A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis
Phase: PHASE3
Conditions: Seborrheic Dermatitis
Sponsor: Arcutis Biotherapeutics, Inc.

Confidential 
Page 1 of 86 
Title Page 
ARQ-154-304 
A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled 
Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered 
QD in Subjects with Seborrheic Dermatitis (STRATUM) 
Sponsor: 
Arcutis Biotherapeutics, Inc. 
3027 Townsgate Road, Suite 300 
Westlake Village, CA 91361 
Sponsor Representative: 
David Berk, MD 
Vice President, Clinical Development 
Tel.:  +1 805 418 5006 Ext. 711 
E-mail: dberk@arcutis.com
IND Number:  
142047 
Protocol Version: 
Amendment 2 
Date:  
05 May 2022 
GCP Statement 
This study is to be performed in full compliance with the protocol, International Conference on Harmonisation Good 
Clinical Practices (ICH GCP), and applicable regulatory requirements. All required study documentation will be 
archived as required by regulatory authorities. 
Confidentiality Statement 
This document contains confidential information. It contains proprietary information of Arcutis Biotherapeutics, Inc. 
Any viewing or disclosure of such information that is not authorized in writing by Arcutis Biotherapeutics, Inc. is 
strictly prohibited. Such information may be used solely for the purpose of reviewing or performing this study. 

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SITE INVESTIGATOR SIGNATURE PAGE 
ARQ-154-304 
A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and 
Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects with Seborrheic Dermatitis 
SPONSOR: 
Arcutis Biotherapeutics, Inc. 
3027 Townsgate Road, Suite 300 
Westlake Village, CA 91361 
ISSUE DATE: 
05 May 2022 
I have read this protocol, including all appendices, and I agree that it contains all necessary 
details for me and my staff to conduct this study as described. I will conduct this study as 
outlined herein, in accordance with the current International Conference on Harmonisation Good 
Clinical Practices (ICH GCPs) and applicable local and regional regulations. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Arcutis Biotherapeutics, Inc.. I will discuss the material with them to 
ensure that they are fully informed about ARQ-154 foam 0.3% and the study. 
I agree that I or my designee will completely inform all subjects in this study concerning the 
pertinent details and purpose of the study prior to their agreement to participate in the study in 
accordance with cGCPs and regulatory authority requirements. I will be responsible for 
maintaining each subject’s consent form in the study file and providing each subject with a 
signed copy of the consent form. 
I agree to maintain the confidentiality of all information received or developed in connection 
with this protocol. 
Investigational Site Name: 
Print Investigator Name: 
Investigator Signature: __________________________________  Date:  _______________ 

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SUMMARY OF CHANGES 
The following sections have been changed in Protocol Amendment 2 of the ARQ-154-304 
protocol: 
Section 
Summary of Changes 
Amendment 2 
4.5.2 Exclusion Criteria 
Exclusion 6: Clarified that Baseline/Screening C-SSRS (for 
adolescents and adults 12 years old and older) indicative of 
suicidal ideation or behavior, whether lifetime or 
recent/recurrent is exclusionary.  
6.3.2 Secondary Endpoint 
Updated  the multiple testing strategy for the secondary 
endpoints to include use of the Fallback Method. 
Appendix 1: Body and Scalp 
Diagram 
Updated scalp diagram. 
Editorial changes made throughout to improve accuracy or readability. 

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TABLE OF CONTENTS 
1.
PROTOCOL SUMMARY ..........................................................................................11 
1.1. 
Synopsis ......................................................................................................................11 
1.2. 
Study Schema .............................................................................................................17 
1.3. 
Schedule of Visits and Assessments ...........................................................................18 
2.
BACKGROUND AND RATIONALE .......................................................................20 
2.1. 
Introduction .................................................................................................................20 
2.2. 
Conclusions on Toxicity Findings ..............................................................................21 
2.3. 
Clinical Studies ...........................................................................................................22 
2.3.1. 
Seborrheic Dermatitis Phase 2a ..................................................................................22 
2.4. 
Rationale for Development .........................................................................................22 
2.4.1. 
Dose Selection ............................................................................................................23 
2.4.2. 
Risks and/or Benefits to Subjects ...............................................................................23 
3.
STUDY OBJECTIVES AND ENDPOINTS ..............................................................24 
3.1. 
Study Objectives .........................................................................................................24 
3.1.1. 
Primary Objective .......................................................................................................24 
3.2. 
Study Endpoints ..........................................................................................................24 
3.2.1. 
Primary Endpoint ........................................................................................................24 
3.2.2. 
Secondary Endpoints ..................................................................................................24 
4.
INVESTIGATIONAL PLAN .....................................................................................25 
4.1. 
Overall Study Design and Plan ...................................................................................25 
4.2. 
Number of Sites and Subjects .....................................................................................25 
4.3. 
Subject Participation ...................................................................................................25 
4.4. 
Subject Identification Number Assignment ................................................................25 
4.5. 
Selection of Study Population ....................................................................................25 
4.5.1. 
Inclusion Criteria ........................................................................................................25 
4.5.2. 
Exclusion Criteria .......................................................................................................26 
4.6. 
Randomization ............................................................................................................28 
4.7. 
Prohibitions and Concomitant Therapy ......................................................................28 
4.8. 
Treatment ....................................................................................................................30 
4.8.1. 
IP Supplies, Packaging, and Labeling ........................................................................30 

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4.8.2. 
Treatment Administration ...........................................................................................30 
4.8.3. 
Treatment Compliance ................................................................................................31 
4.8.4. 
Blinding ......................................................................................................................31 
4.8.5. 
Breaking Treatment Codes .........................................................................................32 
4.8.6. 
Removal of Subjects from Investigational Product ....................................................32 
4.8.7. 
Removal of Subjects from the Study ..........................................................................33 
5.
STUDY PROCEDURES ............................................................................................33 
5.1. 
Safety Assessments .....................................................................................................33 
5.1.1. 
Screening ....................................................................................................................33 
5.1.2. 
Contraception Requirements ......................................................................................34 
5.1.3. 
Baseline .......................................................................................................................35 
5.1.4. 
Physical Examination .................................................................................................35 
5.1.5. 
Vital Signs, Height and Weight ..................................................................................36 
5.1.6. 
Laboratory Tests .........................................................................................................36 
5.1.7. 
Patient Health Questionnaire Depression Scale (PHQ-8) ..........................................37 
5.1.8. 
Patient Health Questionnaire Depression Scale (Modified PHQ-A) ..........................37 
5.1.9. 
Children’s Depression Inventory 2 (Parent Report) ...................................................38 
5.1.10. 
Columbia-Suicide Severity Rating Scale (C-SSRS) ...................................................38 
5.1.11. 
Local Tolerability Assessment ...................................................................................39 
5.1.12. 
Pigmentation Assessment ...........................................................................................40 
5.1.13. 
Adverse Events ...........................................................................................................40 
5.2. 
Efficacy Evaluations ...................................................................................................40 
5.2.1. 
Investigator Global Assessment (IGA) .......................................................................40 
5.2.2. 
Overall Assessment of Erythema ................................................................................41 
5.2.3. 
Overall Assessment of Scaling ...................................................................................41 
5.2.4. 
Worst Itch-Numerical Rating Scale (WI-NRS) ..........................................................42 
5.2.5. 
Scalpdex ......................................................................................................................42 
5.2.6. 
Dermatology Life Quality Index (DLQI) and Children’s Dermatology Life 
Quality Index (CDLQI) ..............................................................................................42 
5.2.7. 
Body Surface Area (BSA) ..........................................................................................43 
5.3. 
Other Evaluations .......................................................................................................43 
5.3.1. 
Pharmacokinetics Assessment ....................................................................................43 

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5.3.2. 
Dermal Imaging ..........................................................................................................43 
5.4. 
Final Study Visit .........................................................................................................43 
5.5. 
Early Termination Visit ..............................................................................................43 
5.6. 
Unscheduled Visit .......................................................................................................44 
5.7. 
Adverse Events ...........................................................................................................44 
5.7.1. 
Adverse Event Definition ...........................................................................................44 
5.7.2. 
Serious Adverse Event ................................................................................................44 
5.7.3. 
Suspected Unexpected Serious Adverse Reaction (SUSAR) .....................................46 
5.7.4. 
Safety Review with Subject ........................................................................................46 
5.7.5. 
Adverse Event Reporting ............................................................................................46 
5.8. 
Reporting Pregnancy ..................................................................................................48 
5.9. 
Treatment Stopping Rules ..........................................................................................48 
6.
DATA ANALYSIS ....................................................................................................49 
6.1. 
Statistical Methods ......................................................................................................49 
6.1.1. 
Determination of Sample Size ....................................................................................50 
6.1.2. 
Subjects to Analyze ....................................................................................................50 
6.1.3. 
Interim Analysis ..........................................................................................................50 
6.1.4. 
Background and Demographic Characteristics ..........................................................50 
6.1.5. 
Study Disposition........................................................................................................51 
6.1.6. 
Protocol Deviations and Eligibility Deviations ..........................................................51 
6.1.7. 
Investigational Product Application Compliance .......................................................51 
6.1.8. 
Pharmacokinetics Analysis .........................................................................................51 
6.2. 
Safety Analysis ...........................................................................................................51 
6.2.1. 
Adverse Events ...........................................................................................................51 
6.2.2. 
Clinical Laboratory Results ........................................................................................51 
6.2.3. 
Vital Signs ..................................................................................................................51 
6.2.4. 
Local Tolerance Assessments .....................................................................................52 
6.2.5. 
Medical History and Physical Examinations ..............................................................52 
6.3. 
Efficacy Evaluation ....................................................................................................52 
6.3.1. 
Primary Endpoint ........................................................................................................52 
6.3.2. 
Secondary Endpoint ....................................................................................................52 
7.
STUDY ADMINISTRATION ...................................................................................53 

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7.1. 
Ethics ..........................................................................................................................53 
7.1.1. 
Ethics Review Board ..................................................................................................53 
7.1.2. 
Ethical Conduct of the Study ......................................................................................53 
7.1.3. 
Subject Information and Consent/Assent ...................................................................53 
7.2. 
Study Completion and Termination ............................................................................54 
7.2.1. 
Study Completion .......................................................................................................54 
7.2.2. 
Study Termination ......................................................................................................54 
7.3. 
Study Monitoring ........................................................................................................54 
7.4. 
Data Quality Assurance ..............................................................................................55 
7.5. 
Data Handling and Record Keeping ...........................................................................55 
7.6. 
Protocol Amendments and Deviations .......................................................................55 
7.7. 
Confidentiality and Privacy ........................................................................................56 
7.8. 
Conflict of Interest ......................................................................................................56 
7.9. 
Report Format .............................................................................................................56 
7.10. 
Publication Policy .......................................................................................................56 
8.
REFERENCES ...........................................................................................................57 
9.
APPENDICES ............................................................................................................58 
APPENDIX 1. BODY & SCALP DIAGRAM ...........................................................................58 
APPENDIX 2. PATIENT HEALTH QUESTIONNAIRE DEPRESSION SCALE 
(PHQ-8) ......................................................................................................................60 
APPENDIX 3. MODIFIED PATIENT HEALTH QUESTIONNAIRE DEPRESSION 
SCALE (PHQ-A) ........................................................................................................61 
APPENDIX 4. CHILDREN’S DEPRESSION INVENTORY 2 (PARENT REPORT) ............62 
APPENDIX 5. COLUMBIA-SUICIDE SEVERITY RATING SCALE (C-SSRS) 
BASELINE/SCREENING VERSION .......................................................................63 
APPENDIX 6. COLUMBIA-SUICIDE SEVERITY RATING SCALE (C-SSRS) 
SINCE LAST VISIT VERSION ................................................................................66 
APPENDIX 7. SCALPDEX .......................................................................................................69 
APPENDIX 8. DERMATOLOGY LIFE QUALITY INDEX (DLQI) ......................................70 
APPENDIX 9. CHILDREN’S DERMATOLOGY LIFE QUALITY INDEX (CDLQI) ...........72 
APPENDIX 10. NIAID DMID TOXICITY TABLE .................................................................74 
APPENDIX 11. COVID-19 STUDY SITE GUIDANCE ..........................................................84 

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LIST OF TABLES 
Table 1: 
Excluded Medications and Treatments .......................................................................29 
Table 2: 
Laboratory Tests .........................................................................................................36 
LIST OF FIGURES 
Figure 1: 
Contraception Requirements for Female Subjects .....................................................35 

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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation 
Definition 
AE 
Adverse Event 
AMP 
Adenosine Monophosphate 
BSA 
Body Surface Area 
Cmax 
Maximum Concentration 
CDI 
Children’s Depression Inventory 
CDLQI 
Children's Dermatology Life Quality Index 
COPD 
Chronic Obstructive Pulmonary Disease 
eCRF 
Case Report Form 
C-SSRS
Columbia-Suicide Severity Rating Scale 
CTCAE 
Common Terminology Criteria for Adverse Events 
DLQI 
Dermatology Life Quality Index 
ERB 
Ethics Review Board 
FDA 
U.S. Food and Drug Administration 
FOCBP 
Female of Childbearing Potential 
GCP 
Good Clinical Practices 
IB 
Investigational Brochure 
IC50 
Half Maximal Inhibitory Concentration 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
ID 
Identification 
IGA 
Investigator Global Assessment 
IND 
Investigational New Drug 
IP 
Investigational Product 
IRB 
Institutional Review Board 
ITT 
Intent to Treat 
IWRS 
Interactive Web Response System 
Kg 
Kilogram 
LED 
Light Emitting Device 
µg 
Microgram 
MedDRA 
Medical Dictionary for Regulatory Activities 

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Abbreviation 
Definition 
Mg 
Milligram 
Min 
Minute 
mL 
Milliliter 
NCI 
National Cancer Institute 
NIH 
National Institutes of Health 
Ng 
Nanogram 
NOAEL 
No Observed Adverse Effect Level 
NRS 
Numeric Rating Score 
P-450
Cytochrome P450 
PDE-4 
Phosphodiesterase 4 
PHQ-8 
Patient Health Questionnaire 
PHQ-A 
Modified Patient Health Questionnaire for Adolescents 
PI 
Principal Investigator 
PK 
Pharmacokinetics 
QD 
Once Daily ("quaque die") 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SD 
Standard Deviation 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
US 
United States 
WI-NRS 
Worst Itch Numeric Rating Score 

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1.
PROTOCOL SUMMARY
1.1. 
Synopsis
Name of Sponsor/Company: Arcutis Biotherapeutics, Inc. 
Protocol Number: 
ARQ-154-304 
Phase: 3 
IND: 142047 
Protocol Title: A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study 
of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects with 
Seborrheic Dermatitis 
Clinical Indication: Seborrheic Dermatitis 
Investigational Product: ARQ-154 foam investigational product (IP) will be supplied as 
ARQ-154 foam 0.3%.  The active ingredient in ARQ-154 foam is roflumilast, a 
phosphodiesterase 4 (PDE-4) inhibitor. Matching vehicle foam will contain only excipients of 
ARQ-154 foam. 
Subjects will be randomized 2:1 to receive ARQ-154 foam 0.3% or matching vehicle foam 
once daily (QD) applied to all areas of seborrheic dermatitis. Areas of application will be all 
areas affected including face, scalp, trunk, or intertriginous/genital regions, with a maximum 
BSA of 20%. Subjects should maintain treatment areas with IP for the duration of the study 
regardless of whether treatable areas of seborrheic dermatitis clear. New lesions that appear 
during the treatment period should also be treated. 
Study Design: This is a phase 3, randomized, parallel group, double blind, vehicle-controlled 
study in which ARQ-154 foam 0.3% or vehicle foam is applied QD for 8 weeks to subjects 
9 years of age and older with at least moderate seborrheic dermatitis affecting the scalp and/or 
rest of body. 
Primary Objective: The purpose of this study is to assess the safety and efficacy of ARQ-154 
foam 0.3% administered once daily (QD) vs vehicle foam for 8 weeks in subjects with 
seborrheic dermatitis.   
Study Sites: Approximately 50 sites in North America 
Number of Subjects (planned): 450 
Study Population: Subjects will be male and female children and adolescents (9-17 y/o) and 
adults (≥18 y/o). Subjects will have a minimum Investigator Global Assessment 
(IGA) = ‘Moderate’ (3) for study entry. Randomization will be stratified by study site and 
Baseline disease severity (IGA = 3 or IGA = 4). 

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Duration of Participation for Subjects: Screening (up to 4 weeks) + Treatment phase 
(8 weeks) for a total of up to approximately 12 weeks. 
Main Criteria for Inclusion: 
1. Participants legally competent to sign and give informed consent or
(for children/adolescents) assent with consent of a parent(s) or legal guardian, as
required by local law.
2. Males and females ages 9 years and older (inclusive) at the time of consent.
3. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as
determined by the Investigator. Stable disease for the past 4 weeks.
4. Seborrheic dermatitis up to 20% BSA involvement.  Involvement may be of the scalp
and/or face and/or trunk and/or intertriginous areas.
5. An Investigator Global Assessment (IGA) disease severity of at least Moderate (‘3’) at
Baseline.
6. Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least
Moderate (‘2’) at Baseline.
7. Female subjects of childbearing potential (FOCBP) must have a negative serum
pregnancy test at Screening (Visit 1) and negative urine pregnancy test at Baseline
(Visit 2). In addition, sexually active FOCBP must agree to use at least one form of a
highly effective or a barrier method of contraception throughout the trial according to
Contraception Requirements for Female Subjects (see Figure 1).
8. Females of non-childbearing potential must either be premenarchal, post-menopausal
with spontaneous amenorrhea for at least 12 months (post-menopausal status should be
confirmed with FSH testing) or have undergone surgical sterilization according to
Contraception Requirements for Female Subjects (Figure 1).
9. Subjects in good health as judged by the Investigator, based on medical history,
physical examination, vital signs, serum chemistry labs, hematology values, and
urinalysis.
10. Subjects are considered reliable and capable of adhering to the Protocol and visit
schedule according to the Investigator judgment.

