Clinical trial NCT04091646
Conditions: Seborrheic Dermatitis
Sponsor: Arcutis Biotherapeutics, Inc.
Start date: 2019-12-04; Completion date: 2020-08-21
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a parallel group, double blind, vehicle-controlled study assessed the safety and efficacy of roflumilast foam (ARQ-154) vs placebo foam in participants with seborrheic dermatitis.

Detailed description:

Arms: arm 1: Participants apply roflumilast foam 0.3% once daily (QD) to all areas of seborrheic dermatitis once daily for 8 weeks. arm 2: Participants apply inactive vehicle foam matched to roflumilast foam QD for 8 weeks.
Interventions: intervention 1: Roflumilast Foam 0.3% intervention 2: Vehicle foam
Intervention descriptions: intervention 1: Roflumilast foam for topical application. intervention 2: Vehicle foam for topical application.

Protocol documents:
Prot_000.pdf: 




Protocol ARQ-154-203 
Arcutis, Inc. 
Amendment 1 
 
07 January 2020 
Confidential 
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SUMMARY OF CHANGES 
The following sections have been changed in Amendment 1 of the ARQ-154-203 protocol. 
Section 
Summary of Changes 
Protocol Title 
Update protocol title from Phase 2b to Phase 2a throughout the 
protocol as applicable 
Synopsis 
Updated to align with changes made within the body of the 
protocol 
3.3.1.2 Psoriasis Phase 2b 
Updated Figures 1 and 2 
4.2 Number of Subjects 
Increase the number of subjects to be enrolled in the study to 184. 
Remove the limit of 20% total enrollment for IGA of ‘Severe’  
4.4.1 Inclusion Criteria 
Clarified inclusion 6 to include at least Moderate scores for 
Overall Assessments of Erythema and Scaling at Baseline 
4.4.2 Exclusion Criteria 
Previous exclusion 8: remove exclusion criteria for 
hypersensitivity to PDE-4 inhibitors. 
Exclusion 9: clarify exclusion criteria for suicidal ideation. 
Exclusion 10: specified 4 week washout period for subjects with a 
history of a major surgery. 
Exclusion 12: specified physical limitations for subjects with 
scalp involvement. 
Exclusion 16: specified family members of enrolled subjects 
residing in the same household are excluded from the study. 
5.1.1 Screening 
Revised to allow subjects to re-screen one time 
5.1.2 Baseline 
Allow Screening lab results to be used for Baseline lab 
assessments if the Baseline visit occurs within 14 days of 
Screening 
5.1.4 Vital Signs, Height, 
Weight 
Specified blood pressure to be collected while the subject is 
sitting/resting for at least 5 minutes 
5.2 Efficacy Evaluations 
Clarify every effort must be made for the same evaluator to 
complete the IGA, Overall Assessments of Erythema and Scaling 
5.8 Reporting Pregnancy 
Clarify guidance for pregnancy reporting. 
6.1.3 Interim Analysis 
Add an interim analysis for futility  
6.3.3 Exploratory Endpoints 
Add an exploratory endpoint for IGA 
Appendix 5 
Added image for Scalpdex. 
Appendix 6 
Move Toxicity Table from Appendix 5 to 6 
Editorial changes made throughout to improve accuracy or readability 
 
 


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TABLE OF CONTENTS 
1 
PROTOCOL SUMMARY ................................................................................................... 8 
1.1 
Synopsis .......................................................................................................................... 8 
1.2 
Study Schema .............................................................................................................. 15 
1.3 
Schedule of Visits and Assessments ........................................................................... 16 
2 
ABBREVIATIONS ............................................................................................................. 18 
3 
BACKGROUND AND RATIONALE .............................................................................. 20 
3.1 
Introduction ................................................................................................................. 20 
3.2 
Preclinical Studies ....................................................................................................... 21 
3.2.1 
Toxicity Summary ................................................................................................ 21 
3.3 
Clinical Studies ............................................................................................................ 22 
3.3.1 
Topical Roflumilast Cream ................................................................................... 22 
3.3.2 
Oral Roflumilast Tablet ........................................................................................ 27 
3.4 
Rationale for Development......................................................................................... 27 
3.4.1 
Dose Selection ...................................................................................................... 28 
3.4.2 
Risks and/or Benefits to Subjects ......................................................................... 29 
4 
INVESTIGATIONAL PLAN ............................................................................................ 29 
4.1 
Overall Study Design and Plan .................................................................................. 29 
4.2 
Number of Subjects..................................................................................................... 29 
4.3 
Subject Participation .................................................................................................. 29 
4.3.1 
Randomization ...................................................................................................... 30 
4.3.2 
Numbering of Subjects ......................................................................................... 30 
4.4 
Selection of Study Population .................................................................................... 30 
4.4.1 
Inclusion Criteria .................................................................................................. 30 
4.4.2 
Exclusion Criteria ................................................................................................. 31 
4.4.3 
Removal of Subjects from Investigational Product .............................................. 32 
4.4.4 
Removal of Subjects from the Study .................................................................... 33 
4.5 
Study Restrictions ....................................................................................................... 34 
4.5.1 
Prohibitions and Concomitant Therapy ................................................................ 34 
4.6 
Treatment .................................................................................................................... 35 
4.6.1 
IP Supplies, Packaging and Labeling.................................................................... 35 
4.6.2 
Blinding................................................................................................................. 35 
4.6.3 
Treatment Administration ..................................................................................... 36 
4.6.4 
Treatment Compliance .......................................................................................... 36 
5 
STUDY PROCEDURES .................................................................................................... 37 
5.1 
Safety Assessments ...................................................................................................... 37 
5.1.1 
Screening............................................................................................................... 37 
5.1.2 
Baseline ................................................................................................................. 38 


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5.1.3 
Physical Examination............................................................................................ 38 
5.1.4 
Vital Signs, Height and Weight ............................................................................ 38 
5.1.5 
Laboratory Tests ................................................................................................... 38 
5.1.6 
Patient Health Questionnaire depression scale (PHQ-8) ...................................... 39 
5.1.7 
Columbia-Suicide Severity Rating Scale (C-SSRS) ............................................. 40 
5.1.8 
Local Tolerability Assessments ............................................................................ 40 
5.1.9 
Pigmentation Assessment ..................................................................................... 42 
5.1.10 
Adverse Events ..................................................................................................... 42 
5.2 
Efficacy Evaluations ................................................................................................... 42 
5.2.1 
Investigator Global Assessment (IGA) ................................................................. 42 
5.2.2 
Overall Assessment of Erythema .......................................................................... 43 
5.2.3 
Overall Assessment of Scaling ............................................................................. 44 
5.2.4 
Body Surface Area (BSA) .................................................................................... 44 
5.2.5 
Worst Itch Numerical Rating Scale (WI-NRS) .................................................... 44 
5.2.6 
Scalpdex ................................................................................................................ 45 
5.2.7 
Dermatology Life Quality Index (DLQI) ............................................................. 45 
5.2.8 
Dermal Imaging .................................................................................................... 45 
5.3 
Pharmacokinetics Assessment ................................................................................... 45 
5.4 
Final Study Visit .......................................................................................................... 46 
5.5 
Early Termination Visit ............................................................................................. 46 
5.6 
Unscheduled Visit........................................................................................................ 46 
5.7 
Adverse Events ............................................................................................................ 46 
5.7.1 
Adverse Event Definition ..................................................................................... 46 
5.7.2 
Serious Adverse Event .......................................................................................... 46 
5.7.3 
Suspected Unexpected Serious Adverse Reaction (SUSAR) ............................... 48 
5.7.4 
Safety Review ....................................................................................................... 48 
5.7.5 
Adverse Event Reporting ...................................................................................... 48 
5.8 
Reporting Pregnancy .................................................................................................. 50 
5.9 
Treatment Stopping Rules ......................................................................................... 50 
5.9.1 
Emergency Unblinding ......................................................................................... 51 
6 
DATA ANALYSIS .............................................................................................................. 51 
6.1 
Statistical Methods ...................................................................................................... 51 
6.1.1 
Determination of Sample Size .............................................................................. 52 
6.1.2 
Subjects to Analyze ............................................................................................... 52 
6.1.3 
Interim Analysis .................................................................................................... 52 
6.1.4 
Background and Demographic Characteristics ..................................................... 53 
6.1.5 
Study Disposition .................................................................................................. 53 
6.1.6 
Protocol Deviations and Eligibility Deviations .................................................... 53 
6.1.7 
Investigational Product Compliance ..................................................................... 53 
6.2 
Study Objective ........................................................................................................... 53 
6.2.1 
Primary Objective ................................................................................................. 53 


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6.3 
Efficacy Evaluation ..................................................................................................... 53 
6.3.1 
Primary Efficacy Endpoint ................................................................................... 53 
6.3.2 
Secondary Endpoints ............................................................................................ 54 
6.3.3 
Exploratory Endpoints .......................................................................................... 54 
6.4 
Safety Evaluation ........................................................................................................ 55 
6.4.1 
Adverse Events ..................................................................................................... 55 
6.4.2 
Local Tolerance Assessments ............................................................................... 55 
6.4.3 
Medical History and Physical Examinations ........................................................ 55 
6.4.4 
PHQ-8 ................................................................................................................... 56 
6.4.5 
C-SSRS ................................................................................................................. 56 
6.4.6 
Clinical Laboratory Results and Vital Signs/Weight Measurements ................... 56 
6.4.7 
Prior and Concomitant Medications ..................................................................... 56 
6.5 
Patient Reported Outcomes Analyses ....................................................................... 56 
6.5.1 
WI-NRS ................................................................................................................ 56 
6.5.2 
Dermatology Life Quality Index (DLQI) ............................................................. 57 
6.5.3 
Scalpdex ................................................................................................................ 57 
6.6 
Pharmacokinetic Analysis .......................................................................................... 57 
7 
STUDY ADMINISTRATION............................................................................................ 57 
7.1 
Ethics ............................................................................................................................ 57 
7.1.1 
Ethics Review Board ............................................................................................. 57 
7.1.2 
Ethical Conduct of the Study ................................................................................ 58 
7.1.3 
Subject Information and Consent.......................................................................... 58 
7.2 
Study Completion and Termination .......................................................................... 58 
7.2.1 
Study Completion ................................................................................................. 58 
7.2.2 
Study Termination ................................................................................................ 58 
7.3 
Study Monitoring ........................................................................................................ 59 
7.4 
Data Quality Assurance .............................................................................................. 59 
7.4.1 
Verification of Blinding ........................................................................................ 59 
7.5 
Data Handling and Record Keeping ......................................................................... 59 
7.6 
Protocol Amendments and Deviations ...................................................................... 60 
7.7 
Confidentiality and Privacy ....................................................................................... 60 
7.8 
Conflict of Interest ...................................................................................................... 61 
7.9 
Report Format ............................................................................................................. 61 
7.10 
Publication Policy........................................................................................................ 61 
8 
REFERENCES .................................................................................................................... 62 
9 
APPENDICES ..................................................................................................................... 63 
 
 


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LIST OF TABLES 
 
Table 1: Excluded Medications and Treatments ........................................................................... 34 
Table 2: Laboratory Tests ............................................................................................................. 39 
 
 
LIST OF FIGURES 
 
Figure 1. 
ARQ-151-201: Achievement of IGA Success (IGA=0/1 plus 2-grade 
improvement) (ITT) ................................................................................................ 25 
Figure 2. 
ARQ-151-201: Achievement of Intertriginous-IGA (I-IGA) Success (I-
IGA=0 or 1 plus 2-grade improvement) (ITT) ........................................................ 26 
 
 
LIST OF APPENDICES 
 
Appendix 1: Patient Health Questionnaire depression scale (PHQ8) ........................................... 63 
Appendix 2: Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline/Screening 
Version .................................................................................................................... 64 
Appendix 3: Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version ........ 67 
Appendix 4: Dermatology Life Quality Index (DLQI) ................................................................. 70 
Appendix 5: Scalpdex ................................................................................................................... 72 
Appendix 6: 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 …………………………………………………………...73 
 
 


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1 
PROTOCOL SUMMARY 
1.1 
Synopsis 
Protocol Title: 
A Phase 2a, 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 
Investigational Product: 
ARQ-154 foam investigational product will be supplied at 
a concentration of 0.3%. 
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 QD applied to all areas of 
seborrheic dermatitis. Areas of application will be all areas 
affected including the face, scalp, trunk, or 
intertriginous/genital regions, with a maximum BSA of 
20%. Subjects should maintain treatment of areas with 
investigational product 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. 
IND 
142047 
Clinical Indication: 
Seborrheic dermatitis 
Study Design: 
This is a parallel group, double blind, vehicle-controlled 
study in which ARQ-154 foam 0.3% or vehicle foam is 
applied QD x 8 weeks to adult subjects with at least 
moderate seborrheic dermatitis affecting the scalp and/or 
rest of body 
Study Objectives: 
To assess the safety and efficacy of ARQ-154 foam 0.3% 
administered once daily (QD) vs vehicle foam x 8 weeks in 
adult subjects with seborrheic dermatitis   
Study Sites: 
Multicenter study with approximately 20 sites   
Study Population: 
Subjects will be male and female adults. 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). 
Inclusion Criteria 
1. Participants legally competent to sign and give 


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informed consent.  
2. Males and females ages 18 years and older (inclusive) 
at the time of consent. 
3. Clinical diagnosis of seborrheic dermatitis of at least 3 
months duration as determined by the Investigator. 
Stable disease for the past 4 weeks.   
4. Seborrheic dermatitis of the scalp and/or face and/or 
trunk and/or intertriginous areas up to ≤20% BSA 
involvement. 
5. An Investigator Global Assessment (IGA) of 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. 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 highly effective contraception 
throughout the trial.  Highly effective forms of 
contraception include: 
oral/implant/injectable/transdermal contraceptives, 
intrauterine device, and partner’s vasectomy.  If barrier 
methods are used (e.g., condom with spermicide, 
diaphragm with spermicide), then 2 forms of conception 
are required. The use of abstinence as a contraceptive 
measure is acceptable as long as this is a consistent part 
of a lifestyle choice and a backup method has been 
identified if the subject becomes sexually active. 
8. Females of non-childbearing potential must either be 
post-menopausal with spontaneous amenorrhea for at 
least 12 months or have undergone surgical sterilization 
(permanent sterilization methods include hysterectomy, 
bilateral oophorectomy, hysteroscopic sterilization, 
bilateral tubal ligation or bilateral salpingectomy). 
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 


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to the Protocol and visit schedule according to the 
Investigator judgment. 
Exclusion Criteria 
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 of treated area(s) to either 
natural or artificial sunlight, tanning bed or other LED. 
3. Subjects who cannot discontinue the use of strong 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 who cannot discontinue the use of strong P-
450 cytochrome inducers e.g., efavirenz, nevirapine, 
glucocorticoids, barbiturates (including phenobarbital), 
phenytoin, rifampin, and carbamazepine for two weeks 
prior to the Baseline visit (Visit 2) and during the study. 
5. Subjects with PHQ-8 >10 at Screening or Baseline 
visits.  
6. Previous treatment with ARQ-151 cream. 
7. Subjects who have received oral roflumilast (Daliresp®, 
Daxas®) or other PDE-4 inhibitors (apremilast) within 
the past 4 weeks.   
8. Known allergies to excipients in ARQ-154 foam 
 
 
 
 
9. Known or suspected:  
• severe renal insufficiency or moderate to severe hepatic 
disorders 
• hypersensitivity to component(s) of the investigational 
products  
• history of severe depression, suicidal ideation or 
Screening/Baseline C-SSRS indicative of suicidal 
ideation, whether lifetime or recent/current 
10. Subjects with a history of a major surgery within 4 
weeks prior to Baseline (Visit 2) or has a major surgery 


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planned during the study. 
11. Subjects with any condition on the treatment area 
which, in the opinion of the Investigator, could 
confound efficacy measurements. 
12. Subjects unable to apply product to the scalp due to 
physical limitations if the subject has current or history 
of seborrheic dermatitis involving the scalp. 
13. Females who are pregnant, wishing to become pregnant 
during the study, or are breast-feeding. 
14. A clinically relevant history of abuse of alcohol or other 
drugs, at the discretion of the Investigator. 
15. Subjects who are unable to communicate, read or 
understand the local language, or who display another 
condition, which in the Investigator’s opinion, makes 
them unsuitable for clinical study participation. 
16. Subjects who are family members of the clinical study 
site, clinical study staff, or sponsor, or family members 
residing in the same household of enrolled subjects. 
17. Any condition that in the Investigator’s assessment 
would preclude the subject from participating in the 
study. 
Duration of Participation for 
Subjects: 
Screening (up to 4 weeks) + Treatment phase (8 weeks) and 
follow-up (1 week post-treatment completion) for a total of 
up to approximately 13 weeks 
Key Assessments: 
Safety will be monitored through application site 
assessments, safety labs, and Adverse Events (AEs). Safety 
will also be monitored by C-SSRS and PHQ-8 assessments.  
Efficacy assessments will include IGA, Overall Assessment 
of Erythema, Overall Assessment of Scaling, WI-NRS, 
Scalpdex, and DLQI.  
Pharmacokinetic samples will be collected at pre-dose for 
all subjects. Refer to the Schedule of Visits and 
Assessments (Section 1.3) for detailed schedules of the 
study assessments. 
Study Endpoints 
The Primary Efficacy Endpoint will be defined as:  
• Achievement of an IGA score of ‘clear’ or ‘almost 
clear’ PLUS a 2-grade improvement from Baseline 
at week 8   


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The Secondary Efficacy Endpoints will include: 
• Achievement of an IGA score of ‘clear’ or ‘almost 
clear’ PLUS a 2-grade improvement from Baseline 
at weeks 2 and 4 
• Change from Baseline in Overall Assessment of 
Erythema score at weeks 2, 4, and 8 
• Change from Baseline in Overall Assessment of 
Scaling score at weeks 2, 4, and 8 
• Achievement of an Overall Assessment of Erythema 
(0-3 scale) score of 0 or 1 PLUS a 2-grade 
improvement from Baseline at weeks 2, 4, and 8 
• Achievement of an Overall Assessment of Scaling 
(0-3 scale) score of 0 or 1 PLUS a 2-grade 
improvement from Baseline at weeks 2, 4, and 8 
• Change in WI-NRS pruritus score at weeks 2, 4, and 
8, as compared to Baseline 
• 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 weeks 2, 4, 
and 8. 
Exploratory Endpoints will include: 
• Change in Scalpdex total score from Baseline at 
weeks 2, 4, and 8 
• Achievement of an Overall Assessment of Erythema 
(0-3 scale) score of 0 or 1 at weeks 2, 4, and 8 
• Achievement of an Overall Assessment of Scaling 
(0-3 scale) score of 0 or 1 at weeks 2, 4, and 8 
• Achievement of an Overall Assessment of Erythema 
(0-3 scale) score of 0 at weeks 2, 4, and 8 
• Achievement of an Overall Assessment of Scaling 
(0-3 scale) score of 0 at weeks 2, 4, and 8 
• 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 weeks 2, 4, 
and 8 
• Change from Baseline in DLQI at weeks 2, 4, and 8 
• Change from Baseline in BSA affected at week 8 
• A 2-grade improvement in IGA from Baseline 


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Statistical Considerations: 
There are approximately 184 subjects planned for this 
study; randomized 2:1 to ARQ-154 foam 0.3% : vehicle 
QD, stratified by study site and baseline disease severity.   
A sample size of 184 subjects will provide approximately 
90% power to detect an active response of at least 55.8%, 
assuming 159 (86%) subjects complete the study and a 
vehicle response of 30%, based on two-group X2 test of 
equal proportions (without continuity correction, using a 2-
sided alpha of 0.10). 
One interim futility analysis is planned when the first 60 
subjects randomized have had the opportunity to complete 
the 8 week disease assessment.  This futility analysis will 
be non binding and will be used for decision making on 
further expansion of the clinical development program in 
seborrheic dermatitis.  Accrual to this study will not be held 
during the conduct and interpretation of this futility 
analysis.   
Descriptive statistics will be presented for endpoint 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 stratification factors study site and baseline disease 
severity.  The analysis will be performed on the Intention-
to-Treat (ITT) population and missing data will be imputed 
using multiple imputation.  
Continuous secondary endpoints will be analyzed using 
Analysis of Covariance with treatment and stratification 
factor 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. 
All subjects who are randomized and receive at least one 
confirmed dose of IP will be included in the safety 
population.  
Adverse events (AEs) will be summarized by preferred 


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term, system organ class, and treatment group for all 
treatment-emergent AEs, serious AEs, related AEs, AEs 
leading to withdrawal from investigational product. 
Safety laboratory parameters and vital signs will be 
summarized at each visit using descriptive statistics or 
frequencies and percentages, as appropriate. Changes from 
baseline in laboratory values and vital signs will also be 
summarized by visit. In addition, changes from baseline in 
weight and laboratory values will be summarized using 
shift tables. 
 
 
 


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1.2 
Study Schema 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Screening (Visit 1) 
Baseline (Visit 2) 
Randomization and Treatment Day 0 
ARQ-154 
0.3% 
Vehicle Foam 
 8-Week Treatment Period (Visits 3, 4, & 5) 
Follow Up Period / Visit 6 
A Phase 2a, 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 
 
Approximately 184 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 
 
Wk 2  
Day 14 
 
Wk 4 
Day 28 
 
Wk 8 
Day 56 
 
Wk 9 
Day 63 
Visit 
1 
2 
3 
4 
5 
6 
Visit Window 
-4 weeks 
 
+/- 3 day 
+/- 5 days 
+/- 5 days 
+/-5 days 
Informed consent/assent 
X 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
Physical examinationa 
X 
X 
 
 
X 
 
I/E criteria 
X 
X 
 
 
 
 
Randomization 
 
X 
 
 
 
 
Hematology, Serum 
Chemistries, and Urine 
Analysis  
X 
X 
 
 
X 
 
Vital signs, height, weightb 
X 
X 
X 
X 
X 
X 
IGAc, Overall Assessment of 
Erythemac, Overall Assessment 
of Scalingc 
X 
X 
X 
X 
X 
X 
WI-NRS, DLQI, Scalpdex 
X 
X 
X 
X 
X 
BSA 
X 
X 
 
 
X 
 
Application Site Reaction 
Assessment/Local Tolerabilityd  
 
X 
 
X 
X 
 
Pigmentation Assessmente 
X 
X 
X 
X 
X 
X 
C-SSRS, PHQ-8 
X 
X 
X 
X 
 
Medical Photographyf 
 
X 
X 
X 
X 
 
Pregnancy testg 
X 
X 
 
X 
X 
 
PK drawsh 
 
X 
X 
X 
 
IP/vehicle application at the 
study sitei 
 
X 
X 
 
 
 
Dispense study medication kitj 
 
X 
X 
X 
 
Dispense/review diary 
 
X 
X 
X 
X 
 
Weigh study medication kitk 
 
X 
X 
X 
X 
 
Compliance calculationl 
 
X 
X 
X 
X 
 
Adverse event assessment 
X 
X 
X 
X 
X 
X 
Concomitant medications 
X 
X 
X 
X 
X 
X 
Footnotes: 
a Limited physical examination: skin, lungs, and heart only 
b  Height will be collected at Baseline and Week 8. Weight will be collected at all study visits. Subject to void prior to weight 
being taken. Remove any jackets, outerwear and shoes. Remove any objects of significant weight (i.e. cell phones, wallet, key 
chains). A 5% weight loss from Baseline should be reported to the medical monitor. 
c   IGA will be a 5-point scale ranging from clear (0) to severe (4). IGA should be completed prior to other physician 
assessments.  Overall assessment of erythema (0-3 scale) and overall assessment of scaling (0-3 scale) will be completed. 
d  Local tolerability Assessments: The Investigator local tolerability assessment of skin irritation (Berger and Bowman skin 
irritation score) should be performed prior to the investigational product application at Baseline, and at Weeks 4 and 8. 
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. Subjects will perform the local tolerability assessment 10-15 
minutes post-drug application at Baseline, and recall assessments at Weeks 4 and 8 for the subject’s ‘0-3’ burning/stinging 
assessment. 


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e An assessment for hypopigmentation and hyperpigmentation will be performed by the Investigator at all clinic visits. 
f At selected sites, medical photography will be obtained for target lesions.  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. 
g A pregnancy test will be administered to all females of child-bearing potential. A serum pregnancy test will be performed at 
the Screening visit only. A urine pregnancy test will be performed at Baseline, Week 4, and Week 8. A negative result is 
required for continued participation in the study, and results must be available prior to dispensing of investigational product at 
each visit. 
h PK draws (trough / pre-dose) will be collected at Days 0, 28 and 56.  At baseline, this draw will be pre-dose relative to drug 
application in the clinic. Ensure study medication is not applied in the area where PK will be drawn. 
i   Subjects to apply assigned IP at the study site at every designated visit, to confirm understanding of instruction on how to 
apply initially.  
j Kits will be dispensed based on %BSA affected. See IP Handling Manual for details.   
k     The entire kit should be weighed and recorded at every visit. See IP Handling Manual for details. 
l Compliance calculation is described in the IP Handling Manual 
 
 
 
 


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2 
 
ABBREVIATIONS 
AE 
Adverse Event 
AMP 
Adenosine Monophosphate 
AUC 
Area Under the Curve 
BSA 
Body Surface Area 
Cmax 
Maximum Concentration 
COPD 
Chronic Obstructive Pulmonary Disease 
CRF 
Case Report Form 
C-SSRS 
Columbia-Suicide Severity Rating Scale 
CTCAE 
Common Terminology Criteria for Adverse Events 
DLQI 
Dermatology Life Quality Index 
DNA 
Deoxyribonucleic Acid 
ERB 
Ethics Review Board 
FDA 
U.S. Food and Drug Administration 
FOCBP 
Female of Child Bearing Potential 
GCP 
Good Clinical Practices 
HC 
Health Canada 
HCA 
Alpha-Hydroxycinnamaldehyde 
HPRT 
Hypoxanthine-guanine Phosphoribosyl Transferase 
IB 
Investigational Brochure 
IC50 
Half Maximal Inhibitory Concentration 
ICF 
Informed Consent Form 
ICH  
International Conference on Harmonisation 
IGA 
Investigator Global Assessment 
I-IGA 
Intertriginous IGA  
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
ITT 
Intent to Treat 
IWRS 
Interactive Web Response System  
LED 
Light Emitting Device 
µg 
Microgram 
MedDRA 
Medical Dictionary for Regulatory Activities 
mITT 
Modified Intent to Treat 
mL 
Milliliter 
MMRM 
Mixed effect Model Repeat Measurement  
MTD 
Maximum Tolerated Dose 
NCI 
National Cancer Institute 
NIH 
National Institutes of Health 
NOAEL 
No Observed Adverse Effect Level 


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Ng 
Nanogram 
NRS 
Numerical Rating Score  
PASI 
Psoriasis Area and Severity Index 
PDE-4 
Phosphodiesterase 4 
PHQ-8 
Patient Health Questionnaire depression scale 
PI 
Principal Investigator  
PK 
Pharmacokinetics 
PP 
Per Protocol  
QD 
Once Daily ("quaque die") 
SAE 
Serious Adverse Event 
TEAE 
Treatment Emergent Adverse Event 
Th1 
Type 1 T Helper Cell 
Th17 
Type 17 T Helper Cell 
Tmax 
Time to reach maximum concentration 
V79 
Chinese hamster cell line 
WI-NRS 
Worst Itch – Numeric Rating Scale 
 
 
 


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3 
BACKGROUND AND RATIONALE 
3.1 
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. 
 
The Sponsor is developing topical roflumilast in several formulations (ARQ-151 cream and 
ARQ-154 foam) and indications.  To date, ARQ-151 cream has been evaluated in studies in 
psoriasis and atopic dermatitis.  Additionally, two PDE-4 inhibitors have been marketed for 
dermatologic indications in the US and elsewhere, including OTEZLA® as an oral therapy for 
moderate to severe plaque psoriasis in adults and EUCRISA® as a topical therapy for mild to 
moderate atopic dermatitis in individuals 2 years of age and older.  The present study will be the 
first study of ARQ-154 foam. 
 
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.  It may be associated with certain medications and conditions 
such as Parkinson’s disease and other neurologic conditions, Down syndrome, and HIV 
infection.  Seborrheic dermatitis is generally a clinical diagnosis.  The exact cause of seborrheic 
dermatitis remains unknown.  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 
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 




















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interval between the Screening and Baseline visits may be up to 4 weeks, the anticipated 
maximum duration of subject participation is ~13 weeks. 
4.3.1 Randomization 
Subjects will be randomly assigned to apply ARQ-154 foam 0.3% QD or vehicle foam QD to 
lesions of seborrheic dermatitis up to a maximum application area of 20% BSA.   
 
Assignment of active drug or vehicle will be made at a 2:1 ratio according to a computer-
generated randomization list.  Randomization will be stratified by study site and baseline disease 
severity (IGA = 3 or IGA = 4). 
 
Randomization will take place at Baseline after the subject has been found to be fully eligible for 
participation.  Kits containing investigational product (IP) will be assigned to each subject using 
an internet-based randomization system (IWRS). A subject may receive more than one kit for the 
treatment period.  
 
The kits and foam cans are blinded and each kit is numbered with a unique kit number.  
4.3.2 Numbering of Subjects 
All screened subjects will be identified by a unique five-digit subject ID number.  The first two 
digits correspond to the site number (assigned by the Sponsor), the next three digits correspond 
to the sequential order in which the subject is screened for the study (e.g., Subject ID 10001: 
Site 10, first subject screened 001 for that site). Site number 10 will be the first site in the study. 
 
The clinical site is responsible for maintaining a current log of subject ID number assignments 
and the kit number assigned to that subject.  The subject ID number 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.).  
4.4 
Selection of Study Population 
4.4.1 Inclusion Criteria 
Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the 
study: 
1. Participants legally competent to sign and give informed consent.  
2. Males and females ages 18 years and older (inclusive) at the time of consent. 
3. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the 
Investigator.  Stable disease for the past 4 weeks.  
4. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to 
≤20% BSA involvement. 
5. An Investigator Global Assessment (IGA) of disease severity of at least Moderate (‘3’) at 
Baseline.   


