoint(s) for any planned study assessment must be 
documented in a “Note to File,” which is approved by the relevant Sponsor study team member 
and then archived in the study Sponsor and site study files; this will NOT constitute a protocol 
amendment. 
• The IRB/IEC will be informed of any safety issues that require alteration of the safety monitoring 
or amendment of the ICF. 
NOTE:  Assessments and procedures should be performed pre-dose on clinic visit days except for LTS at 
Weeks 1, 2 and 4. 
7.1 Visit 1; Screening Period (Day -30 to Day -1)  
After the subject has signed the consent/assent form, potential study subjects will undergo Screening 
procedures and assessments to confirm eligibility to participate in the study.  Screening assessments will 
include the following: 
• Demography recording 
• Fitzpatrick skin type 
• Medical history recording (including all medications administered up to 30 days prior to screening, 
and all systemic [oral and injectable] medications used by the subject for the treatment of AD prior 
to 30 days before Screening) 
• Serum pregnancy test (females of child-bearing potential) 
• Brief physical examination (including height and weight, body mass index will be calculated in the 
CRF) 
• Vital signs measurements 
• Blood sample collection for clinical laboratory tests (serum chemistry, hematology, diagnostic 
tests) 
• Urinalysis 
• AE recording (from the time the ICF is signed) 
• Concomitant medication recording  
• vIGA-AD™ score (excluding subject’s scalp)  
• %BSA affected calculation (excluding subject’s scalp) 
• EASI (excluding subject’s scalp)  
To determine subject eligibility at Screening, a single repeat of tests or procedures may be allowed at the 
discretion of the Investigator.  The Medical Monitor should be consulted if needed. 

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7.2 Visit 2; Baseline (Day 1)  
On Day 1, subjects will be reassessed to confirm continued eligibility to participate in the study.  All subjects 
who continue to meet study eligibility criteria will be randomized to treatment. 
The following additional procedures and assessments will be performed at the Baseline Visit: 
• Changes to medical history will be recorded 
• Urine pregnancy test (females of child-bearing potential) 
• Brief physical examination 
• Vital signs measurement 
• ECG recording (at a subset of study sites only) 
• Blood sample collection for clinical laboratory tests (serum chemistry, hematology, diagnostic 
tests) 
NOTE: Blood sample collection for clinical laboratory tests is not required at the Baseline Visit if 
it has been ≤14 days since samples were collected at Screening and the results of those clinical 
laboratory tests were not clinically significant.  
• Urinalysis 
NOTE: Urine sample collection for urinalysis is not required at the Baseline Visit if it has been 
≤14 days since samples were collected at Screening and the results of those analyses were not 
clinically significant.  
• Photography of a representative area of the subject’s disease area (at a subset of study sites only) 
• AE recording 
• Concomitant medication recording 
• vIGA-AD™ score (excluding subject’s scalp) 
• %BSA affected calculation (excluding subject’s scalp) 
• EASI (excluding subject’s scalp) 
• Investigator-assessed LTS (pre-dose) 
• 
 
• 
 
• PP-NRS 
• 
 
• 
 
• Subject (or caregiver)-assessed LTS (pre-dose) 
• Dispense diary (subjects or their caregivers will be instructed on how and when to complete diary) 
• Subject randomized to study treatment 
• Dispense study drug 
• Instruction on how to apply study drug 
• Study drug application under supervision 

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7.3 Visit 3; Week 1 (Day 8 ±2 Days)  
The following procedures and assessments will be performed at Visit 3: 
• Vital signs 
• vIGA-AD™ score (excluding subject’s scalp) 
• %BSA affected calculation (excluding subject’s scalp)  
• EASI (excluding subject’s scalp) 
• 
 
• 
 
• PP-NRS 
• 
 
• 
 
• AE recording 
• Concomitant medication recording 
• Collect and review subject diaries for treatment compliance 
• Dispense subject diaries 
• Collect and dispense study drug 
• Review instructions on how to apply study drug 
• Study drug application under supervision  
• Investigator-assessed LTS (post-dose) 
• Subject (or caregiver)-assessed LTS (post-dose) 
7.4 Visit 4; Week 2 (Day 15 ±2 Days)  
The following procedures and assessments will be performed at Visit 4: 
• Vital signs measurement 
• Photography of a representative area of the subject’s disease area (at a subset of study sites only) 
• AE recording 
• Concomitant medication recording 
• vIGA-AD™ score (excluding subject’s scalp) 
• %BSA affected calculation (excluding subject’s scalp)  
• EASI (excluding subject’s scalp) 
• 
 
• 
 
• PP-NRS 
• 
 
• 
 
• Collect and review subject diaries for treatment compliance 

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• Dispense subject diaries 
• Collect and dispense study drug 
• Review instructions on how to apply study drug 
• Study drug application under supervision 
• Investigator-assessed LTS (post-dose) 
• Subject (or caregiver)-assessed LTS (post-dose) 
7.5 Visit 5; Week 4 (Day 29 ±2 Days)  
The following procedures and assessments will be performed at Visit 5: 
• Urine pregnancy test (females of child-bearing potential) 
• Brief physical examination 
• Vital signs measurement 
• ECG recording (at a subset of study sites only) 
• Blood sample collection for clinical laboratory tests (serum chemistry, hematology, diagnostic 
tests) 
• Urinalysis 
• Blood sample collection for PK analysis (at a subset of study sites only) 
• Photography of a representative area of the subject’s disease area (at a subset of study sites only) 
• AE recording 
• Concomitant medication recording 
• vIGA-AD™ score (excluding subject’s scalp) 
• %BSA affected calculation (excluding subject’s scalp)  
• EASI (excluding subject’s scalp) 
• 
 
• 
 
• PP-NRS 
• 
 
• 
 
• Collect and review subject diaries for treatment compliance 
• Dispense subject diaries 
• Collect and dispense study drug 
• Review instructions on how to apply study drug 
• Study drug application under supervision 
• Investigator-assessed LTS (post-dose) 
• Subject (or caregiver)-assessed LTS (post-dose) 

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7.6 Visit 6; Week 8 (Day 57 ±2 Days)  
The following procedures and assessments will be performed at Visit 6: 
• Urine pregnancy test (females of child-bearing potential) 
• Brief physical examination 
• Vital signs measurement 
• Blood sample collection for clinical laboratory tests (serum chemistry, hematology, diagnostic 
tests) 
• Urinalysis 
• Blood sample collection for PK analysis (at a subset of study sites only) 
• ECG recording (at a subset of study sites only) 
• Photography of a representative area of the subject’s disease area (at a subset of study sites only) 
• vIGA-AD™ score (excluding subject’s scalp) 
• %BSA affected calculation (excluding subject’s scalp)  
• EASI (excluding subject’s scalp) 
• 
 