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Main Criteria for Exclusion: 
1. Subjects who cannot discontinue treatment with therapies for the treatment of
seborrheic dermatitis prior to the Baseline visit and during the study according to
Excluded Medications and Treatments (Table 1).
2. Planned excessive exposure to treated area(s) to either natural or artificial sunlight,
tanning bed, or other LED.
3. Subjects who cannot discontinue to use of strong systemic P-450 cytochrome inhibitors
e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole,
nefazodone, saquinavir, suboxone and telithromycin for two weeks prior to the
Baseline visit (Visit 2) and during the study.
4. Subjects with PHQ-8 (≥18 years old, inclusive) or modified PHQ-A (adolescents,
12 to 17 years old, inclusive) score ≥10 at Screening or Baseline visits.
5. Subjects (9-11 years old, inclusive) with a CDI-2 (parent report) raw score ≥17 for
females and ≥18 for males at Screening or Baseline visits.
6. History of severe depression, suicidal ideation or behavior, Baseline/Screening
C-SSRS (for adolescents and adults 12 years old and older) indicative of suicidal
ideation or behavior, whether lifetime or recent/recurrent.
7. Previous treatment with ARQ-151 or ARQ-154.
8. Subjects who have received oral roflumilast (Daliresp®, Daxas®), or apremilast
(Otezla®) within the past 4 weeks.
9. Known allergies or hypersensitivity to component(s) of the investigational product
which includes roflumilast, petrolatum, isopropyl palmitate, methylparaben,
propylparaben, diethylene glycol monoethyl ether, hexylene glycol, cetearyl alcohol,
dicetyl phosphate and ceteth-10 phosphate.
10. Known or suspected:
a.
Severe renal insufficiency as evidenced by calculated creatinine clearance
<30 mL/min
b. Moderate to severe hepatic disorders (Child-Pugh B or C)
11. Liver function test results excursions that exceed:
•
AST or ALT > 2x ULN
•
Total bilirubin:
−
1.5x ULN or
−
>ULN and ≤1.5x ULN and direct bilirubin is >35% of total bilirubin
•
ALP ≥ 2x ULN
12. Subjects with active pityriasis/tinea amiantacea.

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13. Subjects with a history or a major surgery within 4 weeks prior to Baseline (Visit 2) or
has a major surgery planned during the study.
14. Subjects with any serious medical condition or clinically significant laboratory
abnormality that would prevent study participation or place the subject at significant
risk, as determined by the Investigator.
15. Subjects with any condition on the treatment area which, in the opinion of the
Investigator, could confound efficacy measurements.
16. Subjects/caregivers unable to apply product to the scalp due to physical limitations if
the subject has current or history of seborrheic dermatitis involving the scalp.
17. Females who are pregnant, wishing to become pregnant during the study, or are
breast-feeding.
18. A clinically relevant history of abuse of alcohol or other drugs within 6 months prior to
Screening.
19. Current or history of cancer within 5 years from Screening with the exception of fully
treated skin basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in
situ of the cervix.
20. Subjects, parent(s)/legal guardian(s) of children/adolescent subjects who are unable to
communicate, read, or understand the local language.
21. Subjects who are family members of the clinical study site, or clinical study staff, or
Sponsor, or family members residing in the same household of enrolled subjects.
22. Any condition that in the Investigator’s assessment would preclude the subject from
participating in the study.
Key Assessments: Safety will be monitored through assessment of application site reaction, 
pigmentation, vital signs/weight, physical examinations, safety labs, and Adverse Events 
(AEs). Safety will also be monitored by C-SSRS, CDI-2 (children 9-11 y/o), and PHQ-8 
(in adults) or modified PHQ-A (adolescents 12-17 y/o) assessments. 
All AEs that occur after the first applications of IP through the end of the study should be 
collected. All SAEs should be collecting starting at Screening. 
Efficacy assessments will be evaluated utilizing: 
•
IGA
•
Overall Assessment of Erythema
•
Overall Assessment of Scaling
•
Worst Itch-Numeric Rating Scale (WI-NRS)
•
Scalpdex, DLQI/CDLQI, and BSA.

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Pharmacokinetic Assessment: 
•
Pharmacokinetic samples (trough) will be collected for all subjects at the Week 4
and Week 8 visits.
Study Endpoints:  
The Primary Efficacy Endpoint will be: 
•
IGA success, defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point
improvement at Week 8
The Secondary Efficacy Endpoints will include: 
•
In subjects with a Baseline WI-NRS pruritus score of ≥4, achievement of a
≥4-point improvement from Baseline in WI-NRS pruritus score at Week 8
(“WI-NRS Success at Week 8”)
•
WI-NRS Success at Week 4
•
WI-NRS Success at Week 2
•
IGA Success at Week 4
•
Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 at Week 8
•
Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 at
Week 8
•
Achievement of an IGA score of ‘clear’ at Week 8
•
IGA Success at Week 2
Additional exploratory endpoints will be included in the Statistical Analysis Plan (SAP).  
Statistical Methods: Approximately 450 subjects are planned for this study. 
Approximately 300 subjects will receive ARQ-154 foam 0.3% QD; approximately 
150 subjects will receive matching vehicle foam QD. 
The randomization scheme will be 2:1 (ARQ-154 foam 0.3% QD: matching vehicle QD) 
stratified by study site and Baseline IGA (IGA=3 vs IGA=4). 
This sample size provides >90% power to detect a 25% difference between treatment groups 
on IGA success at α=0.01 using a 2-sided Cochran-Mantel-Haenszel test stratified by the 
randomization factors. The results from a recent phase 2a study (ARQ-154-203) of ARQ-154 
compared to vehicle treatment were used to estimate the treatment difference. Specifically, in 
the phase 2a trial, 73.8% of subjects demonstrated IGA success in the ARQ-154 foam 0.3% 
group and 40.9% of subjects demonstrated IGA success in the vehicle group. 
The number of subjects to be enrolled will also provide sufficient power for the secondary 
endpoints. Additionally, the larger study size is included in order to provide 
additional/sufficient numbers of subjects on ARQ-154 treatment for a safety database. 

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Descriptive statistics will be presented for the subject disposition, demographics, baseline 
characteristics, treatment compliance, efficacy endpoints, and safety data collected in the 
clinical trial. This includes the number and percentage of subjects for binary 
endpoints/categorical data, and mean, SD, median, minimum, and maximum for continuous 
data. 
The primary endpoint of ‘IGA success at Week 8’ will be analyzed using a Cochran-Mantel-
Haenszel test stratified by the randomization factors of the study center and IGA score at 
Baseline (‘moderate’ vs. ‘severe’). The analysis will be performed on the Intention-to-Treat 
(ITT) population and missing data will be imputed using multiple imputations. 
Continuous secondary endpoints will be analyzed using Analysis of Covariance with treatment 
and stratification factors as independent variables. The ITT population will be used, and 
missing data will be imputed using multiple imputation. Binary secondary endpoints will be 
analyzed similarly to the primary endpoint. 
Secondary endpoints will only be tested statistically if the primary endpoint is considered 
statistically significant. To control for multiple comparisons among the secondary endpoints, 
the following multiplicity procedure will be used: 
Upon demonstration of statistical significance of the primary endpoint, the alpha level of 0.01 
will be split between testing of the WI-NRS success endpoints and other secondary efficacy 
endpoints. The testing over the WI-NRS success endpoints and the other secondary efficacy 
endpoints will be sequential, utilizing the Fallback Method for unused alpha. 
For the testing of WI-NRS success endpoints, an alpha level of 0.0033 will be used and will 
use a hierarchical method to first test WI-NRS success at Week 8, followed by WI-NRS at 
Week 4, followed by WI-NRS success at Week 2.  Should all three of these endpoints be 
statistically significant at the 0.0033 level, then this unused alpha will be carried to the other 
secondary endpoint group, which would then be tested at the .0033+.0067=0.01 level. 
An alpha level of 0.0067 (the remainder of the allotted 0.01) or the full 0.01 pending the 
results of the WI-NRS endpoint testing, will be used to hierarchically test IGA Success at 
Week 4, Scaling score of 0 at Week 8, Erythema score of 0 at Week 8, the percentage of 
subjects who attain IGA of 0 at Week 8, and IGA Success at Week 2.All subjects who are 
randomized and receive at least one confirmed dose of investigational product or vehicle foam 
will be included in the safety population. 
Efficacy analyses will be conducted in the ITT population. Sensitivity analyses may be 
conducted in the subset of the ITT population for whom the primary endpoint assessment was 
not missed due to COVID-19 disruption. 
Adverse events will be summarized by preferred term, system organ class, and treatment 
group for all AEs, serious AEs, related AEs, AEs leading to withdrawal from investigational 
product, and AEs leading to withdrawal from study. 

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1.2. 
Study Schema 
Screening (Visit 1) 
Baseline (Visit 2) 
Randomization and Treatment Day 0 
ARQ-154 
Foam 0.3% 
Vehicle 
Foam 
8-Week Treatment Period
(Visits 3, 4, & 5) 
A Phase 3, 8-Week, Parallel Group, Double Blind, 
Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 
Foam 0.3% Administered in Subjects with Seborrheic Dermatitis 
Approximately 450 children, adolescent and adult subjects with 
seborrheic dermatitis will be randomized 2:1 to receive either: 
•
ARQ-154 foam 0.3%, or
•
Vehicle foam

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1.3. 
Schedule of Visits and Assessments 
Study Procedure 
Screen 
Baseline 
Day 0 
Week 2 
Day 14 
Week 4 
Day 28 
Week 8a 
Day 56 
Visit 
1 
2 
3 
4 
5 
Visit Window 
-4 weeks
± 3 days 
± 5 days 
± 5 days 
Informed consent/assent 
X 
Medical/surgical history, demography 
X 
Physical examinationb 
X 
X 
X 
Fitzpatrick Skin Type 
X 
I/E criteria 
X 
X 
Randomization 
X 
Hematology, Chemistry, and Urinalysisc 
X 
X 
X 
X 
Vital signs, weight, heightd 
X 
X 
X 
X 
X 
IGA, Overall Assessment of Erythema, 
Overall Assessment of Scalinge  
X 
X 
X 
X 
X 
BSAf 
X 
X 
X 
X 
X 
DLQI/CDLQIg, Scalpdex 
X 
X 
X 
X 
X 
Daily WI-NRSh at home (non-clinic) 
Day -7 through Day 56 
Local Tolerability Assessmenti 
X 
X 
X 
Pigmentation Assessmentj 
X 
X 
X 
X 
X 
C-SSRS, CDI-2/PHQ-8/PHQ-Ak
X 
X 
X 
X 
Medical Photographyl 
X 
X 
X 
X 
Serum pregnancy testm 
X 
Urine pregnancy testn 
X 
X 
X 
PK samplingo 
X 
X 
IP application and subject/family trainingp 
X 
X 
Dispense investigational product kitq 
X 
X 
X 
Dispense / review dosing diary 
X 
X 
X 
X 
Weigh investigational productr 
X 
X 
X 
X 
Compliance calculations 
X 
X 
X 
Adverse event assessmentt 
X 
X 
X 
X 
Prior & Concomitant medications 
X 
X 
X 
X 
X 

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Footnotes from table above: 
a
Subjects that terminate early should return to the study site for the Week 8 assessments. 
b
Limited physical examination: skin (including assessment of Fitzpatrick Skin Type at Screening only), lungs, 
and heart only. 
c
To be collected at Screening, Baseline/Day 0, Week 4/Day28, and Week 8/Day 56. For subjects <18 years of 
age, if the Baseline/Day 0 visit occurs within 3 weeks of Screening, the Screening lab results may be utilized. 
d
Height will be collected at Baseline and Week 8. Weight will be collected at all study visits. Subject to void 
prior to weight. 
e
IGA will be a 5-point scale ranging from clear (0) to severe (4). IGA should be completed prior to other 
physician assessments and by the same Evaluator at each study visit. Overall Assessment of Erythema 
(0-3 scale) and Overall Assessment of Scaling (0-3 scale) will be completed. 
f
Total BSA affected by seborrheic dermatitis will be determined by the subject’s hand method, where the 
subject’s hand (including fingers) surface area is assumed to equal 1% of body surface area. 
g
The DLQI will be completed by subjects ≥17 years of age. The CDLQI will be completed for subjects 
9 to 16 years old, inclusive. 
h
WI-NRS will be completed by subjects daily at home starting 7 days prior to the Baseline/Day 0 visit to Day 56 
(Week 8) visit. Daily WI-NRS will be completed in the evening prior to IP application (except at Baseline and 
Week 2 when IP is applied at the clinic). 
i
Local tolerability assessments to be recorded prior to IP application for the Investigator assessment of skin 
irritation (Berger and Bowman skin irritation score) and 10-15 minutes post IP application for the subject’s 
‘0-3’ burning/stinging assessment. Note for investigator tolerability assessments: reactions at the site of IP 
application, which may occur post-Baseline, should be differentiated from the preexisting inflammation 
associated with the subject’s seborrheic dermatitis. At Week 4 and Week 8, subjects will provide a recall 
assessment of burning/stinging experienced post IP application on the day prior to the clinic visit. 
j 
An assessment for hypopigmentation and hyperpigmentation will be performed by the Investigator at all visits. 
k 
Adolescents and adults will complete the C-SSRS (12 years of age and older). Adults will complete the PHQ-8. 
Adolescents (ages 12 to 17 inclusive) will complete the PHQ-A (PHQ-9 modified). Parents/caregivers will 
complete CDI-2 (parent report) for children 9-11 years of age, inclusive.  The CDI-2 will be completed 
throughout the study for subjects 9-11 years old at the time of assent.  
l
Medical photography will be obtained for target lesions by all study sites. All efforts will be made to de-identify
the subjects.
m
A serum pregnancy test will be administered to all females of child-bearing potential at the Screening visit only. 
Follicle Stimulating Hormone (FSH) testing will be performed at Screening (if indicated) to confirm post-
menopausal status. 
n
A urine pregnancy test will be performed at the Baseline, Weeks 4 and 8 to all females of child-bearing 
potential. A negative result is required for continued participation in the study, and results must be available at 
each visit prior to dispensing of investigational product. 
o
PK samples (trough) will be collected on Day 28 (Week 4) and Day 56 (Week 8). Ensure investigational
product is not applied in the area where PK will be drawn.
p
Subjects to apply assigned IP in the study site at every designated visit. 
q
Kits will be dispensed based on % BSA. See IP Handling Plan for details. 
r
Each IP canister in the Kit should we weighed and recorded at every visit. See IP Handling Plan for details. 
s
Compliance calculation is described in the IP Handling Plan. 
t
All AEs should be collected starting after the first application of the IP through the end of the study. All SAEs 
should be collected starting after the signing of the informed consent through 30 days after the last day of the IP 
application or the end of the study (whichever is later).  