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6. Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least 
Moderate (‘2’) at Baseline. 
7. 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 highly effective contraception 
throughout the trial.  Highly effective forms of contraception include: 
oral/implant/injectable/transdermal contraceptives, intrauterine device, and partner’s 
vasectomy.  If barrier methods are used (e.g., condom with spermicide, diaphragm with 
spermicide), then 2 forms of conception are required. The use of abstinence as a 
contraceptive measure is acceptable as long as this is a consistent part of a lifestyle choice 
and a backup method has been identified if the subject becomes sexually active. 
8. Females of non-childbearing potential must either be post-menopausal with spontaneous 
amenorrhea for at least 12 months or have undergone surgical sterilization (permanent 
sterilization methods include hysterectomy, bilateral oophorectomy, hysteroscopic 
sterilization, bilateral tubal ligation or bilateral salpingectomy). 
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. 
4.4.2 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 of treated area(s) to either natural or artificial sunlight, tanning 
bed or other LED. 
3. Subjects who cannot discontinue the use of strong 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 and during 
the study. 
4. Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, 
nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and 
carbamazepine for two weeks prior to the Baseline (Visit 2) and during the study. 
5. Subjects with PHQ-8 >10 at Screening or Baseline visits. 
6. Previous treatment with ARQ-151 cream. 
7. Subjects who have received oral roflumilast (Daliresp®, Daxas®) or other PDE-4 inhibitors 
(apremilast) within the past 4 weeks. 




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5. Weight loss of >5% from baseline if not dieting and after consultation with the Sponsor, at 
the Investigator’s discretion. 
6. C-SSRS indicative of suicidal ideation or a PHQ-8 score ≥15, after consultation with a 
mental health professional, the Sponsor, and at the Investigator’s discretion. 
7. Requirement for use of prohibited concomitant medication (see Table 1) after consultation 
with the Sponsor and Medical Monitor. 
8. Subject’s repeated failure to comply with protocol requirements or study related procedures. 
9. The subject interrupts trial investigational product application for more than 50% of 
scheduled doses. 
4.4.4 Removal of Subjects from the Study 
 
A subject may be removed from study participation for any of the following reasons: 
 
1. Subject’s decision to withdraw from the study. 
2. Subject is lost to follow up. 
3. Termination of the study by the Sponsor, FDA, or other regulatory authorities. 
 
 


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4.5 
Study Restrictions 
4.5.1 Prohibitions and Concomitant Therapy 
Prohibited medications and products are detailed in Table 1.   
Table 1: Excluded Medications and Treatments 
Excluded Medications and Treatments 
Wash out period prior to Baseline (Day 0) 
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 
4 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) 
Note:  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. 
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 randomized 
investigational product to untreated areas only. 
 


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Generally, the addition of new medications, including nonprescription medications, during the 
course of 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 ‘Exclusions’ (Table 1).  
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.   
4.6 
Treatment 
4.6.1 IP Supplies, Packaging and Labeling 
ARQ-154 foam 0.3% or vehicle foam will be provided in a dispense can containing 
approximately 60 grams of foam.  The cans will be packaged in kits, each containing two cans. 
The number of kits dispensed to a subject will be based on the BSA involvement.  It is 
anticipated that the maximum number of kits dispensed to a subject will be two. The kits and 
cans will be labeled in a blinded manner.  The kit(s) dispensed to a subject will be labeled with a 
unique number. 
 
The Sponsor will supply sufficient quantities of the investigational product (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. 
4.6.2 Blinding 
This is a double-blind study, therefore neither the subjects nor the Investigator, clinical 
personnel, or Sponsor will be aware of which treatment an individual has received. 


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4.6.3 Treatment Administration 
At the randomization visit (Baseline visit), the study staff will demonstrate to the subject how to 
apply ARQ-154 foam or vehicle foam using the first container 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.  
 
IP will be applied QD in the evening (except at Baseline and Week 2, in which case IP will be 
applied at the study site) to areas of lesions of seborrheic dermatitis.  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 in.  Subjects should 
not use other hair products for at least an hour before or after application.  Subjects should 
maintain treatment of areas with the IP for the duration of the study regardless of whether 
treatable areas of seborrheic dermatitis clear. 
 
For Non-scalp Lesions: IP should be applied QD to affected areas and rubbed in until 
disappeared.  Subjects should maintain treatment of areas with IP for the duration of the study 
regardless of whether treatable areas of seborrheic dermatitis clear. 
 
Re-training will be conducted at subsequent visits as needed (i.e., if the returned pump(s) weighs 
substantially different than the expected weight). 
Subjects should not wash areas (or otherwise expose to water, eg, 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 a Body Diagram even if that area has cleared during the treatment period. New 
plaques that develop during the study should be treated as well. 
 
Each IP can will be weighed prior to dispensing at the baseline visit or subsequent visits. IP cans 
must be returned by subjects at each study visit, both empty and full, and will be weighed. If the 
subject’s actual use is substantially different than the expected use for the subject’s BSA (see IP 
Handling Manual), the subject will be retrained on the IP application technique. 
4.6.4 Treatment Compliance  
Weight of the IP applied will be measured for reporting purposes. IP cans will be weighed at 
each follow-up clinic visit. The weight of the IP can will be collected prior to the IP application 


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and after the IP application at Baseline and Week 2. Weight of the IP applied and the IP cans will 
be recorded in the source notes and in the eCRF. 
Subjects will complete a daily diary recording the date and time of each dose applied, any missed 
doses, and a comment section should the subjects have a comment, e.g., record potential Adverse 
Events (AEs). Site personnel will review the diaries at each clinic visit and use the information to 
question the subject regarding compliance and AEs and then record appropriate information in 
source documents and complete Case Report Forms (CRFs).  If a subject misses a 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 IP application period and does not miss more than 3 
consecutive doses.  
Compliance will be assessed by review of the dosing diary. If the diary shows less than 80% of 
expected use, the subject is using too little IP and retraining must be conducted and documented.  
Compliance will be documented in source and in eCRF. 
5 
STUDY PROCEDURES 
5.1 
Safety Assessments 
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. 
This study assesses the safety and efficacy of ARQ-154 foam. Safety will be determined by 
evaluating physical examinations, local tolerability assessments, vital signs/weight, clinical 
laboratory parameters, PHQ-8, 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 
Within 4 weeks prior to the first dosing (Baseline visit), subjects will be provided details of study 
requirements and sign an informed consent.  Medical history and demographic data including 
sex, age, race, ethnicity, body weight (kg), and height (cm) will be recorded.  Each subject will 
undergo seborrheic dermatitis assessments, a physical examination, vital sign measurements 
(blood pressure, heart rate, and temperature), PHQ-8, C-SSRS, and laboratory tests: hematology, 
chemistry, urinalysis and serum (Screening) and urine (Baseline) pregnancy tests for female 
subjects of child bearing potential. 
All screened subjects will receive a screening number according to Section 4.3.2 and be entered 
into the IWRS and eCRF. Subjects that fail to meet the eligibility criteria will be designated as a 
screen failure and entered into the IWRS and eCRF as such. 


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Subjects may be re-screened one time, the original assigned Subject ID screening number will be 
used for re-screening. 
5.1.2 Baseline 
Randomization will take place at the Baseline visit after the subject has been found to be fully 
eligible for participation. The subject is considered enrolled into the study once randomization 
occurs and the subject has been assigned to one of the treatment groups. 
 
If the Baseline visit occurs within 14 days of Screening, the Screening lab results may be 
utilized. 
5.1.3 Physical Examination 
 
Physical examinations will be performed as follows: 
 
Screening, Baseline and Week 8.   
The physical exam will be limited to skin, lungs and heart only. 
5.1.4 Vital Signs, Height and Weight 
 
Vital signs will be collected at timepoints noted below: 
 
Blood pressure, heart rate, and temperature will be measured at Screening, Baseline, Weeks 2, 4, 
8, and 9.  
 
Height will be collected at Baseline and Week 8.  
 
Weight will be collected at Screening, Baseline, Weeks 2, 4, 8, and 9. Subject to void prior to 
weight being taken and remove any jackets, outerwear and shoes. Remove any objects of 
significant weight (i.e. cell phones, wallet, key chains). A 5% weight loss from Baseline should 
be reported to the medical monitor. Blood pressure will be collected while the subject is 
sitting/resting for at least 5 minutes. 
5.1.5 Laboratory Tests 
All tests listed in Table 2 below will be performed according to the Schedule of Visits and 
Assessments (Section 1.3), unless otherwise noted. The collection of specimens will be in a non-
fasting state. In addition, laboratory safety tests may be performed at various 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, ship, and 
report receipt instructions. 


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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 child bearing potential only) 
• 
Serum pregnancy test (hCG)*** 
* 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. 
** Baseline, Weeks 4, and 8, for FOCBP only  
*** At Screening, for FOCBP only 
5.1.6 Patient Health Questionnaire depression scale (PHQ-8)  
The 8 item PHQ-8 Assessment (see Appendix 1) will be completed by the subject at the 
following visits: 
 
Screening, Baseline, Week 4, and Week 8 
 
A subject with a PHQ-8 score of ‘15’ or above should be referred promptly to a mental health 
care professional and, if currently applying investigational product, consideration should be 
given to discontinuation from investigational product.   
 
Subjects with PHQ-8 >10 at Screening or Baseline will be excluded from the study. 
 
PHQ-8 score is the sum of the responses for the 8 questions. 
 


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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) 
5.1.7 Columbia-Suicide Severity Rating Scale (C-SSRS)  
C-SSRS Assessments will be performed as follows: 
 
Screening, Baseline, Week 4, and Week 8. 
 
The administration schedule of the C-SSRS will be: 
 
• 
The Baseline-Screening version (Appendix 2) will be used at Screening to provide a pre-
treatment assessment baseline.  
o If a subject has a score greater than 0 in suicidal ideation, this is important and 
may indicate the need for mental health intervention. The Investigator should give 
consideration to not enrolling the subject in the study.  
• 
On all subsequent visits, the Since Last Visit version (Appendix 3) will be used. 
o Any score greater than 0 in the suicidal ideation score is important and may 
indicate the need for mental health intervention and consideration be given to 
discontinuation from IP. This should result in prompt referral to a mental health 
professional and/or possibly the emergency room. The Medical Monitor should be 
contacted.  
 
The trained administrator will conduct the C-SSRS.  The C-SSRS administrator will be trained 
via the C-SSRS training video. A training certificate for the administer(s) will be on file in the 
trial master file at the site. 
 
An 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. 
5.1.8 Local Tolerability Assessments  
The Investigator Local Tolerability Assessment will be an overall assessment of local tolerability 
and performed as follows: 
Baseline, Weeks 4 and 8  
Application site reactions will be graded at the timepoints outlined in the Schedule of Visits and 
Assessments (Section 1.3).  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.   


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The Investigator assessments will be conducted by the Investigator prior to any investigational 
product application in the study site.  
 
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 edema 
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 an overall assessment of local tolerability and 
performed as follows: 
Baseline, Weeks 4 and 8 
This assessment will be administered at Baseline by the site 10 to 15 minutes after IP application 
at the study site. Assessments at the study site during Weeks 4 and 8 will be a recall assessment 
of the subject’s experience 10-15 minutes after IP application since the last study visit.  
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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5.1.9 Pigmentation Assessment 
The Investigator will assess for pigmentation in areas affected previously and/or currently by 
seborrheic dermatitis at the following visits: 
Screening, Baseline, Weeks 2, 4, 8 and 9. 
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. 
5.1.10 Adverse Events  
Adverse events (AEs) will be collected beginning at informed consent and assessed at the 
following visits and throughout the study: 
Screening, Baseline, Weeks 2, 4 and 8, and 9 
AE collection will end upon completion of study participation for subjects who complete or early 
terminate from the study without any new or ongoing AEs. Subjects with new or ongoing related 
AEs upon study completion or early termination will be followed for up to one month after the 
end of treatment until the symptoms or clinically significant abnormal laboratory test value(s) 
return to normal or acceptable levels, as judged by the Investigator. 
Treatment emergent AEs will be followed in the clinic for up to one month at the Investigator’s 
discretion until resolved or otherwise judged as clinically stable. 
For further details on Adverse Events, see Section 5.7. 
5.2 
Efficacy Evaluations  
5.2.1 Investigator Global Assessment (IGA) 
Investigator’s Global Assessments (‘whole body’ and ‘intertriginous area’) will be performed at 
the study visits listed below. The IGA should be completed prior to any other physician 
assessments. 
 
Screening, Baseline, Weeks 2, 4, 8, and 9 
 
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.  
 


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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. 
 
Investigator Global Assessment of Disease (IGA) 
 
Score 
Description 
0 
Completely clear: No erythema, no scaling (hypo-hyperpigmentation can be 
present) 
1 
Almost clear: Residual slight erythema and/or trace amounts of scaling 
2 
Mild: Pink to red color and/or slight scaling 
3 
Moderate: Distinct 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 at the following study visits: 
 
Screening, Baseline, Weeks 2, 4, 8, and 9 
 
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 
 


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5.2.3 Overall Assessment of Scaling 
Overall Assessment of Scaling will be performed at the following study visits: 
 
Screening, Baseline, Weeks 2, 4, 8, and 9 
 
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. 
 
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 Body Surface Area (BSA) 
BSA Assessments will be performed as follows: 
Screening, Baseline, and Week 8 
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 (BSA).   
5.2.5 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 Assessments will be performed as follows: 
Screening, Baseline, Weeks 2, 4, and 8 
 


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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”). Subjects will 
complete the WI-NRS pruritus assessment. 
 
 
 
5.2.6 Scalpdex  
The Scalpdex will be completed as follows: 
 
Screening, Baseline, Weeks 2, 4, and 8 
 
Subjects will complete the Scalpdex. See Appendix 5 for the Scalpdex. 
5.2.7 Dermatology Life Quality Index (DLQI) 
The DLQI will be completed as follows: 
 
Screening, Baseline, Weeks 2, 4, and 8 
 
Subjects will complete the DLQI. See Appendix 4 for the DLQI. 
5.2.8 Dermal Imaging 
Medical photography will be performed at selected sites at Baseline, Weeks 2, 4, and 8 using 
Canfield photography equipment. 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. 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. 
5.3 
Pharmacokinetics Assessment 
Plasma PK assessments will be performed as follows for all subjects at all sites: 
 
Baseline, Weeks 4 and 8 
PK draws will be collected while the subject is having serum chemistries drawn. At Baseline, the 
draws will be pre-dose drug application in the clinic. Ensure the IP is not applied in the area 
where PK will be drawn. 


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5.4 
Final Study Visit 
The approximate final study visit will occur at Week 9. The procedures performed during these 
visits 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 followed to resolution as outlined in Section 5.1.10. 
5.5 
Early Termination Visit 
If a subject is withdrawn or wishes to exit the study, a termination visit will be scheduled. This 
visit should include the procedures and assessments that would be performed at the Week 9 visit 
(Day 63). 
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 judgment of the Investigator.  
5.7 
Adverse Events 
5.7.1 Adverse Event Definition 
An AE means 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 a medicinal (investigational) product, whether or not related to the medicinal 
(investigational) product.  
AEs will be collected following informed consent of the subject through subject study 
completion.  
A treatment emergent adverse event (TEAE) is defined as an AE that started post application of 
IP at the Baseline visit through study completion.  
Application site reactions will be considered adverse events if they require intervention, 
suspension or discontinuation of IP.  
5.7.2 Serious Adverse Event 
The definitions and reporting requirements of Health Canada/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. If any AEs are serious, as defined by ICH 
Guidelines for Clinical Safety, required procedures will be followed.  
All SAEs will be reported to the Sponsor via fax or e-mail within 24 hours of becoming aware of 
the event, whether or not the SAEs are deemed drug-related. Refer to the Safety Reporting 
Instructions for details on how to submit the SAE Report. All serious event reporting will adhere 
to ICH E6: Guideline for Good Clinical Practice and ICH E2A: Clinical Safety Data 


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Management: Definitions and Standards for Expedited Reporting.:  The ERB/IRB will be 
notified of the Alert Reports as per HC, FDA, ICH and the IRB/ERB’s policies and procedures. 
An SAE is any AE that in the view of either the PI or Sponsor, results in any of the following 
outcomes:  Death, a life-threatening AE, inpatient hospitalization or prolongation of existing 
hospitalization, a persistent or significant incapacity or substantial disruption of the ability to 
conduct normal life functions, or a congenital anomaly/birth defect.  Important medical events 
that may not result in death, be life-threatening, or require hospitalization may be considered 
serious when, based upon appropriate medical judgment, they may jeopardize the subject and 
may require medical or surgical intervention to prevent one of the outcomes listed in the above 
definition. Examples of such medical events include allergic bronchospasm requiring intensive 
treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in 
inpatient hospitalization, or the development of drug dependency or drug abuse.  
 
Life-threatening is defined as an AE that in the view of the PI or Sponsor, places the subject at 
immediate risk of death. It does not include an AE that, had it occurred in a more severe form, 
might have caused death. 
Hospitalization does not include the following: 
• Rehabilitation facilities, hospice facilities or respite care (e.g. caregiver relief) 
• Nursing homes or skilled nursing facilities 
• Emergency room 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 elsewhere in the current IND/CTA. 


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If a SAE occurs to a subject on this study, contact the Medical Monitor within one business day 
of knowledge of event.  
5.7.3 Suspected Unexpected Serious Adverse Reaction (SUSAR) 
 
This 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 
At each follow-up 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.   
 
AEs (whether serious or non-serious) and clinically significant abnormal laboratory test value(s) 
will be evaluated by the Investigator and treated and/or followed up for up to one month after 
end of treatment until the symptoms or value(s) return to normal, 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). Outcome may be classified as resolved, improved, unchanged, worse, fatal 
or unknown (lost to follow-up). 
5.7.5 Adverse Event Reporting 
The Investigator will review each event and assess its relationship to drug treatment (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 (resolved, improved, 
unchanged, worse, fatal, or unknown/lost to follow-up) of each event will be noted. 
 


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The relationship of each AE to the IP will be assessed using the following definitions: 
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. 


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AEs will be coded using the most current MedDRA® version available at the start of the study 
(e.g., 21.0 or higher). 
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 the conclusion of the pregnancy.   
The Investigator is responsible for reporting all available pregnancy information on the 
pregnancy report and submitting to the Medical Monitor 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. Any pregnancy complication must be reported as a SAE. 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. Any infant death 
that occurs after the 30 day reporting period that the Investigator suspects is related to the 
Investigational Product must also be reported as a SAE.    
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 IP, 
the Investigator should immediately contact the Medical Monitor to discuss if the subject should 
be discontinued from the investigational product.   
 
Treatment for any individual subject will be discontinued if the subject:  
• 
Experiences a serious adverse event (SAE) or a clinically significant non-serious AE 
which in the opinion of the Principal Investigator or Medical Monitor warrants 
discontinuation from the IP for that subject’s well-being. 
• 
A severe (Grade 3) laboratory abnormality (confirmed by repeat sample and considered 
related to IP).  
o See Appendix 6 for details. 
Dosing of IP for an individual subject may be suspended for safety concerns other than those 
described above, at the discretion of the Investigator if he/she feels the subject’s safety may be 
threatened. 
A subject with a PHQ-8 score of ‘15’ or above should be referred promptly to a mental health 
care professional and consideration be given to discontinuation from IP.   
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. 


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As noted above, study treatment must be discontinued immediately in the event of a female 
subject’s pregnancy.   
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.   
 
Treatment should be discontinued: 
• 
If the reaction reoccurs, treatment should be discontinued permanently, and the subject 
followed until the reaction resolves.  Given the excellent local toleration in the Phase 1/2a 
study, such reactions are possible, but unlikely. 
5.9.1 Emergency Unblinding 
Treatment assignment should remain blinded unless the knowledge is necessary to determine 
emergency medical care, as determined by the Investigator. Emergency unblinding will be done 
using the study IWRS system in consultation with the Medical Monitor and the Sponsor’s CMO. 
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 IP 
discontinued. 
6 
DATA ANALYSIS 
Data will be handled and processed according to the Contract Research Organization’s 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 
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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. 
P-values of less than 0.10 will be considered statistically significant based on a two-sided test 
unless otherwise specified.  No adjustments for multiplicity are planned. 
6.1.1 Determination of Sample Size 
A sample size of approximately 184 subjects are 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 121 subjects will receive ARQ-154 foam 0.3% QD; approximately 63 subjects 
will receive vehicle foam QD.   
A sample size of 184 subjects will provide approximately 90% power to detect an active 
response of at least 58.5%, assuming 159 subjects complete the study and a vehicle response of 
30%, based on two-group X2 test of equal proportions (without continuity correction), using a 2-
sided alpha of 0.10. 
6.1.2 Subjects to Analyze 
Safety population will include all subjects who are enrolled and received at least one confirmed 
dose of IP. This population will be used for all safety analyses.    
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. 
Per-Protocol (PP) Population will include all subjects who are in the safety population, were at 
least 80% compliant with IP application, and showed no other serious deviations from the study 
protocol. This population will be used as a sensitivity analysis of primary and secondary efficacy 
endpoints. 
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. 
6.1.3 Interim Analysis 
One interim futility analysis is planned when the first 60 subjects randomized have had the 
opportunity to complete the 8 week disease assessment.  This futility analysis will be non 
binding and will be used for decision making on further expansion and timing of the clinical 
development program in seborrheic dermatitis.  Accrual to this study will not be held during the 
conduct and interpretation of this futility analysis.  To maintain the integrity of the remaining 


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data to be collected, only sponsor staff responsible for planning further development in the 
seborrheic dermatitis program will be provided with results.  This futility analysis will use a 
stopping rule defined by the rho family with parameter = 0.1.   
 
6.1.4 Background and Demographic Characteristics 
Demographic and baseline disease characteristics and vital sign information will be summarized 
descriptively for all randomized subjects.  
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 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 by the expected number 
(amount) of IP for each subject.  Compliance will be summarized descriptively by treatment 
group.  Amount of IP (weight) used will also be summarized. 
6.2 
Study Objective 
6.2.1 Primary Objective 
To assess the safety and efficacy of ARQ-154 foam 0.3% administered QD vs vehicle x 8 weeks 
in adults with seborrheic dermatitis. 
6.3 
Efficacy Evaluation 
6.3.1 Primary Efficacy Endpoint 
The primary efficacy variable 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-grade 
improvement from Baseline at Week 8. 
 


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The primary endpoint will be analyzed using a Cochran-Mantel-Haenszel test stratified by the 
stratification factors study site and baseline disease severity. Statistical significance will be 
concluded at the 5% significance level (2-sided). 
 
Missing IGA scores will be imputed using multiple imputation. 
6.3.2 Secondary Endpoints 
The Secondary Efficacy Endpoints will include: 
• Achievement of an IGA score of ‘clear’ or ‘almost clear’ PLUS a 2-grade improvement 
from Baseline at weeks 2 and 4 
• Change from Baseline in Overall Assessment of Erythema score at weeks 2, 4, and 8 
• Change from Baseline in Overall Assessment of Scaling score at weeks 2, 4, and 8 
• Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 or 1 PLUS a 
2-grade improvement from Baseline at weeks 2, 4, and 8 
• Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 or 1 PLUS a 2-
grade improvement from Baseline at weeks 2, 4, and 8 
• Change in WI-NRS pruritus score at weeks 2, 4, and 8, as compared to Baseline 
• 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 weeks 2, 4, and 8 
The binary endpoints will be analyzed using a Cochran-Mantel-Haenszel test stratified by study 
site and baseline disease severity similar to the primary endpoint.  
The continuous endpoints will be analyzed using an analysis of covariance with treatment, study 
site, baseline disease severity, and baseline value as independent variables. Statistical 
comparison between the active treatment arm and vehicle arm will be facilitated by using 
contrasts.  
The endpoints measuring change from baseline in overall assessment of erythema and scaling 
will be statistically tested using CMH row-mean scores test.   
6.3.3 Exploratory Endpoints 
Exploratory Endpoints will include: 
• Change in Scalpdex total score from Baseline at Weeks 2, 4, and 8 
• Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 or 1 at weeks 
2, 4, and 8 
• Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 or 1 at weeks 2, 
4, and 8 
• Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 at weeks 2, 4, 
and 8 


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• Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 at weeks 2, 4, 
and 8 
• 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 weeks 2, 4, and 8 
• Change from Baseline in DLQI at weeks 2, 4, and 8 
• Change from Baseline in BSA affected at week 8  
• A 2-grade improvement in IGA from Baseline 
6.4 
Safety Evaluation 
Descriptive statistics will be calculated for safety data and presented by visit and treatment group 
for quantitative safety data and frequency counts will be compiled for classification of qualitative 
safety data. Summaries of local tolerability and pigmentation will be presented by visit and 
treatment group. 
6.4.1 Adverse Events 
All treatment-emergent AEs occurring during the study will be recorded and classified on the 
basis of MedDRA terminology for the safety population. Treatment-emergent AEs are those AEs 
with an onset on or after the date of study treatment. All treatment-emergent AEs will be 
summarized by treatment group, the number of subjects reporting treatment-emergent AEs, 
system organ class, preferred term, severity, relationship, and seriousness. 
Serious adverse events (SAEs) will be listed by subject. SAEs will be summarized by treatment 
group, severity, and relationship to study treatment.  
For AEs, each subject will be counted only once within a system organ class or a preferred term 
using the event with the greatest relationship and greatest severity. 
All information pertaining to AEs noted during the study will be listed by subject, detailing the 
verbatim description given by the Investigator, preferred term, system organ class, start date, 
stop date, severity, action taken regarding IP, corrective treatment, outcome, and drug 
relatedness. The event onset will also be shown relative (in number of days) to date of first 
application. In addition, a listing of subjects who prematurely discontinue from the IP due to 
adverse events will also be provided. 
6.4.2 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.   
6.4.3 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 


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events and included in AE tabulations. 
6.4.4 PHQ-8 
Data for PHQ-8 will be analyzed by a shift in state of severity using the following scoring 
system: 
• 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) 
6.4.5 C-SSRS 
The C-SSRS will be analyzed per the Columbia–Suicide Severity Rating Scale Scoring and Data 
Analysis Guide. 
6.4.6 Clinical Laboratory Results and Vital Signs/Weight Measurements 
All clinical laboratory results and vital signs measurements and their change from baseline 
(pre-dose), will be summarized by treatment group along with time point of collection. 
A shift table summarizing out-of-normal range shifts from baseline by treatment group will be 
provided for clinical laboratory results.  
Shift tables (from baseline) by treatment group will summarize the number of subjects who gain 
or lose >5% body weight over the course of the study, as well as subjects who gain or lose >10% 
body weight over the course of the study. 
6.4.7 Prior and Concomitant Medications 
Prior and concomitant medication information for all randomized subjects will be presented in a 
by-subject listing.  Summary tables by treatment group will be presented by World Health 
Organization-Anatomical Therapeutic Chemical Classification System (WHO-ATC) therapeutic 
category and product. 
6.5 
Patient Reported Outcomes Analyses 
6.5.1 WI-NRS  
Change from baseline in itch severity will be analyzed by treatment group and over time using 
the WI-NRS scale.  For subjects with WI-NRS pruritus score ≥ 6 at baseline, the proportion of 
subjects with a 4-point reduction in WI-NRS pruritus score at weeks 2, 4, and 8 as compared to 
Baseline will be calculated by treatment group and analyzed using a Cochran-Mantel-Haenszel 
test stratified by study site and baseline disease severity (see secondary endpoints). 


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6.5.2 Dermatology Life Quality Index (DLQI) 
Change from baseline in DLQI total score will be analyzed at weeks 2, 4, and 8 using an analysis 
of covariance with treatment, baseline score, and the stratification factors as independent 
variables.  
6.5.3 Scalpdex 
The Scalpdex will be analyzed as change from Baseline in total score as assessed at weeks 2, 4, 
and 8 using an analysis of covariance with treatment, baseline score, and the stratification factors 
as independent variables.  
6.6 
Pharmacokinetic Analysis 
Plasma drug concentrations at pre-dose will be summarized using descriptive statistics. 
 
For all subjects, blood samples for the determination of roflumilast and its N-oxide metabolite 
will be collected at scheduled time points as delineated in the Schedule of Visits and 
Assessments (Section 1.3).   
A manual for blood sampling, collection, processing, and sample shipment will be provided in a 
separate document.  
7 
STUDY ADMINISTRATION 
7.1 
Ethics 
7.1.1 Ethics Review Board  
Before enrollment of patients 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 or 
IEC, as required by FDA (21 CFR § 56), Health Canada, and ICH GCP regulations.  A letter 
documenting the IRB or IEC 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 or IEC. However, the frequency of these reports will depend on IRB or IEC requirements. 
As soon as possible after completion or termination of the study, the Investigator will submit a 
final report to the IRB or IEC per the IRB or IEC requirements, and in compliance with FDA and 
Health Canada regulations and ICH GCP guidelines. 
The Investigator, the Sponsor, or designee shall promptly notify the IRB or IEC of any SAEs, 
SUSARs, or any other information that may affect the safe use of the IP during the study, per the 
IRB or IEC local requirements, and in compliance with FDA and Health Canada regulations and 
ICH GCP guidelines. 


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7.1.2 Ethical Conduct of the Study 
This research will be carried out in accordance with the protocol, the principles of the Tri-
Council Policy Statement (TCPS), the ethical principles set forth in the Declaration of Helsinki, 
and the ICH harmonized tripartite guideline regarding GCP (E6 Consolidated Guidance, 
April 1996). 
7.1.3 Subject Information and Consent 
The Investigator is responsible for obtaining written informed consent from each individual 
participating in this study after adequate explanation (in non-technical terms) of the purpose of 
the study, the procedures to be carried out and the potential hazards before undertaking any 
study-related procedures. The Investigator must use the most current approved consent form for 
documenting written informed consent. Subjects will be assured that they may withdraw from 
the study at any time without jeopardizing their medical care. Each informed consent will be 
read, appropriately signed and dated by the subject, the Investigator conducting the consent 
discussion, and by an impartial witness if required by local requirements.   
Subjects will be given a signed copy of their ICF. 
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 IP development 


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7.3 
Study Monitoring 
Prior to the initiation of the clinical investigation, Sponsor representatives or designees will 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 CRFs.  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. 
7.4 
Data Quality Assurance 
In order to ensure the collection of accurate, 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.   
The Clinical Study Report will be audited by the Premier Research’s Quality Assurance (QA) 
department and the QA audit certificate will be included in the study report. 
All clinical data will undergo a 100% quality control check prior to clinical database lock. Edit 
checks are then 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. 
7.4.1 Verification of Blinding 
The treatment assignments for all enrolled subjects will be unblinded only after the conclusion of 
the study. Specifically, the blind will be broken only after all data are verified, entered into the 
database, and validated; subject evaluability assessments are performed and entered into the 
database; and the database is locked. 
7.5 
Data Handling and Record Keeping 
During the clinical study, the Investigator will maintain adequate records, including medical 
records, records detailing the progress of the study for each subject, laboratory reports, signed 
informed consent forms, investigational product disposition records, correspondence with the 
ERB/IRB and Study Monitor/Sponsor, AE reports, and information regarding subject 
discontinuation and completion of the clinical investigation. 
 