• 
 
• PP-NRS 
• 
 
• 
 
• Investigator-assessed LTS 
• Subject (or caregiver)-assessed LTS 
• AE recording 
• Concomitant medication recording 
• Collect subject diaries 
• Review subject diaries for treatment compliance 
• Collect study drug 
• Enrollment in OL-LTE study (optional) 
7.7 Phone Contact at Weeks 3 (Day 22 ±2 Days) and 6 (Day 43 ±2 Days)  
Subjects or their caregivers will be contacted by phone at Weeks 3 and 6 to review study drug application 
instructions and to record AEs and concomitant medication use.  Subjects should be reminded to complete 
their daily diary and bring it with them to the next clinic visit. 
7.8 Follow-Up Visit 7; Week 9 (Day 64 ±2 Days)  
Subjects who complete Visit 6/Week 8 but do not enroll in the OL-LTE study will return to the study site at 
Week 9 to complete Follow-Up assessments as follows: 
• Brief physical examination 

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• Vital signs measurement 
• If needed, blood sample collection for clinical laboratory tests 
• If needed, urinalysis 
• vIGA-AD™ score (excluding subject’s scalp) 
• %BSA affected calculation (excluding subject’s scalp)  
• EASI (excluding subject’s scalp) 
• 
 
• 
 
• PP-NRS 
• 
 
• 
 
• AE recording 
• Concomitant medication recording 
7.9 Early Termination Visit  
Subjects who withdraw early from the study will be asked to return to the study site to complete Early 
Termination assessments as follows: 
• Urine pregnancy test (females of child-bearing potential) 
• Brief physical examination 
• Vital signs measurement 
• Blood sample collection for clinical laboratory tests 
• Urinalysis 
• ECG recording (at a subset of study sites only) 
• vIGA-AD™ score (excluding subject’s scalp) 
• %BSA affected calculation (excluding subject’s scalp)  
• EASI (excluding subject’s scalp) 
• 
 
• 
 
• PP-NRS 
• 
 
• 
 
• Investigator-assessed LTS 
• Subject-assessed LTS 
• AE recording 
• Concomitant medication recording 
• Collect subject diaries 

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• Review subject diaries for treatment compliance 
• Collect study drug 
7.10 Unscheduled Visit  
Subjects may have an unscheduled visit for AE follow-up, study drug dispensation, make-up for a missed 
visit, or other reason.  The following assessments may be performed: 
• Urine pregnancy test (females of child-bearing potential) 
• Brief physical examination 
• Vital signs measurement 
• Blood sample collection for clinical laboratory tests (serum chemistry, hematology, diagnostic 
tests) 
• Urinalysis 
• ECG recording (at a subset of study sites only) 
• vIGA-AD™ score (excluding subject’s scalp) 
• %BSA affected calculation (excluding subject’s scalp)  
• EASI (excluding subject’s scalp) 
• Investigator-assessed LTS 
• Subject (or caregiver)-assessed LTS 
• PP-NRS 
• AE recording 
• Concomitant medication recording 
• Dispense and/or collect subject diaries 
• Review subject diaries for treatment compliance 
• Dispense and/or collect study drug 
• Review instructions on how to apply study drug 
7.11 End of Study  
The end of study is defined as when the last active subject has completed the Week 9 Follow-up Visit which 
is 1 week after the end of treatment (if subject does not enroll in the OL-LTE study) OR the last active subject 
has completed the 8 weeks of treatment in this study (if subject is eligible and enrolls in the OL-LTE study). 

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8 Safety Monitoring and Reporting  
8.1 Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest  
The Investigator or site staff is responsible for detecting, documenting, and reporting events that meet the 
definition of an AE, SAE, or AESIs.  At each visit/contact, subjects should be questioned in a general way so 
as not to introduce bias in detecting AEs and/or SAEs.  Open-ended and non-leading verbal questioning of the 
subject is the preferred method to inquire about AE occurrence. 
Investigators are not obligated to actively seek AEs or SAEs in former study subjects.  However, if the 
Investigator learns of any SAE, including a death, at any time after a subject has been discharged from the 
study, and he/she considers the event reasonably related to the study drug or study participation, the 
Investigator should promptly notify the Sponsor. 
A narrative will be written and included in the Clinical Study Report for all SAEs and AESIs, and for all AEs 
that lead to study discontinuation. 
8.1.1 Definition of Adverse Events  
An AE is any untoward medical occurrence in a subject temporally associated with the use of a medicinal 
product, whether considered causally related or not related to the medicinal product. 
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. 
Events meeting the definition of an AE include: 
• Any abnormal laboratory test results (hematology, clinical chemistry) or other safety assessments 
(e.g., vital signs measurements), including those that worsen from Baseline, and felt to be 
clinically significant in the medical and scientific judgment of the Investigator 
• Exacerbation of a chronic or intermittent pre-existing condition (e.g., plaque psoriasis) including 
either an increase in frequency and/or intensity of the condition 
• For skin-related AEs, it should be noted whether or not the event is in the area of active application 
of study drug, and/or if spreading beyond the application site. 
• New conditions detected or diagnosed after study drug administration even though it may have 
been present prior to the start of the study 
• Signs, symptoms, or the clinical sequelae of a suspected interaction 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study drug or a 
concomitant medication (overdose per se will not be reported as an AE/SAE) 
• "Lack of efficacy" or "failure of expected pharmacological action" per se will not be reported as an 
AE or SAE.  Such instances will be captured in the efficacy assessments.  However, the signs, 
symptoms, and/or clinical sequelae resulting from lack of efficacy will be reported as AE or SAE 
if they fulfill the definition of an AE or SAE. 
Events that do not meet the definition of an AE include: 
• Any clinically significant abnormal laboratory findings or other abnormal safety assessments that 
are associated with the underlying disease, unless judged by the Investigator to be more severe 
than expected for the subject’s condition 

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• The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the subject’s condition 
• Medical or surgical procedure (e.g., endoscopy, appendectomy); the condition that leads to the 
procedure is an AE 
• Situations where an untoward medical occurrence did not occur (social and/or convenience 
admission to a hospital) 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at 
the start of the study that do not worsen 
8.1.2 Definition of Serious Adverse Event  
If an event is not an AE per Section 8.1.1, then it cannot be an SAE even if serious conditions are met (e.g., 
hospitalization for signs/symptoms of the disease under study, death due to progression of disease, etc.). 
An SAE is any untoward medical occurrence that, at any dose: 
• Results in death 
• Is life-threatening 
− 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 were more severe. 
• Requires hospitalization or prolongation of existing hospitalization 
− In general, signifies that the subject has been detained (usually involving at least an overnight 
stay) at the hospital or emergency ward for observation and/or treatment that would not have 
been appropriate in the physician’s office or outpatient setting.  Complications that occur 
during hospitalization are AEs.  If a complication prolongs hospitalization or fulfills any other 
serious criteria, the event is serious.  When in doubt as to whether “hospitalization” occurred or 
was necessary, the AE should be considered serious. 
− Hospitalization for elective treatment of a pre-existing condition that did not worsen from 
Baseline is not considered an AE. 
• Results in disability/incapacity:  a substantial disruption of a person’s ability to conduct normal life 
functions. 
− This definition is not intended to include experiences of relatively minor medical significance 
such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental trauma 
(e.g., sprained ankle) which may interfere or prevent everyday life functions but do not 
constitute a substantial disruption. 
• Results in a congenital anomaly/birth defect 
Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other 
situations, such as important medical events that may not be immediately life-threatening or result in death or 
hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one 
of the other outcomes listed in the above definition.  These should also be considered serious.  Examples of 
such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for 