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2.
BACKGROUND AND RATIONALE
2.1. 
Introduction
Roflumilast is a phosphodiesterase 4 (PDE-4) inhibitor approved globally to reduce the risk of 
exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) associated 
with chronic bronchitis.  Roflumilast and its active metabolite, roflumilast N-oxide, are high 
affinity selective inhibitors of PDE-4 (a major cyclic-3′,5′-adenosine monophosphate 
(cyclic AMP)-metabolizing enzyme), whose activity leads to accumulation of intracellular cyclic 
AMP.  There are four different subtypes of PDE-4: PDE-4a, PDE-4b, PDE-4c, and PDE-4d, each 
with several isoforms (splicing variants).  IC50 values of both roflumilast and roflumilast N-oxide 
for the different PDE-4 isoforms and subtypes are mostly sub-nanomolar and single digit 
nanomolar (Hatzelmann 2010).  The PDE-4 family of enzymes are the most prevalent 
phosphodiesterases in immune cells and inhibition of PDE-4 subtypes has been associated with 
anti-inflammatory effects in many biological systems. 
Roflumilast was initially developed as a 500 µg tablet for oral therapy in patients with COPD, 
and as such has been thoroughly evaluated in nonclinical studies.  The safety profile is 
well-established, and the results of those studies are relevant to the dermal roflumilast 
(ARQ-151 cream and ARQ-154 foam) development program.  Oral roflumilast (500 µg tablet) 
was approved by Health Canada as DAXAS® in December 2010 and by the US FDA as 
DALIRESP® in February 2011 for the treatment of COPD.  The study sponsor has conducted 
nonclinical studies in which roflumilast is applied dermally. 
The dermal nonclinical program for ARQ-151 cream followed current International Conference 
on Harmonisation (ICH) guidelines and includes a 13-week dermal toxicity study in minipigs, a 
13-week dermal toxicity study in mice, a 39-week dermal toxicity study in minipigs, a skin
sensitization study in guinea pigs, a phototoxicity study, an eye irritation study and a 104-week
carcinogenicity study in mice, the in life portion of which is complete.
Refer to the current ARQ-154 Investigator’s Brochure (IB) for the most current PDE-4 dermal 
and oral/systemic nonclinical and clinical information. 
Seborrheic dermatitis is a common, chronic inflammatory skin disease characterized by 
erythematous, scaly plaques, often with a yellowish, oily, moist, and/or greasy appearance, 
affecting areas of sebaceous gland abundance.  Frequently involved sites include the scalp 
(including retroauricular areas), eyebrows, ears, nasolabial folds, eyelids, trunk, and 
intertriginous areas.  There may be associated pruritus and/or pigmentary changes.  Seborrheic 
dermatitis affects about 2% of the adult population (Borda 2015, Dessinioti 2013) and occurs in 
the adolescent population as well.  Treatment of seborrheic dermatitis may vary by location on 
the body involved, eg, scalp or non-scalp and periocular or not.  For the scalp, anti-dandruff 
shampoos are often used such as anti-fungals, zinc products, selenium sulfide, salicylic acid, or 
tar.  Topical corticosteroid products may also be used.  Scalp lesions of seborrheic dermatitis can 
present a particular treatment challenge and form thick crusts which may not respond to topical 
steroids or antifungals.  On non-scalp regions such as the face, topical antifungals or low potency 
topical corticosteroids are typically used.  However, importantly, topical antifungals may 
demonstrate limited efficacy and topical steroids may demonstrate tachyphylaxis and cause 

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important adverse events, particularly on the face, such as telangiectasias, acne, atrophy, rosacea, 
and ocular complications.  Since seborrheic dermatitis is a chronic condition, treatment with 
topical steroids is particularly problematic due to the need for prolonged treatment duration, 
which may result in side effects.  Other medications which have been used for seborrheic 
dermatitis include topical sulfur/sulfonamide products, topical calcineurin inhibitors, and oral 
retinoids. 
Given the unmet need for new medical therapies for seborrheic dermatitis, and the precedent of 
topical anti-inflammatory agents as treatments for seborrheic dermatitis, the Sponsor pursued 
development of ARQ-154 foam for the treatment of seborrheic dermatitis.  Relative to topical 
formulations such as a cream or gel, the foam formulation in the present study is well suited for 
the treatment of the scalp, where seborrheic dermatitis may predominate and be most difficult to 
treat.  Foams have the ability to access skin lesions in hair-bearing areas and have commonly 
been used for treating scalp psoriasis (e.g., Olux® and Luxiq® foams) and seborrheic dermatitis 
(e.g., Extina® foam).  Results of the phase 2a study of ARQ-154 foam 0.3% in adults with 
seborrheic dermatitis suggest that ARQ-154 may be a highly efficacious and well-tolerated novel 
topical treatment. 
Arcutis is also developing a related cream formulation of roflumilast, ARQ-151 cream. A phase 
3 program of ARQ-151 cream 0.3% for plaque psoriasis recently completed, and phase 2 results 
of ARQ-151 cream 0.15% and 0.05% for atopic dermatitis are available. The composition of 
ARQ-154 topical roflumilast foam includes minimal qualitative or quantitative changes relative 
to the composition of ARQ-151 topical roflumilast cream.  Compared to ARQ-151, ARQ-154 
foam also involves addition of a propellant that is eliminated at delivery.  Since the composition 
of ARQ-154 foam is very close to the composition of ARQ-151 cream, Arcutis plans to rely on 
the nonclinical development program for ARQ-151 topical cream, as detailed below, in order to 
support the ARQ-154 foam development program. 
2.2. 
Conclusions on Toxicity Findings 
The safety profile of oral roflumilast is well-established.  An extensive systemic toxicity program 
that evaluated both roflumilast and its active N-oxide metabolite in multiple species via the oral 
route of administration was conducted to support registration of the 500 µg tablet for COPD. 
The previously conducted systemic toxicity program included studies to evaluate reproductive 
toxicity, genotoxicity and carcinogenicity, and the results of those studies are included in the 
labeling for oral roflumilast. 
To support the development of ARQ-151 topical cream a GLP-compliant dermal toxicity 
program is being conducted.  To date, no new risks have been identified through the dermal 
toxicity program.  In the 13-week dermal toxicity studies in minipigs and mice, and a 39-week 
dermal toxicity study in minipigs, no evidence of systemic toxicity was observed.  
Histopathological evaluation of skin in the minipig study included very slight to slight erythema 
at all treatment levels, and minor degrees of irritation such as hyperplasia.  The NOAEL in both 
studies was the 1% concentration of ARQ-151 (20 mg/kg), the highest dose administered and the 
maximum feasible concentration. 

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Across the dermal and systemic toxicology programs, the exposure to parent drug and N-oxide 
metabolite differs by route and species. While exposure to roflumilast and its active metabolite 
are likely to be higher following topical administration of ARQ-151 relative to oral 
administration, when the margins from the toxicity studies are considered as a whole, the 
NOAELs across routes and species provide assurance that the anticipated exposures with 
ARQ-151 cream will be safe. 
2.3. 
Clinical Studies 
2.3.1. 
Seborrheic Dermatitis Phase 2a 
ARQ-154-203 (NCT 04091646) was a Phase 2a, parallel group, double blind, vehicle-controlled 
study that evaluated ARQ-154 foam 0.3% for the treatment of seborrheic dermatitis involving 
the scalp, face, and/or body. ARQ-154 foam 0.3% or matching vehicle was applied once daily 
(QD) for eight weeks to adult subjects with a minimum Investigator Global Assessment (IGA) of 
moderate (IGA of 3 on a 5-point scale from 0 to 4). A total of 226 subjects were randomized at a 
ratio of 2:1 to receive ARQ-154 foam 0.3% or matching vehicle foam. All randomized subjects 
were included in both the safety and intent-to-treat (ITT) populations. 
The study demonstrated that ARQ-154 foam 0.3% was highly efficacious (including early 
timepoints), safe, and well-tolerated following once-daily topical application in subjects with 
moderate to severe seborrheic dermatitis. The study’s primary endpoint was IGA Success, 
defined as achievement of an IGA score of ‘clear’ or ‘almost clear’ PLUS a 2-grade 
improvement from Baseline at Week 8. This endpoint was met with IGA success in 73.8% of 
subjects in the ARQ-154 treatment group vs. 40.9% of vehicle-treated subjects (p<0.0001).  IGA 
success was greater with ARQ-154 than vehicle starting at the first post-baseline visit at Week 2 
(33.8% of ARQ-154 vs 14.5% of vehicle subjects, p=0.0029). Worst Itch-Numeric Rating Scale 
(WI-NRS) success at Week 8, defined as a ≥4-point improvement from Baseline was 64.6% for 
ARQ-154 vs. 33.3% for vehicle (p=0.0006), with statistical significance as early as Week 2 
(52.8% for ARQ-154 vs 22.8% for vehicle, p=0.0005). 
ARQ-154 foam 0.3% was safe and demonstrated excellent tolerability based on adverse event 
(AE) reporting and both investigator-rated and subject-rated local tolerability assessments.  No 
serious adverse events (SAEs) were reported, and only a few subjects reported treatment-related 
adverse events (TEAEs) (1.9% with ARQ-154 and 4.2% with vehicle) or discontinued study 
drug due to AEs (1.3% with ARQ‑154 and 2.8% with vehicle).  Most (>90%) TEAEs were grade 
1 or grade 2, i.e., mild or moderate.  Systemic exposure to roflumilast and roflumilast N-oxide in 
subjects with seborrheic dermatitis treated with ARQ-154 foam 0.3% appeared comparable to 
that of subjects with psoriasis treated with ARQ‑151 cream 0.3%, when adjusted for body 
surface area (BSA). 
2.4. 
Rationale for Development 
The development plan for ARQ-154 foam will leverage experience to date with ARQ-151 cream, 
which has been safe, well tolerated, and effective in multiple Phase 2 studies for the treatment of 
plaque psoriasis or atopic dermatitis.  Given the unmet need for new medical therapies for 
seborrheic dermatitis and the results of a phase 2a study of ARQ-154 foam 0.3% in seborrheic 

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dermatitis, the Sponsor is pursuing development of ARQ-154 foam 0.3% for the treatment of 
seborrheic dermatitis in this phase 3 study.  Relative to topical formulations such as a cream or 
gel, the foam formulation in the present study is expected to be well suited for the treatment of 
the scalp, where seborrheic dermatitis may predominate. 
2.4.1. 
Dose Selection 
ARQ-154 foam at 0.3% was selected for this study to match the dose of ARQ-154 foam from the 
phase 2a study ARQ-154-203. The 0.3% dose is also consistent with the dose of the related 
roflumilast cream formulation (ARQ-151 cream 0.3%) which is being evaluated in phase 3 for 
plaque psoriasis. The 0.3% dose for ARQ-151 cream was selected based on results of the phase 
2b study plaque psoriasis study ARQ-151-201, in which the 0.3% concentration demonstrated 
greater efficacy that the 0.15% concentration.  In that phase 2b study, there were no differences 
in the safety profiles of the two doses, supporting that it was not necessary to evaluate doses less 
than 0.3% in seborrheic dermatitis.  The Sponsor expects similar doses to be safe and effective in 
seborrheic dermatitis, as supported by the phase 2a seborrheic dermatitis study ARQ-154-203. 
Additionally, many cases of seborrheic dermatitis may be challenging to treat or refractory to 
standard treatment (particularly in patients with neurologic conditions, as included here) and the 
Sponsor is targeting greater efficacy than commonly used topical antifungals and low potency 
steroids, further supporting the choice to evaluate the 0.3% dose. 
Consistent with the close similarities between ARQ-151 and ARQ-154 formulations, study 
ARQ-154-203 demonstrated comparable pharmacokinetics with ARQ-154 foam as have been 
described with ARQ-151 cream.  Additionally, pharmacokinetics in seborrheic dermatitis 
appeared comparable to those seen in plaque psoriasis and atopic dermatitis. 
2.4.2. 
Risks and/or Benefits to Subjects 
Based on efficacy data from subjects randomized to active treatment group of the phase 2a study 
ARQ-154-203, including at Week 2, it is expected that subjects in the present study 
ARQ-154-304 will experience improvement in their seborrheic dermatitis.  Subjects randomized 
to the vehicle treatment group may also see some improvement as the formulation of ARQ-154 
may have a moisturizing effect. 
The safety monitoring practices employed in this protocol (i.e., physical examinations, vital 
signs/weight, local skin toleration assessments, hematology, serum chemistry, urinalysis, 
PHQ-8/PHQ-A/CDI-2, C-SSRS and AE questioning) are adequate to protect the subjects’ safety 
and should detect expected AEs.  The lack of nausea and vomiting seen in ARQ-151 cream and 
ARQ-154 foam studies to date may be related to the lack of ‘peak to trough’ Cmax variation, 
lower Cmax values than observed following oral administration, or bypassing of the 
gastrointestinal tract with topical administration. 
Oral roflumilast has now been used for almost a decade in the treatment of COPD exacerbations 
and its safety record has been well-documented.  The known adverse effects of oral treatment in 
the COPD population (nausea, diarrhea, weight loss, psychiatric AEs) are readily monitored as 
specific in this protocol. The current protocol is designed to detect these adverse events and 
others should they occur, and provides guidance for management, as necessary, to ensure patient 
safety.  Furthermore, the safety profiles of ARQ-151 and ARQ-154 at doses ranging from 

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0.15% to 0.5% in the preceding studies in seborrheic dermatitis and psoriasis suggests that 
ARQ-154 foam 0.3% will be similarly safe and well tolerated in the present study. 
3.
STUDY OBJECTIVES AND ENDPOINTS
3.1. 
Study Objectives 
3.1.1. 
Primary Objective 
The primary objective of this study is to assess the safety and efficacy of ARQ-154 foam 
0.3% administered once daily (QD) vs vehicle foam for 8 weeks in subjects with seborrheic 
dermatitis. 
3.2. 
Study Endpoints 
3.2.1. 
Primary Endpoint 
The primary efficacy endpoint in this study is success in Investigator Global Assessment (IGA) of 
disease severity, defined as an IGA score of ‘clear’ or ‘almost clear’ plus a 2-point improvement 
at Week 8. 
3.2.2. 
Secondary Endpoints 
The Secondary Efficacy Endpoints will include: 
•
In subjects with a Baseline WI-NRS pruritus score of ≥4, achievement of a ≥4-point
improvement from Baseline in WI-NRS pruritus score at Week 8 (“WI-NRS Success
at Week 8”)
•
WI-NRS Success at Week 4
•
WI-NRS Success at Week 2
•
IGA Success at Week 4
•
Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 at Week 8
•
Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 at Week 8
•
Achievement of an IGA score of ‘clear’ at Week 8
•
IGA Success at Week 2
Additional exploratory endpoints will be included in the SAP. 

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4.
INVESTIGATIONAL PLAN
4.1. 
Overall Study Design and Plan 
This is a phase 3, parallel group, double blind, vehicle-controlled study in which ARQ-154 foam 
0.3% or vehicle foam is applied QD x 8 weeks to subjects 9 years of age and older with at least 
moderate seborrheic dermatitis affecting the scalp and/or rest of body.  
4.2. 
Number of Sites and Subjects 
A total of up to approximately 450 subjects will be enrolled at approximately 50 study sites in 
North America. Additional countries or study sites may be added, as necessary. Subjects will be 
male and female children (9 - 11 y/o), adolescents (12 - 17 y/o) and adults (≥18 y/o). Subjects 
will have an IGA of disease severity of at least Moderate (‘3’) at Baseline. Subjects must have no 
more than 20% BSA of seborrheic dermatitis. All lesions on a subject will be treated including 
the scalp, face, trunk, and intertriginous areas. 
4.3. 
Subject Participation 
Subject participation involves a minimum of 5 clinic visits, including Screening, Baseline/Day 0, 
Week 2, Week 4, and Week 8. The interval between Screening and Baseline visits may take up 
to 4 weeks, the anticipated maximum duration of subject participation is 12 weeks. 
4.4. 
Subject Identification Number Assignment 
All subjects who sign an informed consent or assent (children/adolescents) form will be assigned 
a unique 5-digit subject identification (ID) number by the interactive web response system 
(IWRS). The first 2 digits correspond to the study site number (assigned by the Sponsor), the 
next 3 digits (starting with 800) correspond to the sequential order in which the subject is 
screened for the study (e.g., Subject ID <11800>: Site 11, subject number 800, as the first subject 
screened by that site). The subject ID will remain the same in the event the subject is rescreened. 
The study site is responsible for maintaining a current log of subject ID number assigned to each 
subject. The subject ID number will be used to identify the subject throughout the study and is 
required to be entered on all clinical study documentation (e.g., case report forms, labeling of 
clinical materials and sample containers, investigational product accountability logs, etc.). 
4.5. 
Selection of Study Population 
4.5.1. 
Inclusion Criteria 
Subjects must fulfill all the following inclusion criteria to be eligible for participation in the 
study: 
1. Participants legally competent to sign and give informed consent or
(for children/adolescents) assent with consent of a parent(s) or legal guardian, as required
by local law.
2. Males and females ages 9 years and older (inclusive) at the time of consent.

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3. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as
determined by the Investigator. Stable disease for the past 4 weeks.
4. Seborrheic dermatitis up to 20% BSA involvement.  Involvement may be of the scalp
and/or face and/or trunk and/or intertriginous areas.
5. An Investigator Global Assessment (IGA) disease severity of at least Moderate (‘3’) at
Baseline.
6. Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least
Moderate (‘2’) at Baseline.
7. Female subjects of childbearing potential (FOCBP) must have a negative serum
pregnancy test at Screening (Visit 1) and negative urine pregnancy test at Baseline
(Visit 2). In addition, sexually active FOCBP must agree to use at least one form of
highly effective or a barrier method of contraception throughout the trial according to
Contraception Requirements for Female Subjects (see Figure 1).
8. Females of non-childbearing potential must either be premenarchal, post-menopausal
with spontaneous amenorrhea for at least 12 months (post-menopausal status should be
confirmed with FSH testing) or have undergone surgical sterilization according to
Contraception Requirements for Female Subjects (Figure 1).
9. Subjects in good health as judged by the Investigator, based on medical history, physical
examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
10. Subjects are considered reliable and capable of adhering to the Protocol and visit
schedule according to the Investigator judgment.
4.5.2. 
Exclusion Criteria 
Subjects who meet any of the following exclusion criteria will be excluded from participation in 
the study: 
1. Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic
dermatitis prior to the Baseline visit and during the study according to Excluded
Medications and Treatments (Table 1).
2. Planned excessive exposure to treated area(s) to either natural or artificial sunlight,
tanning bed, or other LED.
3. Subjects who cannot discontinue to use of strong systemic P-450 cytochrome inhibitors
e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole,
nefazodone, saquinavir, suboxone and telithromycin for two weeks prior to the Baseline
visit (Visit 2) and during the study.
4. Subjects with PHQ-8 (≥18 years old, inclusive) or modified PHQ-A
(adolescents, 12 to 17 years old, inclusive) score ≥10 at Screening or Baseline visits.
5. Subjects (9-11 years old, inclusive) with a CDI-2 (parent report) raw score ≥17 for
females and ≥18 for males at Screening or Baseline visits.