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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) 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, 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), 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 
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 Inc., including but not limited 
to the IB, this protocol, CRF/eCRF, the IP, and any other study information, remain the sole and 
exclusive property of Arcutis 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 Inc. The Investigator further agrees to take all reasonable precautions to prevent the 


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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 Inc., or proprietary interests in the IP under study. This documentation must be 
provided prior to the Investigator’s participation in the study. 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, 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. 
Bethke, TD, Lahu, G.  High absolute bioavailability of the new oral phosphodiesterase-4 
inhibitor roflumilast.  Int. J Clin Pharmacol Ther.  2011; 49:51-57. 
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; 2017. 
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.  
Hatzelmann, A, Morcillo, EJ, Lungarella, G, Adnot, S, Sanjar, S, Beume, R, 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 1.0, August 2019 
Kimball AB, Naegeli AN, Edson-Heredia E, Lin C-Y, Gaich C, Nikai E, Wyrwich K, 
Yosipovitch G. 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 
Liu, D, Chow, P, Strawn, S, et al. Chronic Nasolabial Fold Seborrheic Dermatitis Successfully 
Controlled with Crisaborole. Journal of Drugs in Dermatology. 2018;17(5):577-578  
Michalski, JM, Golden, G, Ikari, J, and Rennard, S I. (2012), PDE4: A Novel Target in the 
Treatment of Chronic Obstructive Pulmonary Disease. Clinical Pharmacology & Therapeutics, 
91: 134–142 
Naegeli, AN, Flood, E, Tucker, J, Devlen, J, Edson-Heredia, E. 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. 
Wedzicha, JA, Calverley, PMA, Klaus, FR.  Roflumilast: a review of its use in the treatment of 
COPD.  International Journal of Chronic Obstructive Pulmonary Disease (2016) 11:81-90. 
 
Yosipovitch, G, et al. (2019), Peak Pruritis Numerical Rating Scale: psychometric validation and 
responder definition for assessing itch in moderate-to-severe atopic dermatitis. Br J Dermatol.  
doi:10.1111/bjd.17744     


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9 
APPENDICES 
Appendix 1: Patient Health Questionnaire depression scale (PHQ8) 
 
 
   
  
 


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Appendix 2: Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline/Screening Version 
 
 


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Appendix 3: Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit Version 
 


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Appendix 4: Dermatology Life Quality Index (DLQI) 
 
 
 
 
DERMATOLOGY LIFE QUALITY INDEX 
 
 
 
 
 
 
 
 
 
 
 
 
 
 DLQI 
Site No:  
 
 
 
 
Date: 
 
 
 
 
 
Score: 
Name:  
 
 
 
 
 
 
 
 
 
 
 
Address: 
 
 
 
 
Diagnosis: 
 
 
 
 
 
 
The aim of this questionnaire is to measure how much your skin problem has affected your life OVER 
THE LAST WEEK.  Please tick  one box for each question. 
 
 
1. 
Over the last week, how itchy, sore,  
 
 
 
Very much 
 
 
painful or stinging has your skin    
 
 
 
A lot 
 
 
 
been?   
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
2. 
Over the last week, how embarrassed 
 
 
 
Very much 
 
 
or self conscious have you been because   
 
 
A lot 
 
 
 
of your skin? 
 
  
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
3. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin interfered with you going 
 
  
 
 
A lot 
 
 
 
shopping or looking after your home or   
 
 
A little  
 
 
garden?        
 
 
 
 
 
 
Not at all 
 
Not relevant  
 
 
4. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin influenced the clothes  
 
 
 
 
A lot 
 
 
 
you wear? 
 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
Not relevant  
 
 
5. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin affected any social or  
 
 
 
 
A lot 
 
 
 
leisure activities? 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant  
 
 
6. 
Over the last week, how much has your  
 
 
 
Very much 
 
 
skin made it difficult for   
 
 
 
 
A lot 
 
 
 
you to do any sport? 
 
 
 
 
 
A little  
 
 
 
 
 
 
 
 
 
 
Not at all 
 
 
 
 
 
 
 
 
 
 
Not relevant  
 
 
7. 
Over the last week, has your skin prevented 
 
 
Yes 
 
 
 
you from working or studying?  
 
 
 
No 
 
 
 
 
 
 
 
 
 
 
 
Not relevant  
 
 
 


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


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Appendix 5: Scalpdex 
 
 
 
 















SAP_001.pdf: 
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 1 of 161
   Statistical Analysis Plan
Sponsor
Arcutis Biotherapeutics, Inc.
Protocol Title:
A Phase 2a, 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
Protocol Number:
ARQ-154-203
Premier Research PCN:
ARCU210100
Document Version:
Final 1.0
Document Date: 
08-Sep-2020
Approvals
Role
Signatures
Date (dd-Mmm-yyyy)
Biostatistician
Print Name: 
Sign Name:
Premier Senior 
Reviewer
Print Name: 
Sign Name:
Arcutis 
Biotherapeutics, 
Inc. Representative
Print Name: 
Sign Name:
		
		


	


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 2 of 161
Document History
Not applicable.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 3 of 161
Table of Contents
Approvals........................................................................................................................................ 1
Document History........................................................................................................................... 2
Table of Contents............................................................................................................................ 3
List of Tables .................................................................................................................................. 5
List of Figures................................................................................................................................. 5
1.
Overview............................................................................................................................. 6
2.
Study Objectives and Endpoints......................................................................................... 6
2.1.
Study Objectives ........................................................................................................... 6
2.1.1. Primary Objective ......................................................................................................... 6
2.2.
Study Endpoints............................................................................................................ 6
2.2.1. Safety Endpoints........................................................................................................... 6
2.2.2. Efficacy Endpoints........................................................................................................ 7
3.
Overall Study Design and Plan........................................................................................... 8
3.1.
Overall Design .............................................................................................................. 8
3.2.
Sample Size and Power................................................................................................. 8
3.3.
Study Population........................................................................................................... 8
3.4.
Treatments Administered.............................................................................................. 8
3.5.
Method of Assigning Subjects to Treatment Groups.................................................... 9
3.6.
Blinding and Unblinding............................................................................................... 9
3.7.
Schedule of Events........................................................................................................ 9
4.
Statistical Analysis and Reporting.................................................................................... 12
4.1.
Introduction................................................................................................................. 12
4.2.
Interim Analysis and Data Monitoring ....................................................................... 12
5.
Analysis Populations......................................................................................................... 12
6.
General Issues for Statistical Analysis.............................................................................. 13
6.1.
Statistical Definitions and Algorithms........................................................................ 13
6.1.1. Baseline....................................................................................................................... 13
6.1.2. Adjustments for Covariates......................................................................................... 13
6.1.3. Multiple Comparisons................................................................................................. 13
6.1.4. Handling of Dropouts or Missing Data....................................................................... 14
6.1.5. Analysis Visit Windows ............................................................................................. 16
6.1.6. Pooling of Sites........................................................................................................... 16
6.1.7. Derived Variables ....................................................................................................... 16
6.1.8. Data Adjustments/Handling/Conventions .................................................................. 18
6.2.
Special Handling for COVID-19 Disruptions............................................................. 19
7.
Study Patients/Subjects and Demographics...................................................................... 20


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
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7.1.
Disposition of Subjects and Withdrawals................................................................... 20
7.2.
Protocol Deviations..................................................................................................... 20
7.3.
Demographics and Other Baseline Characteristics..................................................... 20
7.4.
Exposure and Compliance .......................................................................................... 21
8.
Efficacy Analysis.............................................................................................................. 21
8.1.
Primary Efficacy Analysis.......................................................................................... 21
8.2.
Secondary Efficacy Analysis ...................................................................................... 23
8.2.1. IGA ............................................................................................................................. 23
8.2.2. Overall Assessment of Erythema................................................................................ 23
8.2.3. Overall Assessment of Scaling ................................................................................... 24
8.2.4. WI-NRS ...................................................................................................................... 24
8.3.
Exploratory Efficacy Analysis.................................................................................... 25
9.
Safety and Tolerability Analysis....................................................................................... 26
9.1.
Adverse Event............................................................................................................. 26
9.1.1. Adverse Events Leading to Withdrawal ..................................................................... 26
9.1.2. Deaths and Serious Adverse Events ........................................................................... 26
9.2.
Local Tolerability Assessments.................................................................................. 27
9.3.
Clinical Laboratory Evaluations ................................................................................. 27
9.4.
Vital Signs................................................................................................................... 27
9.5.
PHQ-8 ......................................................................................................................... 28
9.6.
C-SSRS ....................................................................................................................... 28
9.7.
Physical Examination.................................................................................................. 28
9.8.
Concomitant Medication............................................................................................. 28
10.
Changes from Planned Analysis ....................................................................................... 29
11.
Other Planned Analysis..................................................................................................... 30
11.1.
Pharmacokinetic Analysis........................................................................................... 30
12.
References......................................................................................................................... 30
13.
Tables, Listings, and Figures ............................................................................................ 30
13.1.
Planned Table Descriptions ........................................................................................ 30
13.1.1. Demographic Data ...................................................................................................... 31
13.1.2. Efficacy Data .............................................................................................................. 31
13.1.3. Safety Data.................................................................................................................. 35
13.2.
Planned Listing Descriptions...................................................................................... 38
14.
Tables, Listings, and Listing Shells .................................................................................. 40
14.1.
Standard Layout for all Tables, Listings, and Figures................................................ 40
14.2.
Planned Table Shells................................................................................................... 42
14.3.
Planned Listing Shells............................................................................................... 113


Statistical Analysis Plan, 
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Protocol Number ARQ-154-203
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Appendix 1: Premier Research Library of Abbreviations .......................................................... 149
List of Tables
Table 1: Schedule of Events ......................................................................................................... 10
Table 2: Analysis Visit Windows ................................................................................................. 16
Table 3: IGA ................................................................................................................................. 21
Table 4: Erythema Grades ............................................................................................................ 23
Table 5: Scaling Grades................................................................................................................ 24
Table 6: Demographic Data Summary Tables.............................................................................. 31
Table 7: Efficacy Data Summary Tables...................................................................................... 31
Table 8: Safety Data Summary Tables ......................................................................................... 35
Table 9: Planned Listings.............................................................................................................. 38
List of Figures
Figure 1: Standardized Layout...................................................................................................... 41
Figure 2: Planned Table Shells ..................................................................................................... 43


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
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1.
Overview
This statistical analysis plan (SAP) describes the planned analysis and reporting for Arcutis 
Biotherapeutics, Inc. protocol number ARQ-154-203 (A Phase 2a, 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), dated 07-Jan-2020 Amendment 
Version 1.0. Reference materials for this statistical plan include the protocol and the 
accompanying sample data collection documents. Operational aspects related to collection and 
timing of planned clinical assessments are not repeated in this SAP unless relevant to the planned 
analysis.
The structure and content of this SAP provides sufficient detail to meet the requirements 
identified by the Food and Drug Administration (FDA), European Medicines Agency (EMA), 
and International Conference on Harmonization (ICH) of Technical Requirements for 
Registration of Pharmaceuticals for Human Use: Guidance on Statistical Principles in Clinical 
Trials1. All work planned and reported for this SAP will follow internationally accepted 
guidelines, published by the American Statistical Association2 and the Royal Statistical Society3, 
for statistical practice.
The planned analyses identified in this SAP may be included in clinical study reports (CSRs), 
regulatory submissions, or future manuscripts. Also, post-hoc exploratory analyses not 
necessarily identified in this SAP may be performed to further examine study data. Any post-hoc 
or unplanned, exploratory analysis performed and included in the CSR will be clearly identified 
as such in the final CSR.
The statistical plan described hereafter is an a priori plan. It will be submitted to file prior to any 
unblinded inferential or descriptive analysis of data pertaining to Arcutis Biotherapeutics, Inc.’s 
study ARQ-154-203.
2.
Study Objectives and Endpoints
2.1.
Study Objectives
2.1.1. Primary Objective
The primary objective is to assess the safety and efficacy of ARQ-154 foam 0.3% (Roflumilast 
Foam 0.3%) administered once daily (QD) vs vehicle foam x 8 weeks in adult subjects with 
seborrheic dermatitis
2.2.
Study Endpoints
2.2.1. Safety Endpoints
The safety endpoints of this study include the following:
x
Local tolerability assessments
x
Clinical laboratory parameters
x
Adverse events (AEs)
x
Columbia-Suicide Severity Rating Scale (C-SSRS)


Statistical Analysis Plan, 
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x
Patient Health Questionnaire depression scale (PHQ-8)
x
Vital signs
x
Physical examinations
2.2.2. Efficacy Endpoints
2.2.2.1.
Primary Efficacy Endpoint
The primary efficacy endpoint of this study is achievement of an Investigator Global Assessment 
(IGA) score of “clear” or “almost clear” PLUS a 2-grade improvement from baseline at Week 8.
2.2.2.2.
Secondary Efficacy Endpoints
The secondary efficacy endpoints of this study include the following:
x
Achievement of an IGA score of “clear” or “almost clear” PLUS a 2-grade improvement 
from baseline at weeks 2 and 4.
x
Change from baseline in Overall Assessment of Erythema score at weeks 2, 4, and 8.
x
Change from baseline in Overall Assessment of Scaling score at weeks 2, 4, and 8.
x
Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 or 1 PLUS a 
2-grade improvement from baseline at weeks 2, 4, and 8.
x
Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 or 1 PLUS a 2-
grade improvement from baseline at weeks 2, 4, and 8.
x
Change and percent change in Worst Itch – Numeric Rating Scale (WI-NRS) pruritus 
score at weeks 2, 4, and 8, as compared to baseline.
x
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 weeks 2, 4, and 8.
2.2.2.3.
Exploratory Efficacy Endpoints
The exploratory efficacy endpoints of this study include the following:
x
Change and percent change in Scalpdex total score from baseline at weeks 2, 4, and 8.
x
Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 or 1 at weeks 
2, 4, and 8.
x
Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 or 1 at weeks 2, 
4, and 8.
x
Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 at weeks 2, 4, 
and 8.
x
Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 at weeks 2, 4, 
and 8.
x
Change and percent change from baseline in Dermatology Life Quality Index (DLQI) at 
weeks 2, 4, and 8.
x
Change and percent change from baseline in body surface area (BSA) affected at week 8.
x
A 2-grade improvement in IGA from Baseline.
x
Incidence of a 2 point reduction from baseline in the WI-NRS (among subjects with WI-
NRS ≥2 at baseline).
x
Achievement of an IGA score of “clear” or “almost clear” PLUS a 2-grade improvement 
from Baseline at week 9.


Statistical Analysis Plan, 
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Protocol Number ARQ-154-203
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x
Change from baseline in Overall Assessment of Erythema score at week 9.
x
Change from baseline in Overall Assessment of Scaling score at week 9.
x
Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 or 1 PLUS a 
2-grade improvement from baseline at week 9.
x
Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 or 1 PLUS a 2-
grade improvement from Baseline at week 9.
3.
Overall Study Design and Plan
3.1.
Overall Design
This is an 8-week, parallel group, double blind, vehicle-controlled study for the treatment of 
subjects with seborrheic dermatitis. This study will include both male and female adults having 
an IGA score of at least “Moderate” (3), and approximately 184 subjects will be enrolled. After 
having met all inclusion criteria, and none of the exclusion criteria, subjects will be randomized in a 
2:1 ratio to ARQ-154 foam 0.3% QD (Roflumilast foam 0.3%) or Vehicle foam QD which will be 
applied to areas of lesions of seborrheic dermatitis. There will be screening for up to 4 weeks 
followed by 8 weeks of treatment phase. Subjects will have to apply the study drug once a day in the 
evening, except for on Day 0 and Week 2, the study drug is applied at the study site. Subjects have to 
record the date and time each dose has been applied, any missed doses, and any additional comments. 
There will be a follow-up visit approximately 1 week after treatment has been completed.
3.2.
Sample Size and Power
A sample size of approximately 184 subjects is planned for the study. Subjects will be 
randomized in a 2:1 ratio to ARQ-154 foam 0.3% (Roflumilast Foam 0.3%): vehicle foam QD, 
stratified by study site and baseline disease severity. Approximately 121 subjects will receive 
ARQ-154 foam 0.3% QD (Roflumilast Foam 0.3%); approximately 63 subjects will receive 
vehicle foam QD. A sample size of 184 subjects will provide approximately 90% power to detect 
an active response of at least 58.5%, assuming 159 subjects complete the study and a vehicle 
response of 30%, based on two-group Chi-squared test of equal proportions (without continuity 
correction), using a 2-sided alpha of 0.10.
3.3.
Study Population
Study population consists of male and female subjects of age 18 years or older with no more than 
20% BSA of seborrheic dermatitis. Subjects should have a minimum IGA of ‘Moderate’ (3) at 
baseline. 
3.4.
Treatments Administered
Subjects who meet the eligibility criteria will be randomized to 1 of the 2 following treatment 
groups in a 2:1 ratio (active:vehicle):
x
ARQ-154 foam 0.3% QD (Roflumilast Foam 0.3%) 
x
Matching vehicle foam QD.


Statistical Analysis Plan, 
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Protocol Number ARQ-154-203
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3.5.
Method of Assigning Subjects to Treatment Groups
Subjects will be randomized and assigned to active drug or vehicle in a 2:1 ratio according to a 
computer-generated randomization list. Randomization will be stratified by study site and 
baseline disease severity (IGA = 3 or IGA = 4).
3.6.
Blinding and Unblinding
This is a double-blind study, therefore neither the subjects nor the Investigator, clinical 
personnel, or sponsor will be aware of which treatment an individual has received. Emergency 
unblinding will be done using the study internet-based randomization system (IWRS) system in 
consultation with the Medical Monitor and the sponsor’s Chief Medical Officer (CMO).
3.7.
Schedule of Events
A detailed schedule of events for the study is provided in Table 1.


Statistical Analysis Plan, 
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Table 1: Schedule of Events
Study Procedure
Screen
Baseline 
Day 0
Wk 2
Day 14
Wk 4
Day 28
Wk 8
Day 56
Wk 9
Day 63
Visit
1
2
3
4
5
6
Visit Window
-4 weeks
+/- 3 day
+/- 5 days
+/- 5 days
+/-5 days
Informed consent/assent
X
Medical history
X
Physical examinationa
X
X
X
I/E criteria
X
X
Randomization
X
Hematology, Serum
Chemistries, and Urine 
Analysis
X
X
X
Vital signs, height, weightb
X
X
X
X
X
X
IGAc, Overall Assessment of 
Erythemac, Overall Assessment
of Scalingc
X
X
X
X
X
X
WI-NRS, DLQI, Scalpdex
X
X
X
X
X
BSA
X
X
X
Application Site Reaction
Assessment/Local Tolerabilityd
X
X
X
Pigmentation Assessmente
X
X
X
X
X
X
C-SSRS, PHQ-8
X
X
X
X
Medical Photographyf
X
X
X
X
Pregnancy testg
X
X
X
X
PK drawsh
X
X
X
IP/vehicle application at the
study sitei
X
X
Dispense study medication kitj
X
X
X
Dispense/review diary
X
X
X
X
Weigh study medication kitk
X
X
X
X
Compliance calculationl
X
X
X
X
Adverse event assessment
X
X
X
X
X
X
Concomitant medications
X
X
X
X
X
X
a    Limited physical examination: skin, lungs, and heart only
b    Height will be collected at Baseline and Week 8. Weight will be collected at all study visits. Subject to void prior to weight 
being taken. Remove any jackets, outerwear, and shoes. Remove any objects of significant weight (i.e., cell phones, wallet, 
key chains). A 5% weight loss from Baseline should be reported to the medical monitor.
c    IGA will be a 5-point scale ranging from clear (0) to severe (4). IGA should be completed prior to other physician 
assessments. Overall assessment of erythema (0-3 scale) and overall assessment of scaling (0-3 scale) will be completed.
d    Local tolerability Assessments: The Investigator local tolerability assessment of skin irritation (Berger and Bowman 
skin irritation score) should be performed prior to the investigational product application at Baseline, and at Weeks 4 
and 8. 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. Subjects will perform the local tolerability 


Statistical Analysis Plan, 
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Protocol Number ARQ-154-203
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assessment 10-15 minutes post-drug application at Baseline, and recall assessments at Weeks 4 and 8 for the subject’s 
‘0-3’ burning/stinging assessment.
e    An assessment for hypopigmentation and hyperpigmentation will be performed by the investigator at all clinic visits.
f    At selected sites, medical photography will be obtained for target lesions. 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.
g   A pregnancy test will be administered to all females of child-bearing potential. A serum pregnancy test will be performed at 
the Screening visit only. A urine pregnancy test will be performed at Baseline, Week 4, and Week 8. A negative result is 
required for continued participation in the study, and results must be available prior to dispensing of investigational product at 
each visit.
h   PK draws (trough / pre-dose) will be collected at Days 0, 28 and 56. At baseline, this draw will be pre-dose relative to drug 
application in the clinic. Ensure study medication is not applied in the area where PK will be drawn.
i    Subjects to apply assigned IP at the study site at every designated visit, to confirm understanding of instruction on how to 
apply initially.
j    Kits will be dispensed based on %BSA affected. See IP Handling Manual for details.
k    The entire kit should be weighed and recorded at every visit. See IP Handling Manual for details.
l
Compliance calculation is described in the IP Handling Manual.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
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4.
Statistical Analysis and Reporting
4.1.
Introduction
Data processing, tabulation of descriptive statistics, calculation of inferential statistics, and 
graphical representations, will be performed primarily using SAS (release 9.4 or higher). If the 
use of other software is warranted for analyses conducted by Premier Research, the final 
statistical methodology report will detail what software was used for what purposes.
Continuous (quantitative) variable summaries will include the number of subjects (n) with 
non-missing values, mean, standard deviation (SD), median, minimum, and maximum.
Categorical (qualitative) variable summaries will include the frequency and percentage of 
subjects who are in the particular category or each possible value. In general, the denominator 
for the percentage calculation will be based upon the total number of subjects in the study 
population for the treatment group, unless otherwise specified. 
Unless otherwise indicated, all statistical tests will be conducted at the 0.10 significance level 
using 2-tailed tests, and P values will be reported. Corresponding 90% confidence intervals (CIs) 
will be presented for statistical tests. In addition, 95% CIs have been added for the efficacy table 
summaries as requested by sponsor. Wilson confidence intervals for binomial proportions will be 
computed.
Statistical testing will be performed at the 0.10 level using two-tailed tests. 
ARQ-154 0.3% foam will be described as “Roflumilast Foam 0.3%” throughout the tables, 
figures, and listings.
4.2.
Interim Analysis and Data Monitoring
Based on protocol section 6.1.3, one interim futility analysis was planned when the first 60 
subjects randomized and have had the opportunity to complete the 8 week disease assessment. 
This futility analysis will be nonbinding and will be used for decision making on further 
expansion of the clinical development program in seborrheic dermatitis. The sponsor considered 
that the analysis is no longer needed for decision making and interim analysis was not carried out 
upon their request. This interim analysis was not meant to change the accrual to or conduct of 
this trial.  
5.
Analysis Populations
The following analysis populations are planned for this study:
x
Safety Population (SAF): The Safety population includes all subjects who are enrolled 
and received at least 1 confirmed dose of investigational product (IP). This population 
will be used for all safety analyses.
x
Intent-To-Treat Population (ITT): The ITT population includes all randomized 
subjects. This population will be used as sensitivity analysis of primary and secondary
endpoints along with disposition.


Statistical Analysis Plan, 
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Protocol Number ARQ-154-203
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x
Modified Intent-To-Treat Population (mITT): The mITT population includes all 
randomized subjects with the exception of subjects who missed the week 8 IGA 
assessment specifically due to the novel coronavirus disease (COVID-19) disruption. 
This population will be the primary analysis population for the analysis of efficacy 
endpoints.
x
Pruritus Population (PRU4): The PRU population is a subset of the ITT population and 
includes 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.
x
Pruritus Population (PRU2): The PRU population is a subset of the ITT population and 
includes subjects with WI-NRS pruritus score ≥2 at Baseline. This population will be 
used for the analysis of achievement of a 2-point reduction in WI-NRS pruritus score as 
compared to Baseline.
x
Pharmacokinetic Population (PK): 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. Analyses using the PK Population will be presented in a
separate PK report, provided by the pharmacokineticist.
6.
General Issues for Statistical Analysis
6.1.
Statistical Definitions and Algorithms
6.1.1. Baseline
The last observation recorded on or before the day of first dose of IP will be used as the baseline 
observation for all calculations of change from baseline for all the efficacy and vital signs data. 
For the laboratory and PHQ data, the last observation recorded before the first dose of IP will be 
used as the baseline observation for all calculations of change from baseline. 
For subject tolerability assessments, baseline is derived as the last non-missing measurement 
taken on the day of first application of study drug.
6.1.2. Adjustments for Covariates
If there is a statistical difference among treatment groups with respect to baseline characteristics, 
that variable may be added to the statistical models as a blocking factor or covariate to determine 
the effect on treatment.
Subgroup analyses may be generated for the baseline covariates.
6.1.3. Multiple Comparisons
No adjustments will be made for multiple comparisons; all analyses will be conducted at the α = 
0.10 level.


Statistical Analysis Plan, 
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6.1.4. Handling of Dropouts or Missing Data
Any subject who prematurely withdraws from the study will have their last available data 
assigned to an analysis window as described in Section 6.1.5. 
For the primary efficacy endpoint of IGA score, the primary analysis will impute missing values 
using a regression-based multiple imputation model. This is a three step process. 
1. The first step is to understand the pattern of missingness. In order to perform the multiple
imputation, a monotone missing pattern has to be achieved. For example, if there exists
values for baseline and Week 8 visits, but missing values for the Week 2 or 4 visits,
Markov-Chain Monte-Carlo (MCMC) method will be used to impute the small amount of
missing data that may be missing at the intermediate visits that is required to make the
missing data pattern monotone before applying the multiple imputation algorithm. This
method uses a non-informative Jeffreys prior to derive the posterior mode from the
expectation-maximization (EM) algorithm as the starting values for the MCMC method.
MCMC method will use seed of 878508. The IGA score will be treated as a continuous
variable for this step. To avoid values that could not be observed in practice, imputed
values will be constrained to be integers in the range of 0 to 4.
a.
The table below will determine the number of datasets to be imputed in this step.
Determine the proportion of datapoints with non-monotone pattern across all
visits and subjects which could be derived as a percentage of number of
nonmonotone data points/total number of expected data points.
This can be determined as 
௡௨௠௕௘௥௢௙௡௢௡௠௢௡௧௢௡௘௩௜௦௜௧௦
௧௢௧௔௟௡௨௠௕௘௥௢௙௩௜௦௜௧௦௔௖௥௢௦௦௔௟௟௦௨௕௝௘௖௧௦∗100
Non-monotone 
Missing Data
Number of 
Imputed Datasets
≤ 2%
1
> 2% to ≤ 5%
3
> 5%
10
2. Once the monotone pattern is achieved, the next step is to implement the imputation
algorithm. For this, the Predictive Mean Matching method (PMM) will be used. This
method is particularly helpful if the normality assumption is violated. For subjects with
complete data up to a particular visit, a PMM model will be fit that includes the outcome
at that visit as the dependent variable and as independent variables, baseline IGA score,
treatment group, and investigational site at baseline using a seed of 633621. This process
will be repeated 25 times, resulting in a total of 25 to 250 complete analysis datasets,
depending on the number of imputed monotone datasets that are required. The seed may


Statistical Analysis Plan, 
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be changed after unblinding in case of any issues with the imputation process, and it will 
be documented in the CSR if any change is required.
3. For each completed dataset, compute the necessary derived variables. The dichotomous
success rate (clear or almost clear with at least a 2-point change from baseline) will be
derived. The results obtained will be analyzed using the Cochran-Mantel-Haenszel
(CMH) analysis for each of the complete analysis data sets stratified by baseline IGA
score and site. The results will be combined into one multiple imputation inference (odds
ratio, associated confidence interval and P value) using PROC MIANALYZE as
illustrated4.
This approach to imputation should be superior to other strategies such as carrying forward the 
last available observation, which may yield unrealistic imputed values. Also, the use of multiple 
imputation avoids the problem of artificially increasing power through data imputation associated 
with single-imputation methods because it accounts for the uncertainty associated with the 
imputation. Other missing data will not be imputed, with the exception of incomplete dates as 
described in Section 6.1.8. For responder analysis, only observed data will be used. Only observed 
data will be summarized using descriptive statistics.
The SAS pseudo code for the multiple imputation process is listed below:
Step 1:
proc mi data=example seed=878508 nimpute=XX round=1 out=example_1;
   mcmc impute=monotone;
   var <baseline score> ………… <visit8 score>;
run;
Step 2:
proc mi data=example_1 seed=633621 nimpute=XX  out=example_2;
  class <treatment> <site>;
  monotone regpmm(<baseline score> ………… <visit8 score>);
  var <treatment> <site> <baseline score> ………… <visit8 score>;
run;
XX will be the determined based on the proportion of missing data across visits.
Step 3: This step involves running CMH test stratified by pooled site and baseline iga score on 
each completed dataset and combining the results using proc mianalyze.
proc freq data=example noprint;
by <imputationnumber> <visit> ;
tables <site>*<baseline score>*<treatment>*<outcome>/ cmh alpha=0.1;
output out=example_stat cmh;
run;
In order to apply PROC MIANALYZE, normalizing transformations have to be applied to odds 
ratio. P values are obtained using Wilson Hilferty transformation as illustrated4. 


Statistical Analysis Plan, 
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6.1.5. Analysis Visit Windows
Visits will be analyzed as scheduled. Unscheduled, early termination visits, and/or repeated 
measurements will only be included if a scheduled measurement is not available and the early 
termination or unscheduled/repeated measurement falls within the analysis visit windows as 
described in Table 2. The windows follow the Schedule of Events in Table 1. 
Unscheduled/repeated measurements will be listed.
Table 2: Analysis Visit Windows
For Week 9 visit, only lower limit will be used and if the study day falls on or after the lower 
limit, the unscheduled or early termination visit would be set to week 9 as appropriately. 
Visit Name
Visit Number Target Start Day
Lower Limit
Upper Limit
Week 2
3
14
2
22
Week 4
4
28
23
42
Week 8
5
56
43
61
Week 9
6
63
62
6.1.6. Pooling of Sites
Sites will be pooled for statistical analysis as follows. For analysis, sites should have a minimum 
of 10 randomized subjects. The smallest sites will be grouped sequentially in order of smallest to 
largest, restricting to those sites that did not meet the minimum enrollment of 10, until each pooled 
site has a minimum of 10 subjects with at least 1 subject in each treatment group.
6.1.7. Derived Variables
x
IGA success = IGA of “Clear” or “Almost Clear” plus a 2-grade improvement from 
Baseline.
x
Compliance = number of applications divided by the expected number of IP applications 
for each subject. Compliance will be calculated using drug accountability data over the 
entire treatment period for each subject, up to treatment completion or discontinuation.
x
Number of expected IP applications = calculated as last treatment date - first 
treatment date + 1.
x
Treatment end date = for subjects that completed the study it is calculated as week 8 
date obtained from COMP CRF. If subjects are missing week 8 date, the last available 
date from SV will be used. If subject discontinued from study, the last available 
COMP date will be used. In the absence of date in COMP page, the last available date 
from SV with visit performed will be used.
x
Number of IP applications = number of expected IP applications – missed IP 
applications as collected in the CRF.