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allergic bronchospasm, blood dyscrasias, or convulsions that do not result in hospitalization, or development 
of drug dependency or drug abuse. 
8.1.3 Adverse Events of Special Interest  
In prior clinical studies, contact dermatitis, folliculitis, and headache have been identified as AEs of particular 
clinical importance and will be reported as AESIs in this study whether or not the AE is considered related to 
study drug.   
In each case study drug may be continued or discontinued, based on Investigator judgment, and may be 
restarted when the event resolves.  In addition, the following information must be collected for each of these 
AESIs: 
Contact Dermatitis 
The study site should collect location, duration, size, associated symptoms (itching, burning, pain), severity 
(mild, moderate, severe), time to onset, and photograph the affected site (if possible).  If the subject or 
caregiver contacts the study site to report significant skin irritation at or near the site of study drug application 
between study visits, the subject should be brought in for an unscheduled visit, if possible. 
Headache   
The study site should collect duration, severity (mild, moderate, severe), time to onset, and location (e.g., 
frontal, temporal, occipital, diffuse). 
Follicular Event 
The study site should collect the location, duration, size, associated signs and symptoms (itching, burning, 
pain, erythema), severity (mild, moderate, severe), describe morphology [scale (keratotic/cornified) or no 
scale (non-keratotic/non-cornified)], time to onset, and photograph the affected site (if possible).  Additional 
information regarding management of folliculitis is provided in Section 8.2.1.2.4. 
In particular, the term ‘folliculitis’ may not correctly describe the morphology of the observed local follicular 
events as these appear to be more consistent with a keratoses pilaris-like follicular based papule. Tapinarof 
upregulates components of the stratum corneum, including involucrin, hornerin, and filaggrin and increased 
cornification at, and subsequent mechanical occlusion of, the follicular ostia has been suggested to be a 
potentially on target mechanism by which these lesions may develop in some individuals treated with 
tapinarof cream. Additional morphologic description will help to more fully and appropriately characterize 
these follicular events.      
Possible descriptors include, but are not limited to: 
• Folliculitis 
− Non-inflammatory 
− Inflammatory  
• Milia 
− Non-inflammatory 
− Inflammatory  
• Keratosis pilaris  

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− Non-inflammatory 
− Inflammatory  
Additional AESIs may be identified during the evaluation of safety data for the Clinical Study Report. 
8.2 Classification of Adverse Events  
8.2.1 Assigning Severity Rating for Adverse Events  
8.2.1.1 
Criteria for Determining Adverse Event Severity  
The Investigator will make an assessment of the severity of each AE and SAE according to the National 
Cancer Institute CTCAE, v. 5.0, 2017.  For terms not specified with the CTCAE, the criteria in Table 5 should 
be used to determine the grade severity. 
Table 5: 
Criteria for Determining the Grade/Severity of Adverse Event Terms Not Specified by 
the National Cancer Institute CTCAE  
Grade 
Criteria 
1 
Mild; asymptomatic or mild symptoms, clinical or diagnostic observations only; intervention not indicated 
2 
Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental activities of 
daily livinga 
3 
Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization 
indicated; disabling; limiting self-care activities of daily livingb 
4 
Life threatening consequences; urgent intervention indicated 
5 
Death related to adverse event 
a. Instrumental activities of daily living refer to preparing meals, shopping for groceries or clothes, using the telephone, managing 
money, etc. 
b. Self-care activities of daily living refer to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and 
not bedridden. 
CTCAE = Common Terminology Criteria for Adverse Events. 
 
AE severity should be recorded in the appropriate section of the AE CRF and in the subject’s source 
documents. 
8.2.1.2 
Toxicity Management Criteria  
8.2.1.2.1 Grade 1 or Grade 2 Adverse Event  
Subjects who develop a Grade 1 or Grade 2 AE may continue investigational product at the discretion of the 
Investigator.  Subjects who choose to withdraw from study due to a Grade 1 or 2 AE should have study 
withdrawal/early termination evaluations completed. 
8.2.1.2.2 Grade 3 Adverse Event  
Subjects who develop a Grade 3 AE should be managed as follows: 
• If the Investigator has compelling evidence that the Grade 3 AE has not been caused by 
investigational product, then dosing may continue after discussion with the Medical Monitor. 
• Subjects who develop a Grade 3 AE that the Investigator considers related to investigational 
product should have the investigational product discontinued.  Subjects experiencing Grade 3 AEs 
requiring permanent discontinuation of investigational product should be followed weekly until 
resolution or stability of the AE and encouraged to have withdrawal study evaluations completed. 

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8.2.1.2.3 Grade 4 Adverse Event  
Subjects who develop a Grade 4 AE should have investigational product permanently discontinued. 
Subjects experiencing Grade 4 AEs requiring permanent discontinuation of investigational product should be 
followed weekly until resolution or stability of the AE and encouraged to have withdrawal study evaluations 
completed. 
8.2.1.2.4 Folliculitis  
Subjects using tapinarof topically may experience folliculitis. The majority of these events are mild or 
moderate and do not require intervention or interruption in study drug use. On close inspection, the 
morphology is similar to that of keratosis pilaris suggesting that the potential mechanism may be increased 
follicular cornification with subsequent follicular plugging.  Importantly, AhR regulates the epidermal 
differentiation complex and tapinarof has been shown to repair the skin barrier through activation of stratum 
corneum components including fillagrin, hornerin and involucrin. This latter point suggests that the keratosis 
pilaris-like reaction may be an on-target effect associated with a therapeutic response to tapinarof cream.  
While the majority of events have not required nor resulted in the need for intervention, several approaches 
can be employed to manage those patients with folliculitis who may be symptomatic including temporary 
interruption of study drug use at sites of folliculitis and/or the local application to affected areas of topical 
keratolytics such as 12% lactic acid lotion or 5-10% urea creams or lotions. 
8.2.1.2.5 Other Management Criteria:  
The Medical Monitor should be notified if any of the following occur: 
• Severe signs or symptoms, or significant changes in any of the safety assessments, that put the 
safety of the subject at risk (e.g., laboratory tests or vital signs, etc.) as judged by the Investigator. 
8.2.2 Assigning Causal Relationship to Study Drug  
The Principal Investigator or sub-Investigator is to make the causality assessment.  The reasonable possibility 
of the relationship of an AE to study drug is to be assessed with careful medical consideration at the time of 
evaluation of an AE.  The following definitions are to be used for the relationship of the AE to study drug: 
• Related:  A clinical event, including laboratory test abnormality, with a temporal relationship to 
study drug administration that makes a causal relationship plausible, unlikely attributed to 
concurrent disease or other drugs or chemicals, and that follows a clinically reasonable response 
on re-administration (rechallenge) or withdrawal (dechallenge), although information on drug 
withdrawal may be lacking or unclear. 
• Not related:  A clinical event, including laboratory test abnormality, with a temporal relationship 
to study drug administration that makes a causal relationship improbable and/or in which other 
drugs, chemicals, or underlying disease provide a plausible explanation. 
Any AEs /SAEs assessed as related to study participation (e.g., protocol-mandated procedures, invasive tests, 
or change in existing therapy) or related to study drug will be recorded from the time a subject consented to 
participate in the study up to and including any follow-up contact. 
All AEs, whether related to study drug or not, must be fully and completely documented on the AE page of 
the CRF and in the subject’s clinical record.  In the event a subject is withdrawn from the study because of an 
AE, the primary reason for withdrawal (i.e., due to an AE) must be recorded on the CRF as such. 