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6. History of severe depression, suicidal ideation or behavior, Baseline/Screening C-SSRS
(for adolescents and adults 12 years old and older) indicative of suicidal ideation or
behavior, whether lifetime or recent/recurrent.
7. Previous treatment with ARQ-151 or ARQ-154.
8. Subjects who have received oral roflumilast (Daliresp®, Daxas®), or apremilast (Otezla®)
within the past 4 weeks.
9. Known allergies or hypersensitivity to component(s) of the investigational product which
includes roflumilast, petrolatum, isopropyl palmitate, methylparaben, propylparaben,
diethylene glycol monoethyl ether, hexylene glycol, cetearyl alcohol, dicetyl phosphate
and ceteth-10 phosphate.
10. Known or suspected:
a.
Severe renal insufficiency as evidenced by calculated creatinine clearance
<30 mL/min
b. Moderate to severe hepatic disorders (Child-Pugh B or C)
11. Liver function test results that exceed:
•
AST or ALT > 2x ULN
•
Total bilirubin
−
1.5x ULN or
−
>ULN and ≤1.5x ULN and direct bilirubin is >35% of total bilirubin
•
ALP ≥ 2x ULN
12. Subjects with active pityriasis/tinea amiantacea.
13. Subjects with a history or a major surgery within 4 weeks prior to Baseline (Visit 2) or
has a major surgery planned during the study.
14. Subjects with any serious medical condition or clinically significant laboratory
abnormality that would prevent study participation or place the subject at significant risk,
as determined by the Investigator.
15. Subjects with any condition on the treatment area which, in the opinion of the
Investigator, could confound efficacy measurements.
16. Subjects/caregivers unable to apply product to the scalp due to physical limitations if the
subject has current or history of seborrheic dermatitis involving the scalp.
17. Females who are pregnant, wishing to become pregnant during the study, or are
breast-feeding.
18. A clinically relevant history of abuse of alcohol or other drugs within 6 months prior to
Screening.

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19. Current or history of cancer within 5 years from Screening with the exception of fully
treated skin basal cell carcinoma, cutaneous squamous cell carcinoma, or carcinoma in
situ of the cervix.
20. Subjects, parent(s)/legal guardian(s) of children/adolescent subjects who are unable to
communicate, read, or understand the local language.
21. Subjects who are family members of the clinical study site, or clinical study staff, or
Sponsor, or family members residing in the same household of enrolled subjects.
22. Any condition that in the Investigator’s assessment would preclude the subject from
participating in the study.
4.6. 
Randomization 
Randomization will take place at the Baseline (Day 0) visit after the Investigator confirms the 
subject to be fully eligible for participation as outlined in Section 4.5. Subjects will be randomly 
assigned to apply ARQ-154 foam 0.3% QD or vehicle foam QD. Assignment of ARQ-154 or 
vehicle will be made at a 2:1 ratio and stratified by study site and baseline disease severity 
(IGA = 3 or IGA = 4) according to a computer-generated randomization list. Kits containing 
canisters of IP will be assigned to each subject using the IWRS. A subject may receive more than 
one kit for the treatment period. The kits and canisters are blinded and each kit is numbered with 
a unique kit number.  
4.7. 
Prohibitions and Concomitant Therapy 
Prohibited medications and products are detailed in Table 1. 
Generally, the addition of new medications, including nonprescription medications, during the 
study is discouraged.  However, the short-term use of a medication may be authorized by the 
Investigator.  The Investigator must make the decision to authorize the use of any such a 
medication only after consideration of the clinical situation, the potential for masking symptoms 
of a more significant underlying event, and whether the use of the medication will compromise 
the outcome or validity of the clinical investigation.  If medication is required, the name, 
strength, frequency, duration of use, and reason for use will be recorded in source documents and 
transcribed to Case Report Forms.  Medications which have been used chronically by subjects, in 
particular statins and anti-hypertensives, are allowed for use during the study, except as 
prohibited in ‘Excluded Medications and Treatments’ (Table 1).  

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Table 1: 
Excluded Medications and Treatments 
Excluded Medications and Treatments 
Wash Out Period Prior to Baseline 
(Day 0) 
Etanercept 
4 weeks 
All other Biologics 
12 weeks or 5 half-lives, which is longer 
Systemic treatment with antifungal agents, corticosteroids, 
immunosuppressive therapies, retinoids, roflumilast, or 
Otezla® 
4 weeks 
Topical antifungals, corticosteroids, calcineurin inhibitors, 
sulfur-based treatments, medical devices, Eucrisa®, azelaic 
acid, or metronidazole 
2 weeks 
Medicated shampoos (e.g., coal tar, keratolytics including 
salicylic acid, antifungals, zinc pyrithione, selenium 
sulfide, corticosteroids, medical devices) 
2 weeks 
Topical medications used on the scalp for conditions 
besides seborrheic dermatitis, e.g., use of topical minoxidil 
for androgenetic alopecia 
2 weeks 
Phototherapy, tanning beds, other light emitting devices 
4 weeks 
Investigational drugs 
12 weeks (biologics) or 5 half-lives, 
whichever is longer; 
5 half-lives (orals); 
2 weeks (topical) 
Strong systemic P-450 cytochrome inhibitors 
(e.g., indinavir, nelfinavir, ritonavir, clarithromycin, 
itraconazole, ketoconazole, nefazodone, saquinavir, 
suboxone and telithromycin).  
2 weeks 
Intravenous administration of antibiotics or antiviral agents 
1 week 
Note: 
1.
Eye drop and nasal corticosteroid preparations are allowed.  Inhaled corticosteroid preparations are
allowed if used for a stable condition and at a stable dose for > 28 days before Screening and are
continued at the same dose throughout the study.
2.
Non-medicated emollients, moisturizers and sunscreens will be allowed once daily as normally used by
the subjects and applied at least 3 hours after application of investigational product to untreated areas
only.
3.
Only non-medicated shampoos are permitted. Medicated shampoos (e.g., coal tar, keratolytics including
salicylic acid, antifungals, zinc pyrithione, selenium sulfide, corticosteroids, medical devices) are
prohibited.  Subjects should not use other hair products for at least an hour before or after application of
investigational product.

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4.8. 
Treatment 
4.8.1. 
IP Supplies, Packaging, and Labeling 
The active ingredient in ARQ-154 foam is roflumilast, a phosphodiesterase 4 (PDE-4) inhibitor. 
Matching vehicle foam will contain only excipients of ARQ-154 foam. ARQ-154 foam 0.3% or 
vehicle foam will be provided in a canister containing approximately 60 grams of foam. Two 
canisters of IP will be packaged in each kit. The number of kits dispensed to a subject will be 
based on the BSA involvement. The kits and canisters will be labeled with a unique number to 
maintain blinding. 
The Sponsor will supply sufficient quantities of the IP (ARQ-154 foam 0.3%, and matching 
vehicle) to each site to allow for completion of this study. 
Records will be made of the receipt and dispensing of the investigational product supplied. At 
the conclusion of the study, any unused investigational product will be returned to the Sponsor or 
designee, or destroyed, as per Sponsor instructions. 
Refer to the most current version of the IP Handling Manual for details on the accountability, 
storage, and management of ARQ-154 and matching vehicle. 
4.8.2. 
Treatment Administration 
Initial treatment with the IP will occur on Day 0. At the randomization visit (Baseline), the study 
staff will demonstrate to the subject how to apply ARQ-154 foam 0.3% or vehicle foam using 
the first canister from the kit that is assigned to the subject at randomization. Study site staff will 
be trained to ensure a proper amount is dispensed from the foam can and applied to seborrheic 
dermatitis lesion(s) as a thin film and rubbed in thoroughly but gently, until the ‘white’ has 
disappeared. For scalp lesions, special attention should be given to ensuring adequate 
investigational product is applied to scalp skin and not rubbed off on hair. The subject will 
then practice dispensing a similar amount of investigational product and applying to seborrheic 
dermatitis lesion(s).  The study staff will confirm that the subject’s application technique is 
correct. 
Subjects will be instructed to apply IP QD in the evening (except at Baseline and Week 2, in 
which case IP will be applied at the study site) to areas of seborrheic dermatitis lesions identified 
by the Investigator at Baseline using a Body and Scalp Diagram (see Appendix 1). IP will be 
applied at least 20 minutes before going to bed. 
For Scalp Lesions: IP will be applied when the skin and hair on the scalp is dry.  Subjects should 
dispense IP on their fingers, then part hair where there are lesions and rub IP into scalp skin. As 
the IP is applied, the subject should move any hair away to ensure that sufficient foam is applied 
directly to the affected skin on the scalp. Subjects should not use other hair products for at least 
an hour before or after application. 
For Non-scalp Lesions: IP should be applied to affected areas as a thin layer and rubbed in 
thoroughly but gently until the foam has disappeared. 

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Subjects should not wash areas (or otherwise expose to water, e.g., swimming) where ARQ-154 
foam or vehicle has been applied until at least 4 hours after IP application and preferably not 
until the following morning. 
Subjects should continue to apply the IP to all treatment areas identified by the Investigator at 
Baseline using the Body and Scalp Diagram (see Appendix 1), even if that area has cleared 
during the treatment period. New lesions that develop during the study should be treated as well. 
Application will be to all areas affected including the face, scalp, trunk, and intertriginous areas. 
A Body and Scalp Diagram should be used to record existing and new areas of seborrheic 
dermatitis involvement that are subject to treatment.  
Parents/caregivers should wash their hands with soap and water after applying IP to a child. 
Parents/caregivers who are pregnant or women of childbearing potential who are trying to 
become pregnant, or who are breastfeeding, or planning to breastfeed during the study should 
avoid accidental exposure by either avoiding applying IP or by wearing gloves during its 
application. 
4.8.3. 
Treatment Compliance 
Weight of the IP applied will be measured for reporting purposes. Each IP canister will be 
weighed individually prior to dispensing at the Baseline visit or subsequent visits. IP canisters 
must be returned by subjects at each study visit (both empty and full) and will be weighed 
individually. Record IP canister weight in the source notes and in the eCRF. 
Subjects will complete a daily diary recording the date and time of each IP dose applied, any 
missed doses, and any relevant comments (e.g., potential AEs or reason for missed dose).  Site 
personnel will review the diary at each visit and use the information to question the subject 
regarding compliance and AEs and then record appropriate information in source documents and 
complete eCRFs. If a subject misses a scheduled dose, they should be instructed to return to the 
protocol IP administration schedule (i.e., if subject forgets a dose they should wait until that 
evening and apply as usual). 
A subject will be considered compliant with the dosing regimen if the subject applies at least 
80% of the expected applications during the entire IP application period (Baseline to Week 8) 
and does not miss more than 3 consecutive doses. 
Compliance will be assessed by review of the dosing diary. Re-training will be conducted at 
subsequent visits as needed, i.e., if the returned canister weighs substantially different than the 
expected weight, the diary shows less than 80% of expected use, or more than 3 consecutive 
doses are missed. 
Compliance will be documented in the source and eCRF. 
4.8.4. 
Blinding 
This is a double-blinded study, therefore neither the subjects nor the Investigator, clinical 
personnel, or Sponsor will be aware of which treatment an individual subject receives. 

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4.8.5. 
Breaking Treatment Codes 
In the event of a medical emergency where breaking the blind is required to provide medical care 
to the subject, the Investigator may obtain treatment assignment directly from the IWRS system 
for that subject. Refer to the current version of the ARQ-154-304 IWRS Plan for details on 
unblinding. Treatment assignment should, however, remain blinded unless the assignment 
knowledge is necessary to determine subject emergency medical care. The rationale for 
unblinding must be clearly explained in source documentation and on the eCRF, along with the 
date on which the treatment assignment was obtained. The Investigator is requested to contact 
the Medical Monitor promptly in the event of any treatment unblinding. 
Blinding of study treatment is critical to the integrity of this clinical trial and therefore, if a 
subject’s treatment assignment is disclosed to the Investigator, the subject will have the study 
treatment discontinued. All subjects will be followed until study completion unless consent to do 
so is specifically withdrawn by the subject. 
4.8.6. 
Removal of Subjects from Investigational Product 
A subject may discontinue from receiving the IP for any of the following reasons: 
•
Occurrence of any medical condition or circumstance that, in the opinion of the
Investigator, exposes the subject to substantial risk and/or does not allow the subject
to adhere to the requirements for IP administration as per the Protocol.
•
Occurrence of or considerable worsening of an AE (described in Section 5.7) that, in
the opinion of the Investigator in consultation with the Medical Monitor and Sponsor,
represents an unacceptable risk to the subject if he/she continues in the study.
The Investigator must follow the subject until the AE resolves or satisfactorily
stabilizes.
•
IP application must be discontinued immediately in the event of a female subject’s
pregnancy.
•
Subject’s decision to withdraw from receiving IP.
•
Weight loss of >5% from Baseline, if not dieting or intentionally trying to lose
weight, at the Investigator’s discretion and after consultation with the
Medical Monitor and Sponsor.
•
C-SSRS indicative of suicidal ideation
•
PHQ-8/PHQ-A score ≥15 if determined by Investigator in consultation with a mental
health professional.
•
CDI-2 raw score of ≥32 if determined by Investigator in consultation with a mental
health professional.
•
Requirement for use of prohibited concomitant medication (Table 1) after
consultation with the Sponsor and Medical Monitor.
•
Subjects repeated failure to comply with protocol requirements or study related
procedures.

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4.8.7. 
Removal of Subjects from the Study 
A subject may be removed from study participation for any of the following reasons: 
•
Subject’s decision to withdraw from the study.
•
Subject’s death.
•
Subject is lost to follow-up. A subject will be considered lost to follow-up after three
phone and three email attempts and documentation of a certified letter sent to the
subject’s address.
•
Termination of the study by the Sponsor, FDA, or other regulatory authorities.
5.
STUDY PROCEDURES
The Schedule of Visits and Assessments (Section 1.3) summarizes the clinical procedures to be 
performed at each visit. Individual clinical procedures are described in detail below. Additional 
evaluations/testing may be deemed necessary by the Investigator and/or the Sponsor for reasons 
related to subject safety. 
5.1. 
Safety Assessments 
This study assesses the safety and efficacy of ARQ-154 foam 0.3%. Safety will be determined by 
evaluating physical examinations, vital signs/weight, local tolerability assessments, 
pigmentation, clinical laboratory parameters, PHQ-8/PHQ-A/CDI-2, C-SSRS, and AEs as 
outlined in the Schedule of Visits and Assessments (Section 1.3). If deemed necessary, additional 
safety assessments will be performed at the discretion of the Investigator. 
5.1.1. 
Screening 
Before a subject’s participation in the clinical study, the Investigator is responsible for obtaining 
written informed consent from the subject or written assent from subjects (ages 9-17yrs) and 
consent from their parent(s) or legal guardian(s) after adequate explanation of the study design, 
anticipated benefits, and the potential risks. Informed consent must be obtained before 
completion of any non-standard of care study-specific procedures. Procedures that are part of 
standard of care are not considered study-specific and, therefore, may be performed prior to 
obtaining consent and used to confirm eligibility provided they occur within the time allowance 
outlined in the Schedule of Visits and Assessments (Section 1.3). A subject is considered a 
participant of the trial once the ICF or written assent for subjects ages 9-17yrs is completely 
signed. 
The following procedures/assessments will be performed at the Screening Visit (within 4 weeks 
after signing the ICF/assent): 
•
Review of medical and surgical history
•
Review of childbearing potential (female subjects) and contraceptive use
(Section 5.1.2)

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•
Collection of demographic data including age, sex, race, ethnicity
•
Limited physical examination of skin (including assessment of Fitzpatrick Skin Type
at Screening only), lungs, and heart
•
Vitals signs including temperature, heart rate, blood pressure
•
Collection of body weight (kg)
•
Laboratory tests: hematology, chemistry, urinalysis, serum pregnancy (for female
subjects of childbearing potential)
•
Seborrheic dermatitis assessments: IGA, BSA, Overall Assessment of Erythema,
Overall Assessment of Scaling, Pigmentation Assessment
•
Completion of DLQI/CDLQI, Scalpdex, C-SSRS, CDI-2/PHQ-8/PHQ-A
•
Collection of prior and concomitant medication
All screened subjects will receive a subject identification number (see Section 4.4) and be 
entered into the eCRF. Subjects that fail to meet the eligibility criteria will be designated as a 
screen failure and entered in the IWRS and eCRF as such. Subjects who are unable to enroll 
within the screening window will be rescreened.  
Subjects may be re-screened one time. The original assigned subject ID number will be used for 
re-screening. 
Subjects who consent but do not proceed with enrollment will be considered a screen failed 
subject. 
5.1.2. 
Contraception Requirements 
Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at 
Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2). In addition, sexually 
active FOCBP must agree to use at least one form of a highly effective or barrier method of 
contraception throughout the trial according to Contraception Requirements for Female Subjects 
(Figure 1). 