Statistical Analysis Plan, 
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x
Weight of IP (g) = dispensed can weight – returned can weight.
x
BMI (kg/m2) = (weight in kg)/[(height in cm/100)2]. For Week 2, and 4, baseline height 
will be used to derive BMI. For Week 8, and 9, Week 8 height will be used to derive BMI
since height is not collected at all visits.
x
BMI Categories;
•
Underweight - BMI < 18.5
•
Normal           - 18.5 <= BMI <= 24.9
•
Overweight     - 25.0 <= BMI < = 29.9
•
Obese               -  BMI >= 30.0  
x
WI-NRS 4-point reduction = achievement of a 4-point reduction in WI-NRS pruritus 
score at Weeks 2, 4, and 8 compared to baseline, calculated only for subjects with a pruritus 
score of  ≥ 4 at baseline.
x
WI-NRS 2-point reduction = achievement of a 2-point reduction in WI-NRS pruritus 
score at Weeks 2, 4, and 8 compared to baseline, calculated only for subjects with a pruritus 
score of  ≥2 at baseline.
x
DLQI Score = sum of the 10 questions (individual questions scored as Very much=3, A 
lot=2, A little=1, Not at all=0, Not relevant=0, Question 7: Yes=3, No=0, with Not relevant 
recorded to 0; range for score 0 to 30). If 1 item is missing, it is scored as 0 for that item. 
If 2 or more items are missing, the score should not be calculated.
x
PHQ-8 = sum of the 8 questions (individual questions scored as Not at all=0, Several 
days=1, More than half the days=2, and Nearly every day=3; range for score 0 to 24). If 
more than 1 item is missing the score should not be calculated.  If 1 item is missing the 
score is calculated as (sum of answered items*8)/number of answered items.
x
Scalpdex score transformation = Scalpdex is rated on a 1 to 5 scale which will be 
transformed to 0 to 100 Scale where 1=0; 2=25; 3=50; 4=75; 5=100. This transformed 
score is used to calculate scale scores.
x
Emotions Scale = average of (Q2, Q4, Q5, Q6, Q7, Q9, Q10, Q11, Q12, Q14, Q16, 
Q17, Q19, Q20, Q22) after transforming to 0 to 100 scale as mentioned above. 
Q refers to question number. Q19 will be reverse scored i.e., 1=100; 2=75; 3=50; 
4=25; 5=0.
x
Symptoms Scale = average of (Q1, Q3, Q8) after transforming to 0 to 100 scale as 
mentioned above. Q refers to question number.


Statistical Analysis Plan, 
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Protocol Number ARQ-154-203
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x
Functioning Scale = average of (Q13, Q15, Q18, Q21, Q23) after transforming to 
0 to 100 scale as mentioned above. Q refers to question number.
x
Scalpdex Total Score = calculated as mean of all the 23 scalpdex questions using 
the transformed scale of 0 to 100. Q19 will be reverse scored i.e., 1=100; 2=75; 
3=50; 4=25; 5=0 while calculating the mean. Q refers to question number.
x
Change from baseline = value at current time point – value at baseline. 
x
TEAE = any AE with an onset date/time after the first application of IP.
x
C-SSRS Suicidal Ideation = A “yes” answer at any time during treatment to any one of 
the five suicidal ideation questions (Categories 1-5: Wish to be Dead, Non-specific Active 
Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent 
to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan Active 
Suicidal Ideation with Specific Plan and Intent).
x
C-SSRS Suicidal Behavior = A “yes” answer at any time during treatment to any one of 
the five suicidal behavior questions (Categories 6-10: Preparatory Acts or Behavior, 
Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), Completed Suicide).
6.1.8. Data Adjustments/Handling/Conventions
All collected data will be presented in CDISC datasets. Data not subject to analysis according to 
this plan will not appear in any tables or graphs but will be included only in the CDISC datasets.
All P values will be displayed in four decimals and rounded using standard scientific notation (eg, 
0.XXXX). If a P value less than 0.0001 occurs it will be shown in tables as <0.0001; similarly, if 
a P value greater than 0.9999 occurs it will be shown in tables as >0.9999.
Adverse events will be coded using the MedDRA version 23.0 thesaurus.
A treatment-related AE is any AE with a relationship to the study drug of possibly, probably, 
likely, or missing.
For partial AE and medication start dates:
x
If the year is unknown, then do not impute the date but assign a missing value.
x
If the year is known, but the month or month and day is unknown, then:
o
If the year matches the year of first dose date and the end date (if present) is after 
first dose date, then impute as the month and day of the first dose date.
o
Otherwise, assign 01 January.
x
If the year and month are known, but the day is unknown, then:


Statistical Analysis Plan, 
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Protocol Number ARQ-154-203
PCN Number ARCU210100
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o
If the month and year match the month and year of the first dose date, then impute 
as the day of the first dose date.
o
Otherwise, assign 01.
For partial AE and medication end dates:
x
If the year is unknown, then do not impute the date but assign as missing value.
x
If the year is known, but the month or month and day is unknown, then:
o
If the year matches the year of the last date of the study (date of last contact if 
subject lost to follow-up; date of completion or early termination otherwise), then 
impute as the month and day of the last date of the study.
o
Otherwise, assign 31 December.
x
If the year and month are known, but the day is unknown, then:
o
If the month and year match the month and year of the last date of the study, then 
impute as the day of the last date of the study.
o
Otherwise, assign the last day of the month.
6.2.
Special Handling for COVID-19 Disruptions
In some cases, study visits will have to be delayed/not performed as a result of COVID-19 
disruptions (e.g., sites were closed or subjects were under stay-at-home orders). Where possible, 
study sites may collect post-baseline data from subjects remotely by telemedicine; this will be 
clearly documented in the source. If possible, sites should adhere to the protocol visit window for 
remote data collection.
Investigator assessments and subject questionnaires normally completed directly in the tablet 
during on-site visits should be completed on the appropriate paper source documents. The 
following assessments/questionnaires are approved to be collected via telemedicine/remotely:
x
WI-NRS
x
DLQI
x
Scalpdex
x
C-SSRS 
x
PHQ-8
x
Subject Local Tolerability
The following assessments cannot be completed via telemedicine/remotely:
x
IGA
x
BSA
x
Investigator Local Tolerability
x
Overall Assessment of Erythema
x
Overall Assessment of Scaling
x
Pigmentation Assessment


Statistical Analysis Plan, 
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Protocol Number ARQ-154-203
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x
Subject Weight
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 
institutional review board and Sponsor. All protocol deviations which occurred as a result of 
COVID-19 disruptions (e.g., visits out of window, missed assessments, etc.) will be 
differentiated from other protocol deviations. 
Subjects who were affected by COVID-19 disruptions by either missing their Week 8 visit or 
being discontinued before having a Week 8 visit due to COVID-19 related disruptions will be 
excluded from the mITT population, as described in Section Error! Reference source not 
found..
7.
Study Patients/Subjects and Demographics
7.1.
Disposition of Subjects and Withdrawals
Disposition will include tabulations of the number of subjects randomized into each treatment 
group, the number of subjects who received treatment, subjects completing the study, tabulated 
reasons for discontinuation from the study overall and due to COVID-19 disruption, and number 
of subjects in each analysis population. Disposition will be summarized for all subjects who were 
entered into database by treatment group and overall.
7.2.
Protocol Deviations
The number of subjects with major protocol deviations and/or eligibility deviations will be 
summarized in categories by treatment group and overall for subjects in Safety population.
7.3.
Demographics and Other Baseline Characteristics
Summary statistics for age, gender (including child-bearing potential), race, ethnicity, height, 
weight, baseline disease characteristics (IGA, Overall Assessment of Erythema, Overall 
Assessment of Scaling, Scalpdex, WI-NRS), percent BSA, and BMI will be presented by 
treatment group and overall.   
A summary of treatment history, including history of response, intolerance, or contraindication 
to topical corticosteroids and/or topical antifungals will be provided.
For the continuous variables, the number of non-missing values and the mean, standard 
deviation, minimum, median and maximum will be tabulated. 
For ordinal variables such as the IGA, and WI-NRS, summary statistics including the mean, 
median, and range of the ordinal variable will be presented as well as frequency counts of each 
level of the ordinal variable.  
For the categorical variables, the counts and proportions of each value will be tabulated.   
These analyses will be conducted for the mITT and Safety populations.


Statistical Analysis Plan, 
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Protocol Number ARQ-154-203
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7.4.
Exposure and Compliance
The number of IP applications by each subject based on diary data will be summarized using 
descriptive statistics appropriate for continuous variables. 
The amount of IP used by each subject based on can weight will be summarized descriptively by 
treatment group using continuous methods.  
A subject will be considered compliant with the dosing regimen if the subject applies at least 
80% of the expected applications during the IP application period and does not miss more than 3
consecutive doses.
Investigational product application compliance will be calculated based on number of 
applications divided by the expected number of IP applications. Compliance will be summarized 
descriptively by treatment group using the following categories:
> 100%
≥ 80% - ≤100%
< 80%
8.
Efficacy Analysis
8.1.
Primary Efficacy Analysis
The IGA is an ordinal scale with five severity grades which is reported only in integers. 
Table 3 illustrates the description of each severity grade. 
Table 3: IGA
Score
Description
0
Completely clear: No erythema, no scaling (hypo-hyperpigmentation can be 
present)
1
Almost clear: Residual slight erythema and/or trace amounts of scaling
2
Mild: Pink to red color and/or slight scaling
3
Moderate: Distinct 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)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
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For this study, the primary estimand is the odds ratio of achieving IGA success at 8 weeks; that 
is, the ratio of the odds of achieving IGA success at 8 weeks ARQ-154 (Roflumilast Foam 0.3%) 
relative to the odds of success at 8 weeks of using a matching vehicle cream. In the course of the 
8-week randomized treatment period, subjects may be exposed to possible known or unknown 
inter-current events that could possibly impact the estimand, such as treatment discontinuation 
due to a specific adverse effect or perhaps a lack of effect. However, the COVID-19 pandemic 
related issues may impact the integrity of the interpretation of the primary endpoint analysis; thus 
the “Principle Stratum Strategy” has been adopted to handle subjects impacted by COVID-19 
related issues by removing them from the analysis entirely; thus the stratum of subjects included 
in this analysis are those who either have a Week 8 visit or were discontinued for a reason other 
than COVID-19 related issues. Discontinuations for any other reasons or other known or 
unknown intercurrent events will be handled using the “Treatment Policy Strategy” where the 
ITT principle will serve as the analytical basis for interpreting the estimand. In other words, the 
odds ratio of achieving IGA success for ARQ-154 (Roflumilast Foam 0.3%) relative to vehicle at 
8 weeks will be evaluated regardless of the occurrence of any such intercurrent event, with the 
exception of subjects who are unable to attend the week 8 visit due to COVID-19 disruption.  
The study database will collect whether or not subjects missed a visit specifically due to COVID-
19 disruption.  It is the sponsor’s assumption that data missing due to COVID-19 disruption are 
MCAR, and therefore, the mITT population will be no different than the ITT population for the 
purpose of generating this result. Under this assumption, the use of the mITT population will 
provide an unbiased estimate and facilitate the interpretation of the study in the presence of 
COVID-19 disruption.  This estimand shall be estimated using the CMH approach. This 
approach produces an estimate which is the combined odds ratio resulting from adjusting for the 
possible effects of two classification factors – investigative site and baseline disease severity.
The primary efficacy endpoint is success in IGA of disease severity, defined as an IGA of “Clear”
or “Almost Clear” plus a 2-grade improvement from Baseline at Week 8.
The primary endpoint will be analyzed using a CMH test stratified by site (throughout all 
analyses that use stratification, it will be based on the pooling algorithm described in Section 
6.1.6) and baseline IGA.  Statistical significance will be concluded at the 10% significance level 
(2-sided). Additionally, both 90% and 95% Wilson CIs for proportion of successes in each 
treatment group will be presented.
For the primary analysis, missing IGA scores will be imputed using multiple imputation as 
described in Section 6.1.4. These imputations will result in a minimum of 25 to a maximum of 
250 complete analysis datasets, depending on the number of imputed monotone datasets that are 
required.
The CMH analyses will be performed separately for each of the complete analysis data sets, and 
the results will be combined into one multiple imputation inference (estimated treatment effect 
and associated CI and P value). 
Sensitivity analyses of the primary endpoint will also be performed using the original (non-
imputed) dataset. These will include a repeated measures logistic regression model (GEE) with 
IGA success as the dependent variable and treatment, site, baseline IGA score, and visit as the 
independent variables, as well as the above described CMH test on the non-imputed data. 
All other missing data for all other analyses and summaries will remain missing and will not be 


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Protocol Number ARQ-154-203
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imputed. Only observed data will be included in the summaries showing descriptive statistics. 
The primary efficacy analysis will be based on mITT population and these analyses will be 
repeated for the ITT population.  
If subjects were unable to attend the week 8 visit due to COVID-19 related issues they will be 
excluded from the primary analyses for efficacy, which is handled by the mITT population. 
8.2.
Secondary Efficacy Analysis
All secondary efficacy analyses will be performed using the mITT and ITT populations.
8.2.1. IGA
Achievement of an IGA score of “clear” or “almost clear” PLUS a 2-grade improvement 
from Baseline at weeks 2 and 4 will be analyzed similar to the primary efficacy endpoint 
using CMH test stratified by site , and baseline IGA with the exception that missing data 
will not be imputed. In addition, the number and percentage of subjects in each category will 
be summarized by treatment and visit. Additionally, both 90% and 95% Wilson CIs for 
proportion of successes in each treatment group will be presented.
8.2.2. Overall Assessment of Erythema 
The assessment is performed at Screening, Baseline, and Weeks 2, 4, 8, and 9. The score is 
reported in ordinal scale with severity grades ranging from 0-3. 
x
Analysis of change and percent change from baseline in Overall Assessment of Erythema 
at Weeks 2, 4, and 8 will be performed using descriptive summaries (mean, median, inter 
quartile range) by treatment group and study visit. The treatment groups will be 
compared using an exact Wilcoxon rank-sum test as continuous variable. In addition, the 
number and percentage of subjects in each category will be summarized by treatment and
study visit. 
x
Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 or 1 PLUS a 
2-grade improvement from Baseline at Weeks 2, 4, and 8 will be analyzed using CMH
tests stratified by site, and baseline IGA similar to the primary analysis above, with the
exception that missing data will not be imputed. Additionally, both 90% and 95% Wilson 
CIs for proportion of successes in each treatment group will be presented.
Table 4 illustrates description of erythema grades. 
Table 4: Erythema Grades
Score Description
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


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8.2.3. Overall Assessment of Scaling
This assessment is performed at Screening, Baseline, and Weeks 2, 4, 8, and 9. The score is 
reported in ordinal scale with severity grades ranging from 0-3.
x
Analysis of change and percent change from baseline in Overall Assessment of Scaling 
score at weeks 2, 4, and 8 will be performed using descriptive summaries (median, inter 
quartile range) by treatment group and study visit. The treatment groups will be 
compared using an exact Wilcoxon rank-sum test as continuous variable.
x
In addition, the number and percentage of subjects in each category will be summarized 
by treatment and visit. Achievement of an Overall Assessment of Scaling (0-3 scale) 
score of 0 or 1 PLUS a 2-grade improvement from Baseline at weeks 2, 4, and 8 will be 
analyzed using CMH tests stratified by site, and baseline IGA similar to the primary 
analysis above, with the exception that missing data will not be replaced. Additionally, 
both 90% and 95% Wilson CIs for proportion of successes in each treatment group will 
be presented.
Table 5 illustrates description of scaling grades. 
Table 5: Scaling Grades
Score
Description
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
8.2.4. WI-NRS
WI-NRS scale ranges from 0 to 10 with 0 being “no itch” and 10 equaling “worst imaginable 
itch”. This will be determined by asking the subject’s assessment of worst itch over the past 24 
hours.
x
Analysis of change from baseline in WI-NRS pruritus score at Weeks 2, 4, and 8 will be 
performed using descriptive summaries (mean, median, inter quartile range) by treatment 
group and study visit. In addition, the number and percentage of subjects for each scale 
score will be summarized by treatment and visit.
x
$nalysis of change from baseline in WI-NRS pruritus score at Weeks 2, 4, and 8 will be 
analyzed using an analysis of covariance with the factors treatment, study site (grouped 
as specified in Section 6.1.6), baseline IGA, and baseline value of the respective scale as 
independent variables. The LS Means, standard errors, 90% CIs, 95% CIs, and P values 
for change from baseline and testing difference in treatments will be presented.
x
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 Weeks 2, 4, and 8 will be 
analyzed using CMH tests stratified by site and baseline IGA similar to the primary 
analysis above, with the exception that missing data will not be replaced. This will be 
summarized using PRU4 population. Additionally, both 90% and 95% Wilson CIs for 


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proportion of successes in each treatment group will be presented.
8.3.
Exploratory Efficacy Analysis
Exploratory efficacy analysis will be performed for subjects belonging to mITT and ITT 
populations.
The exploratory endpoints include:
x
Change and percent change in Scalpdex total score from baseline at Weeks 2, 4, and 8
x
Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 or 1 at
Weeks 2, 4, and 8
x
Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 or 1 at 
Weeks 2, 4, and 8
x
Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 at Weeks 
2, 4, and 8
x
Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 at Weeks 
2, 4, and 8
x
Change and percent change from baseline in DLQI at Weeks 2, 4, and 8
x
Change and percent change from baseline in BSA affected at Week 8
x
A 2-grade improvement in IGA from Baseline.
x
Incidence of a 2 point reduction from baseline in the WI-NRS (among subjects with WI-
NRS ≥ 2 at baseline
x
Achievement of an IGA score of “clear” or “almost clear” PLUS a 2-grade improvement 
from Baseline at week 9.
x
Change from baseline in Overall Assessment of Erythema score at week 9.
x
Change from baseline in Overall Assessment of Scaling score at week 9.
x
Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 or 1 PLUS a 
2-grade improvement from baseline at week 9.
x
Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 or 1 PLUS a 2-
grade improvement from Baseline at week 9.
Scalpdex questionnaire consists of 23 questions which are categorized into emotions, symptoms 
and functioning scales. The scale scores and total score are calculated as described in the Section
6.1.7. Change and percent change from baseline for Scalpdex scale scores along with total score 
are summarized descriptively. In addition, number and percentages for each Scalpdex question is 
summarized by study visit and treatment group. 
Change and percent change from baseline for DLQI, and BSA will be summarized descriptively. 
In addition change from baseline values for Scalpdex scale scores and total score, DLQI, and 
BSA will be analyzed using an analysis of covariance with the factors treatment, study site 
(grouped as specified in Section 6.1.6), baseline IGA, and baseline value of the respective scale 
as independent variables. Statistical comparisons between the treatment groups will be obtained 
using contrasts. The LS Means, standard errors, 90% CIs, 95% CIs, and P values for change 
from baseline and testing difference in treatments will be presented.


Statistical Analysis Plan, 
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Protocol Number ARQ-154-203
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Analysis of 2 point reduction from baseline in the WI-NRS (among subjects with WI-NRS ≥ 2 at 
baseline) will be conducted similarly as described in Section 8.2.4; i.e., CMH test stratified by 
site and baseline IGA will be presented for Weeks 2, 4, and 8 for PRU2 population.
For efficacy analysis purposes, the data that is collected by ERT will be used for BSA 
summarization.
9.
Safety and Tolerability Analysis
Safety will be evaluated from reported AEs, physical examinations, local tolerability assessments, 
changes in clinical laboratory values, changes in vital signs/weight, C-SSRS, and PHQ-8 results.
All safety analyses will be performed on the Safety population.
9.1.
Adverse Event
All AEs, TEAEs, and SAEs will be coded using the MedDRA dictionary version 23.0.
A treatment emergent AE (TEAE) is defined as an AE that started post application of IP at the 
Baseline visit through study completion. An overall summary of TEAEs will be provided; this 
will present number and percent of subjects who reported at least 1: TEAE (including all TEAEs, 
TEAEs by maximum severity, and TEAEs by greatest relationship), SAE, discontinued the study 
due to a TEAE, or had a TEAE resulting in death.
The number and percent of subjects reporting TEAEs, grouped by MedDRA system organ class 
and preferred term, will be tabulated by severity or greatest relationship to study IP and treatment 
group. In the case of multiple occurrences of the same TEAE within the same subject, each subject 
will only be counted once for each preferred term.
In the summaries showing severity and relationship to study medication the event with the 
maximum severity (mild < moderate < severe) or strongest relationship (not related < related) 
will be reported. If a particular event is missing the severity and/or relationship, then the 
strongest possible severity or relationship will be assumed for analysis (severity = severe, 
relationship = likely).
In the AE data listings, all AEs will be displayed. AEs that are treatment emergent will be 
flagged.
9.1.1. Adverse Events Leading to Withdrawal
A summary of incidence rates (frequencies and percentages) of TEAEs leading to withdrawal of 
study drug, by treatment group, SOC, and preferred term will be prepared for the Safety 
Population. No inferential statistical tests will be performed.
A data listing of AEs leading to withdrawal of study drug will also be provided, displaying 
details of the event(s) captured on the CRF.
9.1.2. Deaths and Serious Adverse Events
Any deaths that occur during the study will be listed.


Statistical Analysis Plan, 
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Serious adverse events (SAEs) will be listed and tabulated by system organ class and preferred 
term and presented by treatment group, severity, and relationship to study treatment.  
9.2.
Local Tolerability Assessments
The investigator’s assessment of the application site reaction will be summarized by study visit 
using both categorical methods (number and percentage of subject with each score) as well as 
continuous methods (e.g., mean, median, etc.). Categorical summaries will be provided for 
dermal response as well as other effects. No inferential statistical tests will be performed.
The subject’s assessment of the application site reaction will be summarized similarly.
9.3.
Clinical Laboratory Evaluations
Laboratory test results will be summarized descriptively by treatment and study visit as both 
observed values and change from baseline values for continuous hematology, chemistry, and 
urinalysis results. Categorical urinalysis results will be summarized using frequencies by study 
visit and treatment.
The number of subjects with clinical laboratory values below, within, or above the normal range 
by study visit and in relation to baseline will be tabulated for each clinical laboratory analyte by 
treatment group (shift table).
Abnormal results will be flagged in the listings. In addition, pregnancy test results and hormonal 
laboratory results will be listed.
9.4.
Vital Signs
Descriptive summaries of observed values and changes from baseline will be calculated for 
systolic blood pressure, diastolic blood pressure, heart rate, height, weight, body mass index and 
oral body temperature by treatment group and visit.
Changes in weight by treatment group will summarize the number of subjects who gain or lose 
>=5% of their baseline body weight during the course of the study, as well as subjects who gain 
or lose >=10% of their baseline body weight over the course of the study by treatment group and 
visit.
BMI is derived as specified in Section 6.1.7. Shift tables by treatment group for subjects who 
shift from their baseline BMI category (underweight, normal, overweight, obese) to a different 
BMI category throughout the course of the study will be provided by treatment group and visit.
Upon sponsor’s request, shift in BMI, and changes in weight are summarized by intentional and 
unintentional or missing weight loss question captured in the CRF. 


Statistical Analysis Plan, 
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9.5.
PHQ-8
Data for PHQ-8 will be classified using each subject’s total score at a time point into a category 
based on the following scoring system: 
x
None – Minimal depression (0 to 4)
x
Mild depression (5 to 9)
x
Moderate depression (10 to 14)
x
Moderately severe depression (15 to 19)
x
Severe depression (20 to 24)
Shift tables showing the category of severity at each visit by treatment group will be presented.
9.6.
C-SSRS
The C-SSRS is a questionnaire that prospectively assesses Suicidal Ideation and Suicidal 
Behavior. At the Screening study visit, “Baseline/Screening” version of the C-SSRS will be 
used. This version assesses Suicidal Ideation and Suicidal Behavior during the subject’s lifetime 
and during the past 6 months. For the Screening visit, “lifetime” experience of the subject with 
Suicidal Ideation and Suicidal Behavior will be summarized. From Baseline visit, the “Since 
Last Visit” version will be used.
Suicidality data collected on the C-SSRS will be listed for all subjects. Tables will include results 
from the Suicidal Ideation and Suicidal Behavior sections of the C-SSRS. Frequencies and 
percentages of subjects with a response of “Yes” at any point on the Suicidal Ideation and 
Suicidal Behavior items will be summarized by study visit and treatment group. 
9.7.
Physical Examination
The number and percentage of subjects with normal and abnormal findings in the physical 
examination will be displayed at each study visit and treatment group.
9.8.
Concomitant Medication
Prior and concomitant medications will be summarized descriptively by treatment group, ATC 
level 4, and preferred term using counts and percentages.
Prior medications will be presented separately from concomitant medications. Medications that 
started before the first application of IP will be considered prior medications whether or not they 
were stopped prior to the first application of study drug. Any medications continuing or starting 
after the first application of study drug will be considered to be concomitant. If a medication 
starts before the first application of study drug and continues after the first application of study 
drug it will be considered both prior and concomitant.
Medications will be coded using WHODrug Global B3, version September 2019.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 29 of 161
10.
Changes from Planned Analysis
Based on protocol amendment, the significance level has been changed from 0.05 to 0.10. 
However, protocol Section 6.3.1 indicates alpha = 0.05 but section 6.1 indicates significance 
level to be 0.10. The alpha level of 0.10 is the intended level, and this SAP uses 0.10 as 
significance level as documented throughout. The PRU4 and PRU2 populations have been added 
to facilitate WI-NRS analysis. These populations are not included in the protocol. Additional 
exploratory endpoints have been added in the SAP which are not specified in the protocol. They 
are:
x
Incidence of a 2 point reduction from baseline in the WI-NRS (among subjects with WI-
NRS ≥ 2 at baseline
x
Achievement of an IGA score of “clear” or “almost clear” PLUS a 2-grade improvement 
from Baseline at week 9
x
Change from baseline in Overall Assessment of Erythema score at week 9
x
Change from baseline in Overall Assessment of Scaling score at week 9
x
Achievement of an Overall Assessment of Erythema (0-3 scale) score of 0 or 1 PLUS a 
2-grade improvement from baseline at week 9
x
Achievement of an Overall Assessment of Scaling (0-3 scale) score of 0 or 1 PLUS a 2-
grade improvement from Baseline at week 9. 
x
In addition, percentage change from baseline summaries have been added for Scalpdex, 
DLQI, BSA and WI-NRS.
Based on the sponsor’s request the following changes have been made:
x
95% CIs have been added in the efficacy table summaries along with 90% CIs as the 
alpha level is 0.1.
x
If a subject is unable to attend the week 8 visit due to COVID-19, they will be excluded 
from the primary analyses for efficacy. To facilitate this, mITT population has been 
added to replace the ITT population.
x
The ITT population will be used as a sensitivity analysis of the primary, secondary, and 
exploratory efficacy analysis along with disposition.
x
ANCOVA analysis has been added for change in baseline scores of Erythema, Scaling 
and WI-NRS.
x
A new BMI shift table has been added.
x
Shift from baseline in Weight and BMI tables are repeated based on the 
intentional/nonintentional or missing weight loss question captured in the CRF.
x
For efficacy analysis purposes, data collected from ERT will be used for BSA 
summarization.
x
Per Protocol population and associated analyses have been removed as they were 
considered to be uninformative.
x
ANCOVA analysis have been added for change from baseline scores for WI-NRS and 
BSA.
x
Wilcoxon rank sum test has been added to summarize the continuous data associated with 
Overall Assessment of Erythema and Scaling.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 30 of 161
An interim analysis was planned to make a decision on further expansion of the clinical 
development program for seborrheic dermatitis. The sponsor considered the interim analysis as
no longer needed for decision making and therefore no interim analysis was conducted. The 
interim analysis was not meant to change enrollment or conduct of this trial.
11.
Other Planned Analysis
11.1.
Pharmacokinetic Analysis
All PK collection information from the eCRF will be presented in a listing.
Concentration data and pk parameters will be summarized by timepoint (concentrations data) and 
treatment group using summary statistics. In addition, PK concentration and parameter listings 
will be presented as well.
12.
References
1. US Federal Register. (1998) International Conference on Harmonization; Guidance on 
Statistical Principles for Clinical Trials. Department of Health and Human Services: Food 
and Drug Administration [Docket No. 97D-0174]. Federal Register Volume 63, Number 179, 
pages 49583-49598. September 16, 1998.
2. ASA. (2016) Ethical Guidelines for Statistical Practice. Prepared by the Committee on 
Professional Ethics, April 2016. http://www.amstat.org/about/ethicalguidelines.cfm
3. RSS. (2014) The Royal Statistical Society: Code of Conduct, 2014. 
http://www.rss.org.uk/Images/PDF/join-us/RSS-Code-of-Conduct-2014.pdf.
4. Ratitch, B., Lipkovich, I., & O’Kelly, M. (2013). Combining Analysis Results from Multiply 
Imputed Categorical Data. 
PharmaSUG. https://www.pharmasug.org/proceedings/2013/SP/PharmaSUG-2013-SP03.pdf
13.
Tables, Listings, and Figures
All TLFs will have a header showing the sponsor company name and protocol and a footer 
showing the version of SAS, the file name and path, and the source of the data (e.g., listing 
number).
13.1.
Planned Table Descriptions
The following are planned summary tables for protocol number ARQ-154-203. The table 
numbers and page numbers are place holders only and will be determined when the tables are 
produced.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 31 of 161
13.1.1. Demographic Data 
Table 6: Demographic Data Summary Tables
Number
Population
Title
Topline
Table 14.1.1
All 
Randomized
Summary of Subject Disposition 
X
Table 
14.1.2.1
Safety
Summary of Demographics and Baseline 
Characteristics 
X
Table 
14.1.2.2
mITT
Summary of Demographics and Baseline 
Characteristics 
Table 14.1.3
Safety
Previous Treatment History of Seborrheic 
Dermatitis
X
Table 14.1.4
Safety
Summary of Protocol Deviations
Table 14.1.5
Safety
Summary of Prior Medications by ATC 
Class Level 4 and Preferred Term
Table 14.1.6
Safety
Summary of Study Drug Exposure and 
Compliance 
13.1.2. Efficacy Data 
Table 7: Efficacy Data Summary Tables
Number
Population
Title
Topline
Table 14.2.1.1 mITT
Summary and Change from Baseline in 
Investigator Global Assessment (IGA) 
Grades by Study Visit – Observed Data
Table 14.2.1.2 ITT
Summary and Change from Baseline in 
Investigator Global Assessment (IGA) 
Grades by Study Visit – Observed Data
Table 14.2.1.3 mITT
Summary and Change from Baseline in 
Investigator Global Assessment (IGA) 
Grades by Study Visit – Multiple Imputation
X
Table 14.2.1.4 ITT
Summary and Change from Baseline in 
Investigator Global Assessment (IGA) 
Grades by Study Visit – Multiple Imputation
Table 14.2.1.6 mITT
Summary of Investigator Global Assessment 
(IGA) Grades and Success by Study Visit 
Categorical Results – Observed Data