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8.3 Time Period and Frequency for Event Assessment and Follow-Up  
8.3.1 Adverse Event Reporting  
All AEs will be collected from the time of signed informed consent until the final visit. 
Any AEs assessed as related to study participation (e.g., protocol-mandated procedures, invasive tests, or 
change in existing therapy) will be collected from the time a subject consented to participate in the study up to 
and including any follow-up contact. 
All SAEs will be recorded in the CRF and reported to the Sponsor within 24 hours via email or phone (refer 
to Medical Monitor / Sponsor Information Page for contact information) (see Section 8.4). 
8.3.2 Follow-Up of Adverse Events  
After the initial AE/SAE report, the Investigator is required to proactively follow each subject at subsequent 
visits/contacts.  All SAEs and nonserious AEs will be followed until resolution, until the condition stabilizes, 
until the event is otherwise explained, or if the subject is lost to follow-up. 
The Investigator will assess the outcome of each AE using the following criteria: 
• Recovered/Resolved:  The event has improved or subject recuperated. 
• Recovered/Resolved with sequelae:  The subject has recuperated but retained pathological 
conditions resulting from the prior disease or injury. 
• Recovering/Resolving:  The event is improving. 
• Not recovered/Not resolved:  The event has not improved or subject recuperated. 
• Unknown:  The outcome of the event is not known, not observed, not recorded, or refused. 
• Fatal:  Termination of life as an outcome of the AE. 
8.4 Reporting Procedures  
8.4.1 Serious Adverse Event Reporting  
When an Investigator determines that an AE meets the protocol definition of an SAE during the study, he/she 
must notify the Sponsor using an SAE Report Form within 24 hours of the study site personnel’s 
knowledge of the event, regardless of the Investigator assessment of the relationship of the event to study 
drug.  Relevant information will be entered on the AE page and on all other applicable pages of the CRF; 
source documentation should not be sent with the SAE Report Form unless requested. 
Follow-up information received on SAEs should be emailed or faxed to the Sponsor within 1 business day of 
receipt (refer to Medical Monitor/ Sponsor Information Page for contact information).  This information 
should be included on a follow-up SAE form and filed with the original SAE information. 
All SAEs will be followed until resolution, until the condition stabilizes, until the event is otherwise 
explained, or until the subject is lost to follow-up. 
The completed SAE Report form should be submitted via email or fax to the SAE Reporting Contact which 
can be found on the Medical Monitor/ Sponsor Information Page of this protocol. 
Do not delay reporting a suspected SAE in order to obtain additional information.  Any additional 
information, if collected, can be reported as a follow-up to the initial report. 

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8.4.2 Regulatory Reporting Requirements for Serious Adverse Events  
Prompt notification by the Investigator to the Sponsor of SAEs (even for non-interventional post-marketing 
studies) is essential so that legal obligations and ethical responsibilities towards the safety of subjects and the 
safety of a product under clinical investigation are met. 
The Sponsor has a legal responsibility to notify both the local regulatory authority and other regulatory 
agencies about the safety of a product under clinical investigation.  The Sponsor will comply with 
country-specific regulatory requirements relating to safety reporting to the regulatory authority, IRB/IEC, and 
Investigators. 
Investigator safety reports are prepared for suspected unexpected serious adverse reactions according to local 
regulatory requirements and are forwarded to Investigators as necessary. 
An Investigator who receives an Investigator safety report describing a SAE(s) or other specific safety 
information (e.g., summary or listing of SAEs) from the Sponsor will file it with the Investigator’s Brochure 
and will notify the IRB/IEC, if appropriate, according to local requirements. 
8.5 Pregnancy Management and Reporting  
Any female subject who becomes pregnant during the study will be withdrawn.  Details will be collected for 
all pregnancies in female subjects and female partners of male subjects that begin after the start of dosing and 
through the Follow-up visit.  Pregnancy is not automatically considered an AE. 
If a pregnancy is reported, then the Investigator should complete a Pregnancy Report Form and submit via 
email or fax to the Pregnancy Reporting Contact for which contact information can be found on the Medical 
Monitor / Sponsor Information Page of this protocol, within 2 weeks of learning of the pregnancy.  The 
subject will also be followed to determine the outcome of the pregnancy.  Information on the status of the 
mother and child will be forwarded to the Sponsor.  Generally, follow-up will be no longer than 6 to 8 weeks 
following the estimated delivery date.  Any premature termination of the pregnancy will be reported. 
Any SAE occurring in association with a pregnancy brought to the Investigator’s attention after the subject 
has completed the study and considered by the Investigator as possibly related to the study drug must be 
promptly reported to the Sponsor or the Sponsor’s representative. 
The Investigator must attempt to collect pregnancy information on any female partners of male study subjects 
who become pregnant while the subject is enrolled in the study.  Pregnancy information must be reported to 
the Sponsor or the Sponsor’s representative as described above.  The partner will also be followed to 
determine the outcome of the pregnancy.  Information on the status of the mother and child will be forwarded 
to Sponsor or the Sponsor’s representative.  Generally, follow-up will be no longer than 6 to 8 weeks 
following the estimated delivery date.  Any premature termination of the pregnancy will be reported on the 
Pregnancy Report Form. 

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9 Data Management  
For this study, subject data will be entered into the Sponsor-defined CRFs, transmitted electronically to the 
Sponsor or designee, and combined with data provided from other sources in a validated data system. 
Management of clinical data will be performed in accordance with applicable Sponsor standards and data 
cleaning procedures will be used to ensure the integrity of the data, e.g., errors will be corrected, and 
inconsistencies queried in the data. 
Adverse events and relevant medical history will be coded using the most current version of the Medical 
Dictionary for Regulatory Activities.  Concomitant medications will be coded with the most current version of 
World Health Organization Drug Global Dictionary. 
The Investigator will retain original source documents and the Sponsor will receive CRF-required data as 
electronic datasets.  Subject initials will not be collected or transmitted to the Sponsor. 