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Figure 1: 
Contraception Requirements for Female Subjects 
5.1.3. 
Baseline 
Each subject will undergo Baseline assessments outline in the Schedule of Visits and 
Assessments (Section 1.3). For subjects <18years, if the Baseline (Day 0) visit occurs within 
3 weeks of Screening, the Screening lab results may be utilized.  
Randomization and IP kit assignment will take place, via IWRS, after the subject has been found 
to be fully eligible for participation. A subject will be considered enrolled into the study upon 
randomization. 
5.1.4. 
Physical Examination 
Physical examinations will be performed according to the Schedule of Visits and Assessments 
(Section 1.3). The physical exam will be limited to skin (including assessment of Fitzpatrick skin 
type at Screening only), lungs, and heart only.  
Fitzpatrick skin phototype assessment will be rated as follows: 
I.
Always burns easily; never tans (sensitive)
II.
Always burns easily; tans minimally (sensitive)
III.
Burns moderately; tans gradually (light brown) (normal)
IV.
Burns minimally; always tans well (moderate brown) (normal)
V.
Rarely burns; tans profusely (dark brown) (insensitive)
VI.
Never burns; deeply pigmented (insensitive)

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5.1.5. 
Vital Signs, Height and Weight 
Vital signs will be performed according to the Schedule of Visits and Assessments (Section 1.3). 
Blood pressure, heart rate, and temperature will be measured while the subject is sitting/resting 
for at least 5 minutes. 
Height will be collected at Baseline and Week 8. 
Subjects should void prior to weight being taken and remove any objects of significant weight 
(i.e., jackets, outerwear, shoes, cell phones, wallet, key chains, etc.). A 5% unintentional weight 
loss from Baseline should be reported to the medical monitor. 
5.1.6. 
Laboratory Tests 
All tests listed in Table 2 will be performed according to the Schedule of Visits and Assessments 
(Section 1.3) unless otherwise noted. For subjects <18 years old, Screening safety lab results 
collected within 3 weeks of the Baseline visit may be utilized as the Baseline safety lab 
assessment. No food restrictions are required for the collection of specimens. In addition, 
laboratory safety tests may be performed at unscheduled time points, if deemed necessary by the 
Investigator. Laboratory samples will be sent to the central lab. Refer to the most current Central 
Laboratory Manual for collection, processing, shipping, and report receipt instructions. 
Table 2: 
Laboratory Tests 
Hematology 
Serum Chemistry 
•
Hemoglobin
•
Hematocrit
•
Total and differential leukocyte count
•
Red blood cell count with indices and morphology
•
Platelet count
•
Blood Urea Nitrogen
•
Bilirubin (total and direct)
•
Alkaline phosphatase
•
Aspartate aminotransferase
•
Alanine aminotransferase
•
Albumin
•
Sodium
•
Potassium
•
Chloride
•
Glucose
•
Creatinine
Urinalysis 
Additional Tests 
•
pH
•
Specific gravity
•
Protein*
•
Glucose
•
Ketones
•
Bilirubin
•
Blood*
•
Nitrite*
•
Urobilinogen
•
Leukocyte esterase*
•
Urine pregnancy test
(for females of childbearing potential only)
•
Serum pregnancy test (hCG) **
•
FSH test (post-menopausal females only)
•
Pharmacokinetic (PK) assessments
*If urinalysis is positive for protein, blood, nitrite, and/or leukocyte esterase, a microscopic examination
(for red blood cells, white blood cells, bacteria, casts, and epithelial cells) will be performed.
**At Screening for FOCBP only 

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5.1.7. 
Patient Health Questionnaire Depression Scale (PHQ-8) 
The PHQ-8 Assessment (see Appendix 2) will be completed by adult subjects according to the 
Schedule of Visits and Assessments (Section 1.3). 
PHQ-8 score is the sum of the responses for the 8 questions. 
Five severity categories of depression are defined as follows: 
•
None – Minimal depression (0 to 4)
•
Mild depression (5 to 9)
•
Moderate depression (10 to 14)
•
Moderately severe depression (15 to 19)
•
Severe depression (20 to 24)
A subject with a PHQ-8 score of 10-14 should be referred to a mental health professional for 
evaluation, regardless of the reason for their change in score. 
A subject with with a PHQ-8 score of ≥15 should be immediately referred to a mental healthcare 
professional and Investigators in consultation with the mental health professional should 
consider interruption or discontinuation of the IP.  
5.1.8. 
Patient Health Questionnaire Depression Scale (Modified PHQ-A) 
The Modified PHQ-A Assessment (Appendix 3) will be completed by adolescent subjects 
(12-17 years old, inclusive) according to the Schedule of Visits and Assessments (Section 1.3). 
Modified PHQ-A score is the sum of the responses for the 8 questions. 
Five severity categories of depression are defined as follows: 
•
None - Minimal depression (0 to 4)
•
Mild depression (5 to 9)
•
Moderate depression (10 to 14)
•
Moderately severe depression (15 to 19)
•
Severe depression (20 to 24)
A subject with a modified PHQ-A score of 10-14 should be referred to a mental health 
professional for evaluation, regardless of the reason for their change in score.  
A subject with a modified PHQ-A score ≥15 should be immediately referred to a mental health 
professional, and Investigators in consultation with the mental health professional should 
consider interruption or discontinuation of the IP.  

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5.1.9. 
Children’s Depression Inventory 2 (Parent Report) 
The CDI-2 Assessment will be performed according to the Schedule of Assessments 
(Section 1.3) for subjects 9-11 years old, inclusive. Subjects 9-11 years old at the time of assent 
will complete the CDI-2 throughout the study. 
The CDI-2 quantifies depressive symptomatology using reports from children/adolescents, 
teachers, and parents or caregivers. It is recommended for use in initial evaluation and is 
appropriate when there is a need for an assessment and robust description of a child’s depressive 
symptoms. 
This study will use the CDI Parent Report Form. An example of the Parent Repot Form is 
presented in Appendix 4. 
A subject with a CDI-2 raw total score of ≥21 for females and ≥22 for males should be referred 
to a mental health professional for evaluation. 
A subject with a CDI-2 raw total score of ≥32 should be referred to a mental health professional, 
and Investigators in consultation with the mental health professional should consider interruption 
or discontinuation of the investigational product.  
5.1.10. 
Columbia-Suicide Severity Rating Scale (C-SSRS) 
C-SSRS Assessments will be performed according to the Schedule of Visits and Assessments
(Section 1.3) for subjects 12 years old and older.
The administration schedule of the C-SSRS will be: 
•
The Baseline-Screening version (Appendix 5) will be used at Screening to provide a
pre-treatment assessment baseline.
•
On all subsequent visits, the Since Last Visit version (Appendix 6) will be used.
•
A score greater than 0 at the Screening or Baseline visit in suicidal ideation may
indicate the need for mental health intervention. The Investigator should not enroll
the subject in the study.
•
Any score greater than 0 in the suicidal ideation score may indicate the need for
mental health intervention. The Investigator should give consideration for the subject
to discontinue from the IP and prompt referral to a mental health professional and/or
possibly the emergency room. The Medical Monitor should be contacted.
The C-SSRS administrator will be trained via C-SSRS training video. A training certificate for 
the administrator(s) will be on file in the trial master file at the site. 
The Investigator must review the completed C-SSRS. A qualified mental health care provider 
must be available, immediately if needed, to refer the subject for further evaluation. 

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5.1.11. 
Local Tolerability Assessment 
The Investigator Local Tolerability Assessment will be performed according to the Schedule of 
Visits and Assessments (Section 1.3).  
Application site reactions will be graded at each timepoint. Irritation reactions are graded using 
the scale detailed in the following section (Berger 1982). Reactions at the site of product 
application, which may occur post-Baseline, should be differentiated from the preexisting 
inflammation associated with the subject’s seborrheic dermatitis. 
For the Baseline visit, when IP is applied in the clinic, the Investigator assessments will be 
conducted by the Investigator prior to IP application. 
Dermal Response 
0 = no evidence of irritation 
1 = minimal erythema, barely perceptible 
2 = definite erythema, readily visible; minimal edema or minimal papular response 
3 = erythema and papules 
4 = definite erythema  
5 = erythema, edema and papules 
6 = vesicular eruption 
7 = strong reaction spreading beyond application site 
Other Effects 
A = slight glazed appearance 
B = marked glazing 
C = glazing with peeling and cracking 
D = glazing with fissures 
E = film of dried serous exudates 
F = small petechial erosions and/or scabs 
G = no other effects 
The Subject Local Tolerability Assessment will be performed according to the Schedule of Visits 
and Assessments (Section 1.3). 
This assessment will be administered by the site 10 to 15 minutes after IP application in the 
clinic at Baseline and recall assessments at Weeks 4 and 8. 
Grade 
Sensation Following Investigational Product Application 
0 (none) 
No sensation 
1 (mild) 
Slight warm, tingling sensation; not really bothersome 
2 (moderate) 
Definite warm, tingling sensation that is somewhat bothersome 
3 (severe) 
Hot, tingling/stinging sensation that has caused definite discomfort 

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5.1.12. 
Pigmentation Assessment 
The Investigator will assess for pigmentation in areas affected previously and/or currently by 
seborrheic dermatitis according to the Schedule of Visits and Assessments (Section 1.3). 
Hypopigmentation and hyperpigmentation will be scored individually using a 0 – 3 scale: ‘0’ for 
none, ‘1’ for mild, ‘2’ for moderate, and ‘3’ for severe. 
5.1.13. 
Adverse Events 
Adverse events (AEs) will be collected and assessed throughout the study according to the 
Schedule of Visits and Assessments (Section 1.3). The Investigator is responsible for ensuring 
that all adverse events observed by the clinical staff or reported by the subject that occur after the 
first application of investigational product through the end of the study are recorded in the 
subject’s medical record and the eCRF. 
The Investigator is responsible for ensuring that all serious adverse events observed by the 
clinical staff or reported by the subject that occur after signing of the informed consent through 
30 days after the last day of the application of the investigational product or the end of study 
(whichever is later) are recorded in the subject’s medical record and are submitted per SAE 
reporting requirements (Section 5.7.2). 
AEs (whether serious or non-serious) and clinically significant abnormal laboratory test value(s) 
will be evaluated by the PI and treated and/or followed up for up to 30 days after end of 
treatment or until the symptoms or value(s) return to the subject’s baseline value, or acceptable 
levels, as judged by the Investigator. 
Refer to Section 5.7 for further details on Adverse Events. 
5.2. 
Efficacy Evaluations 
Investigators will be trained in the administration of rating scales. A training certificate is issued 
upon successful completion of the training and will be valid for 12 months, unless compliance 
issues are identified that warrant retraining. 
5.2.1. 
Investigator Global Assessment (IGA) 
Investigator’s Global Assessments (‘whole body’ and ‘intertriginous area’) will be performed at 
according to the Schedule of Visits and Assessments (Section 1.3). The IGA should be 
completed prior to any other physician assessments. 
The IGA is a static evaluation of qualitative overall seborrheic dermatitis severity. This global 
assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4). 
Each grade is defined by a distinct and clinically relevant morphologic description that 
minimizes inter-observer variability. 
Every effort must be made for the same Evaluator to complete the IGA for the subject at 
every study visit, particularly for Baseline and Week 8. 

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Investigator Global Assessment of Disease (IGA) 
Score 
Description 
0 
Clear: No erythema, no scaling (hypo-hyperpigmentation can be present) 
1 
Almost clear: Slight erythema and/or trace (barely perceptible) amounts of scaling 
2 
Mild: Pink to red color and/or slight scaling 
3 
Moderate: Distinct erythema (redness) and/or clearly visible scaling 
4 
Severe: Severe erythema (intense, fiery red) and/or severe scaling (coarse, thick scales 
with flaking onto clothes or skin) 
5.2.2. 
Overall Assessment of Erythema 
Overall Assessment of Erythema will be performed according to the Schedule of Visits and 
Assessments (Section 1.3). 
Overall Assessment of Erythema is a static qualitative evaluation, involving an ordinal scale with 
4 severity grades (reported only in integers of 0 to 3).  Each grade is defined by a distinct and 
clinically relevant morphologic description that minimizes inter-observer variability.  
Every effort must be made for the same Evaluator to complete the Overall Assessment of 
Erythema for the subject at every study visit, particularly for Baseline and Week 8. 
Overall Assessment of Erythema 
Symptom 
Score 
Description 
Erythema 
0 
None: No evidence of erythema 
1 
Mild: Barely perceptible erythema which is faint or patchy 
2 
Moderate: Distinct erythema, 
3 
Severe: Intense (fiery red) erythema 
5.2.3. 
Overall Assessment of Scaling 
Overall Assessment of Erythema will be performed according to the Schedule of Visits and 
Assessments (Section 1.3). 
Overall Assessment of Scaling are static qualitative evaluations, involving an ordinal scale with 
4 severity grades (reported only in integers of 0 to 3).  Each grade is defined by a distinct and 
clinically relevant morphologic description that minimizes inter-observer variability.  
Every effort must be made for the same Evaluator to complete the Overall Assessment of 
Scaling for the subject at every study visit, particularly for Baseline and Week 8. 

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Overall Assessment of Scaling 
Symptom 
Score 
Description 
Scaling 
0 
None: No scaling evident on lesions 
1 
Mild: Barely detectable, scattered, small flaking scales 
2 
Moderate: Scales clearly visible and prominent 
3 
Severe: Coarse, thick scales, with flaking into clothes or skin 
5.2.4. 
Worst Itch-Numerical Rating Scale (WI-NRS) 
Given that itch is an important symptom of seborrheic dermatitis, a WI-NRS assessment is 
included in the present study.  A responder analysis will be performed to evaluate achievement 
of a 4-point reduction of WI-NRS, which has been described as optimal for demonstrating a level 
of clinically meaningful improvement in itch severity in other skin conditions, including other 
forms of eczema (Yosipovitch 2019) and psoriasis (Kimball 2016). 
WI-NRS Assessment will be performed by subjects daily at home according to the Schedule of 
Visits and Assessments (Section 1.3) starting 7 days prior to the scheduled Baseline/Day 0 visit 
up to the Week 8/Day 56 visit. Subjects will be provided with a diary to record their daily 
WI-NRS assessments. 
The WI-NRS has been developed as a simple, single item to assess the patient-reported severity 
of this symptom at its highest intensity during the previous 24-hour period. (Naegeli 2015). The 
WI-NRS will be determined by asking the subject’s assessment of worst itch over the past 
24 hours. The scale is from ‘0 to 10’ (“no itch” to “worst imaginable itch”).  
5.2.5. 
Scalpdex 
The Scalpdex (Appendix 7) will be performed by subjects according to the Schedule of Visits 
and Assessments (Section 1.3). 
5.2.6. 
Dermatology Life Quality Index (DLQI) and Children’s Dermatology Life 
Quality Index (CDLQI) 
The DLQI (ages 17+ years) and CDLQI (ages 9-16 years, inclusive) will be performed according 
to the Schedule of Visits and Assessments (Section 1.3). The DLQI/CDLQI is a simple, 
self-administered and user-friendly validated questionnaire. The DLQI/CDLQI is designed to 
measure the health-related quality of life of patients suffering from a skin disease. The 
DLQI/CDLQI consists of 10 questions concerning patients’ perception of the impact of skin 
diseases on different aspects of their health-related quality of life over the last week.  

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The DLQI (Appendix 8) will be completed by subjects ages 17 years and older. The CDLQI 
(Appendix 9) will be completed by caregivers of subjects ages 9-16 years. 
5.2.7. 
Body Surface Area (BSA) 
BSA assessments will be performed according to the Schedule of Visits and Assessments 
(Section 1.3).  
The BSA affected by seborrheic dermatitis will be determined by the subject’s hand method, 
where the subject’s hand (including fingers) surface area is assumed to equal 1% of body surface 
area. 
5.3. 
Other Evaluations 
5.3.1. 
Pharmacokinetics Assessment 
Pharmacokinetic (PK) samples will be collected according to the Schedule of Visits and 
Assessments (Section 1.3) for all subjects.  
•
PK will be evaluated through trough sampling at Week 4 and Week 8.
PK samples will be collected while the subject is having serum chemistries drawn, when 
applicable. Ensure the IP is not applied in the area where PK will be drawn. 
5.3.2. 
Dermal Imaging 
Medical photography as supportive evidence of clinical outcome will be conducted by all sites 
using Canfield equipment. Photos will be obtained according to the Schedule of Visits and 
Assessments (Section 1.3). Photography should be focused on single lesions or specific body 
sections (e.g., arm). Body or half body photos should only be taken if necessary. For subjects 
with seborrheic dermatitis lesions on the face, scalp, and/or body, effort should be made to 
prioritize obtaining a photograph of the facial lesion(s). All efforts will be made to de-identify 
the subjects. Subjects who are unwilling to participate in the medical photography will be 
allowed to opt out of this procedure and documented on the informed consent. Refer to the 
current Photography Manual for instructions regarding photography. 
5.4. 
Final Study Visit 
The approximate final study visit will occur at Week 8 (Day 56). The procedures performed 
during this visit are described in the Schedule of Visits and Assessments (Section 1.3). A 5-day 
scheduling window is allowed for this visit. Adverse events will be recorded as reported by the 
participant or and followed to resolution (as necessary) as outlined in Section 5.7. 
5.5. 
Early Termination Visit 
If a subject is withdrawn from the study, an early termination visit will be scheduled. This visit 
should include the procedures and assessments that would be performed at the Week 8 visit 
(Day 56). Subjects who withdraw consent from study participation, will not be required to 
perform an early termination visit. 