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 32 of 161
Number
Population
Title
Topline
Table 14.2.1.7 ITT
Summary of Investigator Global Assessment 
(IGA) Grades and Success by Study Visit 
Categorical Results – Observed Data
Table 14.2.1.9 mITT
Summary of Investigator Global Assessment 
(IGA) Grades and Success by Study Visit –
Multiple Imputation
Categorical Results
X
Table 
14.2.1.10
ITT
Summary of Investigator Global Assessment 
(IGA) Grades and Success by Study Visit –
Multiple Imputation
Categorical Results
Table 
14.2.1.11
mITT
Summary of Investigator Global Assessment 
(IGA) Grades and Success by Study Visit 
Tabulation of Fitted Point Estimates from 
Generalized Estimating Equations for Binary 
Response – Observed Data
Table 
14.2.1.12
ITT
Summary of Investigator Global Assessment 
(IGA) Grades and Success by Study Visit 
Tabulation of Fitted Point Estimates from 
Generalized Estimating Equations for Binary 
Response – Observed Data
Table 
14.2.1.13
mITT
Summary of Investigator Global Assessment 
(IGA) – 2-grade Improvement from Baseline
– Observed Data
Table 14.2.2.1 mITT
Summary and Change from Baseline in 
Overall Assessment of Erythema – Severity 
Grades by Study Visit – Wilcoxon Test
Table 14.2.2.2 mITT
Summary of Overall Assessment of 
Erythema – Severity Grades and Success by 
Study Visit
Categorical Results
X
Table 14.2.2.3 ITT
Summary and Change from Baseline in 
Overall Assessment of Erythema – Severity 
Grades by Study Visit
Table 14.2.2.4 ITT
Summary of Overall Assessment of 
Erythema – Severity Grades and Success by 
Study Visit
Categorical Results


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 33 of 161
Number
Population
Title
Topline
Table 14.2.2.5 mITT
Summary of Overall Assessment of 
Erythema – Success Score of 0 or 1 and 
Success Score of 0 by Study Visit
Table 14.2.2.6 ITT
Summary of Overall Assessment of 
Erythema – Success Score of 0 or 1 and 
Success Score of 0 by Study Visit
Table 14.2.2.7 mITT
Summary and Change from Baseline in 
Overall Assessment of Erythema – Severity 
Grades by Study Visit – Wilcoxon Test
Table 14.2.2.8 ITT
Summary and Change from Baseline in 
Overall Assessment of Erythema – Severity 
Grades by Study Visit – Wilcoxon Test
Table 14.2.3.1 mITT
Summary and Change from Baseline in 
Overall Assessment of Scaling – Severity 
Grades by Study Visit
Table 14.2.3.2 mITT
Summary of Overall Assessment of Scaling –
Severity Grades and Success by Study Visit
Categorical Results
X
Table 14.2.3.3 ITT
Summary and Change from Baseline in 
Overall Assessment of Scaling – Severity 
Grades by Study Visit
Table 14.2.3.4 ITT
Summary of Overall Assessment of Scaling –
Severity Grades and Success by Study Visit
Categorical Results
Table 14.2.3.5 mITT
Summary of Overall Assessment of Scaling –
Success Score of 0 or 1 and Success Score of 
0 by Study Visit
Table 14.2.3.6 ITT
Summary of Overall Assessment of Scaling –
Success Score of 0 or 1 and Success Score of 
0 by Study Visit
Table 14.2.3.7 mITT
Summary and Change from Baseline in 
Overall Assessment of Scaling – Severity 
Grades by Study Visit – Wilcoxon Test
Table 14.2.3.8 ITT
Summary and Change from Baseline in 
Overall Assessment of Scaling – Severity 
Grades by Study Visit – Wilcoxon Test
Table 14.2.4.1 mITT
Summary and Change from Baseline in 
Worst Itch – Numeric Rating Scale (WI-
NRS) Pruritus Score by Study Visit
X
Table 14.2.4.2 ITT
Summary and Change from Baseline in 
Worst Itch – Numeric Rating Scale (WI-
NRS) Pruritus Score by Study Visit


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 34 of 161
Number
Population
Title
Topline
Table 14.2.4.3 PRU4-mITT Worst Itch – Numeric Rating Scale (WI-
NRS) Pruritus Score Success by Study Visit
X
Table 14.2.4.4 PRU2-mITT Worst Itch – Numeric Rating Scale (WI-
NRS) Pruritus Score Success by Study Visit
Table 14.2.4.5 PRU4-ITT
Worst Itch – Numeric Rating Scale (WI-
NRS) Pruritus Score Success by Study Visit
Table 14.2.4.6 PRU2-ITT
Worst Itch – Numeric Rating Scale (WI-
NRS) Pruritus Score Success by Study Visit
Table 14.2.4.7 mITT
Summary of Worst Itch – Numeric Rating 
Scale (WI-NRS) by Study Visit - ANCOVA
Table 14.2.4.8 ITT
Summary of Worst Itch – Numeric Rating 
Scale (WI-NRS) by Study Visit - ANCOVA
Table 14.2.4.9 mITT
Summary of Worst Itch - Numeric Rating 
Scale (WI-NRS) by Study Visit - Categorical 
Scale
Table 
14.2.4.10
ITT
Summary of Worst Itch - Numeric Rating 
Scale (WI-NRS) by Study Visit - Categorical 
Scale
Table 14.2.5.1 mITT
Change from Baseline in Scalpdex by Study 
Visit
Table 14.2.5.2 mITT
Summary of Scalpdex by Study Visit -
ANCOVA 
Table 14.2.5.3 ITT
Change from Baseline in Scalpdex by Study 
Visit
Table 14.2.5.4 ITT
Summary of Scalpdex by Study Visit -
ANCOVA 
Table 14.2.5.5 mITT
Categorical Summary of Individual 
Responses by Study Visit – Scalpdex 
Questionnaire 
Table 14.2.5.6 ITT
Categorical Summary of Individual 
Responses by Study Visit – Scalpdex 
Questionnaire
Table 14.2.6.1 mITT
Change from Baseline in Dermatology Life 
Quality Index (DLQI) by Study Visit
Table 14.2.6.2 mITT
Summary of Dermatology Life Quality Index 
(DLQI) by Study Visit – ANCOVA 
Table 14.2.6.3 ITT
Change from Baseline in Dermatology Life 
Quality Index (DLQI) by Study Visit
Table 14.2.6.4 ITT
Summary of Dermatology Life Quality Index 
(DLQI) by Study Visit – ANCOVA 


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 35 of 161
Number
Population
Title
Topline
Table 14.2.7.1 mITT
Change from Baseline in Body Surface Area 
(BSA) by Study Visit
Table 14.2.7.2 mITT
Summary of Body Surface Area (BSA) by 
Study Visit – ANCOVA 
Table 14.2.7.3 ITT
Change from Baseline in Body Surface Area 
(BSA) by Study Visit
Table 14.2.7.4 ITT
Summary of Body Surface Area (BSA) by 
Study Visit – ANCOVA 
13.1.3. Safety Data 
Table 8: Safety Data Summary Tables
Number
Population Title
Topline
14.3.1 Displays of Adverse Events
Table 14.3.1.1
Safety
Summary of Treatment Emergent Adverse Events 
X
Table 14.3.1.2
Safety
Incidence of Treatment Emergent Adverse Events by System Organ Class 
and Preferred Term
Table 14.3.1.3
Safety
Incidence of Treatment Emergent Adverse Events by System Organ Class, 
Preferred Term, and Maximum Severity
Table 14.3.1.4
Safety
Incidence of Treatment Emergent Adverse Events by System Organ Class, 
Preferred Term, and Relationship to Study Drug
Table 14.3.1.5
Safety
Incidence of Treatment Emergent Adverse Events Leading to Study Drug 
Discontinuation by System Organ Class and Preferred Term
14.3.2 Summary of Deaths, Other Serious and Significant Adverse Events
Table 14.3.2.1
Safety
Incidence of Serious Adverse Events by System Organ Class and Preferred 
Term
Table 14.3.2.2
Safety
Incidence of Serious Adverse Events by System Organ Class, Preferred 
Term, and Relationship to Study Drug
Table 14.3.2.3
Safety
Incidence of Serious Adverse Events by System Organ Class, Preferred 
Term, and Maximum Severity
14.3.3 Narratives of Deaths, Other Serious and Certain Other Significant Adverse Events
Table 14.3.3.1
Safety
Listing of Adverse Events Leading to Study Drug Discontinuation
Table 14.3.3.2
Safety
Listing of Serious Adverse Events
Table 14.3.3.3
Safety
Listing of Deaths
14.3.4 Abnormal Laboratory Value 
NA


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
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Number
Population Title
Topline
14.3.5 Laboratory Data Summary Tables
Table 
14.3.5.1.1
Safety
Summary of Serum Chemistry Laboratory Results by Study Visit
Table 
14.3.5.1.2
Safety
Shift from Baseline in Clinical Chemistry Laboratory Results by Study 
Visit
Table 
14.3.5.2.1
Safety
Summary of Hematology Laboratory Results by Study Visit
Table 
14.3.5.2.2
Safety
Shift from Baseline in Hematology Laboratory Results by Study Visit
Table 
14.3.5.3.1
Safety
Summary of Quantitative Urinalysis Laboratory Results by Study Visit
Table 
14.3.5.3.2
Safety
Shift from Baseline in Quantitative Urinalysis Laboratory Results by Study 
Visit
Table 
14.3.5.3.3
Safety
Summary of Qualitative Urinalysis Laboratory Results by Study Visit
14.3.6 Other Safety Data Summary Tables
Table 14.3.6.1
Safety
Shift from Baseline in Patient Health Questionnaire (PHQ-8) by Study Visit
Table 
14.3.6.2.1
Safety
Summary of Investigator Local Tolerability Assessment by Study Visit
Table 
14.3.6.2.2
Safety
Summary of Investigator Local Tolerability Assessment (Dermal Response) 
by Study Visit
Categorical Results
Table 
14.3.6.2.3
Safety
Summary of Investigator Local Tolerability Assessment (Other Effects) by 
Study Visit
Categorical Results
Table 
14.3.6.3.1
Safety
Summary of Subject Local Tolerability Assessment by Study Visit
Table 
14.3.6.3.2
Safety
Summary of Subject Local Tolerability Assessment by Study Visit
Categorical Results
X
Table 
14.3.6.4.1
Safety
Summary of Vital Signs by Study Visit
Table 
14.3.6.4.2
Safety
Shift from Baseline in Weight by Study Visit
Table 
14.3.6.4.3
Safety
Shift from Baseline in BMI by Study Visit
Table 
14.3.6.4.4
Safety
Shift from Baseline in Weight by Study Visit –   by Weight Loss 
Intentional/Non-Intentional


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 37 of 161
Number
Population Title
Topline
Table 
14.3.6.4.5
Safety
Shift from Baseline in BMI by Study Visit – by Weight Loss 
Intentional/Non-Intentional
Table 14.3.6.5
Safety
Summary of Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal 
Ideation and Suicidal Behavior by Study Visit
Table 14.3.6.6
Safety
Summary of Physical Examination by Study Visit
Table 14.3.6.7
Safety
Summary of Concomitant Medications by ATC Class Level 4 and Preferred 
Term
14.4 Pharmacokinetic and Pharmacodynamic Summary Tables
14.4.1.1
PK
Summary of Pharmacokinetic Results by Study Visit
14.4.1.2
PK
Summary of Pharmacokinetic Parameters by Study Visit


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 38 of 161
13.2.
Planned Listing Descriptions
The following are planned data and patient/subject data listings for protocol number ARQ-154-
203.
In general, one listing will be produced per CRF domain. All listings will be sorted by site, and 
subject number. All calculated variables will be included in the listings. Screen failures will only 
be presented in Listing 16.2.2.1.
In all listings a blank line will be placed between each subject. Within a data listing, if an item 
appears line after line (e.g., repetition of subject number), then only the first occurrence will be 
displayed.
In data listings, the information for one subject will be kept on one page if at all possible, rather 
than splitting a subject’s information across pages.
Table 9: Planned Listings
Number
Population
Title
16.2.1 Subject Discontinuations/Completions
Listing 16.2.1.1
All Subjects
Subject Disposition
Listing 16.2.1.2
All Subjects
Subject Visits
16.2.2 Protocol Deviations
Listing 16.2.2.1
All Subjects
Inclusion and Exclusion Criteria Not Met
Listing 16.2.2.2
All Subjects
Protocol Deviations
16.2.3 Subjects Excluded from the Efficacy Analyses
Listing 16.2.3
All Subjects
Analysis Populations
16.2.4 Demographic Data and Other Baseline Characteristics
Listing 16.2.4.1
All Subjects
Subject Demographics
Listing 16.2.4.2
All Subjects
Medical History
16.2.5 Compliance and/or Drug Concentration Data
Listing 16.2.5.1
All Subjects
Study Drug Application at the Study Site
Listing 16.2.5.2
All Subjects
Cans
Listing 16.2.5.3
All Subjects
Diary Dispensation
Listing 16.2.5.4
All Subjects
Compliance (CRF)
Listing 16.2.5.5
All Subjects
Missed Doses
Listing 16.2.5.6
PK 
Pharmacokinetic Blood Collection
Listing 16.2.5.7
PK 
Pharmacokinetic Calculated Parameters
16.2.6 Individual Efficacy Response Data
Listing 16.2.6.1
All Subjects
Investigator Global Assessment (IGA)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 39 of 161
Number
Population
Title
Listing 16.2.6.2
All Subjects
Overall Assessment of Erythema
Listing 16.2.6.3
All Subjects
Overall Assessment of Scaling
Listing 16.2.6.4
All Subjects
Worst Itch Numerical Rating Scale (WI-NRS)
Listing 16.2.6.5
All Subjects
Scalpdex
Listing 16.2.6.6
All Subjects
Dermatology Life Quality Index (DLQI)
Listing 16.2.6.7
All Subjects
Body Surface Area (BSA) including Scalp
16.2.7 Adverse Event Listings (by Subject)
Listing 16.2.7.1
All Subjects
Adverse Events
16.2.8 Laboratory Values (by Subject)
Listing 16.2.8.1.1
All Subjects
Clinical Laboratory Data: Clinical Chemistry
Listing 16.2.8.1.2
All Subjects
Clinical Laboratory Data: Hematology
Listing 16.2.8.1.3
All Subjects
Clinical Laboratory Data: Urinalysis
Listing 16.2.8.1.4
Female Subjects
Clinical Laboratory Data: Serum and Urine Pregnancy Test
16.2.9 Other Clinical Observations and Measurements (by Subject)
Listing 16.2.9.1
All Subjects
Investigator Local Tolerability Assessments
Listing 16.2.9.2
All Subjects
Subject Local Tolerability Assessments
Listing 16.2.9.3
All Subjects
Pigmentation Assessment
Listing 16.2.9.4.1
All Subjects
Vital Signs
Listing 16.2.9.4.2
All Subjects
Vital Signs - Weight
Listing 16.2.9.5
All Subjects
Physical Examination
Listing 16.2.9.6
All Subjects
Medical Photography
Listing 16.2.9.7
All Subjects
Prior and Concomitant Medications
Listing 16.2.9.8
All Subjects
Patient Health Questionnaire (PHQ-8) 
Listing 16.2.9.9
All Subjects
Columbia-Suicide Severity Rating Scale (C-SSRS)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 40 of 161
14.
Tables, Listings, and Listing Shells
14.1.
Standard Layout for all Tables, Listings, and Figures
The following standard layout will be applied to all TLFs in support of this study. Note that 
programming notes may be added if appropriate after each TLF shell.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 41 of 161
Figure 1: Standardized Layout
Arcutis Biotherapeutics, Inc.
Page X of Y
Protocol: ARQ-154-203
<Version>
<Table, Listing, Figure> xx.x.x
<Title of Table Listing or Figure>
<Study Population and if applicable subgroup Description>
____________________________________________________________________________________________________________
Body of Table, Listing or Figure
___________________________________________________________________________________________________________
<Note: If directly Applicable>
Footnote 1 <if applicable>  Recommendation is to keep footnotes to a minimum
Footnote 2 <if applicable>
Footnote n <if applicable>
Footnote n+1 <pgm path and name>, <date>


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 42 of 161
14.2.
Planned Table Shells
See Figure 2 below.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 43 of 161
Figure 2: Planned Table Shells
Table 14.1.1
Summary of Subject Disposition
All Randomized Subjects
Status
Roflumilast Foam 0.3%
(N=XX)
Vehicle 
(N=XX)
Overall
(N=XX)
Study Populations:
   ITT Population [1]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Safety Population [2]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%) 
   mITT Population [3]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   PRU4 Population [4]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   PRU2 Population [5]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   PK Population [6]   
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Completed Study
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Ongoing in Study
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Prematurely Discontinued from Study
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Reason for Discontinuation:
      Withdrawal by Subject
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Sponsor’s Decision
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      PI’s Decision
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Non-Compliance
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Protocol Violation
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Lost to Follow-up
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Adverse Event
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Death
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Pregnancy
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Other
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: COVID-19 = novel coronavirus disease; IGA = investigator global assessment; ITT = Intent-to-treat; mITT = modified intent-to-treat; PI = principal 
investigator; PK = Pharmacokinetic; PRU2 = Subjects with WI-NRS Pruritus Score ≥2 at Baseline; PRU4 = Subjects with WI-NRS Pruritus Score ≥4 at Baseline; WI-
NRS = Worst Itch - Numeric Rating Scale.
Note: Percentages are n/Number of subjects randomized within planned treatment and overall*100.
[1] The ITT population includes all randomized subjects.
[2] The Safety population includes all subjects who are enrolled and received at least 1 confirmed dose of IP.
[3] The mITT population includes all randomized subjects with the exception of subjects who missed the week 8 IGA assessment specifically due to COVID-19 
disruption.
[4] The PRU4 population is a subset of the ITT population and includes 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.
[5] The PRU2 population is a subset of the ITT population and includes subjects with WI-NRS pruritus score ≥ 2 at Baseline. This population will be used for the 
analysis of achievement of a 2-point reduction in WI-NRS pruritus score as compared to Baseline.
[6] The PK population includes 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.
Reference Listings: 16.2.1, 16.2.3
Table 14.1.1 (cont.) 


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 44 of 161
Summary of Subject Disposition
All Randomized Subjects
Status
Roflumilast Foam 0.3%
(N=XX)
Vehicle 
(N=XX)
Overall
(N=XX)
Prematurely Discontinued from the Study Due 
to COVID-19 Disruption
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    Reason for Discontinuation:
        XXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
        XXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
        XXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
        XXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: COVID-19 = novel coronavirus disease; ITT = Intent-to-treat; IP = investigational product; PI = principal investigator; PK = 
Pharmacokinetic.
Note: Percentages are n/Number of subjects randomized within planned treatment and overall*100.
[1] The ITT population includes all randomized subjects.
[2] The Safety population includes all subjects who are enrolled and received at least 1 confirmed dose of IP.
[3] The mITT population includes all randomized subjects with the exception of subjects who missed the week 8 disease assessment specifically due to 
COVID-19 disruption.
[4] The PRU4 population is a subset of the ITT population and includes 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.
[5] The PRU2 population is a subset of the ITT population and includes subjects with WI-NRS pruritus score ≥ 2 at Baseline. This population will be used 
for the analysis of achievement of a 2-point reduction in WI-NRS pruritus score as compared to Baseline.
[6] 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.
Reference Listings: 16.2.1, 16.2.3
Programming note: “Ongoing in Study” row will be removed once the database has hardlocked and all subjects have completed the study; 
For COVID Disruption, list only the reasons for discontinuation as populated in the database.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 45 of 161
Table 14.1.2.1
Summary of Demographics and Baseline Characteristics
Safety Population
Variable
   Statistic or Category
Roflumilast Foam 
0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Age (years)
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Gender
   Male
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Female
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Child-Bearing Potential? [1]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Yes
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   No
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Ethnicity
   Hispanic or Latino
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Not Hispanic or Latino
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Race
   American-Indian or Alaska Native
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Asian
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Black or African-American
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Native Hawaiian or Other Pacific Islander
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   White
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Other
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   More than One Race
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: BSA = body surface area; IGA = investigator global assessment; WI-NRS = Worst Itch – Numeric Rating Scale.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100.
[1] Only captured for female subjects; percentages are based on the number of female subjects in the Safety population.
[2] The % BSA affected by seborrheic dermatitis. 
[3] 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, which ranges from “no itch” to “worst imaginable itch”.
Reference Listings: 16.2.4.1, 16.2.6.1, 16.2.6.2, 16.2.6.3, 16.2.6.4, 16.2.6.5, 16.2.6.7, 16.2.9.4.1, 16.2.9.4.2


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 46 of 161
Table 14.1.2 (cont.)
Demographics and Baseline Characteristics
Safety Population
Variable
   Statistic or Category
Roflumilast Foam 
0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Height (cm)
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Weight (kg)
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Body Mass Index (kg/m2)
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Body Surface Area (%) [2]
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Baseline IGA
   Completely Clear 
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Almost Clear
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Mild
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Moderate
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Severe
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: BSA = body surface area; IGA = investigator global assessment; WI-NRS = Worst Itch – Numeric Rating Scale.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100.
[1] Only captured for female subjects; percentages are based on the number of female subjects in the Safety population.
[2] The % BSA affected by seborrheic dermatitis. 
[3] 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, which ranges from “no itch” to “worst imaginable itch”.
Reference Listings: 16.2.4.1, 16.2.6.1, 16.2.6.2, 16.2.6.3, 16.2.6.4, 16.2.6.5, 16.2.6.7, 16.2.9.4.1, 16.2.9.4.2


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 47 of 161
Table 14.1.2.1 (cont.)
Demographics and Baseline Characteristics
Safety Population
Variable
   Statistic or Category
Roflumilast Foam 
0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Baseline IGA - Numeric
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Baseline Erythema
   None 
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Mild
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Moderate
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Severe
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Baseline Scaling
   None 
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Mild
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Moderate
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Severe
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Baseline Scalpdex
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Baseline WI-NRS - Numeric [3]
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Abbreviations: BSA = body surface area; IGA = investigator global assessment; WI-NRS = Worst Itch – Numeric Rating Scale.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100.
[1] Only captured for female subjects; percentages are based on the number of female subjects in the Safety population.
[2] The % BSA affected by seborrheic dermatitis. 
[3] 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, which ranges from “no itch” to “worst imaginable itch”.
Reference Listings: 16.2.4.1, 16.2.6.1, 16.2.6.2, 16.2.6.3, 16.2.6.4, 16.2.6.5, 16.2.6.7, 16.2.9.4.1, 16.2.9.4.2


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 48 of 161
Table 14.1.2.1 (cont.)
Demographics and Baseline Characteristics
Safety Population
Variable
   Statistic or Category
Roflumilast Foam 
0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Baseline WI-NRS [3]
   0
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   4
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   5
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   6
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   7
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   8
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   9
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   10
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: BSA = body surface area; IGA = investigator global assessment; WI-NRS = Worst Itch – Numeric Rating Scale.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100.
[1] Only captured for female subjects; percentages are based on the number of female subjects in the Safety population.
[2] The % BSA affected by seborrheic dermatitis. 
[3] 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, which ranges from “no itch” to “worst imaginable itch”.
Reference Listings: 16.2.4.1, 16.2.6.1, 16.2.6.2, 16.2.6.3, 16.2.6.4, 16.2.6.5, 16.2.6.7, 16.2.9.4.1, 16.2.9.4.2


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 49 of 161
Table 14.1.2.2
Summary of Demographics and Baseline Characteristics 
mITT Population
(Same shell as Table 14.1.2.1; subjects are summarized by planned treatment, not treatment received; 
Update Note: footnote as Percentages are n/Number of subjects in the mITT population within planned treatment and overall*100.)


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 50 of 161
Table 14.1.3
Previous Treatment History of Seborrheic Dermatitis
Safety Population
Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle 
(N=XX)
Overall
(N=XX)
Inadequate Response, Intolerance or 
Contraindication to 
   Topical Corticosteroids
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Topical Antifungals
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Subjects have Facial Involvement
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Subjects with a 
response of “Yes” are summarized.
Reference Listing: 16.2.4.2


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 51 of 161
Table 14.1.4
Summary of Protocol Deviations 
Safety Population
Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle 
(N=XX)
Overall
(N=XX)
Subjects with Any Protocol Deviations
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Subjects with Major Protocol Deviations
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   XXXXXXXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   XXXXXXXXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   XXXXXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Only major protocol 
deviations are presented. Subjects with any protocol deviations row can include counts from major and minor deviations. Subjects with 
one or more deviations within a type of protocol deviation were counted only once. Protocol Deviations were collected throughout the 
study.
Reference Listing: 16.2.2.2
Programming note: the structure of this table may change depending on the information in the protocol deviations file.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 52 of 161
Table 14.1.5
Summary of Prior Medications by ATC Class Level 4 and Preferred Term
Safety Population
ATC Class Level 4
   Preferred Term
Roflumilast Foam 
0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Subjects with at least 1 Prior Medication
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
ATC Class 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
ATC Class 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: ATC = Anatomic Therapeutic Chemical; PT = preferred term; WHO-DDE = World Health Organization-Drug Dictionary 
Enhanced.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Medications were 
coded using WHO-DDE Global B3 version September 2019. Prior medications are all medications that were started before the 
application of study drug. Medications are displayed by alphabetical order of ATC Level 4 classification, then descending frequency 
of PT within ATC, and then alphabetically by PT. Subjects were counted only once for each ATC and PT.
Reference Listing: 16.2.9.7
Programming note: ATC & PT text should be presented as is from the dataset.


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 53 of 161
Table 14.1.6
Summary of Study Drug Exposure 
Safety Population
Variable
   Statistic / Category
Roflumilast Foam 
0.3%
(N=XX)
Vehicle
(N=XX)
Total Number of IP Applications
   n
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
Total Weight (g)of IP Applied [1]
   n
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
Compliance [2]
   >100%
XX (XX.X%)
XX (XX.X%)
   ≥ 80% - ≤100%
XX (XX.X%)
XX (XX.X%)
   < 80%
XX (XX.X%)
XX (XX.X%)
> 3 Consecutive Missed Doses
XX (XX.X%)
XX (XX.X%)
Compliant [3]
XX (XX.X%)
XX (XX.X%)
Abbreviation: IP = investigational product.
Note: n is the number of subjects in the Safety Population. Percentages are n/Number of subjects in the 
Safety Population within treatment received*100.
[1] Total weight of IP is determined by subtracting returned can weight from the dispensed can weight.
[2] Compliance is calculated based on number of applications divided by the expected number of IP 
applications for each subject*100.
[3] A subject is considered compliant if the subject applies at least 80% of the expected applications during 
the IP application period and does not miss more than 3 consecutive doses.
Reference Listings: 16.2.5.1, 16.2.5.2, 16.2.5.4


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 54 of 161
Table 14.2.1.1
Summary and Change from Baseline in Investigator Global Assessment (IGA) Grades by Study Visit – Observed Data
mITT Population
Roflumilast Foam 0.3%
Vehicle 
Study Visit
(N=XX)
(N=XX)
   Statistic
Observed
Change
Observed
Change
Baseline 
   n
XX
XX
   Mean (SD)
XX.X (X.XX)
XX.X (X.XX)
   Median
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
   Q1, Q3
XX.X
XX.X
Week 2
   n
XX
XX
XX
XX
   Mean (SD)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
   Median
XX.X
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
XX, XX
   Q1, Q3
XX.X
XX.X
XX.X
XX.X
   
Repeat for Week 4, Week 8, Week 9. 
Note: Subjects are summarized by planned treatment. IGA is a static qualitative evaluation of overall seborrheic dermatitis severity involving an ordinal scale 
with 5 severity grades (reported only in integers of 0 to 4) where 0 = Clear; 1 = Almost Clear; 2 = Mild; 3 = Moderate; 4 = Severe. Baseline is the last non-
missing measurement taken on or before the day of first application of study drug. Change from baseline is calculated as result - baseline result. Week 9 
summaries are provided only for the subjects that didn’t rollover to the extension study.
Reference Listing: 16.2.6.1


Statistical Analysis Plan, 
Sponsor Arcutis Biotherapeutics, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 55 of 161
Table 14.2.1.2
Summary and Change from Baseline in Investigator Global Assessment (IGA) Grades by Study Visit – Observed Data
ITT Population
(Same shell as Table 14.2.1.1)
Table 14.2.1.3
Summary and Change from Baseline in Investigator Global Assessment (IGA) Grades by Study Visit – Multiple Imputation
mITT Population
(Same shell as Table 14.2.1.1; Programming note: update “Note:” portion of footnote to add in the following text just after “Note:”:  Separate multiple imputation steps were 
used for monotone and non-monotone missing data. For monotone missing pattern, predictive mean matching model will be used to impute missing value for a subject at particular 
visit having baseline IGA score, treatment group and investigational site as independent variables and study visit as dependent variable. For non-monotone missing IGA values, 
Markov-Chain Monte Carlo (MCMC) method will be used to impute the data at intermediate visits to make the missing data pattern into monotone before applying predictive mean 
matching multiple imputation algorithm. Subjects are summarized by planned treatment.)
Table 14.2.1.4
Summary and Change from Baseline in Investigator Global Assessment (IGA) Grades by Study Visit – Multiple Imputation
ITT Population
(Same shell as Table 14.2.1.1; Programming note: update “Note:” portion of footnote to add in the following text just after “Note:”:  Separate multiple imputation steps were 
used for monotone and non-monotone missing data. For monotone missing pattern, predictive mean matching model will be used to impute missing value for a subject at particular 
visit having baseline IGA score, treatment group and investigational site as independent variables and study visit as dependent variable. For non-monotone missing IGA values, 
Markov-Chain Monte Carlo (MCMC) method will be used to impute the data at intermediate visits to make the missing data pattern into monotone before applying predictive mean 
matching multiple imputation algorithm. Subjects are summarized by planned treatment.)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 56 of 161
Table 14.2.1.5
Summary of Investigator Global Assessment (IGA) Grades and Success by Study Visit – Observed Data
Categorical Results
mITT Population
Study Visit
   Category/Statistic 
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Baseline
   0 = Clear
XX (XX.X%)
XX (XX.X%)
   1 = Almost Clear
XX (XX.X%)
XX (XX.X%)
   2 = Mild
XX (XX.X%)
XX (XX.X%)
   3 = Moderate
XX (XX.X%)
XX (XX.X%)
   4 = Severe
XX (XX.X%)
XX (XX.X%)
Week 2
   0 = Clear
XX (XX.X%)
XX (XX.X%)
   1 = Almost Clear
XX (XX.X%)
XX (XX.X%)
   2 = Mild
XX (XX.X%)
XX (XX.X%)
   3 = Moderate
XX (XX.X%)
XX (XX.X%)
   4 = Severe
XX (XX.X%)
XX (XX.X%)
   IGA Success [1]
      Yes 
XX (XX.X%)
XX (XX.X%)
         90% CI [2]
(X.XX, X.XX)
(X.XX, X.XX)
         95% CI [2]
(X.XX, X.XX)
(X.XX, X.XX)
      No 
XX (XX.X%)
XX (XX.X%)
      Odds Ratio (90% CI) [3] 
X.XX (X.XX, X.XX)
      Odds Ratio (95% CI) [3] 
X.XX (X.XX, X.XX)
      P value [3]
X.XXXX
Repeat for all Week 4, Week 8, and Week 9.
Abbreviations: CI = confidence interval; IGA = investigator global assessment.
Note: Percentages are n/Number of subjects in the mITT population within planned treatment at each 
visit*100. Baseline is the last non-missing measurement taken on or before the day of first application of 
study drug. Week 9 summaries are provided only for the subjects that didn’t rollover to the extension study.
[1] IGA success (“Yes”) is defined as an IGA score of “Clear” or “Almost Clear” plus a ≥2-grade improvement 
from baseline; “No” otherwise.
[2] 90% and 95% CI for “Yes” are obtained using Wilson method.
[3] The odds ratio, 90% CI, 95% CI, and P value are obtained from Cochran Mantel Haenszel test (stratified 
by study site and baseline IGA) comparing Roflumilast Foam 0.3% to Vehicle.
Reference Listing: 16.2.6.1