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10 Statistical Considerations and Data Analyses  
This study will evaluate the efficacy and safety of tapinarof cream, 1% compared with vehicle control cream 
in adults and children with AD. 
10.1 General Considerations  
All study data will be summarized by treatment group using descriptive statistics.  Categorical variables will 
be reported using frequency and percentage (e.g., gender, race).  Continuous variables will be reported using 
number of subjects, mean, standard deviation (SD), median, minimum, and maximum.  All efficacy and 
safety data will be listed by subject. 
10.2 Determination of Sample Size  
It is estimated that the proportion of subjects who will achieve a vIGA-AD™ score of 0 or 1 and at least a 2-
grade reduction from Baseline at Week 8 will be 45% for subjects receiving tapinarof compared with 25% for 
subjects receiving vehicle control, based upon the Phase 2 results.  With 400 subjects randomized in a 2:1 
ratio (267 subjects receiving tapinarof, and 133 subjects receiving vehicle control), this will provide 97.2% 
power for statistical significance (2-sided p < 0.05).  The power is calculated from a Fisher Exact sample size 
calculation.  It is assumed that 15% of the subjects receiving tapinarof will be lost to follow-up by 8 weeks 
compared with 30% of the subjects receiving vehicle control.  These subjects will be included in the primary 
analysis using the multiple imputation method. 
10.3 Analysis Populations  
10.3.1 Safety  
All randomized subjects who receive at least 1 application of study drug will be included in the Safety 
population.  Subjects will be analyzed as treated. 
10.3.2 Intent-To-Treat  
All randomized subjects will be included in the Intent-to-treat (ITT) population.  Subjects will be analyzed as 
randomized. 
10.3.3 Per-Protocol  
All subjects in the ITT population who did not have any major protocol deviations or other events that may 
impact the interpretation of the primary efficacy endpoint will be included in the Per Protocol (PP) 
population.   
10.3.4 Pharmacokinetic  
All subjects who undergo plasma PK sampling and have evaluable concentration-time data for analysis will 
be included in the PK population.  A sample that is below the quantification limit of the assay is considered 
evaluable. 
10.4 Planned Analyses  
All efficacy and safety measures over the course of the study will be presented.  Details of planned analyses, 
including the handling of subjects whose visits are impacted by the COVID-19 pandemic, will be described in 
the Statistical Analysis Plan. 

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10.4.1 Disposition and Demographics  
Demographic and baseline characteristics as well as medical history will be summarized using the ITT 
population, including frequency and percentages for categorical variables and mean, SD, median, minimum, 
and maximum for continuous variables. 
The numbers of subjects in the different analysis populations will be summarized by treatment group, 
including overall categories. 
10.4.2 Efficacy Analyses  
All efficacy analyses will be based on the ITT population and will be repeated for the PP population only for 
the primary and secondary efficacy endpoints as supportive analysis. 
10.4.2.1  Primary Endpoint Analyses   
The primary estimand of interest is the composite estimand in a patient population offered treatment with 
tapinarof cream, 1% as compared to vehicle (see Table 6).  Interest is focused on the treatment effect 
measured by the ratio of response rates at Week 8. The primary efficacy endpoint for treatment effectiveness 
is proportion of subjects who achieve vIGA-AD™ score of clear (0) or almost clear (1) and at least a 2-grade 
reduction from bBaseline at Week 8.  Subjects who prematurely discontinue treatment due to an AE or lack of 
efficacy and subjects who use a prohibited medication with significant impact on efficacy evaluations prior to 
Week 8 will be considered treatment failure as of the start of the intercurrent event. 
Table 6 
Primary Estimand Attributes  
Estimand Attribute 
Description 
Treatment 
tapinarof cream, 1% compared to vehicle 
Population 
Intent-to-treat 
Variable of interest 
Proportion of subjects who achieve vIGA-AD™ score of clear 
(0) or almost clear (1) and at least a 2-grade reduction from 
Baseline at Week 8 
Intercurrent event handling 
Subjects who prematurely discontinue treatment due to an AE 
or lack of efficacy and subjects who use a prohibited 
medication with significant impact on efficacy evaluations 
prior to Week 8 will be considered treatment failure.  
Investigator assessments will only include data collected at in-
person visits. 
Summary measure 
Ratio of response rates at Week 8 
The primary efficacy endpoint will be analyzed using a Cochran–Mantel–Haenszel (CMH) test stratified by 
vIGA AD™ score at Baseline (vIGA AD™ scores of 3 or 4) and by age group (2-6 years, 7-11 years, 12-17 
years, 18 years and above). Handling of missing values is described in Section 10.6. 
The primary efficacy endpoint will be analyzed using a Cochran–Mantel–Haenszel (CMH) test stratified by 
vIGA-AD™ score at Baseline (vIGA-AD™ scores of 3 or 4) and by age group (2-6 years, 7-11 years, 12-17 
years, 18 years and above). Handling of missing values is described in Section 10.6. 
10.4.2.2 Secondary and Exploratory Efficacy Endpoint Analyses  
The secondary efficacy endpoints are as follows: 
• Proportion of subjects with ≥ 75% improvement in EASI from Baseline at Week 8 

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• Mean change in %BSA affected from Baseline at Week 8 
• Proportion of subjects with ≥ 90% improvement in EASI from Baseline at Week 8 
• Proportion of subjects > 12 years old with a Baseline PP-NRS score > 4 who achieve ≥ 4-point 
reduction in the PP-NRS from Baseline at Week 8 
Exploratory efficacy endpoints are as follows: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The same methods as discussed for the primary analysis of the primary endpoint will be used to analyze all 
dichotomized secondary endpoints.  The secondary efficacy endpoints will be tested sequentially in the order 
listed.  Testing will stop if non-significance (2-sided p ≥ 0.05) is observed. 
Post-baseline weekly PP-NRS scores will be an average of 7 daily post-baseline PP-NRS scores prior to and 
including the values assessed on the visit date. 
Other efficacy endpoints will be analyzed using CMH test for proportions, and analysis of covariance 
(ANCOVA) model for continuous variables.  CMH tests will be stratified by Baseline vIGA-AD™ score and 
age group, and ANCOVA models will include vIGA-AD™ score and age group as categorical covariates and 
Baseline as a continuous covariate. 
All endpoints will be summarized descriptively as follows:  continuous data will include the mean, SD, 
minimum, maximum, median, and number of observations; descriptive summary statistics for categorical data 
will include frequency counts and percentages. 

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10.4.3 Safety Analyses  
The Safety Population will be used in the analysis of safety data.  Data will be listed by subject and treatment 
and summarized by treatment.  No formal statistical comparisons will be made for safety data. 
The number and proportion of subjects with TEAEs will be summarized by treatment, system organ class, and 
preferred term for all TEAEs, all TEAEs considered by the Investigator to be related to study drug, all SAEs, 
all TEAEs leading to study drug discontinuation, and all TEAEs leading to study discontinuation.  All AE 
summaries will include information for AEs that occurred after administration of the first dose of study drug 
until completion of the final study visit.  Data listings will be provided for subjects who discontinued the 
study due to an AE and for subjects with an SAE. 
Laboratory values will be classified as normal, low or high based on normal ranges supplied by the 
laboratory.  Changes from Baseline in abnormality status will be summarized using shift tables.  For 
quantitative laboratory measures, observed values and changes from Baseline will be summarized 
descriptively by visit and treatment group. 
Observed vital sign values (systolic and diastolic blood pressure, pulse rate, and body temperature) and 
change from Baseline in vital signs will be summarized similarly to the laboratory values. 
Observed ECG parameters and change from Baseline in ECG parameters will be summarized similarly to the 
laboratory values. 
LTS scores will be summarized by treatment and visit for subject (or caregiver) overall assessment and 
Investigator overall assessment separately. 
10.4.4 Analysis of Functional Outcomes and Quality of Life Endpoints  
 
: 
• 
 
   
• 
 
  
• 
 
 
• 
 
 
 
10.4.5 Pharmacokinetic Analyses  
Data will be listed and summarized.  Listings will be sorted by subject and day; summaries will be presented 
by study visit. 
Unless stated otherwise, descriptive summaries for continuous variables will include n, mean, SD, median, 
minimum, and maximum.  Exploratory analyses may include relationships of plasma concentrations with 
subject demographics or AEs. 