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5.6. 
Unscheduled Visit 
Unscheduled visits may be necessary to repeat testing following abnormal laboratory results, for 
follow-up of AEs, or for any other reason, as warranted in the judgement of the Investigator. 
The following information will be collected for all subjects: 
•
Concomitant medications/procedures
•
AEs
5.7. 
Adverse Events
5.7.1. 
Adverse Event Definition
An AE is defined as any untoward medical occurrence associated with the use of a drug in 
humans, whether or not considered drug related. An AE can therefore be any unfavorable and 
unintended sign (including an abnormal laboratory finding), symptom, or disease temporally 
associated with the use of an investigational product, whether or not related to the investigational 
product. 
The definition of AEs includes worsening of a pre-existing medical condition.  Worsening 
indicates that the pre-existing medical condition has increased in severity, frequency, and/or 
duration or has an association with a worse outcome.  When recording such events, provide 
descriptions that the pre-existing condition has changed (e.g., worsening hypertension for a 
subject with pre-existing hypertension).  A pre-existing condition that has not worsened during 
the study or involves an intervention, such as elective cosmetic surgery or a medical procedure 
while on study, is not considered an AE. 
Progression of treatment indication including new or worsening of anticipated clinical signs or 
symptoms, which are collected as clinical efficacy variables and assessed as unequivocally 
associated with the disease progression and /or lack of efficacy, should NOT be reported as 
adverse events unless the disease progression is greater than anticipated in the natural course of 
the disease.  
In general, abnormal laboratory findings without clinical significance (based on the 
investigator’s judgment) are not to be recorded as AEs.  However, abnormal laboratory findings 
that result in new or worsening clinical sequelae, or that require therapy or adjustment in current 
therapy, are considered AEs.  Where applicable, clinical sequelae (not the laboratory 
abnormality) are to be recorded as the AE. 
5.7.2. 
Serious Adverse Event 
The definitions and reporting requirements of the Food and Drug Administration (FDA)/ICH 
Guidelines for Clinical Safety Data Management, Definitions and Standards for Expedited 
Reporting, Topic E2A will be adhered to.  Mandatory reporting of all serious unexpected adverse 
drug reactions (SUSARs) to Health Canada [as per C.05.014 (1) of the FDR] will be adhered. If 
any AEs are serious, as defined by ICH Guidelines for Clinical Safety, required procedures will 
be followed. 

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As SAE is defined as any AE that, in the view of either the PI or Sponsor, meets at least 1 of the 
following serious criteria: 
•
Fatal
•
Life-threatening (places the subject at immediate risk of death)
•
Requires inpatient hospitalization or prolongation of existing hospitalization
•
Results in a persistent or significant incapacity/disability
•
Congenital anomaly/birth defect
•
Other important medical events that, based upon appropriate medical judgment, may
jeopardize the subject and may require medical or surgical intervention to prevent one
of the outcomes listed in the above definition
Hospitalization does not include the following: 
•
Rehabilitation facilities, hospice facilities or respite care (e.g., caregiver relief)
•
Nursing homes or skilled nursing facilities
•
Emergency department visits
•
Same day surgeries (as outpatient/same day/ambulatory procedures)
•
<24 hour admissions for observation or evaluation
Hospitalization or prolongation of hospitalization in the absence of a precipitating, clinical AE is 
not in itself an SAE.  Examples include: 
•
Admission for treatment of a preexisting condition that did not worsen
•
Hospitalizations for cosmetic elective surgery, social, and/or convenience admissions
•
Pre-planned treatments or surgical procedures should be noted in the baseline
documentation for the individual subject
•
Diagnostic and therapeutic procedures, such as surgery, should not be reported as
AEs; however, the medical condition for which the procedure was performed should
be reported if it occurs during the reporting period and meets the definition of an AE.
For example, an acute appendicitis that begins during the AE reporting period should
be reported as an AE, and the resulting appendectomy should be recorded as
treatment of the AE.
Unexpected is defined as an AE that is not listed in the IB or is not listed at the specificity or 
severity that has been observed; or is not consistent with the risk information described in the 
general investigational plan or study documentation.  

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5.7.3. 
Suspected Unexpected Serious Adverse Reaction (SUSAR) 
SUSAR is defined as a serious adverse reaction, the nature or severity of which is not consistent 
with the known study treatment information. A serious event or reaction is not defined as a 
SUSAR when: ‘it is serious but expected’ or it does not fit the definition of an SAE, whether 
expected or not. 
5.7.4. 
Safety Review with Subject 
At each subsequent clinic visit after the Screening visit, subjects will be queried with an 
open-ended question such as: ‘How have you been feeling since your last visit?’  Additionally, 
the study staff will review subject diaries and, if it appears that a potential AE was recorded, 
study staff will query the subject and determine if an AE occurred. 
5.7.5. 
Adverse Event Reporting 
The Investigator is responsible for recording all adverse events, observed by the clinic staff, or 
reported by the subject that occur after the first application of investigational product through the 
end of the study are recorded in the subject’s medical record and the eCRF.  Serious adverse 
events observed by the clinic staff or reported by the subject after signing the informed consent 
form will be recorded.  
All adverse events that meet the criteria for “serious” (i.e., SAEs) will be reported to the Sponsor 
via fax or e-mail to ArcutisPV@EVERSANA.com within 24 hours of becoming aware of the 
event, whether or not the serious events are deemed drug-related.  
All serious event reporting will adhere to ICH E6: Guideline for Good Clinical Practice and ICH 
E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.  
The Institutional Review Board (IRB) will be notified of the Alert Reports as per FDA, ICH and 
the IRB’s policies and procedures. 
The Sponsor, or delegate, will be responsible for reporting SAEs to health authorities per local 
reporting requirements. The Investigator will be responsible for reporting events to their 
respective IRBs/ Ethics Review Board (ERB) in accordance with the IRB/ERB requirements. 
AEs (whether serious or non-serious) and clinically significant abnormal laboratory test value(s) 
will be evaluated by the PI and treated and/or followed for up to one month after end of 
treatment until the symptoms or value(s) return to the subject’s baseline value, or acceptable 
levels, as judged by the Investigator. Where appropriate, medical test(s) and/or examination(s) 
will be performed to document resolution of event(s).  
The Investigator will review each adverse event and assess its relationship to Investigational 
Product (unrelated, unlikely, possibly, probably, likely). Each sign or symptom reported will be 
graded on the NIH NCI CTCAE toxicity grading scale 5-point severity scale (Grade 1, 2, 3, 4 
and 5). The date and time of onset, time relationship to drug dosing, duration, and outcome) of 
each event will be noted. 
The relationship of each AE to the Investigational Product will be assessed using the following 
definitions: 

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Unrelated 
•
The AE must clearly be caused by the subject’s clinical state, or the study
procedure/conditions.
•
Definitely not related to drug.
•
Temporal sequence of an AE onset relative to administration of drug not reasonable.
•
Another obvious cause of an AE.
Unlikely 
•
Time sequence is unreasonable.
•
There is another more likely cause for an AE.
Possibly 
•
Corresponds to what is known about the drug.
•
Time sequence is reasonable.
•
Could have been due to another equally, likely cause.
Probably 
•
Is a known effect of the drug.
•
Time sequence from taking drug is reasonable.
•
Ceases on stopping the drug.
•
Cannot be reasonably explained by the known characteristics of the subject’s
clinical state.
Likely 
•
Is a known effect of the drug (e.g., listed in Physicians' Desk Reference,
Compendium of Pharmaceuticals and Specialties, IB).
•
Time sequence from taking drug is reasonable.
•
Event stops upon stopping drug, event returns upon restarting drug.
The following CTCAE toxicity grading scale 5-point severity scale definitions for rating 
maximum severity will be used: 
Grade 1 
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated. 
Grade 2 
Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental activities of daily living.* 
Grade 3 
Severe or medically significant but not immediately life-threatening; Hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily 
living.** 
Note: An experience may be severe but may not be serious, e.g., severe headache). 
Grade 4 
Life-threatening consequences; urgent intervention indicated. 
Grade 5 
Death related to AE. 
Note: A semi-colon indicates ‘or’ within the description of the grade. 
*
Instrumental activities of daily living refer to preparing meals, shopping for groceries or clothes, using the
telephone, managing money, etc.
** Self-care activities of daily living refer to bathing, dressing and undressing, feeding self, using the toilet, taking 
medications, and not bedridden. 
AEs will be coded using the most current MedDRA® version available at the start of the study. 

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5.8. 
Reporting Pregnancy 
During study participation, all subjects should be instructed to contact the Investigator 
immediately if they suspect they might be pregnant (e.g., missed or late menstrual period).  If 
pregnancy is confirmed, Investigational Product must be discontinued immediately, the subject 
should be referred to an obstetrician experienced in reproductive toxicity for evaluation and 
counseling, and the subject should be followed until conclusion of the pregnancy. 
The Investigator is responsible for reporting all available pregnancy information on the 
pregnancy report to ArcutisPV@EVERSANA.com within 24 hours of becoming aware of the 
event, although pregnancy itself is not considered an AE.  Follow-up information detailing the 
outcome of the pregnancy and the health of the newborn should be reported as it becomes 
available. In addition, any pregnancy resulting in a congenital abnormality or birth defect of the 
newborn, or neonatal death occurring within 30 days of the birth must be reported as a SAE, 
regardless of causality. 
Partner pregnancies of a male subject do not need to be reported. 
5.9. 
Treatment Stopping Rules 
If a subject has non-cutaneous adverse events of concern, clinically significant laboratory values 
or any condition that the investigator determines could possibly be related to the investigational 
product, the Investigator should immediately contact the Medical Monitor to discuss if the 
subject should be discontinued from treatment with investigational product. 
Treatment for any individual subject will be discontinued if the subject experiences: 
•
A SAE or a clinically significant non-serious AE which in the opinion of the Principal
Investigator or Medical Monitor warrants discontinuation from the study for that
subject’s well-being
•
A treatment-emergent severe (Grade 3) laboratory abnormality (confirmed by repeat
sample; see Appendix 10 for more information).
A subject with a PHQ-8/PHQ-A score ≥15 should receive immediate referral to a mental health 
care professional, and Investigators in consultation with the mental health professional should 
consider interruption or discontinuation of the investigational product. 
•
Subjects with a PHQ-8 or modified PHQ-A score of 10-14 should be referred to a
mental health professional for evaluation, regardless of the reason for their change in
score.
A subject with a CDI-2 raw total score ≥32 should be referred to a mental health professional, 
and Investigators in consultation with the mental health professional should consider interruption 
or discontinuation of the investigational product.  
•
Subjects with a CDI-2 raw score ≥21 for females and ≥22 for males should be
referred to a mental health professional for evaluation.

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A subject that is experiencing suicidal ideation and behavior should be referred immediately to a 
qualified mental health care provider and consideration given to discontinuation from IP. 
As noted above, IP must be discontinued immediately in the event of a female subject’s 
pregnancy. 
IP Treatment should be interrupted: 
•
If a subject develops an application site reaction with the clinical appearance of an
‘irritation reaction’, and with a severity of a Dermal Response Score of 5
(erythema, edema, and papules) or greater on the scale of Berger and Bowman,
treatment should be interrupted for up to one week and may then be resumed if the
reaction has, in the opinion of the Investigator, adequately resolved.
IP Treatment should be discontinued: 
•
If the reaction reoccurs. IP should be discontinued permanently, and the subject
followed until the reaction resolves.
For cases of suspected allergic contact dermatitis, the medical monitor and sponsor should be 
notified and there should be discussion about performing patch testing to further evaluate. Patch 
testing is encouraged in such cases. 
In the event of a medical emergency where unblinding is required to provide medical care to the 
subject, refer to the most current IWRS Plan and Breaking Treatment Codes (Section 4.8.5). 
Contact the Medical Monitor and the Sponsor promptly. 
6.
DATA ANALYSIS
Data will be handled and processed according to the Contract Research Organization’s (CRO) 
Standard Operating Procedures, which are written based on the principles of GCP. 
6.1. 
Statistical Methods 
The methodology presented below is a summary of the more detailed analysis plan that will be 
presented in the Statistical Analysis Plan (SAP).  The SAP will be finalized before the database 
is locked and unblinded.  Any changes to the methods described in the final SAP will be 
described and justified in the clinical study report. 
All statistical processing will be performed using SAS® (Version 9.4 or later) unless otherwise 
stated. 
Descriptive statistics will be used to provide an overview of the efficacy, safety and 
pharmacokinetic results.  For categorical parameters, the number and percentage of subjects in 
each category will be presented. The denominator for percentage will be based on the number of 
subjects appropriate for the purpose of analysis.  For continuous parameters, descriptive statistics 
will include n (number of subjects), mean, standard deviation (SD), median, minimum, 
and maximum. 

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6.1.1. 
Determination of Sample Size 
A sample size of approximately 450 subjects is planned for the study. 
The randomization scheme will be 2:1 (ARQ-154 foam 0.3% QD: matching vehicle QD). 
Randomization will be stratified by site and baseline disease severity (IGA = 3 or IGA = 4).  
Approximately 300 subjects will receive ARQ-154 foam 0.3% QD; approximately 150 subjects 
will receive vehicle foam QD. 
A sample size of 450 subjects will provide at least 90% power to detect a 25% difference 
between treatment groups on IGA success at α=0.01 using a 2-sided Cochran-Mantel-Haenszel 
test stratified by the randomization factors. The results from a recent Phase 2a study 
(ARQ-154-203) of ARQ-154 compared to vehicle treatment were used to estimate treatment 
difference. Specifically, in the Phase 2a trial, 73.8% of subjects demonstrated IGA success in the 
ARQ-154 0.3% group and 40.9% of subjects demonstrated IGA success in the vehicle group. 
The number of subjects to be enrolled will also provide sufficient power for the secondary 
endpoints. Additionally, the larger study size is included in order to provide additional/sufficient 
numbers of subjects on ARQ-154 treatment for a safety database. 
6.1.2. 
Subjects to Analyze 
The analysis populations are defined as follows: 
•
Safety population will include all subjects who are randomized and receive at least
one confirmed dose of IP or vehicle foam. This population will be used for all safety
analyses.
•
Efficacy analyses will be conducted in the Intent-to-Treat (ITT) population.
Sensitivity analyses may be conducted in the subset of the ITT population for whom
the primary endpoint assessment was not missed due to COVID-19 disruption
•
The Intention-to-Treat (ITT) population will include all randomized subjects. This
population will be the primary analysis population for the analysis of efficacy
endpoints.
•
The pruritus population is a subset of the ITT population and include subjects with
WI-NRS pruritus score ≥4 at Baseline. This population will be used for the analysis
of achievement of a 4-point reduction in WI-NRS pruritus score as compared to
Baseline.
6.1.3. 
Interim Analysis 
No interim analyses are planned. 
6.1.4. 
Background and Demographic Characteristics 
Descriptive statistics will be presented for the subject disposition, demographics, Baseline 
characteristics, treatment compliance, efficacy endpoints and safety data collected in the clinical 
trial. This includes the number and percentage of subjects for binary endpoints/categorical data, 
and mean, SD, median, Minimum, and maximum for continuous data.  

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6.1.5. 
Study Disposition 
Number of subjects randomized, receiving IP, completing study, and withdrawing prematurely 
(with reason for withdrawal) will be summarized by treatment group. 
6.1.6. 
Protocol Deviations and Eligibility Deviations 
The number of subjects with important protocol deviations and/or eligibility deviations will be 
summarized in categories by treatment group. 
6.1.7. 
Investigational Product Application Compliance 
The number of IP applications by each subject based on diary data will be summarized using 
descriptive statistics.  
The amount of IP used by each subject based on can weight will be summarized by treatment 
using descriptive statistics. 
IP dose compliance will be calculated based on number of applications divided by the expected 
number (amount) of IP applications for each subject.  Compliance will be summarized 
descriptively by treatment group.  Amount of IP (weight) used will also be summarized. 
6.1.8. 
Pharmacokinetics Analysis 
The PK population will include all subjects receiving the active drug with sufficient plasma 
concentrations of roflumilast to define a profile, as determined by the pharmacokineticist.  This 
population will be used for analyses of PK parameters. 
6.2. 
Safety Analysis 
Descriptive statistics will be calculated for quantitative safety data and frequency counts will be 
compiled for classification of qualitative safety data. The safety population will be used for these 
analyses. 
6.2.1. 
Adverse Events 
Adverse events (AEs) will be summarized by preferred term, system organ class, and treatment 
group for all AEs, serious AEs, related AEs, AEs leading to withdrawal from investigational 
product, and AEs leading to withdrawal from study. 
6.2.2. 
Clinical Laboratory Results 
Shifts in clinical laboratory parameters from Baseline to worst post-Baseline grade will be 
provided. 
6.2.3. 
Vital Signs 
The subject incidence rate of >5% weight loss or gain on study will be provide, as well as 
whether weight loss was explained or unexplained. 