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 57 of 161
Table 14.2.1.6
Summary of Investigator Global Assessment (IGA) Grades and Success by Study Visit – Observed Data
Categorical Results
ITT Population
(Same shell as Table 14.2.1.5; update the first line in “Note:” as “Percentages are n/Number of subjects in the ITT population within planned treatment*100.”)
Table 14.2.1.7
Summary of Investigator Global Assessment (IGA) Grades and Success by Study Visit – Multiple Imputation
Categorical Results
mITT Population
(Same shell as Table 14.2.1.5; The grades and success scores will be based on observed data; update “Note:” portion of footnote to add in the following text just after 
“Note:”: The grades and success scores were obtained from observed dataset. The odds ratio and p values were summarized using multiple imputation dataset. Separate multiple 
imputation steps were used for monotone and non-monotone missing data. For monotone missing pattern, predictive mean matching model will be used to impute missing value for a 
subject at particular visit having baseline IGA score, treatment group and investigational site as independent variables and study visit as dependent variable. For non-monotone 
missing IGA values, Markov-Chain Monte Carlo (MCMC) method will be used to impute the data at intermediate visits to make the missing data pattern into monotone before applying 
predictive mean matching multiple imputation algorithm.)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 58 of 161
Table 14.2.1.8
Summary of Investigator Global Assessment (IGA) Grades and Success by Study Visit – Multiple Imputation
Categorical Results
ITT Population
(Same shell as Table 14.2.1.5; The grades and success scores will be based on observed data; update “Note:” portion of footnote to add in the following text just after 
“Note:”:  The grades and success scores were obtained from observed dataset. The odds ratio and p values were summarized using multiple imputation dataset. Separate multiple 
imputation steps were used for monotone and non-monotone missing data. For monotone missing pattern, predictive mean matching model will be used to impute missing value for a 
subject at particular visit having baseline IGA score, treatment group and investigational site as independent variables and study visit as dependent variable. For non-monotone 
missing IGA values, Markov-Chain Monte Carlo (MCMC) method will be used to impute the data at intermediate visits to make the missing data pattern into monotone before applying 
predictive mean matching multiple imputation algorithm. Percentages are n/Number of subjects in the ITT population within planned treatment at each visit*100.)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 59 of 161
Table 14.2.1.9
Summary of Investigator Global Assessment (IGA) Grades and Success by Study Visit – Observed Data
Tabulation of Fitted Point Estimates from Generalized Estimating Equations for Binary Response
mITT Population
Study Visit
   Category/Statistic 
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Treatment Difference (Roflumilast Foam 0.3% vs Vehicle) [3]
n [1]
Responder [2]
n [1]
Responder [2]
Odds Ratio
90% CI for OR
95% CI for OR
P value
Week 2
XX
XX.X %
XX
XX.X %
X.XX
(XX.XX, XX.XX)
(XX.XX, XX.XX)
X.XXXX
Week 4
XX
XX.X %
XX
XX.X %
X.XX
(XX.XX, XX.XX)
(XX.XX, XX.XX)
X.XXXX
Week 8
XX
XX.X %
XX
XX.X %
X.XX
(XX.XX, XX.XX)
(XX.XX, XX.XX)
X.XXXX
Week 9
XX
XX.X %
XX
XX.X %
X.XX
(XX.XX, XX.XX)
(XX.XX, XX.XX)
X.XXXX
Abbreviations: CI = Confidence interval; IGA = investigator global assessment; OR = odds ratio.
Note: Percentages are n/Number of subjects in the mITT population within planned treatment at each visit*100. Baseline is the last non-missing measurement taken on or
before the day of first application of study drug. Week 9 summaries are provided only for the subjects that didn’t rollover to the extension study.
[1] Number of subjects at each visit.
[2] Number of subjects with an IGA score of “Clear” or “Almost Clear” plus a ≥2-grade improvement from baseline.
[3] Estimates for odds ratio, 90% CI for odds ratio, 95% CI for odds ratio, and P value are from a generalized estimating equations for binary response model, with IGA 
success as the dependent variable and treatment, site, baseline IGA score, and visit as the independent variables. An unstructured correlation matrix was used to model 
the within subject correlation. In case of convergence issues, other covariance structures will be used including Toeplitz, compound symmetry or Autoregressive (1) 
(AR[1]) covariance structure will be used, following this sequence until convergence is achieved. The odds ratio is the estimate of the odds of having IGA response for 
subjects treated with Roflumilast Foam 0.3% relative to that for subjects treated with vehicle.
Reference Listing: 16.2.6.1


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 60 of 161
Table 14.2.1.10
Summary of Investigator Global Assessment (IGA) Grades and Success by Study Visit – Observed Data
Tabulation of Fitted Point Estimates from Generalized Estimating Equations for Binary Response
ITT Population
(Programming note: Same as table shell 14.2.1.9; update first line of note footnote to “Percentages are n/Number of subjects in the ITT population within planned 
treatment at each visit*100.”)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 61 of 161
Table 14.2.1.11
Summary of Investigator Global Assessment (IGA) – 2-grade Improvement from Baseline – Observed Data
mITT Population
Study Visit
   Category/Statistic 
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Week 2
   IGA Success [1]
      Yes 
XX (XX.X%)
XX (XX.X%)
        90% CI [2]
(X.XX, X.XX)
(X.XX, X.XX)
        95% CI [2]
(X.XX, X.XX)
(X.XX, X.XX)
      No 
XX (XX.X%)
XX (XX.X%)
      Odds Ratio (90% CI) [3] 
X.XX (X.XX, X.XX)
      Odds Ratio (95% CI) [3] 
X.XX (X.XX, X.XX)
      P value [3]
X.XXXX
Repeat for all Week 4, Week 8, and Week 9.
Abbreviations: CI = confidence interval; IGA = investigator global assessment.
Note: Percentages are n/Number of subjects in the mITT population within planned treatment*100. Baseline 
is the last non-missing measurement taken on or before the day of first application of study drug. Week 9 
summaries are provided only for the subjects that didn’t rollover to the extension study.
[1] IGA success (“Yes”) is defined as a 2-grade improvement from baseline; “No” otherwise.
[2] 90% and 95% CI for “Yes” are obtained using Wilson method.
[3] The odds ratio, 90% CI, 95% CI, and P value are obtained from Cochran Mantel Haenszel test (stratified 
by study site and baseline IGA) comparing Roflumilast Foam 0.3% to Vehicle.
Reference Listing: 16.2.6.1


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 62 of 161
Table 14.2.1.12
Summary of Investigator Global Assessment (IGA) – 2-grade Improvement from Baseline 
ITT Population
(Programming note: Same as table shell 14.2.1.11; update first line of note footnote to “Percentages are n/Number of subjects in the ITT population within planned 
treatment at each visit*100.”)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 63 of 161
Table 14.2.2.1
Summary and 
Change from 
Baseline in 
Overall 
Assessment of 
Erythema –
Severity Grades
by Study Visit
Wilcoxon Test
mITT Population
Roflumilast Foam 0.3%
Vehicle 
(N=XX)
Study Visit
(N=XX)
   Statistic
Observed
Change
% Change
Observed
Change
% Change
Baseline 
   n
XX
XX
   Mean (SD)
XX.X (X.XX)
XX.X (X.XX)
   Median
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
   Q1, Q3
XX.X
XX.X
   P value [1]
X.XXXX
X.XXXX
Week 2
   n
XX
XX
XX
XX
XX
XX
   Mean (SD)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
   Median
XX.X
XX.X
XX.X
XX.Xs
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
XX, XX
XX, XX
XX, XX
   Q1, Q3
XX.X
XX.X
XX.X
XX.X
XX.X
XX.X
   P value [1]
X.XXXX
X.XXXX
X.XXXX
X.XXXX
X.XXXX
X.XXXX
Repeat for Week 4, Week 8, Week 9. 
Note: Subjects are summarized by planned treatment. 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) where 0 = None; 1 = Mild; 2 = Moderate; 3 = Severe. Baseline is the last non-missing measurement taken on or before the day of first application of study 
drug. Change from baseline is calculated as result - baseline result. Percent change from baseline is calculated as (change from baseline/baseline)*100.
[1] P value was obtained from an exact Wilcoxon rank sum test, comparing Roflumilast Foam 0.3% with Vehicle.
Reference Listing: 16.2.6.2


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 64 of 161
Table 14.2.2.2
Summary of Overall Assessment of Erythema – Severity Grades and Success by Study Visit
Categorical Results
mITT Population
Study Visit
    Category/Statistic 
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Baseline
  0 = None
XX (XX.X%)
XX (XX.X%)
   1 = Mild
XX (XX.X%)
XX (XX.X%)
   2 = Moderate
XX (XX.X%)
XX (XX.X%)
   3 = Severe
XX (XX.X%)
XX (XX.X%)
Week 2
   0 = None
XX (XX.X%)
XX (XX.X%)
   1 = Mild
XX (XX.X%)
XX (XX.X%)
   2 = Moderate
XX (XX.X%)
XX (XX.X%)
   3 = Severe
XX (XX.X%)
XX (XX.X%)
   Erythema Success [1]
      Yes 
XX (XX.X%)
XX (XX.X%)
        90% CI [2]
(X.XX, X.XX)
(X.XX, X.XX)
        95% CI [2]
(X.XX, X.XX)
(X.XX, X.XX)
      No 
XX (XX.X%)
XX (XX.X%)
      Odds Ratio (90% CI) [3] 
X.XX (X.XX, X.XX)
      Odds Ratio (95% CI) [3] 
X.XX (X.XX, X.XX)
      P value [3]
X.XXXX
Repeat for Week 4, Week 8, and Week 9.
Abbreviations: CI = confidence interval; IGA = investigator global assessment.
Note: Percentages are n/Number of subjects in the mITT population within planned treatment*100. Baseline 
is the last non-missing measurement taken on or before the day of first application of study drug. Week 9 
summaries are provided only for the subjects that didn’t rollover to the extension study.
[1] Erythema success (“Yes”) is defined as an Erythema score of “0” or “1” plus a ≥2-grade improvement 
from baseline; “No” otherwise.
[2] 90% and 95% CI for “Yes” are obtained using Wilson method.
[3] The odds ratio, 90% CI, 95% CI, and P value are obtained from Cochran Mantel Haenszel test (stratified 
by study site and baseline IGA) comparing Roflumilast Foam 0.3% to Vehicle.
Reference Listing: 16.2.6.2


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 65 of 161
Table 14.2.2.3
Summary and Change from Baseline in Overall Assessment of Erythema – Severity Grades by Study Visit
Wilcoxon Test
ITT Population
(Programming note: Same as table 14.2.2.1; Update any instances of mITT to ITT in the footnotes.)
Table 14.2.2.4
Summary of Overall Assessment of Erythema – Severity Grades and Success by Study Visit
Categorical Results
ITT Population
(Programming note: Same as table 14.2.2.2. Update the first line of footnotes to “Note: Percentages are n/Number of subjects in the ITT population within planned 
treatment*100.”)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 66 of 161
Table 14.2.2.5
Summary of Overall Assessment of Erythema – Score of 0 or 1 and Score of 0 by Study Visit
Categorical Results
mITT Population
Study Visit
   Category/Statistic 
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Week 2
   Erythema Score of 0 or 1 [1]
      Yes 
XX (XX.X%)
XX (XX.X%)
        90% CI [2]
(X.XX, X.XX)
        95% CI [2]
(X.XX, X.XX)
      No 
XX (XX.X%)
XX (XX.X%)
      Odds Ratio (90% CI) [3] 
X.XX (X.XX, X.XX)
      Odds Ratio (95% CI) [3] 
X.XX (X.XX, X.XX)
      P value [3]
X.XXXX
   Erythema Success Score of 0 [4]
      Yes 
XX (XX.X%)
XX (XX.X%)
        90% CI [2]
(X.XX, X.XX)
(X.XX, X.XX)
        95% CI [2]
(X.XX, X.XX)
(X.XX, X.XX)
      No 
XX (XX.X%)
XX (XX.X%)
      Odds Ratio (90% CI) [3] 
X.XX (X.XX, X.XX)
      Odds Ratio (95% CI) [3] 
X.XX (X.XX, X.XX)
      P value [3]
X.XXXX
Repeat for Week 4, Week 8, and Week 9.
Abbreviations: CI = confidence interval; IGA = investigator global assessment.
Note: Percentages are n/Number of subjects in the mITT population within planned treatment*100. Baseline 
is the last non-missing measurement taken on or before the day of first application of study drug. Week 9 
summaries are provided only for the subjects that didn’t rollover to the extension study.
[1] Erythema (“Yes”) is defined as an Erythema score of “0” or “1”; “No” otherwise.
[2] 90% and 95% CI for “Yes” are obtained using Wilson method for each Success test separately.
[3] The odds ratio, 90% CI, 95% CI, and P value are obtained from Cochran Mantel Haenszel test (stratified 
by study site and baseline IGA) comparing Roflumilast Foam 0.3% to Vehicle.
[4] Erythema success (“Yes”) is defined as an Erythema score of “0”; “No” otherwise.
Reference Listing: 16.2.6.2


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.2.2.6
Summary of Overall Assessment of Erythema – Success Score of 0 or 1 and Success Score of 0 by Study Visit
Categorical Results
ITT Population
(Programming note: Same as table 14.2.2.5. Replace any instances of mITT with ITT)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
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Page 68 of 161
Table 14.2.3.1
Summary and Change from Baseline in Overall Assessment of Scaling – Severity Grades by Study Visit
mITT Population
(Programming note: Same as table 14.2.2.1. Update the footnotes to “Note: Subjects are summarized by planned treatment. Overall Assessment of Scaling is a static 
qualitative evaluation involving an ordinal scale with 4 severity grades (reported only in integers of 0 to 3) where 0 = None; 1 = Mild; 2 = Moderate; 3 = Severe. Baseline is 
the last non-missing measurement taken on or before the day of first application of study drug. Change from baseline is calculated as result - baseline result. Percent 
change from baseline is calculated as (change from baseline/baseline)*100.”; update reference listing to 16.2.6.3)
Table 14.2.3.2
Summary of Overall Assessment of Scaling – Severity Grades and Success by Study Visit
Categorical Results
mITT Population
(Programming note: Same as table 14.2.2.2. Change Reference Listing to 16.2.6.3. Update any instances of Erythema to Scaling)
Table 14.2.3.3
Summary and Change from Baseline in Overall Assessment of Scaling – Severity Grades by Study Visit
ITT Population
(Programming note: Same as table 14.2.2.1. Update the footnotes to “Note: Subjects are summarized by planned treatment. Overall Assessment of Scaling is a static 
qualitative evaluation involving an ordinal scale with 4 severity grades (reported only in integers of 0 to 3) where 0 = None; 1 = Mild; 2 = Moderate; 3 = Severe. Baseline is 
the last non-missing measurement taken before the first application of study drug. Change from baseline is calculated as result - baseline result. Percent change from 
baseline is calculated as (change from baseline/baseline)*100.”; update reference listing to 16.2.6.3)
Table 14.2.3.4
Summary of Overall Assessment of Scaling – Severity Grades and Success by Study Visit
Categorical Results
ITT Population
(Programming note: Same as table 14.2.2.2. Update the first line of footnotes to “Note: Percentages are n/Number of subjects in the ITT population within planned 
treatment*100”. Change Reference Listing to 16.2.6.3. Update any instances of Erythema to Scaling)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 69 of 161
Table 14.2.3.5
Summary of Overall Assessment of Scaling – Success Score of 0 or 1 by Study Visit
Categorical Results
mITT Population
(Programming note: Same as 14.2.2.5. Update reference listing to 16.2.6.3; Change any instance of Erythema to Scaling)
Table 14.2.3.6
Summary of Overall Assessment of Scaling – Success Score of 0 or 1 by Study Visit
Categorical Results 
ITT Population
(Programming note: Same as 14.2.2.5. Update reference listing to 16.2.6.3; Change any instance of Erythema to Scaling and replace mITT with ITT in the footnotes)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 70 of 161
Table 14.2.4.1
Summary and Change from Baseline in Worst Itch – Numeric Rating Scale (WI-NRS) Pruritus Score by Study Visit
mITT Population
Roflumilast Foam 0.3%
Vehicle 
(N=XX)
Study Visit
(N=XX)
   Statistic
Observed
Change
% Change
Observed
Change
% Change
Baseline 
   n
XX
XX
   Mean (SD)
XX.X (X.XX)
XX.X (X.XX)
   Median
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
   Q1, Q3
XX.X
XX.X
Week 2
   n
XX
XX
XX
XX
XX
XX
   Mean (SD)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
XX.X (X.XX)
   Median
XX.X
XX.X
XX.X
XX.Xs
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
XX, XX
XX, XX
XX, XX
   Q1, Q3
XX.X
XX.X
XX.X
XX.X
XX.X
XX.X
Repeat for Week 4, Week 8, Week 9. 
Note: Subjects are summarized by planned treatment. 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, which ranges from “no itch” to “worst imaginable itch”. Baseline is the last non-missing measurement taken on or before the day of first application of study drug. Change 
from baseline is calculated as result - baseline result. Percent change from baseline is calculated as (change from baseline/baseline)*100.
Reference Listing: 16.2.6.4


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 71 of 161
Table 14.2.4.2
Summary and Change from Baseline in Worst Itch – Numeric Rating Scale (WI-NRS) Pruritus Score by Study Visit
ITT Population
(Programming note: Same as table 14.2.4.1. Change Reference Listing to 16.2.6.4. Update the footnotes as “Note: Subjects are summarized by planned treatment. 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, which ranges from “no itch” to “worst 
imaginable itch”. Baseline is the last non-missing measurement taken on or before the day of first application of study drug. Change from baseline is calculated as result 
- baseline result. Percent change from baseline is calculated as (change from baseline/baseline)*100.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
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Page 72 of 161
Table 14.2.4.3
Worst Itch – Numeric Rating Scale (WI-NRS) Pruritus Score Success by Study Visit
mITT Population, Subjects with WI-NRS Pruritus Score ≥4 at Baseline (PRU4 Population)
Study Visit
   Category/Statistic 
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Week 2
   WI-NRS Success [1]
      Yes 
XX (XX.X%)
XX (XX.X%)
        90% CI [2]
(X.XX, X.XX)
(X.XX, X.XX)
        95% CI [2]
(X.XX, X.XX)
(X.XX, X.XX)
      No 
XX (XX.X%)
XX (XX.X%)
      Odds Ratio (90% CI) [3] 
X.XX (X.XX, X.XX)
      Odds Ratio (95% CI) [3] 
X.XX (X.XX, X.XX)
      P value [3]
X.XXXX
Repeat for all Week 4, and Week 8.
Abbreviations: CI = confidence interval; IGA = investigator global assessment.
Note: Percentages are n/Number of subjects in the mITT PRU4 population within planned treatment*100.
Baseline is the last non-missing measurement taken on or before the day of first application of study drug.
[1] WI-NRS success (“Yes”) is defined as an achievement of a ≥4-point improvement from baseline score of 
≥4; “No” otherwise.
[2] 90% and 95% CI for “Yes” are obtained using Wilson method.
[3] The odds ratio, 90% CI, 95% CI, and P value are obtained from Cochran Mantel Haenszel test (stratified 
by study site and baseline IGA) comparing ARQ-154 to Vehicle.
Reference Listing: 16.2.6.4


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
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Page 73 of 161
Table 14.2.4.4
Worst Itch – Numeric Rating Scale (WI-NRS) Pruritus Score Success by Study Visit
mITT Population, Subjects with WI-NRS Pruritus Score ≥2 at Baseline (PRU2 Population)
(Programming note: Same as table 14.2.4.3. Update any instances of PRU4 to PRU2. Update footnotes to “Percentages are n/Number of subjects in the mITT PRU2 population 
within planned treatment*100.” Update footnote [1] as “WI-NRS success (“Yes”) is defined as an achievement of a ≥2-point improvement from baseline score of ≥2; “No” otherwise.)
Table 14.2.4.5
Worst Itch – Numeric Rating Scale (WI-NRS) Pruritus Score Success by Study Visit
ITT Population, Subjects with WI-NRS Pruritus Score ≥4 at Baseline (PRU4 Population)
(Programming note: Same as table 14.2.4.3. Update any instances of mITT with ITT)
Table 14.2.4.6
Worst Itch – Numeric Rating Scale (WI-NRS) Pruritus Score Success by Study Visit
ITT Population, Subjects with WI-NRS Pruritus Score ≥2 at Baseline (PRU2 Population)
(Programming note: Same as table 14.2.4.3. Update any instances of PRU4 to PRU2. Update footnotes to “Percentages are n/Number of subjects in the ITT PRU2 population 
within planned treatment*100.” Update footnote [1] as “WI-NRS success (“Yes”) is defined as an achievement of a ≥2-point improvement from baseline score of ≥2; “No” otherwise.)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 74 of 161
Table 14.2.4.7
Summary of Worst Itch – Numeric Rating Scale (WI-NRS) by Study Visit - ANCOVA
mITT Population 
Study Visit
    Statistic [1]
ARQ-154 0.3%
(N=XX)
Vehicle 
(N=XX)
Week 2
    n
XX
XX
    LS Mean Change from Baseline (SE)
X.XX (X.XXX)
X.XX (X.XXX)
        (90% CI for LS Mean Change from Baseline)
(X.XX, X.XX)
(X.XX, X.XX)
        (95% CI for LS Mean Change from Baseline)
(X.XX, X.XX)
(X.XX, X.XX)
    P value for LS Mean Change from Baseline) [2]
X.XXXX
    LS Mean Difference from Vehicle (SE)
(X.XX, X.XX)
        (90% CI for Difference from Vehicle)
X.XX (X.XXX)
        (95% CI for Difference from Vehicle)
X.XX (X.XXX)
    P value for Difference from Vehicle [3]
X.XXXX
Repeat for Week 4, Week 8, and Week 9.
   
Abbreviations: CI = confidence interval; IGA = investigator global assessment; LS = least-squares; SE = standard error.
Note: Subjects are summarized by planned treatment. Baseline is the last non-missing measurement taken on or before the day of first application 
of study drug. 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, 
which ranges from “no itch” to “worst imaginable itch.
[1] Estimates for LS means (change from baseline and difference from vehicle [i.e., change from baseline for Roflumilast Foam 0.3% minus 
change from baseline for vehicle]) and accompanying 90%, 95% CIs, and P values are from an analysis of covariance (ANCOVA) with treatment, 
study site, baseline IGA, and baseline WI-NRS score as independent variables. 
[2] P value for testing change from baseline is zero.
[3] P value for testing difference (Roflumilast Foam 0.3% minus Vehicle) in change from baseline from is zero.
Reference Listings: 16.2.6.1, 16.2.6.4


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
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Table 14.2.4.8
Summary of Worst Itch – Numeric Rating Scale (WI-NRS) by Study Visit - ANCOVA
ITT Population 
(Programming note: Same as table 14.2.4.7; Update any instances of mITT into ITT)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 76 of 161
Table 14.2.4.9
Summary of Worst Itch - Numeric Rating Scale (WI-NRS) by Study Visit - Categorical Scale
mITT Population
Study Visit
   Category 
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Baseline
   0
XX (XX.X%)
XX (XX.X%)
   1
XX (XX.X%)
XX (XX.X%)
   2
XX (XX.X%)
XX (XX.X%)
   3
XX (XX.X%)
XX (XX.X%)
   4
XX (XX.X%)
XX (XX.X%)
   5
XX (XX.X%)
XX (XX.X%)
   6
XX (XX.X%)
XX (XX.X%)
   7
XX (XX.X%)
XX (XX.X%)
   8
XX (XX.X%)
XX (XX.X%)
   9
XX (XX.X%)
XX (XX.X%)
   10
XX (XX.X%)
XX (XX.X%)
Repeat for Week 2, Week 4, and Week 8.
Note: Percentages are n/Number of subjects in the mITT population within planned treatment*100. 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, which ranges from “no itch” to “worst imaginable itch. Baseline is the last non-missing 
measurement taken on or before the day of first application of study drug.
Reference Listing: 16.2.6.4


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.2.4.10
Summary of Worst Itch - Numeric Rating Scale (WI-NRS) by Study Visit - Categorical Scale
ITT Population
(Programming note: Same as table 14.2.4.9; Update any instances of mITT into ITT)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 78 of 161
Table 14.2.5.1
Change from Baseline in Scalpdex by Study Visit
mITT Population
Study Visit
Roflumilast Foam 0.3%
Vehicle 
(N=XX)
   Scale
(N=XX)
      Statistic
Observed
Change
% Change
Observed
Change
% Change
Baseline 
   Emotions [1]
      n
XX
XX
      Mean (SD)
XX.X (X.XX)
XX.X (X.XX)
      Median
XX.X
XX.X
      Min, Max
XX, XX
XX, XX
      Q1, Q3
XX.X
XX.X
   Symptoms [2]
      n
XX
XX
      Mean (SD)
XX.X (X.XX)
XX.X (X.XX)
      Median
XX.X
XX.X
      Min, Max
XX, XX
XX, XX
      Q1, Q3
XX.X
XX.X
   Functioning [3]
      n
XX
XX
      Mean (SD)
XX.X (X.XX)
XX.X (X.XX)
      Median
XX.X
XX.X
      Min, Max
XX, XX
XX, XX
      Q1, Q3
XX.X
XX.X
Repeat for Total Score [4] and continue the same for Week 2, Week 4 and Week 8. 
Note: Subjects are summarized by planned treatment. Baseline is the last non-missing measurement taken before the first application of study drug. Change from baseline 
is calculated as result - baseline result. Percent change from baseline is calculated as (change from baseline/baseline)*100. Scalpdex questionnaire consists of 23 
questions which is divided into 3 scales. Scalpdex is rated on a 1 to 5 scale which is transformed into 0 to 100 scale as follows; 1 = 0; 2 = 25; 3 = 50; 4 = 75; 5 = 100.
[1] Emotions scale is calculated as average of the (Q2, Q4, Q5, Q6, Q7, Q9, Q10, Q11, Q12, Q14, Q16, Q17, Q19, Q20, and Q22; Q19 will be reverse scored i.e., 1 = 100; 
2 = 75; 3 = 50; 4 = 25; 5 = 0) after scale transformation as noted above.
[2] Symptoms scale is calculated as average of the (Q1, Q3, and Q8) after scale transformation as noted above.
[3] Functioning scale is calculated as (Q13, Q15, Q18, Q21, and Q23). 
[4] Total score is calculated as mean of all 23 questions. Q19 will be reverse scored as mentioned in [1].
Reference Listing: 16.2.6.5


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.2.5.2
Summary of Scalpdex by Study Visit - ANCOVA 
mITT Population
Study Visit
   Scale [1]   
      Statistic [2]
Roflumilast Foam 0.3%
(N=XX)
Vehicle 
(N=XX)
Week 2
   Emotions
      n
XX
XX
      LS Mean Change from Baseline (SE)
X.XX (X.XXX)
X.XX (X.XXX)
       (90% CI for LS Mean Change from Baseline)
(X.XX, X.XX)
(X.XX, X.XX)
        (95% CI for LS Mean Change from Baseline)
(X.XX, X.XX)
(X.XX, X.XX)
      P value for LS Mean Change from Baseline) [3]
X.XXXX
      LS Mean Difference from Vehicle (SE)
(X.XX, X.XX)
        (90% CI for Difference from Vehicle)
X.XX (X.XXX)
        (95% CI for Difference from Vehicle)
X.XX (X.XXX)
     P value for Difference from Vehicle [4]
X.XXXX
Continue for Symptoms, Functioning, Total Score; Repeat for Week 4, and Week 8.
   