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10.5 Interim Analyses  
No interim analyses will be performed. 
10.6 Handling of Missing Data  
Every effort will be made to collect complete data at all visits.  
The primary method of handling of missing data will utilize Multiple Imputations (MI).  For sensitivity 
analysis of the primary and secondary endpoints, Last Observation Carried Forward (LOCF) and Treatment 
Failure (TF) will be imputed for missing data. 
For the MI model, 100 imputations will be generated using PROC MI of SAS.  Fully Conditional 
Specification model using the regression method will be used with the response (e.g., vIGA-AD™ score) at 
prior post-Baseline visits, Baseline strata, and treatment group as covariates. The ROUND and MINIMUM 
options will be utilized to ensure imputed values are non-negative integers.  The results of the 100 analyses 
will be transformed into a normal statistic and combined into a single analysis using PROC MIANALYZE. 
Additional sensitivity analyses of the primary endpoint will be performed via tipping point analysis. 

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11 Responsibilities  
11.1 Investigator Responsibilities  
11.1.1 Good Clinical Practice  
The Investigator will ensure that this study is conducted in accordance with the principles of the “Declaration 
of Helsinki” (as amended in Edinburgh, Tokyo, Venice, Hong Kong, and South Africa), International 
Conference on Harmonization guidelines, or with the laws and regulations of the country in which the 
research is conducted, whichever affords the greater protection to the study subject.  For studies conducted 
under a United States Investigational New Drug Application, the Investigator will ensure that the basic 
principles of “Good Clinical Practice,” as outlined in 21 Code of Federal Regulations (CFR) 312, subpart D, 
“Responsibilities of Sponsors and Investigators,” 21 CFR, part 50, 1998, and 21 CFR, part 56, 1998, are 
adhered to.  These standards are consistent with the requirements of the European Community Directive 
2001/20/EC. 
Since this is a “covered” clinical trial, the Investigator will ensure that 21 CFR, Part 54, 1998, is adhered to; a 
“covered” clinical trial is any “study of a drug or device in humans submitted in a marketing application or 
reclassification petition subject to this part that the applicant or Food and Drug Administration relies on to 
establish that the product is effective (including studies that show equivalence to an effective product) or that 
make a significant contribution to the demonstration of safety.”  This requires that Investigators and all sub-
Investigators must provide documentation of their financial interest or arrangements with the Sponsor, or 
proprietary interests in the drug being studied.  This documentation must be provided before participation of 
the Investigator and any sub-Investigator.  The Investigator and sub-Investigator agree to notify the Sponsor 
of any change reportable interests during the study and for 1 year following completion of the study.  Study 
completion is defined as the date that the last subject has completed the protocol-defined activities. 
11.1.2 Institutional Review Board/Independent Ethics Committee Approval  
This protocol and any accompanying material to be provided to the subject (such as advertisements, subject 
information sheets, or descriptions of the study used to obtain informed consent) will be submitted by the 
Investigator or on behalf of the Investigator to an IRB or IEC.  Approval from the IRB or IEC must be 
obtained before starting the study and should be documented in a letter to the Investigator specifying the 
protocol number, protocol version, protocol date, documents reviewed, and date on which the committee met 
and granted the approval. 
Any modifications made to the protocol after receipt of IRB or IEC approval must also be submitted to the 
IRB or IEC for approval before implementation. 
11.1.3 Informed Consent/Assent  
The Investigator is responsible for obtaining written informed consent/assent from each individual 
participating in this study after adequate explanation of the aims, methods, objectives, and potential hazards of 
the study and before undertaking any study-related procedures.  The Investigator must utilize an IRB- or IEC-
approved consent form for documenting written informed consent.  Each informed consent/assent will be 
appropriately signed and dated by the subject or the subject’s legally authorized representative and the person 
obtaining consent. 

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11.1.4 Confidentiality  
The Investigator must assure that subjects’ anonymity will be strictly maintained and that their identities are 
protected from unauthorized parties.  Only subject number, date of birth, and an identification code (i.e., not 
names) should be recorded on any form or biological sample submitted to the Sponsor, IRB or IEC, or 
laboratory.  The Investigator must keep a screening log showing codes, names, and addresses for all subjects 
screened and for all subjects enrolled in the trial. 
The Investigator agrees that all information received from the Sponsor, including but not limited to the 
Investigator Brochure, this protocol, CRFs, the investigational new drug, and any other study information, 
remain the sole and exclusive property of the Sponsor during the conduct of the study and thereafter.  This 
information is not to be disclosed to any third party (except employees or agents directly involved in the 
conduct of the study or as required by law) without prior written consent from the Sponsor.  The Investigator 
further agrees to take all reasonable precautions to prevent the disclosure by any employee or agent of the 
study site to any third party or otherwise into the public domain. 
11.1.5 Study Files and Retention of Records  
The Investigator must maintain adequate and accurate records to enable the conduct of the study to be fully 
documented and the study data to be subsequently verified.  These documents should be classified into at least 
the following 2 categories: (1) Investigator’s study file, and (2) subject clinical source documents. 
The Investigator’s study file will contain the protocol/amendments, CRF and query forms, IRB or IEC and 
governmental approval with correspondence, informed consent, drug records, staff curriculum vitae and 
authorization forms, and other appropriate documents and correspondence. 
The required source data should include at least the following information for each subject: 
• Subject identification (name, date of birth, gender) 
• Documentation that subject meets eligibility criteria, i.e., history, physical examination, and 
confirmation of diagnosis (to support inclusion and exclusion criteria) 
• Participation in trial (including trial number) 
• Trial discussed and date of informed consent 
• Dates of all visits 
• Documentation that protocol-specific procedures were performed 
• Results of efficacy parameters, as required by the protocol 
• Start and end dates (including dose regimen) of trial medication (preferably drug dispensing and 
return should be documented as well) 
• Record of all adverse events and other safety parameters (start and end date, and preferably 
including causality and intensity) 
• Concomitant medication (including start and end dates, dose if relevant; dose changes should be 
recorded) 
• Date of trial completion and reason for early discontinuation, if applicable 
All clinical study documents must be retained by the Investigator until at least 2 years after the last approval 
of a marketing application in an ICH region (i.e., United States, Europe, or Japan) and until there are no 