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6.2.4. 
Local Tolerance Assessments 
For both the Investigator’s and Subject’s assessment of the numeric application site reaction, 
scores will be summarized individually by using number and percentage of subjects by visit, as 
well as mean/median scores. 
6.2.5. 
Medical History and Physical Examinations 
Medical history for all subjects will be presented in a by-subject listing. 
Clinically significant changes observed during physical examination will be captured as adverse 
events and included in AE tabulations. 
6.3. 
Efficacy Evaluation 
Efficacy analyses will be conducted in the Intent-to-Treat (ITT) population.  Sensitivity analyses 
may be conducted in the subset of the ITT population for whom the primary endpoint assessment 
was not missed due to COVID-19 disruption. 
6.3.1. 
Primary Endpoint 
The primary endpoint of ‘IGA success at Week 8’ will be analyzed using a Cochran-Mantel-
Haenszel test stratified by the randomization factors of the study center and IGA score at 
baseline (‘moderate’ v. ‘severe’). The analysis will be performed on the Intention-to-Treat (ITT) 
population and missing data will be imputed using multiple imputation. 
6.3.2. 
Secondary Endpoint 
Continuous secondary endpoints will be analyzed using Analysis of Covariance with treatment 
and stratification factors as independent variables.  The ITT population will be used and missing 
data will be imputed using multiple imputation.  Binary secondary endpoints will be analyzed 
similarly to the primary endpoint. 
Secondary endpoints will only be tested statistically if the primary endpoint is considered 
statistically significant.  To control for multiple comparisons among the secondary endpoints, the 
following multiplicity procedure will be used. 
Upon demonstration of statistical significance of the primary endpoint, the alpha level of 0.01 
will be unequally split between testing of the WI-NRS success endpoints and the other secondary 
efficacy endpoints. The testing over the WI-NRS success endpoints and the other secondary 
efficacy endpoints will be sequential, utilizing the Fallback Method for unused alpha. 
For the testing of WI-NRS success endpoints, an alpha level of 0.0033 will be used and will use 
a hierarchical method to first test WI-NRS success at Week 8, followed by WI-NRS at Week 4, 
followed by WI-NRS success at Week 2.  Should all three of these endpoints be statistically 
significant at the 0.0033 level, then this unused alpha will be carried to the other secondary 
endpoint group, which would then be tested at the .0033+.0067=0.01 level. 
An alpha level of 0.0067 (the remainder of the allotted 0.01) or the full 0.01, pending the results 
of the WI-NRS endpoint testing, will be used to hierarchically test IGA Success at Week 4, 

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Scaling score of 0 at Week 8, Erythema score of 0 at Week 8, the percentage of subjects who 
attain IGA of 0 at Week 8, and IGA Success at Week 2. 
7.
STUDY ADMINISTRATION
7.1. 
Ethics 
7.1.1. 
Ethics Review Board 
Before screening of subjects into the study, the current protocol, ICF, and any accompanying 
material to be provided to the subjects will be reviewed and approved by an appropriate 
IRB/ERB, as required by FDA (21 CFR § 56) or Health Canada and ICH GCP regulations.  A 
letter documenting the IRB approval must be received by the Sponsor before the initiation of the 
study at a clinical site. Amendments to the protocol will be subject to the same requirements as 
the original protocol. 
The Investigator, Sponsor, or designee will submit a progress report at least once yearly to the 
IRB. However, the frequency of these reports will depend on IRB requirements. As soon as 
possible after completion or termination of the study, the Investigator will submit a final report to 
the IRB per the IRB requirements, and in compliance with FDA and ICH GCP guidelines. 
The Investigator, Sponsor, or designee shall promptly notify the IRB of any SAEs, SUSARs, or 
any other information that may affect the safe use of the IP during the study, per the IRB local 
requirements, and in compliance with FDA regulations and ICH GCP guidelines. 
7.1.2. 
Ethical Conduct of the Study 
This research will be conducted in accordance with the protocol, the principles of the 
Tri-Council Policy Statement, the ethical principles set forth in the Declaration of Helsinki, and 
the ICH harmonized tripartite guideline regarding E6 (R2), December 2016. 
7.1.3. 
Subject Information and Consent/Assent 
The Investigator is responsible for obtaining written informed consent or assent 
(for children/adolescents) from everyone participating in this study after adequate explanation 
(in non-technical terms) of the aims, methods, objectives, and potential hazards of the study and 
before undertaking any study-related procedures. The investigator must use the most current IRB 
or ERB-approved consent/assent forms for documenting written informed consent and assent 
(for children/adolescents). Subjects will be assured that they may withdraw from the study at any 
time without jeopardizing their medical care. Each informed consent (or assent as applicable) 
will be read, appropriately signed, and dated by the subject or the subject’s legally authorized 
representative and the person conducting the consent discussion, and by an impartial witness if 
required by the IRB/ERB local requirements. 
Subjects will be given a copy of their ICF/assent. 

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7.2. 
Study Completion and Termination 
7.2.1. 
Study Completion 
The study is considered completed with the last visit of the last subject participating in the study. 
The final data from the investigational site will be sent to the Sponsor (or designee) after 
completion of the final subject visit at that site, in the time frame specified in the Clinical Trial 
Agreement. 
7.2.2. 
Study Termination 
The Sponsor reserves the right to close the investigational site or terminate the study at any time 
for any reason at the sole discretion of the Sponsor. Investigational sites will be closed upon 
study completion. An investigational site is considered closed when all required documents and 
study supplies have been collected and a site closure visit has been performed. The Investigator 
may initiate site closure at any time, provided there is reasonable cause and sufficient notice is 
given in advance of the intended termination. 
Reasons for the early closure of an investigational site by the Sponsor or Investigator may 
include but are not limited to: 
•
Failure of the Investigator to comply with the protocol, the Sponsor’s procedures, or
GCP guidelines.
•
Inadequate recruitment of subjects by the Investigator.
•
Discontinuation of further drug development.
7.3. 
Study Monitoring
Prior to the initiation of the clinical investigation, Sponsor representatives or designees may visit 
the clinical site where the investigation is to be conducted.  Sponsor representatives or designees 
shall ensure that the Investigator understands the investigational status of the investigational 
product, all requirements of the investigation to be undertaken, and all of his/her responsibilities 
as an Investigator.  Sponsor representatives or designees will also visit the clinical site at 
appropriate intervals as required to ensure compliance with the protocol and to verify the 
accuracy and completeness of data reported on the eCRFs.  The Study Director or designees shall 
be available for consultation with the Investigator and serve as liaisons between the clinical site 
and the Sponsor. 
The Sponsor or authorized designees may inspect all documents and records required to be 
maintained by the Investigator, including but not limited to medical records (office, clinic, or 
hospital) and investigational product dispensation logs for the subjects in this clinical 
investigation.  The Investigator must permit access to such records.  The Investigator must 
obtain, as part of informed consent, permission for an authorized representative of the Sponsor, 
or regulatory authorities, to review, in confidence, any records identifying subjects. 

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7.4. 
Data Quality Assurance 
To ensure the collection of adequate, consistent, complete, and reliable data during this clinical 
investigation, Sponsor representatives or designees may conduct audits of participating sites at 
appropriate intervals throughout the study.  The results of these periodic site audits may be 
subject to review by independent auditors at completion of the clinical investigation. 
All clinical data will undergo a quality control check prior to clinical database lock. Edit checks 
are performed for appropriate databases as a validation routine to check for missing data, data 
inconsistencies, data ranges etc. Corrections are made prior to database lock. 
7.5. 
Data Handling and Record Keeping 
During the clinical study, the Investigator will maintain adequate source records, including 
medical records, records detailing the progress of the study for each subject, laboratory reports, 
signed informed consent forms, IP disposition records, correspondence with the IRB or IEC and 
Study Monitor/Sponsor, AE reports, and information regarding subject discontinuation and 
completion of the clinical investigation. 
All required study data will be recorded on eCRFs. Any change of data will be recorded on the 
audit trail and a reason for the change will be entered. 
The Principal Investigator must retain all documentation relating to the study for a period of at 
least 2 years after the last marketing application approval or, if not approved, 2 years following 
the discontinuance of the test article for investigation.  If this requirement differs from any local 
regulations, the local regulations will take precedence unless the local retention policy is less 
than 2 years. 
7.6. 
Protocol Amendments and Deviations 
No change or amendment to this protocol may be made by the Investigator or Sponsor after the 
protocol has been agreed to and signed by all parties unless such change(s) or amendment(s) has 
(have) been agreed upon by the investigator and Sponsor.  Any change agreed upon will be 
recorded in writing, and the written amendment will be signed by the Investigator and Sponsor.  
Institutional review board approval is required prior to the implementation of an amendment, 
unless overriding safety reasons warrant immediate action, in which case the IRB(s)/IEC(s) will 
be promptly notified. 
No deviation from the protocol will be made except to protect the life or physical well-being of a 
subject in an emergency.  Except in such emergencies, prior approval of the Sponsor, and the 
IRB/IEC, is required before deviations from the planned protocol.  All protocol deviations that 
occur during the study will be documented and reported to Sponsor and to the IRB(s)/IEC(s), if 
applicable, according to regulations.  Further details about the documentation, evaluation, and 
follow-up of protocol deviations are detailed in this study’s clinical monitoring plan. 
No waivers to inclusion/exclusion criteria will be granted; subjects need to meet all criteria, 
exactly as specified, to be enrolled.  Additionally, prospective deviations from the protocol or 
investigational plan are not permitted except to protect the life or physical well-being of a subject 
in an emergency.  Deviations that occur unintentionally or are the result of action by the subject 

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must be documented and reported to the IRB(s), if applicable, according to regulations.  Further 
details about the documentation, evaluation, and follow-up of protocol deviations are detailed in 
this study’s clinical monitoring plan. 
7.7. 
Confidentiality and Privacy 
The Investigator must assure that subjects’ anonymity will be strictly maintained and that their 
identities are protected from unauthorized parties. Only an identification code and any other 
unique identifier(s) as allowed by local law (such as date of birth) will be recorded on any form 
or biological sample submitted to the Sponsor. 
The Investigator agrees that all information received from Arcutis Biotherapeutics Inc., including 
but not limited to the IB, this protocol, eCRF, the IP, and any other study information, remain the 
sole and exclusive property of Arcutis Biotherapeutics Inc. 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 Arcutis Biotherapeutics Inc. 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. 
7.8. 
Conflict of Interest 
All study Investigators will provide documentation of their financial interest or arrangements 
with Arcutis Biotherapeutics Inc., or proprietary interests in the investigational drug under study. 
This documentation must be provided prior to the Investigator’s participation in the study. Any 
change to the Investigator’s financial interest during the study and up to one year after study 
completion will be reported to the Sponsor. All Investigators with reported conflict of interest 
will be required to have such conflicts managed in a way that is appropriate to their participation 
in the design and conduct of this study. 
7.9. 
Report Format 
According to the ICH Harmonized Tripartite Guideline (Organization of the Common Technical 
Document for the Registration of Pharmaceuticals for Human Use M4 and the ICH M2 Expert 
Working Group), the final report will be written according to the ICH E3 Guideline 
(Structure and Content of Clinical Study Reports). 
7.10. 
Publication Policy 
The Sponsor is supportive of publishing clinical trial findings.  Any form of publication that is 
derived from this study must be submitted to Arcutis Biotherapeutics Inc. for review and 
approval. The process of coordinating publication efforts is detailed in the Clinical Trial 
Agreement. 

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8.
REFERENCES
Berger RS, Bowman JP. A reappraisal of the 21-day Cumulative Irritation Test in man. 
J. Toxicol Ot & Ocular Toxicol. 1982:1(2);109-115.
Borda LJ, Wikramanayake TC. Seborrheic Dermatitis and Dandruff: A Comprehensive Review. 
J Clin Investigat Dermatol. 2015;3(2):10. 
DALIRESP (roflumilast) tablets [package insert]. AstraZeneca Pharmaceuticals LP, Wilmington, 
DE USA; 2018. 
DAXAS (roflumilast) film-coated tablets [product monograph]. AstraZeneca Canada, Inc., 
Mississauga, Ontario Canada; 2017. 
Dessinioti C, Katsambas A. Seborrheic dermatitis: Etiology, risk factors, and treatments: 
Facts and controversies. Clinics in Dermatology. 2013;31:343-351. 
EUCRISA™ (crisaborole) ointment, 2%, for topical use [package insert]. Pfizer Laboratories 
Div. Pfizer Inc, NY, USA; 2017. 
Hatzelmann A, Morcillo EJ, Lungarella G, et al. The preclinical pharmacology of roflumilast – 
a selective, oral phosphodiesterase 4 inhibitor in development for chronic obstructive pulmonary 
disease. Pulm Pharmacol Ther. 2010;23:235–256. 
Investigator’s Brochure, Edition 4.0, 22 January 2021. 
Kimball AB, Naegeli AN, Edson-Heredia E, et. Psychometric properties of the Itch Numeric 
Rating Scale in patients with moderate-to-severe plaque psoriasis. Br. J. Dermatol. 
2016;175(1):157-162. doi:10.1111/bjd.1446. 
Naegeli AN, Flood E, Tucker J, et al. The Worst Itch Numeric Rating Scale for patients with 
moderate to severe plaque psoriasis or psoriatic arthritis. Int J Dermatol. 2015;54(6):715–22. 
OTEZLA® (apremilast) tablets, for oral use [package insert].  Celgene Corporation, Summit, 
NJ USA; 2017. 
Yosipovitch G, et al. Peak Pruritis Numerical Rating Scale: psychometric validation and 
responder definition for assessing itch in moderate-to-severe atopic dermatitis. Br J Dermatol.  
2019;181(4):761-769. doi:10.1111/bjd.17744. 

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9.
APPENDICES
APPENDIX 1. BODY & SCALP DIAGRAM 
Site personnel to mark treatable areas identified by the Investigator. 
Reminder: Application will be all areas affected including scalp, face, trunk and/or 
intertriginous/genital regions. Subject should continue to apply even if area(s) clears and treat 
new lesions. 

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 The iStock design is a trademark of iStockphoto LP 

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APPENDIX 2. PATIENT HEALTH QUESTIONNAIRE DEPRESSION 
SCALE (PHQ-8) 

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APPENDIX 3. MODIFIED PATIENT HEALTH QUESTIONNAIRE 
DEPRESSION SCALE (PHQ-A) 

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APPENDIX 4. CHILDREN’S DEPRESSION INVENTORY 2 
(PARENT REPORT) 

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APPENDIX 5. COLUMBIA-SUICIDE SEVERITY RATING SCALE 
(C-SSRS) BASELINE/SCREENING VERSION 

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APPENDIX 6. COLUMBIA-SUICIDE SEVERITY RATING SCALE 
(C-SSRS) SINCE LAST VISIT VERSION 

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APPENDIX 7. SCALPDEX 

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APPENDIX 8. DERMATOLOGY LIFE QUALITY INDEX (DLQI) 

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APPENDIX 9. CHILDREN’S DERMATOLOGY LIFE QUALITY INDEX 
(CDLQI) 

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APPENDIX 10. NIAID DMID TOXICITY TABLE 
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, DIVISION OF 
MICROBIOLOGY AND INFECTIOUS DISEASES (DMID) Toxicity Table for Use in 
Trials Enrolling Healthy Adults (2014) Modified 
ABBREVIATIONS USED IN THE FOLLOWING TABLES: 
Abbreviation/Term 
Definition/Explanation 
Abbreviation/Term 
Definition/Explanation 
ALT 
alanine aminotransferase 
LO 
Low 
aPTT 
activated partial thromboplastin 
time 
mEq 
Milliequivalent 
AST 
aspartate aminotransferase 
mmHg 
millimeter of mercury 
AV block 
atrioventricular block 
Ms 
Millisecond 
bpm 
beats per minute 
N 
Normal 
BUN 
blood urea nitrogen 
PT 
prothrombin time 
CK 
creatine kinase 
PTT 
partial thromboplastin time 
CPK 
creatine phosphokinase 
QTc 
QT-interval corrected for 
heart rate 
FEV1 
forced expiratory volume in 
1 second 
QTcB 
Bazett’s corrected QT 
interval 
g 
Gram 
QTcF 
Fridericia’s corrected QT 
interval 
HI 
High 
RBC 
red blood cell 
HPF 
high power field 
Rx 
Therapy 
IU 
international unit 
S 
Second 
IV 
Intravenous 
U 
Unit 
K/CUMM 
x103/mm3 
ULN 
upper limit of normal 
LLN 
lower limit of normal 

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ESTIMATING SEVERITY GRADE 
For abnormalities NOT found elsewhere in the Toxicity Tables use the scale below to estimate 
grade of severity: 
GRADE 1 
Mild: 
Transient or mild discomfort (<48 hours); no medical 
intervention/therapy required 
GRADE 2 
Moderate: 
Mild to moderate limitation in activity - some assistance 
may be needed; no or minimal medical intervention/therapy 
required 
GRADE 3 
Severe: 
Marked limitation in activity, some assistance usually 
required; medical intervention/therapy required 
hospitalizations possible. 
LABORATORY RANGES 
Where discrepancies in the ULN and LLN of laboratory ranges occur between those included in 
this document and those of the laboratory that performs the assays, the values provided by the 
laboratory will be used for assignment of severity grade. 