Abbreviations: CI = confidence interval; IGA = investigator global assessment; LS = least-squares; SE = standard error.
Note: Subjects are summarized by planned treatment. Baseline is the last non-missing measurement taken on or before the day of first application 
of study drug. Scalpdex questionnaire consists of 23 questions which is divided into 3 scales. Scalpdex is rated on a 1 to 5 scale which is 
transformed into 0 to 100 scale as follows; 1 = 0; 2 = 25; 3 = 50; 4 = 75; 5 = 100.
[1] Emotions scale is calculated as average of the (Q2, Q4, Q5, Q6, Q7, Q9, Q10, Q11, Q12, Q14, Q16, Q17, Q19, Q20, and Q22; Q19 will be 
reverse scored i.e., 1 = 100; 2 = 75; 3 = 50; 4 = 25; 5 = 0) after scale transformation as noted above.
Symptoms scale is calculated as average of the (Q1, Q3, and Q8) after scale transformation as noted above.
Functioning scale is calculated as average of (Q13, Q15, Q18, Q21, and Q23) after scale transformation as noted above. 
Total score is calculated as mean of all the 23 questions. Q18 will be reverse scored as mentioned above.
[2] Estimates for LS means (change from baseline and difference from vehicle [i.e., change from baseline for ARQ-154 minus change from 
baseline for vehicle]) and accompanying 90%, 95% CIs, and P values are from an analysis of covariance (ANCOVA) with treatment, study site,
baseline IGA, and baseline Scalpdex scale score as independent variables. 
[3] P value for testing change from baseline is zero.
[4] P value for testing difference (ARQ-154 minus Vehicle) in change from baseline from is zero.
Reference Listings: 16.2.6.1, 16.2.6.5


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.2.5.3
Change from Baseline in Scalpdex by Study Visit 
ITT Population
(Programming note: Same as table 14.2.5.1; Replace any instances of mITT with ITT)
Table 14.2.5.4
Summary of Scalpdex by Study Visit - ANCOVA 
ITT Population 
(Programming note: Same as table 14.2.5.2; Replace any instances of mITT with ITT)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 81 of 161
Table 14.2.5.5
Categorical Summary of Individual Responses by Study Visit – Scalpdex Questionnaire
mITT Population
Roflumilast Foam 0.3% (N=XX)
Vehicle (N=XX)
Question [1]
      Study Visit
Never
Rarely
Sometimes
Often
All the 
time
Never
Rarely
Sometimes
Often
All the time
1. My scalp hurts
      Baseline 
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
X(XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Week 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
X(XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Week 4
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
X(XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Week 8
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
X(XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
2. My scalp itches
      Baseline 
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
X(XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Week 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
X(XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Week 4
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
X(XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Week 8
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
X(XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Continue for all the 23 questions
Note: Percentages are n/Number of subjects in the mITT Population within planned treatment*100. Baseline is the last non-missing measurement taken on or before the day of first 
application of study drug.
[1] These questions are based on the “How often during the past 4 weeks do these statements describe you?” prompt.
Reference Listing: 16.2.6.5


Statistical Analysis Plan, 
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Table 14.2.5.6
Categorical Summary of Individual Responses by Study Visit – Scalpdex Questionnaire 
ITT Population
Table 14.2.6.1
Change from Baseline in Dermatology Life Quality Index (DLQI) by Study Visit 
mITT Population
(Programming note: Same as table 14.2.4.1; Update footnotes as “Note: Subjects are summarized by planned treatment. Baseline is the last non-missing measurement taken 
before the first application of study drug. The DLQI total score is calculated as sum of all the 10 questions at each visit and ranges between 0-30. The individual questions are scored 
as ‘Very much’ or ‘Yes’= 3, ‘A lot’ = 2, ‘A Little’ = 1, ‘Not at all’ or ‘Not Relevant’ = 0. If 1 item is missing, it is scored as 0 for that item. If 2 or more items are missing, the score should 
not be calculated. Percent change from baseline is calculated as (result – baseline result)*100.”; Change reference listing to 16.2.6.6)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.2.6.2
Summary of Dermatology Life Quality Index (DLQI) by Study Visit – ANCOVA 
mITT Population 
(Programming note: Same as table 14.2.4.7; Update Note part of the footnotes as “Note: Subjects are summarized by planned treatment. Baseline is the last non-missing 
measurement taken on or before the day of first application of study drug. The DLQI total score is calculated as sum of all the 10 questions at each visit and ranges between 0-30. The 
individual questions are scored as ‘Very much’ or ‘Yes’= 3, ‘A lot’ = 2, ‘A Little’ = 1, ‘Not at all’ or ‘Not Relevant’ = 0. If 1 item is missing, it is scored as 0 for that item. If 2 or more items 
are missing, the score should not be calculated.”; Change reference listing to 16.2.6.1, 16.2.6.6)
Table 14.2.6.3
Change from Baseline in Dermatology Life Quality Index (DLQI) by Study Visit 
ITT Population
(Programming note: Same as table 14.2.4.1; Update footnotes as “Note: Subjects are summarized by planned treatment. Baseline is the last non-missing measurement taken 
before the first application of study drug. The DLQI total score is calculated as sum of all the 10 questions at each visit and ranges between 0-30. The individual questions are scored 
as ‘Very much’ or ‘Yes’= 3, ‘A lot’ = 2, ‘A Little’ = 1, ‘Not at all’ or ‘Not Relevant’ = 0. If 1 item is missing, it is scored as 0 for that item. If 2 or more items are missing, the score should 
not be calculated. Percent change from baseline is calculated as (result – baseline result)*100.”; Change reference listing to 16.2.6.6)
Table 14.2.6.4
Summary of Dermatology Life Quality Index (DLQI) by Study Visit – ANCOVA 
ITT Population
(Programming note: Same as table 14.2.4.7; Update Note part of the footnotes as “Note: Subjects are summarized by planned treatment. Baseline is the last non-missing 
measurement taken on or before the day of first application of study drug. The DLQI total score is calculated as sum of all the 10 questions at each visit and ranges between 0-30. The 
individual questions are scored as ‘Very much’ or ‘Yes’= 3, ‘A lot’ = 2, ‘A Little’ = 1, ‘Not at all’ or ‘Not Relevant’ = 0. If 1 item is missing, it is scored as 0 for that item. If 2 or more items 
are missing, the score should not be calculated.”; Change reference listing to 16.2.6.1, 16.2.6.6; Update any instances of mITT with ITT)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 84 of 161
Table 14.2.7.1
Change from Baseline in Body Surface Area (BSA) by Study Visit
mITT Population
(Programming note: Same as table 14.2.4.1; Update footnotes as “Note: Subjects are summarized by planned treatment. Baseline is the last non-missing measurement taken on 
or before the day of first application of study drug. Change from baseline is calculated as result - baseline result. Percent change from baseline is calculated as (change from 
baseline/baseline)*100.” Change reference listing to 16.2.6.7)
Table 14.2.7.2
Summary of Body Surface Area (BSA) by Study Visit - ANCOVA
mITT Population
(Programming note: Same as table 14.2.4.7; Update note part of the footnotes as “Note: Subjects are summarized by planned treatment. Baseline is the last non-missing 
measurement taken on or before the day of first application of study drug. The BSA affected by seborrheic dermatitis will be calculated as sum of coverage areas of heard, upper and 
lower limbs, and trunk.” Change reference listings to 16.2.6.1, 16.2.6.7)
Table 14.2.7.3
Change from Baseline in Body Surface Area (BSA) by Study Visit
ITT Population
(Programming note: Same as table 14.2.4.1; Update footnotes as “Note: Subjects are summarized by planned treatment. Baseline is the last non-missing measurement taken on 
or before the day of first application of study drug. Change from baseline is calculated as result - baseline result. Percent change from baseline is calculated as (change from 
baseline/baseline)*100.” Change reference listing to 16.2.6.7; Update mITT with ITT)
Table 14.2.7.4
Summary of Body Surface Area (BSA) by Study Visit - ANCOVA
mITT Population
(Programming note: Same as table 14.2.4.7; Update note part of the footnotes as “Note: Subjects are summarized by planned treatment. Baseline is the last non-missing 
measurement taken on or before the day of first application of study drug. The BSA affected by seborrheic dermatitis will be calculated as sum of coverage areas of heard, upper and 
lower limbs, and trunk.” Change reference listings to 16.2.6.1, 16.2.6.7; Update mITT with ITT)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU0100
AD-ST-33.05  Effective date: 22-Jan-2018
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Page 85 of 161
Table 14.3.1.1
Summary of Treatment Emergent Adverse Events
Safety Population
Category
Roflumilast Foam 
0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Subjects with at least 1 TEAE
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Maximum Severity of TEAE [1]
      Grade 1 (Mild)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 2 (Moderate)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 3 (Severe)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 4 (Life-threatening consequences)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 5 (Death related to AE)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Subjects with a Related TEAE [2]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Subjects with a TEAE Leading to Discontinuation of Study Drug
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Subjects with an SAE
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Subjects with a Grade 5 TEAE [3]
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events; IP = investigational product; SAE = serious adverse event; 
TEAE = treatment emergent adverse event.
Note: Percentages are n/Number of subjects in the Safety population within treatment received*100. A TEAE is defined as an AE that started 
post application of IP at the baseline visit through study completion.
[1] Severity grades are reported according to the CTCAE version 4.0. Subjects are counted only once at the worst severity. If a severity 
designation is missing, it was considered as severe.
[2] AEs with a relationship of possibly, probably, likely, or missing were considered related.
[3] A Grade 5 TEAE is a TEAE leading to death.
Reference Listing: 16.2.7.1


Statistical Analysis Plan, 
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Table 14.3.1.2
Incidence of Treatment Emergent Adverse Events by System Organ Class and Preferred Term
Safety Population
System Organ Class
   Preferred Term
Roflumilast Foam 
0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Subjects with at least 1 TEAE
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
System Organ Class 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
System Organ Class 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: AE = adverse event; IP = investigational product; MedDRA = Medical Dictionary for Regulatory Activities; TEAE = 
treatment emergent adverse event.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. AEs were coded 
using MedDRA version 23.0. A TEAE is defined as an AE that started post application of IP at the baseline visit through study 
completion. Subjects are counted once for each system organ class (SOC) and once for each preferred term (PT). AEs are displayed 
by descending frequency of SOC, then PT within SOC, and then alphabetically by PT.
Reference Listing: 16.2.7.1
Programming note: SOC & PT text should be presented as is from the dataset.


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Table 14.3.1.3
Incidence of Treatment Emergent Adverse Events by System Organ Class, Preferred Term, and Maximum Severity
Safety Population
System Organ Class   
   Preferred Term
      Maximum Severity [1]
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Subjects with at least 1 TEAE
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 1 (Mild)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 2 (Moderate)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 3 (Severe)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 4 (Life-threatening consequences)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 5 (Death related to AE)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
System Organ Class 1
      Grade 1 (Mild)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 2 (Moderate)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 3 (Severe)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 4 (Life-threatening consequences)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 5 (Death related to AE
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
      Grade 1 (Mild)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Grade 2 (Moderate)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
…
Abbreviations: AE = adverse event; IP = investigational product; CTCAE = Common Terminology Criteria for Adverse Events; MedDRA = Medical 
Dictionary for Regulatory Activities; TEAE = treatment emergent adverse event.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. AEs were coded using MedDRA 
version 23.0. A TEAE is defined as an AE that started post application of IP at the baseline visit through study completion. Subjects are counted 
once for each system organ class (SOC) and once for each preferred term (PT) at the maximum severity. 
[1] Severity grades are reported according to the CTCAE version 4.0. The severity shown is the greatest severity reported for a particular subject 
(Death related to AE > Life-threatening consequences > Severe > Moderate > Mild). AEs with a missing severity were counted as Severe. AEs are 
displayed by descending frequency of SOC, then PT within SOC, and then alphabetically by PT.
Reference Listing: 16.2.7.1
Programming note: SOC & PT text should be presented as is from the dataset.


Statistical Analysis Plan, 
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Table 14.3.1.4
Incidence of Treatment Emergent Adverse Events by System Organ Class, Preferred Term, and Relationship to Study Drug
Safety Population
System Organ Class
   Preferred Term
      Relationship [1]
Roflumilast Foam 
0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Subjects with at least 1 TEAE
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Related
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Not Related
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
System Organ Class 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Related
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Not Related
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Related
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Not Related
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: AE = adverse event; IP =investigational product; MedDRA = Medical Dictionary for Regulatory Activities; TEAE = 
treatment emergent adverse event.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. AEs were coded 
using MedDRA version 23.0. A TEAE is defined as an AE that started post application of IP at the baseline visit through study 
completion. Subjects are counted once for each system organ class (SOC) and once for each preferred term (PT) at the greatest 
relationship category. The relationship shown is the greatest relationship reported for a particular subject (Related > Not Related). 
AEs with a missing relationship were counted as Related. AEs are displayed by descending frequency of SOC, then PT within SOC, 
and then alphabetically by PT.
[1] Related = Probably Related, Possibly Related, Likely Related, and Missing; Not Related = Unrelated and Unlikely Related.
Reference Listing: 16.2.7.1
Programming note: SOC & PT text should be in proper case in table, as shown in the shell.


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Table 14.3.1.5
Incidence of Treatment Emergent Adverse Events Leading to Study Drug Discontinuation by System Organ Class and Preferred Term
Safety Population
(Same shell as Table 14.3.1.2)
Table 14.3.2.1
Incidence of Serious Adverse Events by System Organ Class and Preferred Term
Safety Population
(Same shell as Table 14.3.1.2; first-row text is “Subjects with at least 1 SAE”; add SAE = serious adverse event)
Table 14.3.2.2
Incidence of Serious Adverse Events by System Organ Class, Preferred Term, and Relationship to Study Drug
Safety Population
(Same shell as Table 14.3.1.4; first-row text is “Subjects with at least 1 SAE”; add SAE = serious adverse event)


Statistical Analysis Plan, 
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Table 14.3.2.3
Incidence of Serious Adverse Events by System Organ Class, Preferred Term, and Maximum Severity
Safety Population
(Same shell as Table 14.3.1.3; first-row text is “Subjects with at least 1 SAE”; add SAE = serious adverse event)


Statistical Analysis Plan, 
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Table 14.3.3.1
Listing of Adverse Events Leading to Study Drug Discontinuation
Safety Population
Subject 
ID
Treatment 
Received
System Organ Class/
   Preferred Term/
      Verbatim Term
Start Date/Time (Study Day)/
   End Date/Time (Study Day)
CTCAE Toxicity Grade/
   Relationship
Outcome/
  Study Drug Action Taken/
    Other Action Taken
Serious?/
  Criteria Met
XXXXX
XXXXXXXX
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXXXXX
      XXXXXXXXXXXXX
DDMONYYYY/hh:mm (X)/
   DDMONYYYY/hh:mm (X)
XXXXXXXXX/
   XXXXXXXXXX
XXXXXXXXX/
   XXXXXXXXXXXX/
      XXXXXXXXXX
XX
XXXXX
XXXXXXXX
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXXXXX
      XXXXXXXXXXXXX
DDMONYYYY/hh:mm (X)/
   DDMONYYYY/hh:mm (X)
XXXXXXXXX/
   XXXXXXXXXX
XXXXXXXXX/
   XXXXXXXXXXXX/
      XXXXXXXXXX
XX
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXXXXX
      XXXXXXXXXXXXX
DDMONYYYY/hh:mm (X)/
   DDMONYYYY/hh:mm (X)
XXXXXXXXX/
   XXXXXXXXXX
XXXXXXXXX/
   XXXXXXXXXXXX/
      XXXXXXXXXX
XXX/
   XXXXXXXXX
Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events; MedDRA = Medical Dictionary for Regulatory Activities.
Note: Study day is calculated relative to the date of first application of study drug. AEs were coded using MedDRA version 23.0. Severity grades are reported according to the CTCAE 
version 4.0.
Programming note: If time missing, display “- -:- -”. “Other Action Taken” will be either None, Concomitant Medication, Non-drug Therapy, Hospitalization or Prolongation of 
Hospitalization, Discontinued Study or Other; if specify text is needed, concatenate “Concomitant Medication:” or “Other:” with the text. If Serious? is Yes, concatenate all serious 
criteria marked as Yes with a semicolon. If no events meet the criteria for display, present “No events are reported.” SOC & PT text should be presented as is from the dataset.


Statistical Analysis Plan, 
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Table 14.3.3.2
Listing of Serious Adverse Events
Safety Population
(Same shell as Table 14.3.3.1)
Table 14.3.3.3
Listing of Deaths
Safety Population
(Same shell as Table 14.3.3.1)


Statistical Analysis Plan, 
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Table 14.3.5.1.1
Summary of Clinical Chemistry Laboratory Results by Study Visit
Safety Population
Parameter: XXXXXXX (unit)
Study Visit
   Statistic
Roflumilast Foam 0.3%
(N=XX)
Vehicle 
(N=XX)
Overall
(N=XX)
Observed
CFB
Observed
CFB
Observed 
CFB
Baseline
   n
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
Week 8
   n
XX
XX
XX
XX
XX
XX
   Mean (SD)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
XX.X (XX.XX)
   Median
XX.X
XX.X
XX.X
XX.X
XX.X
XX.X
   Min, Max
XX, XX
XX, XX
XX, XX
XX, XX
XX, XX
XX, XX
Continue for other parameters. Sort alphabetically by parameter.
Abbreviation: CFB = change from baseline.
Note: Subjects are summarized by treatment received and overall. Baseline is the last non-missing measurement taken before the first application of study drug.
Reference Listing: 16.2.8.1.1


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Table 14.3.5.1.2
Shift from Baseline in Clinical Chemistry Laboratory Results by Study Visit 
Safety Population
Parameter: XXXXXXX (unit)
Baseline Grade
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Study Visit
Post-Baseline 
Grade
Missing
Low
Normal
High
Total
Missing
Low
Normal
High
Total
Week 8
Missing
Low
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Normal
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
High
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Total
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Repeat for Overall and all clinical chemistry parameters (excluding serum HCG results).
Note: Percentages are n/Number of subjects in the Safety population within treatment received*100. Baseline is the last non-missing measurement taken before the first application of study drug.
Reference Listing: 16.2.8.1.1


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Table 14.3.5.2.1
Summary of Hematology Laboratory Results by Study Visit 
Safety Population
(Same shell as Table 14.3.5.1.1; Reference Listing: 16.2.8.1.2)
Table 14.3.5.2.2
Shift from Baseline in Hematology Laboratory Results by Study Visit 
Safety Population
(Same shell as Table 14.3.5.1.2; Reference Listing: 16.2.8.1.2)
Table 14.3.5.3.1
Summary of Quantitative Urinalysis Laboratory Results by Study Visit 
Safety Population
(Same shell as Table 14.3.5.1.1; Reference Listing: 16.2.8.1.3)
Table 14.3.5.3.2
Shift from Baseline in Quantitative Urinalysis Laboratory Results by Study Visit 
Safety Population
(Same shell as Table 14.3.5.1.2; Reference Listing: 16.2.8.1.3)


Statistical Analysis Plan, 
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Table 14.3.5.3.3
Summary of Qualitative Urinalysis Laboratory Results by Study Visit
Safety Population
Parameter: XXXXXXX (unit)
Study Visit
   Category
Roflumilast Foam 
0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Baseline
   XXXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   XXXXXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Week 8
   XXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   XXXXXXXXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   XXXXXXXX
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Baseline is the last 
non-missing measurement taken before the first application of study drug.
Reference Listing: 16.2.8.1.3


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Table 14.3.6.1
Shift from Baseline in Patient Health Questionnaire (PHQ-8) by Study Visit
Safety Population
Baseline Grade
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Study Visit
   Category [1]
Missing
None
Mild
Moderate
Moderately 
Severe
Severe
Missing
None
Mild
Moderate
Moderately 
Severe
Severe
Week 4
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
   Missing
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
   None
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
   Mild
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
   Moderate
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
   Moderately 
   Severe
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
   Severe
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
XX 
(XX.X%)
Programming note: Add Total category for both column and row. Repeat for Overall and continue for Week 8
Abbreviation: PHQ = patient health questionnaire.
Note: Percentages are n/Number of subjects in the Safety population within treatment received*100. Baseline is the last non-missing measurement taken on or before the day of
first application of study drug. PHQ total score is calculated as sum of the 8 questions (individual questions scored as Not at all=0, Several days=1, More than half the days=2, and 
Nearly every day=3). The total score ranges from 0 to 24. If more than 1 item is missing the score should not be calculated. If 1 item is missing the score is calculated as (sum of 
answered items*8)/number of answered items.
[1] If the total score ranges from 0 to 4, it is classified as None – Minimal Depression; 5 – 9 classified as Mild; 10 – 14 classified as Moderate; 15-19 classified as Moderately 
Severe; 20 – 24 classified as Severe Depression.
Reference Listing: 16.2.9.8


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Table 14.3.6.2.1
Summary of Investigator Local Tolerability Assessment (Dermal Response) by Study Visit 
Safety Population
(Same shell as Table 14.3.5.1.1; Reference Listing: 16.2.9.1; Repeat for Week 4, Week 8; Add “Abbreviation: IP = investigational product.” as the first line of footnotes. Add 
this line at the end in note footnote – “Lower scores indicate no evidence of irritation while higher scores indicate worsening reaction. Investigator tolerability 
assessment should be performed prior to the IP application in the study site. Subjects not meeting this condition on baseline visit are completely removed from the table 
summary. ”; Update the baseline definition as “Baseline is the last non-missing measurement taken on or before the day of first application of study drug.”)


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Table 14.3.6.2.2
Summary of Investigator Local Tolerability Assessment (Dermal Response) by Study Visit
Categorical Results
Safety Population
Study Visit
   Category
Roflumilast Foam 
0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Baseline
    0 = No evidence of irritation
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    1 = Minimal erythema
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    2 = Definite erythema
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    3 = Erythema and papules
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    4 = Definite edema
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    5 = Erythema, edema and papules
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    6 = Vesicular eruption
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    7 = Strong reaction spreading beyond application site
Week 4
    0 = No evidence of irritation
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    1 = Minimal erythema
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    2 = Definite erythema
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    3 = Erythema and papules
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    4 = Definite edema
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    5 = Erythema, edema and papules
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    6 = Vesicular eruption
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    7 = Strong reaction spreading beyond application site
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Repeat for Week 8
Abbreviation: IP = investigational product.
Note: Percentages are n/Number of subjects in the Safety Population within treatment received and overall*100. Baseline is the last 
non-missing measurement taken on or before the day of first application of study drug. Investigator tolerability assessment should be 
performed prior to the IP application in the study site. Subjects not meeting this condition on baseline visit are completely removed 
from the table summary.
Reference Listing: 16.2.9.1


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 100 of 161
Table 14.3.6.2.3
Summary of Investigator Local Tolerability Assessment (Other Effects) by Study Visit
Categorical Results
Safety Population
Study Visit
   Category
Roflumilast Foam 
0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Baseline
   A = Slight glazed appearance
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   B = Marked glazing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   C = Glazing with peeling and cracking
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   D = Glazing with fissures
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   E = Film of dried serous exudates 
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   F = Small petechial erosions and/or scabs
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   G = No other effects
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Week 4
   A = Slight glazed appearance
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   B = Marked glazing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   C = Glazing with peeling and cracking
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   D = Glazing with fissures
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   E = Film of dried serous exudates 
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   F = Small petechial erosions and/or scabs
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   G = No other effects
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Repeat for Week 8
Abbreviation: IP = investigational product.
Note: Percentages are n/Number of subjects in the Safety Population within treatment received and overall*100. Baseline is the last 
non-missing measurement taken on or before the day of first application of study drug. Investigator tolerability assessment should be 
performed prior to the IP application in the study site. Subjects not meeting this condition on baseline visit are completely removed 
from the table summary.
Reference Listing: 16.2.9.1


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 101 of 161
Table 14.3.6.3.1
Summary of Subject Local Tolerability Assessment by Study Visit
Safety Population
(Same shell as Table 14.3.5.1.1; Reference Listing: 16.2.9.2; Repeat for Week 4, Week 8; Add “Abbreviation: IP = investigational product.” as the first line of footnotes. Add this line at 
the end in note footnote – “Lower scores indicate no sensation while higher scores indicate worsening/severe reaction. This assessment should be performed 10 – 15 minutes after the 
application of IP in the study site. Subjects not meeting this condition on baseline visit are completely removed from the table summary. ”) Update Baseline definition as Baseline for 
subject local tolerability assessment is the last non-missing measurement taken on the day of first application of study drug.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
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Page 102 of 161
Table 14.3.6.3.2
Summary of Subject Local Tolerability Assessment by Study Visit
Categorical Results
Safety Population
Study Visit
   Category
Roflumilast Foam 
0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Baseline
    0 = None (no sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    1 = Mild (slight warm, tingling sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    2 = Moderate (definite warm, tingling sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    3 = Severe (hot, tingling/stinging sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Week 4
    0 = None (no sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    1 = Mild (slight warm, tingling sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    2 = Moderate (definite warm, tingling sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
    3 = Severe (hot, tingling/stinging sensation)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Repeat for Week 8
Abbreviation: IP = investigational product.
Note: Percentages are n/Number of subjects in the Safety Population within treatment received and overall*100. Baseline for subject 
local tolerability assessment is the last non-missing measurement taken on the day of first application of study drug. This 
assessment should be performed 10 – 15 minutes after the application of IP in the study site. Subjects not meeting this condition on 
baseline visit are completely removed from the table summary.
Reference Listing: 16.2.9.2


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
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Page 103 of 161
Table 14.3.6.4.1
Summary of Vital Signs by Study Visit
Safety Population
(Same shell as Table 14.3.5.1.1; visits include Baseline, Week 2, Week 4, Week 8, Week 9; parameters include Temperature (°C), Heart Rate (bpm), Sitting Systolic Blood 
Pressure (mmHg), Sitting Diastolic Blood Pressure (mmHg), Height (cm), Weight (kg), BMI (kg/m2) [1]; Update Baseline definition as “Baseline is the last non-missing 
measurement taken on or before the first application of study drug.” [1] Body Mass Index (BMI) = weight (kg) / [height (m)]2. 
Reference Listings: 16.2.9.4.1, 16.2.9.4.2)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
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Table 14.3.6.4.2
Shift from Baseline in Weight by Study Visit 
Safety Population
Study Visit
   Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Week 2
   Change from Baseline ≤-10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline  ≤-5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline ≥5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline ≥10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Week 4
   Change from Baseline ≤-10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline  ≤-5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline ≥5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline ≥10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Week 8
   Change from Baseline ≤-10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline  ≤-5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline ≥5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline ≥10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Programming note: Continue for Week 9
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Baseline is the last non-
missing measurement taken on or before the first application of study drug.
Reference Listing: 16.2.9.4.2


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
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Table 14.3.6.4.3
Shift from Baseline in BMI by Study Visit 
Safety Population
Baseline Grade
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Study 
Visit
Post-
Baseline 
Grade [1]
Missing
Underweight
Normal
Overweight
Obese
Missing
Underweight
Normal
Overweight
Obese
Week 2
Missing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Underweight
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Normal
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Overweight
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Obese
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Repeat for Overall and Week 4, Week 8, and Week 9
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Baseline is the last non-missing measurement taken on or before the day of
first application of study drug. BMI is derived as (weight in kg)/[(height in cm/100)2]. 
[1] If BMI is below 18.5 then it is categorized as underweight; if BMI ranges between 18.5 – 24.9 then it is categorized as Normal; if BMI ranges between 25.0 – 29.9 then it is categorized as 
overweight; if BMI is greater than 30.0 then it is categorized as obese.
Reference Listings: 16.2.9.4.1, 16.2.9.4.2


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
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Page 106 of 161
Table 14.3.6.4.4
Shift from Baseline in Weight by Study Visit – by Weight Loss Intentional/Non-Intentional
Safety Population
Weight Loss: Intentional
Study Visit
   Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Week 2
   Change from Baseline ≤-10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline  ≤-5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline ≥5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline ≥10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Week 4
   Change from Baseline ≤-10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline  ≤-5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline ≥5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline ≥10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Week 8
   Change from Baseline ≤-10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline  ≤-5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline ≥5%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Change from Baseline ≥10%
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Programming note: Continue for Week 9 and repeat for Weight Loss: Not Intentional or Missing
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Baseline is the last non-
missing measurement taken on or before the first application of study drug.
Reference Listing: 16.2.9.4.2


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.3.6.4.5
Shift from Baseline in BMI by Study Visit - by Weight Loss Intentional/Non-Intentional
Safety Population
Weight Loss: Intentional
Baseline Grade
Roflumilast Foam 0.3%
(N=XX)
Vehicle
(N=XX)
Study 
Visit
Post-
Baseline 
Grade [1]
Missing
Underweight
Normal
Overweight
Obese
Missing
Underweight
Normal
Overweight
Obese
Week 2
Missing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Underweight
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Normal
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Overweight
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Obese
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Add Total category for row and column. Repeat for Overall and Week 4, Week 8, and Week 9 and continue for Weight Loss: Not Intentional or Missing
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Baseline is the last non-missing measurement taken on or before the day of
first application of study drug. BMI is derived as (weight in kg)/[(height in cm/100)2]. 
[1] If BMI is below 18.5 then it is categorized as underweight; if BMI ranges between 18.5 – 24.9 then it is categorized as Normal; if BMI ranges between 25.0 – 29.9 then it is categorized as 
overweight; if BMI is greater than 30.0 then it is categorized as obese.
Reference Listings: 16.2.9.4.1, 16.2.9.4.2


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
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Table 14.3.6.5
Summary of Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation and Suicidal Behavior by Study Visit
Safety Population
Study Visit
   C-SSRS Section
Roflumilast Foam 0.3%
Vehicle
Overall
      C-SSRS Item
(N=XX)
(N=XX)
(N=XX)
Screening
   Suicidal Ideation
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Wish to be Dead
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Non-Specific Active Suicidal Thoughts
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Active Suicidal Ideation with Any Methods
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Active Suicidal Ideation with Some Intent
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Active Suicidal Ideation with Specific Plan
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Suicidal Behavior
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Actual Attempt
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Subject Engaged in Non-Suicidal Self-Injurious Behavior
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Interrupted Attempt
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Aborted Attempt
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Preparatory Acts or Behavior
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Repeat for Baseline, Week 4, and Week 8; Add Suicide as a separate row for all visits except Screening.
Abbreviation: C-SSRS = Columbia-Suicide Severity Rating Scale.
Note: Percentages are n/Number of subjects in the Safety population within treatment received and overall*100. Baseline is the last non-missing measurement taken before 
the first application of study drug. The number and percent of subjects who experience the event at least once during treatment are summarized. Subjects are counted once 
for each C-SSRS section and once for each C-SSRS item answered “Yes” during treatment period. “Baseline/Screening” version will be used for Screening visit and “Since 
Last Visit” was used for all other visits.
Reference Listing: 16.2.9.9


Statistical Analysis Plan, 
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Protocol Number ARQ-154-203
PCN Number ARCU210100
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Table 14.3.6.6
Summary of Physical Examination by Study Visit
Safety Population
Study Visit
   Body System
      Category
Roflumilast Foam 0.3%
(N=XX)
Vehicle 
(N=XX)
Overall
(N=XX)
Screening
   Skin
      Normal
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Abnormal (NCS)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Abnormal (CS)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Missing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Total
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Lungs
      Normal
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Abnormal (NCS)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Abnormal (CS)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Missing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Total
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Heart
      Normal
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Abnormal (NCS)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Abnormal (CS)
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Missing
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
      Total
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
                                      Repeat for Baseline, Week 8
Abbreviations: CS = clinically significant; NCS = not clinically significant.
Note: Percentages are n/Number of subjects in the Safety population within treatment received an overall*100. 
Reference Listing: 16.2.9.5


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
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Page 110 of 161
Table 14.3.6.7
Summary of Concomitant Medications by ATC Class Level 4 and Preferred Term
Safety Population
ATC Class Level 4
   Preferred Term
Roflumilast Foam 
0.3%
(N=XX)
Vehicle
(N=XX)
Overall
(N=XX)
Subjects with at least 1 Concomitant Medication
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
ATC Class 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
ATC Class 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 1
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 2
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
   Preferred Term 3
XX (XX.X%)
XX (XX.X%)
XX (XX.X%)
Abbreviations: ATC = Anatomic Therapeutic Chemical; PT = preferred term; WHO-DDE = World Health Organization-Drug Dictionary 
Enhanced.
Note: Percentages are n/Number of subjects in the Safety population within treatment received*100. Medications were coded using 
WHO-DDE Global B3 version September 2019. Concomitant medications are all medications that were continuing or starting after first 
application of study drug. Medications are displayed by alphabetical order of ATC Level 4 classification, then descending frequency of 
PT within ATC, and then alphabetically by PT. Subjects were counted only once for each ATC and PT.
Reference Listing: 16.2.9.7
Programming note: ATC & PT text should be presented as is from dataset.