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pending or contemplated marketing applications in an ICH region; or, if no application is filed or if the 
application is not approved for such indication, until 2 years after the investigation is discontinued and 
regulatory authorities have been notified.  Investigators may be required to retain documents longer if 
required by applicable regulatory requirements, by local regulations, or by an agreement with the Sponsor.  
The Investigator must notify the Sponsor before destroying any clinical study records. 
Should the Investigator wish to assign the study records to another party or move them to another location, the 
Sponsor must be notified in advance. 
If the Investigator cannot guarantee this archiving requirement at the study site for any or all of the 
documents, special arrangements must be made between the Investigator and the Sponsor to store these in 
sealed containers outside of the site so that they can be returned sealed to the Investigator in case of a 
regulatory audit.  When source documents are required for the continued care of the subject, appropriate 
copies should be made for storage outside of the site. 
11.1.6 Electronic Case Report Forms  
For each subject enrolled, a CRF must be completed and signed by the Investigator.  This also applies to 
records for those subjects who fail to complete the study.  If a subject withdraws from the study, the reason 
must be noted on the CRF.  If a subject is withdrawn from the study because of a treatment-limiting AE, 
thorough efforts should be made to clearly document the outcome. 
11.1.7 Drug Accountability  
The Investigator or designee (i.e., pharmacist) is responsible for ensuring adequate accountability of all used 
and unused investigational medicinal product.  This includes acknowledgment of receipt of each shipment of 
study product (quantity and condition), subject dispensing records, and returned or destroyed study product.  
Dispensing records will document quantities received from the Sponsor and quantities dispensed to subjects, 
including kit or lot number, date dispensed, subject identifier number, and the initials of the person dispensing 
the medication. 
At study initiation, the monitor will evaluate the site’s procedure for investigational medicinal product 
disposal/destruction in order to ensure that it complies with the Sponsor requirements.  At the end of the 
study, following final drug inventory reconciliation by the monitor, the study site will dispose of and/or 
destroy all unused investigational medicinal product supplies, including empty containers, according to these 
procedures.  If the site cannot meet the Sponsor’s requirements for disposal, arrangements will be made 
between the site and the Sponsor or its representative for destruction or return of unused investigational 
medicinal product supplies. 
All drug supplies and associated documentation will be periodically reviewed and verified by the study 
monitor over the course of the study. 
11.1.8 Inspections  
The Investigator should understand that source documents for this trial should be made available to 
appropriately qualified personnel from the Sponsor or its representatives, to IRBs or IECs, or to regulatory 
authority or health authority inspectors. 

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11.1.9 Protocol Compliance  
The Investigator is responsible for ensuring the study is conducted in accordance with the procedures and 
evaluations described in this protocol. 
11.2 Sponsor Responsibilities  
11.2.1 Protocol Modifications  
Protocol modifications, except those intended to reduce immediate risk to study subjects, may be made only 
by the Sponsor.  All protocol modifications must be submitted to the IRB or IEC and regulatory authorities in 
accordance with local requirements.  Approval must be obtained before changes can be implemented. 
11.2.2 Study Report and Publications  
A clinical study report will be prepared and provided to the regulatory agency(ies).  The Sponsor will ensure 
that the report meets the standards set out in the ICH Guideline for Structure and Content of Clinical Study 
Reports (ICH E3).  Note that an abbreviated report may be prepared in certain cases. 
After conclusion of the study and without prior written approval from Dermavant Sciences, Inc., Investigators 
in this study may communicate, orally present, or publish in scientific journals or other scholarly media only 
after the following conditions have been met: 
• The results of the study in their entirety have been publicly disclosed by or with the consent of 
Dermavant Sciences, Inc., in an abstract, manuscript, or presentation form; OR 
• The study has been completed at all study sites for at least 5 years. 
No such communication, presentation, or publication will include Dermavant Sciences, Inc. confidential 
information (see Section 11.1.4). 
The Investigator will submit any proposed publication or presentation along with the respective scientific 
journal or presentation forum at least 30 days before submission of the publication or presentation.  The 
Investigator will comply with Dermavant Sciences, Inc. request to delete references to its confidential 
information (other than the study results) in any paper or presentation and agrees to withhold publication or 
presentation for an additional 60 days in order to obtain patent protection if deemed necessary. 
11.2.3 Posting of Information on Publicly Available Clinical Trial Registers  
Study information from this protocol will be posted on publicly available clinical trial registers as required by 
applicable regulations.  Results will be posted as required. 
11.3 Joint Investigator/Sponsor Responsibilities  
11.3.1 Access to Information for Monitoring  
In accordance with ICH Good Clinical Practice guidelines, the study monitor must have direct access to the 
Investigator’s source documentation in order to verify the data recorded in the CRFs for consistency. 
The monitor is responsible for routine review of the CRFs at regular intervals throughout the study to verify 
adherence to the protocol and the completeness, consistency, and accuracy of the data being entered on them.  
The monitor should have access to any subject records needed to verify the entries on the CRFs.  The 
Investigator agrees to cooperate with the monitor to ensure that any problems detected in the course of these 
monitoring visits are resolved. 

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In the event of a COVID-19-like situation necessitating a limit on in-person contact, remote monitoring may 
be performed. 
11.3.2 Access to Information for Auditing or Inspections  
To ensure compliance with Good Clinical Practices and all applicable regulatory requirements, Dermavant 
Sciences, Inc. may conduct a quality assurance audit. 
Authorized representatives of Dermavant Sciences, Inc., a regulatory authority, an Independent Ethics 
Committee or an Institutional Review Board may visit the site to perform audits or inspections, including 
source data verification.  The purpose of a Dermavant Sciences, Inc. audit or inspection is to systematically 
and independently examine all study-related activities and documents to determine whether these activities 
were conducted, and data were recorded, analyzed, and accurately reported according to the protocol, Good 
Clinical Practice guidelines of the International Conference on Harmonization, and any applicable regulatory 
requirements.  The Investigator should contact Dermavant Sciences, Inc. immediately if contacted by a 
regulatory agency about an inspection. 
Representatives of regulatory authorities or of the Sponsor may conduct inspections or audits of the clinical 
study.  If the Investigator is notified of an inspection by a regulatory authority the Investigator agrees to notify 
the Sponsor Medical Monitor immediately.  The Investigator agrees to provide to representatives of a 
regulatory agency or the Sponsor access to records, facilities, and personnel for the effective conduct of any 
inspection or audit. 
11.3.3 Study Discontinuation  
The Sponsor reserves the right to terminate the study at any time.  Should this be necessary, the Sponsor will 
arrange discontinuation procedures and notify the appropriate regulatory authority(ies), IRBs, and IECs.  In 
terminating the study, the Sponsor and the Investigator will assure that adequate consideration is given to the 
protection of the subjects’ interests. 
 
 
 
 
 
 
 
 

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13 Appendices  
Appendix 1. Hanifin and Rajka Criteria for Atopic Dermatitis Diagnosis  
Major Criteria (must have at least three) 
• Pruritus 
• Typical morphology and distribution: 
− Adults: flexural lichenification or linearity 
− Children and infants: involvement of facial and extensor surfaces 
• Chronic or chronically relapsing dermatitis 
• Personal or family history of atopy (asthma, allergic rhinitis, atopic dermatitis) 
Minor Criteria (must have at least three) 
• Xerosis 
• Ichthyosis/keratosis pilaris/palmar hyperlinearity 
• Immediate (Type 1) skin test reactivity 
• Elevated serum IgE 
• Early age at onset 
• Tendency to skin infections (Staphylococcus aureus, herpes simplex)/impaired cellular immunity  
• Tendency to nonspecific hand/foot dermatitis 
• Nipple eczema 
• Cheilitis 
• Recurrent conjunctivitis 
• Dennie-Morgan infraorbital fold 
• Keratoconus 
• Anterior subcapsular cataracts 
• Orbital darkening 
• Facial pallor/erythema 
• Pityriasis alba 
• Anterior neck folds 
• Itch when sweating 
• Intolerance to wool and lipid solvents 
• Perifollicular accentuation 
• Food intolerance 
• Course influenced by environmental/emotional factors 
• White dermographism/delayed blanch 
 
Source: Hanifin, 1980. 
 