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CLINICAL ADVERSE EVENTS 
Cardiovascular 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Arrhythmia 
Asymptomatic, transient signs, no 
Rx required  
Recurrent/persistent; 
symptomatic Rx required 
Hemorrhage, blood loss 
Estimated blood loss ≤100 mL 
Estimated blood loss >100 mL, no 
transfusion required 
Transfusion required 
QTcF (Fridericia’s 
correction)1 or QTcB 
(Bazett’s correction) 
Asymptomatic, QTc interval 
450-479 ms, OR
Increase in interval<30 ms above 
baseline 
Asymptomatic, QTc interval 
480-499 ms, OR
Increase in interval 30-59 ms 
above baseline 
Asymptomatic, QTc interval 
≥500 ms, OR  
Increase in interval ≥60 ms 
above baseline 
PR interval (prolonged) 
PR interval 0.20-0.25 s 
PR interval >0.25 s 
Type II 2nd degree AV block 
OR Ventricular pause >3.0 s 
Respiratory 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Cough 
Transient-no treatment 
Persistent cough 
Interferes with daily activities 
Bronchospasm, acute 
Transient wheeze; no treatment 
Requires treatment; normalizes 
with bronchodilator and  
FEV1 < 80% predicted before 
bronchodilator  
Minimal normalization with 
bronchodilator andFEV1 <80% 
predicted after bronchodilator 
Dyspnea 
Does not interfere with usual and 
social activities 
Interferes with usual and social 
activities, no treatment 
Prevents daily and usual social 
activity or requires treatment 
1 Inclusion dependent upon protocol requirements 

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Respiratory 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Nasal discharge (rhinitis 
infective per CTCAE 4.0) 
- 
Localized; local intervention 
indicated (e.g. topical antibiotic, 
antifungal, or antiviral) 
- 
Pharyngitis (CTCAE 4.0) 
- 
Localized; local intervention 
indicated (e.g. topical antibiotic, 
antifungal, or antiviral) 
IV antibiotic, antifungal, or 
antiviral intervention indicated; 
radiologic or operative 
intervention indicated 
Pneumonitis (rales or rhonchi) 
(CTCAE 4.0) 
Asymptomatic; clinical or 
diagnostic observations only; 
intervention not indicated 
Symptomatic; medical intervention 
indicated; limiting instrumental 
ADL 
Severe symptoms; limiting 
self-care ADL; oxygen indicated 
Lung infection (CTCAE 4.0) 
- 
Moderate symptoms; oral 
intervention indicated 
(e.g. antibiotic, antifungal, 
antiviral) 
IV antibiotic, antifungal, or 
antiviral intervention indicated; 
radiologic, endoscopic, or 
operative intervention indicated 
Gastrointestinal 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Nausea  
No interference with activity 
Some interference with activity 
Prevents daily activities 
Vomiting  
No interference with activity or 
1-2 episodes/24 hours 
Some interference with activity or 
>2 episodes/24 hours 
Prevents daily activity or 
requires IV hydration 
Diarrhea  
2-3 loose or watery stools or  
<400 g/24 hours 
4-5 loose or watery stools or  
400-800 g/24 hours 
6 or more loose or watery stools 
or >800 g/24 hours or requires 
IV hydration 
 
 
 

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Urinary Tract 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Urinary tract infection  
(CTCAE 4.0) 
- 
Localized; local intervention 
indicated (e.g. oral or topical 
antibiotic, antifungal, antiviral) 
IV antibiotic, antifungal, or antiviral 
intervention indicated; radiologic or 
operative intervention indicated 
Reactogenicity 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Local reactions 
Pain 
Does not interfere with activity 
Repeated use of non-narcotic pain 
reliever >24 hours or interferes 
with activity 
Any use of narcotic pain reliever or 
prevents daily activity 
Tenderness 
Discomfort only to touch 
Discomfort with movement 
Significant discomfort at rest 
Erythema/redness 2 
2.5-5 cm 
5.1-10 cm 
>10 cm 
Induration/swelling 3 
2.5-5 cm and does not interfere 
with activity 
5.1-10 cm or interferes with 
activity 
>10 cm or prevents daily activity 
Systemic reactions 
Allergic reaction  
Pruritus without rash  
Localized urticaria  
Generalized urticaria; angioedema 
or anaphylaxis  
Headache  
No interference with activity 
Repeated use of non-narcotic pain 
reliever >24 hours or some 
interference with activity 
Significant; any use of narcotic pain 
reliever or prevents daily activity 
Fatigue  
No interference with activity 
Some interference with activity 
Significant; prevents daily activity 
 
2 In addition to grading the measured local reaction at the greatest single diameter, the measurement should be recorded as a continuous variable. 
3 Induration/swelling should be evaluated and graded using the functional scale as well as the actual measurement. 

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Reactogenicity 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Myalgia 
No interference with activity 
Some interference with activity 
Significant; prevents daily activity 
All Other Conditions 
Mild 
(Grade 1) 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Illness or clinical adverse 
event (as defined according to 
applicable regulations) 
No interference with activity 
Some interference with activity not 
requiring medical intervention 
Prevents daily activity and requires 
medical intervention 
LABORATORY AND VITAL SIGNS TOXICITY GRADING (Some laboratory values have been modified to be consistent 
with the normal ranges of the ACM laboratory used in the present study) 
Blood, Serum, or Plasma Chemistries a 
LO/HI/N b 
Mild 
(Grade 1) c 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Sodium (mEq/L or mmol/L) 
LO 
131-<LLN 
130 
<130 
HI 
>ULN-148
149-150
>150
Potassium (mEq/L or mmol/L) 
LO 
<LLN-3.2 
<3.2-3.1 
<3.1 
HI 
>ULN-5.6
>5.6-5.7
>5.7
Glucose (mg/dL) 
LO mmol/L 
<LLN-3.0 
<3.0-2.2 
<2.2 
HI mmol/L 
>ULN-8.9
>8.9-13.9
>13.9
Blood urea nitrogen 
HI mmol/L 
>8.9-17.8
>17.8-35.5
>35.5
Creatinine 
N 
115-151 (µmol/L)
152-177 (µmol/L)
> 177 (µmol/L)

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Blood, Serum, or Plasma Chemistries a 
LO/HI/N b 
Mild 
(Grade 1) c 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Calcium (CTCAE 4.0) 
LO mmol/L 
<LLN-2.0 
<2.0-1.75 
<1.75 
HI mmol/L 
>ULN-2.9
>2.9-3.1
>3.1
Magnesium (CTCAE 4.0) 
LO mmol/L 
<LLN-0.5 
<0.5-0.4 
<0.4 
Phosphorous (CTCAE 4.0) 
LO mmol/L 
<LLN-0.8 
<0.8-0.6 
<0.6 
Creatine kinase (CPK or CK) (CTCAE 4.0) 
HI 
>ULN-2.5xULN
>2.5xULN-5xULN
>5xULN
Albumin 
LO g/L 
<30-28 
<28-25 
<25 
Total protein 
LO g/L 
<LLN-52 
<52-50 
<50 
Alkaline phosphatase (U/L) (CTCAE 4.0) 
HI 
>ULN-2.5xULN
>2.5xULN-5xULN
>5xULN
AST (U/L) (CTCAE 4.0) 
HI 
>ULN-3xULN
>3xULN-5xULN
>5xULN
ALT (U/L) (CTCAE 4.0) 
HI 
>ULN-3xULN
>3xULN-5xULN
>5xULN
Bilirubin, serum total (mmol/L) (CTCAE 4.0) 
HI mmol/L 
>ULN-1.5xULN
>1.5xULN-3xULN
>3xULN
Bilirubin, serum total (mg/dL) when ALT ≥105 
(Hy’s law) 
HI 
1.3-1.5 
1.6-2.0 
>2.0
Bilirubin, serum direct (mmol/L) (CTCAE 4.0) 
HI mmol/L 
>ULN-1.5xULN
>1.5xULN-3xULN
>3xULN
Amylase (U/L) (CTCAE 4.0) 
HI 
>ULN-1.5xULN
>1.5xULN-2xULN
>2xULN
Lipase (U/L) (CTCAE 4.0) 
HI 
>ULN-1.5xULN
>1.5xULN-2xULN
>2xULN

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Blood, Serum, or Plasma Chemistries a 
LO/HI/N b 
Mild 
(Grade 1) c 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Uric acid (mg/dL/mmol/L) (CTCAE 4.0) 
HI 
>ULN – 10 mg/dL
(0.59 mmol/L)
without physiologic
consequences
- 
>ULN – 10 mg/dL
(0.59 mmol/L) with
physiologic
consequences
a Depending upon the laboratory used, references ranges, eligibility ranges and grading may be split out by sex and/or age. 
b Low, High, Not Graded (N). 
c If initial boundary of grade 1 has gap from reference range or eligibility range, calculations based on the New England Journal of Medicine (NEJM) reference 
ranges. 

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Hematology 
LO/HI/N a 
Mild 
(Grade 1) b 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Hemoglobin (women) (g/dL) 
Hemoglobin (men) (g/dL) 
LO 
10.8-11.3 
9.2-10.7 
<9.2 
LO 
12.0-12.5 
10.0-11.9 
<10.0 
White blood cell count (K/CUMM) 
HI 
11.00-15.00 
15.00-20.00 
>20.00
LO 
2.50-3.50 
1.50-2.49 
<1.50 
Lymphocytes (K/CUMM) 
LO 
0.76-0.90 
0.50-0.75 
<0.5 
Neutrophils (K/CUMM) 
LO 
1.50-1.95  
1.00-1.49 
<1.00 
Eosinophils (K/CUMM) 
HI 
0.58-0.74  
0.75-1.50 
>1.50
Platelets (K/CUMM) 
LO 
120-130
100-120
<100 
Coagulation 
Prothrombin time (PT, seconds) 
HI 
> ULN-14.4
14.5-15.7 
>15.7
Partial thromboplastin time 
(PTT or aPTT, seconds) 
HI 
>ULN-42.1
42.2-50.0 
>50.0
Fibrinogen (mg/dL) (CTCAE 4.0) 
HI 
>ULN-500
501-600
>600
LO 
<LLN-0.75xLLN 
<0.75xLLN-
0.5xLLN 
<0.5xLLN 
Urine 
Protein (dipstick) 
HI 
1+ 
2+ 
>2+
Glucose (dipstick) 
HI 
1+ 
2+ 
>2+
Blood (microscopic) - red blood cells per high 
power field (RBC/HPF) 
HI 
5-10 for males
9-10 for females
11-50
>50 and/or gross
blood
a Low, High, Not Graded. 
b If initial boundary of grade 1 has gap from reference range or eligibility range, calculations based on the New England Journal of Medicine (NEJM) reference 
ranges. 

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Vital Signs 
LO/HI/N a 
Mild 
(Grade 1) b 
Moderate 
(Grade 2) 
Severe 
(Grade 3) 
Fever (°C) c 
HI 
38.0-38.4 
38.5-38.9 
>38.9
Fever (°F) 
HI 
100.4-101.1 
101.2-102.0 
>102.1
Tachycardia - beats per minute 
HI 
101-115
116-130
>130 or ventricular
dysrhythmias
Bradycardia - beats per minute 
LO 
40-45
35-40
<35 
Hypertension (systolic) - mm Hg d 
HI 
141-150
151-160
>160
Hypertension (diastolic) - mm Hg 
HI 
91-95
96-100
>100
Hypotension (systolic) - mm Hg 
LO 
85-89
80-84
<80 
Tachypnea - breaths per minute 
HI 
23-25
26-30
>30
a Low, High, Not Graded. 
b If initial boundary of grade 1 has gap from reference range or eligibility range, calculations based on the New England Journal of Medicine (NEJM) reference 
ranges. 
c Oral temperature; no recent hot or cold beverages or smoking. A protocol should select either °C or °F for inclusion. 
d Assuming subject is awake, resting, and supine; for adverse events, 3 measurements on the same arm with concordant results 

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APPENDIX 11. COVID-19 STUDY SITE GUIDANCE 
 
BACKGROUND 
As the impact of coronavirus disease 2019 (COVID-19) continues to develop, Premier Research 
Inc. and Arcutis Biotherapeutics Inc. have collated the following guidelines in response for study 
sites participating in the ARQ-154-304. While it is ideal for subjects to perform all 
protocol-specific assessments at the study site, both Premier and Arcutis are focused on 
prioritizing subject safety and data integrity. Therefore, the following guidelines will identify 
challenges and mitigation strategies while operating clinical trials remotely. 
REMOTE DATA COLLECTION 
In the event subjects are unable to complete protocol-specific assessments onsite, study sites may 
collect data from subjects remotely via telephone and/or by traditional mail or email. The method 
used for data collection must be clearly documented in the source. Whenever possible, sites 
should adhere to the protocol visit window for remote data collection. Screening and Baseline 
(Day 0) visits/assessments must be performed in the clinic and must NOT be completed 
remotely. If necessary, these visits can be delayed ensuring they are conducted in the clinic and 
not remotely. 
Data collection by phone may be performed. Subjects are contacted via telephone and site staff 
will collect data verbally for all critical data points applicable. Subject responses should be 
recorded in the site source documents. Data collected remotely should be entered into the EDC 
system (iMedidata Rave). 
Data collection by mail or email may also be performed for applicable assessments. Site staff 
will contact subjects via traditional mail or email to collect data using paper versions of study 
questionnaires. C-SSRS cannot be collected by mail/email as this requires subject interview by 
site staff. 
Investigator assessments and subject questionnaires normally completed during on-site visits 
should be completed on the appropriate paper source documents and entered in the EDC. The 
following subject assessments/questionnaires are approved to be collected via 
telemedicine/remotely: 
• C-SSRS 
• PHQ-8/PHQ-A/CDI-2 
• DLQI/CDLQI 
• Scalpdex 
• Subject Local Tolerability 
• Adverse Events 
• Concomitant medication 

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The following Investigator assessments cannot be completed via telemedicine/remotely: 
•
IGA
•
BSA
•
Investigator Local Tolerability
•
Pigmentation Assessment
•
Overall Assessment of Erythema
•
Overall Assessment of Scaling
•
Subject Weight
GUIDELINES FOR REMOTE DATA COLLECTION 
1. Highest priorities: the subject safety and preserving integrity of data are critical.
2. Study visits and procedures must be followed per protocol whenever possible. Any
specific changes in study conduct that deviate from the protocol should be communicated
to the IRB and Sponsor (via reporting to your site assigned CRA). All protocol deviations
which occurred as a result of COVID-19 disruptions (e.g., visits out of window, missed
assessments, etc.) should be differentiated from other PDs. It is prudent to receive IRB
guidance or approval if a deviation is known to occur in advance (i.e., extending IP
application or changing assessment windows, etc.).
3. If, despite all efforts, a planned clinic visit is absolutely not possible due to a COVID-19
related issue (e.g., site has closed, subject prohibited from coming to clinic, etc.),
sponsor’s strong preference is a delayed clinic visit. If the subject can come to clinic
within a reasonable amount of time considering the protocol allowed visit window. If a
delayed clinic visit cannot be completed within 14 days of the protocol specified visit
window, please contact the Medical Monitor for additional guidance.
4. It is critical to ensure subjects have enough IP in the event timely clinic visit(s) is/are not
possible. It is also critical to ensure subjects are instructed to continue to apply IP per
protocol for the duration of their participation in the study. Subjects should also be
reminded to complete their daily diaries and IP compliance should be assessed via phone
if clinic visits are not possible or are delayed.
5. It is critical for preserving data integrity to make every effort possible to have a subject
return to clinic for the Week 8 visit. For visits conducted in the clinic, it is critical to
ensure Rater consistency for all efficacy assessments (e.g., IGA, etc.). If absolutely
necessary, it is preferred to have several missed visits and a delayed Week 8 visit versus
having an Early Termination and no Week 8 visit. If it is not possible for a subject to
return on-site within window for the Week 8 visit, sites should:
a.
Ensure the subject has signed the most current IRB approved ICF.
b. Contact subjects to discuss continue administration of IP and continue to complete
their dosing diaries per regular IP administration instructions.

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c.
Subjects are approved to continue applying IP post Week 8 as long as the following
have been discussed with the subject:
−
Site should confirm the subject has adequate IP to continue dosing and if not ask
the subject to return to the site to pick up additional IP or refer to the current IP
Handling Plan for instructions on shipment of IP from site to subject.
−
Confirm the subject has no AEs that would warrant discontinuation of the IP.
−
Site should discuss any new or ongoing conmed(s) and determine if the use of any
warrant having the subject stop IP application or not.
−
For any female subject of childbearing potential that site should discuss and
confirm the subject has continued her methods of ensuring pregnancy does not
occur. Any deviation from these methods should be discussed further and the site
should determine if IP should be halted or contact the medical monitor or Arcutis
if they have any questions.  A pregnancy test can be performed at the next onsite
visit (this is applicable to prior visits being missed due to COVID-19 as well).
−
Subjects are approved to continue dosing for up to 14 days past their Week 8 visit.
After this, sites should reach out to the Medical Monitor and/or Arcutis directly
for approval to have subjects continue dosing.
−
All the above discussions must be documented in the source.
d. If available, home health nurse visits could be considered for collection of Vital Signs
and Clinical Labs.
e.
In the event a subject is quarantined, has symptoms, or is confirmed positive for
COVID-19, it is the Sponsor’s opinion that IP can continue, assuming no other
contraindications.