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Appendix 2. Fitzpatrick Skin Type Scale  
 
Skin Type 
Sunburn Tendency 
Suntan Tendency  
Type I 
Always burns easily 
Never tan 
Type II 
Always burns easily 
Tans slightly 
Type III 
Burns moderately 
Tans gradually 
Type IV 
Burns minimally 
Tans moderately 
Type V 
Rarely burns 
Tans profusely 
Type VI 
Never burns 
Tans profusely 
 
 
 

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Appendix 3. Validated Investigator Global Assessment Scale for Atopic Dermatitis  
Instructions: 
The IGA score is selected using the descriptors below that best describe the overall appearance of the lesions 
(excluding lesions on the scalp) at a given time point. It is not necessary that all characteristics under 
Morphological Description be present. 
 
 
Score 
Morphological Description 
0 – Clear 
No inflammatory signs of atopic dermatitis (no erythema, no 
induration/papulation, no lichenification, no oozing/crusting). Post-inflammatory 
hyperpigmentation and/or hypopigmentation may be present. 
1 – Almost clear 
Barely perceptible erythema, barely perceptible induration/papulation, and/or 
minimal lichenification. No oozing or crusting. 
2 – Mild 
Slight but definite erythema (pink), slight but definite induration/papulation, and/or 
slight but definite lichenification. No oozing or crusting. 
3 – Moderate 
Clearly perceptible erythema (dull red), clearly perceptible induration/papulation, 
and/or clearly perceptible lichenification. Oozing and crusting may be present. 
4 – Severe 
Marked erythema (deep or bright red), marked induration/papulation, and/or 
marked lichenification. Disease is widespread in extent. Oozing or crusting may be 
present. 
Notes: 
1. In indeterminate cases, please use extent to differentiate between scores. 
For example: 
Patient with marked erythema (deep or bright red), marked papulation and/or marked lichenification that is 
limited in extent, will be considered “3 – Moderate”. 
2. Excoriations should not be considered when assessing disease severity. 
 
Copyright ©2017 Eli Lilly and Company – Used with the permission of Eli Lilly and Company under a Creative Commons 
Attribution-No Derivatives 4.0 International License – https://creativecommons.org/licenses/by-nd/4.0/.  
 
 

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Calculation of EASI score (scalp excluded) 
Four anatomic sites – head, upper extremities, trunk, and lower extremities – are assessed for erythema, 
edema/papulation, excoriation and lichenification as seen on the day of the examination.  The severity of each 
sign is assessed using a 4-point scale, half points may be used (e.g. 0.5, 1.5, 2.5): 
0 = None (Absent) 
1 = Mild 
2 = Moderate 
3 = Severe 
The area affected by AD within a given anatomic site is estimated as a percentage of the total area of that 
anatomic site, based on the %BSA calculation, and assigned a numerical value according to the degree of AD 
involvement. For the purpose of assigning a numerical value for each anatomic site, %BSA ranges will be 
used as follows: 
0 = no (0%) involvement 
1 = > 0% to < 9.50% involvement 
2 = ≥ 9.50% to < 29.50% involvement 
3 = ≥ 29.50% to < 49.50% involvement 
4 = ≥ 49.50% to < 69.50% involvement 
5 = ≥ 69.50% to < 89.50% involvement 
6 = ≥ 89.50% to 100% involvement 
The EASI score will be calculated in the CRF based on the subject’s age, the rating scores for each region, 
and the number of handprints involved for each region. 
 
 

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Appendix 11.  Peak Pruritus-Numeric Rating Scale  
 
The PP-NRS is a scale used to quickly assess itch/pruritus severity over a 24-hour period which will be used 
daily to assess peak pruritus.   
For subjects ages 2 to < 12 years, the PP-NRS will be completed by the caregiver.  For subjects ages > 12 
years, the PP-NRS will be completed by the subject.   
 
PP-NRS 
On a scale of 0 to 10, with 0 being ’no itch‘ and 10 being ’worst itch imaginable‘, how would you rate your 
itch at the worst moment during the previous 24 hours? 
 
 
 
PP-NRS © 2019 Regeneron Pharmaceuticals, Inc. and SAR&D. All rights reserved. Used with permission of 
Regeneron Pharmaceuticals, Inc. and SAR&D 
 
 
 
 
 
 
 
 

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Appendix 15. Investigator-Assessed Local Tolerability Scale  
At each specified study visit, the Investigator (or qualified evaluator) will assess the presence and overall 
degree of irritation at the application sites, according to the 5-point LTS below.  The score will ideally 
represent an “average” across all application sites.  To the fullest extent possible, the same Investigator (or 
designated evaluator) will perform all tolerability assessments for an individual subject throughout the study. 
If the subject is applying study drug to “sensitive areas”, a separate LTS will be used to assess the degree of 
irritation for each of these areas where study drug is applied.  The sensitive areas that will be assessed are 
face, neck, skin folds, axilla, inframammary, anal crux, and genitalia.   
 
Investigator Local Tolerability Scale – Dryness, Erythema, and Peeling 
Score 
Severity 
Description 
0 
No irritation 
No evidence of local irritation/intolerance 
1 
Mild 
Minimal erythema and/or edema, slight glazed appearance 
2 
Moderate 
Definite erythema and/or edema with peeling and/or cracking but does not 
require treatment modification 
3 
Severe 
Erythema, edema glazing with fissures, few vesicles or papules 
4 
Very Severe 
Strong reaction spreading beyond the treated area, bullous reaction, 
erosions 
 
 
 

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Appendix 16. Subject (or Caregiver)-Assessed Local Tolerability Scale  
At each specified study visit, the subject or caregiver will separately assess the presence and degree of 
burning/stinging and itching at the application sites, each according to a 5-point LTS.  The subject or 
caregiver will not score each sensitive area individually but provide one overall score that will ideally 
represent an “average” across all application sites.  For subjects ages < 12 years, the LTS will be completed 
by the caregiver.  For subjects ages > 12 years, the LTS will be completed by the subject. 
 
Subject (Or Caregiver) Local Tolerability Scale – Burning/Stinging 
Score 
Severity 
Description 
0 
None 
Normal, no discomfort 
1 
Slight 
An awareness, but no discomfort and no intervention required 
2 
Mild 
A noticeable discomfort that causes intermittent awareness 
3 
Moderate 
A noticeable discomfort that causes intermittent awareness and interferes 
occasionally with normal daily activities 
4 
Strong/Severe 
A definite continuous discomfort that interferes with normal daily activities 
 
Subject (Or Caregiver) Local Tolerability Scale – Itching 
Score 
Severity 
Description 
0 
None 
Normal, no discomfort 
1 
Slight 
An awareness, but no discomfort and no intervention required 
2 
Mild 
A noticeable discomfort that causes intermittent awareness 
3 
Moderate 
A noticeable discomfort that causes intermittent awareness and interferes 
occasionally with normal daily activities 
4 
Strong/Severe 
A definite continuous discomfort that interferes with normal daily activities 
 
 
 

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