Statistical Analysis Plan, 
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Table 14.4.1.1
Summary of Pharmacokinetic Concentration Results by Study Visit
PK Population
Study Visit
   Time Point
      Statistic
Roflumilast Foam 0.3%
(N=XX)
Baseline
   Predose
       n
XX
       Mean (SD)
XX.X (XX.XX)
       Median 
XX.X
       Min, Max
XX, XX
Week 4
   Predose
       n
XX
       Mean (SD)
XX.X (XX.XX)
       Median 
XX.X
       Min, Max
XX, XX
   Postdose
       n
XX
       Mean (SD)
XX.X (XX.XX)
       Median 
XX.X
       Min, Max
XX, XX
Programming note: Repeat for Week 8 Predose & Postdose
Note: Subjects are summarized by treatment received.
Reference Listing: 16.2.5.6


Statistical Analysis Plan, 
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Table 14.4.1.2
Summary of Pharmacokinetic Parameters by Study Visit
PK Population
Parameter: XXXXXXXX
Study Visit
   Statistic
Roflumilast Foam 0.3%
(N=XX)
Baseline
    n
XX
    Mean (SD)
XX.X (XX.XX)
    Median 
XX.X
    Min, Max
XX, XX
Week 4
    n
XX
    Mean (SD)
XX.X (XX.XX)
    Median 
XX.X
    Min, Max
XX, XX
Week 8
     n
XX
     Mean (SD)
XX.X (XX.XX)
     Median 
XX.X
    Min, Max
XX, XX
Programming note: Continue for all parameters and repeat for Week 8 
Note: Subjects are summarized by treatment received.
Reference Listing: 16.2.5.6


Statistical Analysis Plan, 
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PCN Number ARCU210100
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Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 113 of 161
14.3.
Planned Listing Shells
Listing 16.2.1.1
Subject Disposition
All Subjects
Subject 
ID
Randomized 
Treatment
Did Subject
Complete 
Study?
Date of 
Completion/
Early Termination 
(Study Day)
Date of Last Visit
(Study Day)
Reason for Early 
Termination
  Date of Death/
     Cause of Death
Early Termination 
due to COVID-19 
Disruption
Participating 
in Extension 
Study?
XXXX
XXXXX
Yes
DDMMMYYYY 
(XX)
XX
Yes
XXXX
XXXXX
Yes
DDMMMYYYY 
(XX)
XX
Yes
XXXX
XXXXX
Yes
DDMMMYYYY 
(XX)
XX
No
XXXX
XXXXX
Ongoing
XXXX
XXXXX
No
DDMMMYYYY 
(XX)
DDMMMYYYY 
(XX)
XXXXXX; date of last 
contact: DDMMMYYYY
DDMMMYYYY /
    XXXXXXX
XX
No
Abbreviation: COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of first application of study drug.
Programming Note: If reason for early termination is Other, concatenate the specify text as follows: “Other: XXXXXXXXX”. If reason for early termination is lost to follow-up, 
concatenate with date of last contact as follows: “Lost to follow-up; date of last contact: DDMMMYYYY”. 


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 114 of 161
Listing 16.2.1.2
Subject Visits
All Subjects
Subject ID
Treatment 
Received
Was Visit 
Performed?
Visit
Visit Date
(Study Day)
If Visit not Performed, 
COVID-19 Disruption 
Contributed to Missed Visit
XXXXXX
XXXXXX
Yes
XXXXXXX
DDMMMYYYY (XX)
Yes
XXXXXX
DDMMMYYYY (XX)
Yes
XXXXXXXXX
DDMMMYYYY (XX)
No
XXXXXXX
Yes
XXXXXX
XXXXXX
Yes
XXXXXXX
DDMMMYYYY (XX)
Yes
XXXXXX
DDMMMYYYY (XX)
Abbreviation: COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of first application of study drug.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 115 of 161
Listing 16.2.2.1
Inclusion and Exclusion Criteria
All Subjects
Subject Screen Failed
Date/Time (Study Day) of:
All Inclusion
Criteria Met?
[1]
Any 
Exclusion
Criteria Met?
[2]
Subject ID
Was Subject 
Rescreened?
due to COVID-19 
Disruption
Randomized 
Treatment
Screening
Informed Consent
XXXXXX
XX
XX
XXXXXX
DDMMMYYYY 
(-X)
DDMMMYYYY/hh:mm
(-X) 
Yes
No
XXXXXX
XX
XX
DDMMMYYYY 
DDMMMYYYY/hh:mm
No: 06, 10
No
XXXXXX
XX
XX
DDMMMYYYY 
DDMMMYYYY/hh:mm
No: 01
No
XXXXXX
XXX
XXX
XXXXXX
DDMMMYYYY 
(-X)
DDMMMYYYY/hh:mm
(-X) 
Yes
Yes: 02
XXXXXX
XX
XX
XXXXXX
DDMMMYYYY
(-X) 
DDMMMYYYY
(-X) 
Yes
No
XXXXXX
XX
XX
XXXXXX
DDMMMYYYY 
(-X)
DDMMMYYYY 
(-X)
Yes
No
Abbreviation: COVID-19 = novel coronavirus disease.
Note: If a subject is a rescreen, the latest date of screening and informed consent are presented.
[1] 01 = Participants legally competent to sign and give informed consent; 06 = Overall Assessment of Erythema and Overall Assessment of Scaling scores of Moderate (‘2’) 
at Baseline; 10 = Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.
[2] 02 = Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
Programming note: If more than 1 inclusion or exclusion criterion number exists, concatenate with a comma as shown above. Decode any relevant criteria in the footnotes as shown 
in the example. If no criteria are present for a column, remove the [1] and/or [2] from the column header. Time is only collected for informed consent. If time is missing, display as 
shown in the shell. If subject rescreens, populate the latest date of screening and informed consent.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 116 of 161
Listing 16.2.2.2
Protocol Deviations
All Subjects
Subject 
ID
Treatment 
Received
Event Type
Description
COVID-19 Related
COVID-19 Infection
XXXXXX
XXXXXX
XXXXXXXXXXX
XXXXXXX
XXXXXXXXXXXXXX
XXXXXXXXXXXXXXX
XXXXXX
XXXXXX
XXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXX
XXXXXXXXXXXXXXXX XXXXXXXXXXX
XXXXXX
XXXXXX
XXXXXX
XXXXXX
XXXXXXXXXXXX
XXXXXXXXXXXXXXXXXXXX
XXXXXX
XXXXXX
Abbreviation: COVID-19 = novel coronavirus disease.
Programming note: the structure of this listing may change depending on the information in the protocol deviations file.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 117 of 161
Listing 16.2.3
Analysis Populations
All Subjects
Subject 
ID
Treatment 
Received
Randomization
Safety
[1]
mITT
[2]
Primary Reason(s) for 
Exclusion
Randomized
Treatment
Date/Time
Number
Stratification 
ID
ITT 
[3]
PRU2
[4]
PRU4
[5]
PK
[6]
XXXX
XXXXXX
XXXXX
DDMMMYYY/
hh:mm
XXXX
XXXX
Yes
Yes
Yes
Yes
XXXX
XXXXXXX
XXXXX
DDMMMYYY/
hh:mm
XXXX
XXXX
Yes
Yes
Yes
Yes
XXXX
XXXXXX
No
No
No
No
Subject did not receive at least 
1 dose of IP.
Abbreviations: COVID-19 = novel coronavirus disease; ITT = intent-to-treat; IGA = investigator global assessment; IP = investigational product; mITT = modified intent-to-treat; NA = 
not applicable; WI-NRS = Worst Itch – Numeric Rating Scale. Stratification ID is baseline severity of IGA. If stratification ID = 1 then IGA = Moderate; if 2 then IGA = Severe.
[1] The Safety Population includes all subjects who are enrolled and received at least 1 confirmed dose of IP.
[2] The mITT population includes all randomized subjects with the exception of subjects who missed the week 8 IGA assessment specifically due to COVID-19 disruption.
[3] The ITT Population includes all subjects who are randomized. 
[4] The PRU2 population is a subset of the ITT population and includes subjects with WI-NRS pruritus score ≥ 2 at Baseline. This population will be used for the analysis of 
achievement of a 2-point reduction in WI-NRS pruritus score as compared to Baseline.
[5] The PRU4 population is a subset of the ITT population and includes 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] 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.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 118 of 161
Listing 16.2.4.1
Demographics and Baseline Characteristics
All Subjects
Child-Bearing
Potential? If 
Yes, Specify 
Contraception
Year 
of
Birth
Age
(years) 
[1]
Was 
Photography 
Consent 
Obtained?
Photography 
Consent Date
Subject 
ID
Treatment 
Received
Sex
Ethnicity
Race
Height 
(cm)
Weight 
(kg)
BSA
(%)
XXXXXX
XXXXXX
XXXX
No
YYYY
XX
XXXXXXX
XXXXXXX
Yes
DDMMMYYYY
XX
XX
XX
XXXXXX
XXXXXX
XXXXXX
No
YYYY
XX
XXXXXXX
XXXXXX
Yes
DDMMMYYYY
XX.X
XX
XX
XXXXXX
XXXXXX
XXXX
YYYY
XX
XXXXXXX
XXXXXX
No
XX.X
XX
XX
XXXXXX
XXXXXX
XXXX
YYYY
XX
XXXXXXX
XXXXX
Yes
DDMMMYYYY
XX
XX
XX.X
XXXXXX
XXXXXX
XXXXXX
No
YYYY
XX
XXXXXXX
XXXXXX
Yes
DDMMMYYYY
XX
XX
XX
XXXXXX
XXXXXX
XXXXX
Yes: 
XXXXXXX
YYYY
XX
XXXXXX
XXXXXX
XXX
DDMMMYYYY
XX
XX
XX.X
Abbreviation: BSA = body surface area.
Note: Weight, and BSA are the values at Screening. Height is collected at Baseline Day 0.
[1] Age at Screening. 
Programming Note: If subject has multiple races, concatenate them. If child-bearing potential is Yes, concatenate type of contraception with “:” as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 119 of 161
Listing 16.2.4.2
Medical History
All Subjects
Subject ID
Treatment 
Received
Type of History
Other Medical History Conditions
System Organ Class/
  Preferred Term/
      Verbatim Term
Start Date (Study Day)/
    End Date (Study Day)
XXXXXX
XXXXXX
Topical Corticosteroids: Yes/
Topical Antifungals: No/
Facial Involvement: Yes
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXXXXX
      XXXXXXXXXXXXX
DDMMMYYYY (X)/
   DDMMMYYYY (X)
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXXXXX
      XXXXXXXXXXXXX
DDMMMYYYY (X)/
   DDMMMYYYY (X)
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXXXXX
      XXXXXXXXXXXXX
DDMMMYYYY (X)/
   DDMMMYYYY (X)
XXXXXX
XXXXXX
Topical Corticosteroids: Yes/
Topical Antifungals: Yes/
Facial Involvement: Yes
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXXXXX
       XXXXXXXXXXXXX
DDMMMYYYY (X)/
   Ongoing
Abbreviation: MedDRA = Medical Dictionary for Regulatory Activities.
Note: Study day is calculated relative to the date of first application of study drug. Medical history was coded using MedDRA version 23.0. 
Only subjects with medical history recorded are listed.
Programming note: SOC & PT text should be presented as is from the dataset.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 120 of 161
Listing 16.2.5.1
Study Drug Application at the Study Site
All Subjects
Subject 
ID
Treatment 
Received
Was Study 
Drug 
Application 
Performed at 
Study Site?
Study 
Visit
Date/Time of
Application
Pre-Application 
Can Weight (g) 
Measurement
Post-Application 
Can Weight (g) 
Measurement
Applied 
Dose
(g)
Reason Pre- and/or 
Post-Application 
Can Weight 
Measurement not 
Performed
Kit Number/
   Can ID
XXXX
XXXXXX
Yes
XXXXXX
DDMMMYYYY/HH:MM
XX
XX
XX
XXXX/
   XX
XXXXXX
DDMMMYYYY/HH:MM
XX.X
XX.X
XX.X
XXXX/
   XX
XXXXXX
DDMMMYYYY/HH:MM
XX
XX
XX
XXXX/
   XX
No: XXXXXX
XXXXXX
XXXX
XXXXXX
Yes
XXXXXX
DDMMMYYYY/HH:MM
XX
XX
XX
XXXX/
   XX
XXXXXX
DDMMMYYYY/HH:MM
XX
XX
XX.X
XXXX/
   XX
XXXXXX
DDMMMYYYY/HH:MM
XX
Not Done
XXXXXXXXXXXXX
XXXX/
   XX
Programming note: For Pre & Post-Application Can Weight Measurement columns, if the weight measurement is not performed, set the value to be “Not Done”. If drug 
not administered, concatenate reason as shown in shell.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 121 of 161
Listing 16.2.5.2
Cans
All Subjects
Subject ID
Treatment 
Received
Kit Number/
   Can ID
Can Dispensed?
Reason if No
Date Dispensed 
(Study Day)
Dispense 
Weight (g)
Can Returned?
Reason if No
Date Returned
(Study Day)
Return
Weight (g)
XXXXX
XXXXXX
XXXXX/
   XX
Yes
DDMMMYYYY (X)
XX.X
Yes
DDMMMYYYY (X)
XX.X
XXXXX/
   XX
Yes
DDMMMYYYY (X)
XX.X
Yes
DDMMMYYYY (X)
XX.X
XXXXX/
   XX
Yes
DDMMMYYYY (X)
ND
Yes
DDMMMYYYY (X)
ND
XXXXX
XXXXXX
XXXXX
No: XXXXX
No: XXXXX
Abbreviation: ND = not done.
Note: Study day is calculated relative to the date of first application of study drug.
Programming note: within subject, sort by dispense date, return date, kit number and CAN ID.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 122 of 161
Listing 16.2.5.3
Diary Dispensation 
All Subjects
Subject ID
Treatment 
Received
Diary 
Dispensation
Visit
Diary 
Dispensed?
Date Dispensed 
(Study Day)
Diary 
Returned
Visit
Diary Returned
and Reviewed?
Reason Diary 
not Returned
Date Returned 
(Study Day)
XXXXX
XXXXXX
XXXXXX
Yes
DDMMMYYYY (X)
XXXXXX
Yes
DDMMMYYYY (X)
XXXXXX
Yes
DDMMMYYYY (X)
XXXXXX
Yes
DDMMMYYYY (X)
XXXXXX
Yes
DDMMMYYYY (X)
XXXXXX
No
XXXXXXXXXX
XXXXX
XXXXXX
XXXXX
No
XXXXXX
No
XXXXXXXXX
Note: Study day is calculated relative to the date of first application of study drug.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 123 of 161
Listing 16.2.5.4
Compliance (CRF)
All Subjects
Subject ID
Treatment 
Received
Study
Visit
Subject Compliant with 
Medication?
Date of Compliance 
Check (Study Day)
Compliance [1]
Overall 
Compliance [2]
Was Subject Retrained if not 
Compliant with Medication
XXXXXX
XXXXXX
XXXXXX
XXX
DDMMMYYYY (X)
XX.X %
XX.X %
XXXXXX
XXX
DDMMMYYYY (X)
XX.X %
XXXXXX
XXX
DDMMMYYYY (X)
XX.X %
XXXXXX
XXXXXX
XXXXXX
XXX
DDMMMYYYY (X)
XX.X %
XX.X%
XXXXXX
XXX
DDMMMYYYY (X)
XX.X %
XXXXXX
XX
XXX
Abbreviations: IP = investigational product; CRF = case report form.
Note: Study day is calculated relative to the date of first application of study drug.
[1]This data comes from CRF page, unless otherwise specified. 
[2] Overall compliance will be calculated based on number of applications divided by the expected number of IP applications for each subject. Number of expected IP 
applications is calculated as number of days between first and last application of IP (last treatment date - first treatment date + 1). Number of IP applications is calculated 
as number of expected IP applications – missed IP applications as collected in the CRF.
Programming note: Populate overall compliance only for the first visit.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 124 of 161
Listing 16.2.5.5
Missed Doses
All Subjects
Subject ID
Treatment 
Received
Study
Visit
Date of Missed Dose 
(Study Day)
Missed Dose due to 
COVID-19
Disruption?
Reason for Missed Dose
XXXXXX
XXXXXX
XXXXXX
DDMMMYYYY (X)
No
XXXXXXXXXXXXXX
XXXXXX
DDMMMYYYY (X)
No
XXXXXXXXXXXXXX
XXXXXX
XXXXXX
XXXXXX
DDMMMYYYY (X)
Yes
XXXXXXXXXXXXXX
XXXXXX
XXXXXX
XXXXXX
DDMMMYYYY (X)
No
XXXXXXXXXXXXXX
XXXXXX
DDMMMYYYY (X)
No
XXXXXXXXXXXXXX
Abbreviation: COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of first application of study drug.
Programming note: Only subjects with missed doses should be presented in this listing.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 125 of 161
Listing 16.2.5.6
Pharmacokinetic Blood Collection
PK Population
Subject 
ID
Treatment 
Received
PK Sample Collected 
at this Visit? Reason if 
No
Study Visit
PK Sample 
Collected 
Pre-Dose
Date/Time of Assessment
(Study Day)
Accession
Number
BSA Treated at 
the Time of PK 
Sample Collection
Roflumilast
Concentration
XXXXXX
XXXXXX
XXX
XXXXXX
XXX
DDMMMYYY/HH:MM (X)
XXXXX
XX.X %
XX.X
XXXXXX
XXX
DDMMMYYY/HH:MM (X)
XXXXX
XX %
XX.X
XXXXXX
XXX
DDMMMYYY/HH:MM (X)
XXXXX
XX %
XX.X
XX: XXXXXXXX
XXXXXX
XX
XXXXX
XX %
Abbreviations: BLQ = Below the limit of quantification; PK = pharmacokinetic.
Note: Study day is calculated relative to the date of first application of study drug.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 126 of 161
Listing 16.2.5.7
Pharmacokinetic Calculated Parameters
PK Population
Subject 
ID
Treatment 
Received
Study Visit
AUC0-t
(h*ng/mL)
AUCtau
(h*ng/mL)
Tmax
(h)
Tlag
(h)
Tlast
(h)
Cmax
(ng/mL)
Cmin
(ng/mL)
XXXXX
XXXXXX
XXXXXX
XX
XX
XX
XX
XX
XX
XX
XXXXXX
XX
XX
XX
XX
XX
XX
XX
XXXXXX
XX
XX
XX
XX
XX
XX
XX
XXXXXX
XX
XX
XX
XX
XX
XX
XX
Abbreviation: PK = pharmacokinetic.
Programming note: The above parameters are expected. However the final parameters provided by the pharmacokineticist will be listed and may be different than 
shown.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 127 of 161
Listing 16.2.6.1
Investigator Global Assessment (IGA)
All Subjects
Subject 
ID
Randomized 
Treatment
Was 
Assessment 
Completed? 
Reason if No
If Visit 
Performed, 
COVID-19 
Disruption 
Contributed to 
Delay in 
Assessment
If Visit not 
Performed, 
COVID-19 
Disruption 
Contributed to 
Missed 
Assessment
Study 
Visit
Date/Time of
Assessment 
(Study Day)
Result
Text Result
Change from 
Baseline
IGA 
Success 
[1]
IGA Success
2-grade 
Improvement 
[2]
XXXX
XXXXXX
Yes
No
XXXX
DDMMMYYYY/hh:mm 
(X)
X
XXXXXX
Yes
No
XXXX
DDMMMYYYY/hh:mm 
(X)
X
XXXXXX
X
No
Yes
No
XXXX
DDMMMYYYY/hh:mm 
(X)
X
XXXXXX
X
No 
Yes
No
XXXX
DDMMMYYYY/hh:mm 
(X)
X
XXXXXX
X
Yes
XXXX
XXXXXX
Yes
No
XXXX
DDMMMYYYY/hh:mm 
(X)
X
XXXXXX
No: 
XXXXXXXX
Yes
XXXX
Abbreviation: COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of first application of study drug. Baseline is the last non-missing measurement taken on or before the day of first application of study drug.
Change from baseline is calculated as Result – Baseline.
[1] IGA success (“Yes”) is defined as an IGA score of “Clear” or “Almost Clear” plus a ≥2-grade improvement from baseline at Weeks 2, 4, 8, and 9; “No” otherwise.
[2] IGA success 2-grade improvement (“Yes”) is defined as a 2-grade improvement from baseline; “No” otherwise.
Programming note:  Concatenate reason not done as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 128 of 161
Listing 16.2.6.2
Overall Assessment of Erythema
All Subjects
Subject 
ID
Randomized 
Treatment 
Was 
Assessment 
Completed? 
Reason if No
If Visit 
Performed, 
COVID-19 
Disruption 
Contributed to 
Delay in 
Assessment
If Visit not 
Performed, 
COVID-19 
Disruption 
Contributed 
to Missed 
Assessment
Study 
Visit
Date/Time of 
Assessment 
(Study Day)
Result
Change 
from
Baseline
Erythema 
Success 
(0-1, >=
2-grade
Improve) [1]
Erythema 
Success (0-1 
Score) [2]
Erythema 
Success 
(0 Score) 
[3]
XXXX
XXXXX
Yes
No
XXX
DDMMMYYYY/hh:mm 
(X)
X = XXXX
No
XXX
DDMMMYYYY/hh:mm 
(X)
X = XXXX
XX
No 
No
No
No
XXX
DDMMMYYYY/hh:mm 
(X)
X = XXXX
XXX
Yes
Yes
Yes
No
XXX
DDMMMYYYY/hh:mm 
(X)
X = XXXX
XX
No
No
No
XXXX
XXXXX
Yes
No
XXX
DDMMMYYYY/hh:mm 
(X)
X = XXXX
XX
No: XXXXXX
Yes
XXX
DDMMMYYYY/hh:mm 
(X)
Abbreviation: COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of first application of study drug. Baseline is the last non-missing measurement taken on or before the day of first application of study drug. 
Change from baseline is calculated as Result – Baseline.
[1] Erythema success (0-1, >= 2-grade Improve) (“Yes”) is defined as an Erythema score of “0” or “1” PLUS a 2-grade improvement from Baseline at Weeks 2, 4, 8, and 9; “No” otherwise.
[2] Erythema success (0-1 Score) (“Yes”) is defined as an Erythema score of “0” or “1” at Weeks 2, 4, and 8; “No” otherwise.
[3] Erythema success (0 Score) (“Yes”) is defined as an Erythema score of “0” at Weeks 2, 4, and 8; “No” otherwise.
Programming note:  Concatenate reason not done as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 129 of 161
Listing 16.2.6.3
Overall Assessment of Scaling
All Subjects
(Programming note: Same as shell 16.2.6.2; Update any instances of Erythema in the header, body and footnotes to Scaling)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 130 of 161
Listing 16.2.6.4
Worst Itch Numerical Rating Scale (WI-NRS) 
All Subjects
Subject ID
Randomized 
Treatment
Was 
Assessment
Completed?
Reason if No
If Visit 
Performed, 
COVID-19 
Disruption 
Contributed to 
Delay in 
Assessment/
  Telemedicine
If Visit not 
Performed, 
COVID-19 
Disruption 
Contributed 
to Missed 
Assessment
Study 
Visit
Date/Time of
Assessment 
(Study Day)
Result
Change 
from 
Baseline
WI-NRS
Success 
(baseline ≥ 
4) 
[1]
WI-NRS
Success 
(baseline ≥ 
2) 
[2]
XXXXXX
XXXXXX
Yes
No
XXXX
DDMMMYYYY/hh:mm 
(X)
X
Yes
No
XXXX
DDMMMYYYY/hh:mm 
(X)
X
X
Yes
Yes
Yes
No
XXXX
DDMMMYYYY/hh:mm 
(X)
X
X
Yes
Yes
Yes
No
XXXX
DDMMMYYYY/hh:mm 
(X)
X
X
Yes
Yes
No
XXXXXX
XXXXXX
Yes
XXXX
DDMMMYYYY/hh:mm 
(X)
X
No: XXXXXX
Yes/
  Yes
Yes
XXXX
DDMMMYYYY/hh:mm 
(X)
Abbreviation: COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of first application of study drug. Subjects rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 
(worst itch imaginable). Higher score indicates greater itch intensity. Baseline is the last non-missing measurement taken before the first application of study drug. Change from 
baseline is calculated as Result – Baseline.
[1] 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 Weeks 2, 4, and 8.
[2] In subjects with a baseline WI-NRS pruritus score of ≥2, achievement of a ≥2-point improvement from baseline in WI-NRS pruritus score at Weeks 2, 4, and 8.
Programming note:  Concatenate reason not done as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 131 of 161
Listing 16.2.6.5
Scalpdex
All Subjects
Subject 
ID
Randomized 
Treatment
Assessment
Completed? 
Reason if No
COVID-19 
Disruption 
Contributed to 
Delay 
Assessment/
  Telemedicine
COVID-19 
Disruption 
Contributed 
to Missed 
Assessment
Study 
Visit
Date/Time of 
Assessment
(Study Day)
Question [1]
Result
Text Result
Change 
from 
Baseline
XXXX
XXXXXX
Yes
No
No
XXX
X
DDMMMYYYY/
hh:mm (XX)
Q1. My scalp hurts
1
Never
Q2. My scalp condition makes me feel depressed
2
Rarely
Q3. My scalp itches
3
Sometimes
Q4. I am ashamed of my scalp condition
4
Often
Q5. I am embarrassed by my scalp condition
5
All the time
Q6. I am humiliated by my scalp condition
1
Never
Q7. My scalp condition bleeds
2
Rarely
Q8. I am annoyed by my scalp condition
3
Sometimes
Q9. I am bothered by the appearance of my scalp 
condition
4
Often
Q10. My scalp condition makes me feel self-
conscious
5
All the time
Q11. I am bothered that my scalp condition is 
incurable
1
Never
Programming note: Continue for all questions.
Emotions Scale [2]
XX.X
Symptoms Scale [3]
XX.X
Functioning Scale [4]
XX.X
Total Score [5]
XX.X
  
Abbreviation: COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of first application of study drug. Subjects rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable). 
Higher score indicates greater itch intensity. Baseline is the last non-missing measurement taken on or before the day of first application of study drug. Change from baseline is calculated as Result -
Baseline. Scalpdex is rated on a 1 to 5 scale which will be transformed to 0 to 100 Scale where 1=0; 2=25; 3=50; 4=75; 5=100. This transformed score is used to calculate scale scores. Q refers to 
question number.
[1] These questions are based on the “How often during the past 4 weeks do these statements describe you?” prompt.
[2] Emotions Scale is calculated as average of (Q2, Q4, Q5, Q6, Q7, Q9, Q10, Q11, Q12, Q14, Q16, Q17, Q19, Q20, Q22) after transforming to 0 to 100 scale as mentioned above. Q19 will be reverse 
scored i.e., 1=100; 2=75; 3=50; 4=25; 5=0.
[3] Symptoms Scale is calculated as average of (Q1, Q3, Q8) after transforming to 0 to 100 scale as mentioned above. 
[4] Functioning Scale is calculated as average of (Q13, Q15, Q18, Q21, Q23) after transforming to 0 to 100 scale as mentioned above. 
[5] Total Score is calculated as mean of all 23 questions using the transformed scale. Q18 will be reverse scored as indicated in [2].


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 132 of 161
Listing 16.2.6.6
Dermatology Life Quality Index (DLQI) 
All Subjects
Subject 
ID
Randomized
Treatment 
Study 
Visit
Assessment 
Completed?
Reason if No
If Visit Performed, 
COVID-19 Disruption 
Contributed to Delay 
in Assessment/
   Telemedicine
If Visit not Performed, 
COVID-19 Disruption 
Contributed to Missed 
Assessment
Date/Time of 
Assessment
(Study Day)
Question
Result
Text 
Result
Change 
from 
Baseline
XXXX
XXXX
XXXX
Yes
No
No
DDMMMYYYY/
hh:mm (XX)
1. Over the last week, how itchy, sore, painful 
or stinging has your skin been?
0
Not at all
2. Over the last week, how embarrassed or 
self conscious have you been because of 
your skin?
3
Very 
much
3. Over the last week, how much has your 
skin interfered with you going shopping or 
looking after your home or garden?
3
Very 
much
4. Over the last week, how much has your 
skin influenced the clothes you wear?
3
Very 
much
5. Over the last week, how much has your 
skin affected any social or leisure activities?
2
A lot
6. Over the last week, how much has your 
skin made it difficult for you to do any sport?
1
A little
7. Over the last week, has your skin
prevented you from working or studying? If 
"No", over the last week how much has your 
skin been a problem at work or studying?
3
Yes
8. Over the last week, how much has your 
skin created problems with your partner or 
any of your close friends or relatives?
0
Not 
relevant
9. Over the last week, how much has your 
skin caused any sexual difficulties?
0
Not 
relevant
10. Over the last week, how much of a 
problem has the treatment for your skin been, 
for example by making your home messy, or 
by taking up time?
3
Very 
much
Total Score [1]
18
Abbreviation: COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of the first application of study drug.
[1] The total score ranges between 0-30 and calculated as sum of all the 10 questions at each visit. If 1 item is missing, it is scored as 0 for that item. If 2 or more items are missing, the score should not be 
calculated.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 133 of 161


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 134 of 161
Listing 16.2.6.7
Body Surface Area (BSA) including Scalp
All Subjects 
Subject
ID
Randomized
Treatment
Assessment 
Performed?
Reason if No
If Visit Performed, 
COVID-19 Disruption 
Contributed to Delay 
in Assessment
If Visit not Performed, 
COVID-19 Disruption 
Contributed to Missed 
Assessment
Study 
Visit
Date/Time of 
Assessment
(Study Day)
Result
Test
XXXX
XXXXXX
XXX
XX
XX
XXXX
DDMMMYYYY/
hh:mm (XX)
Coverage Area (Head)
XX 
Coverage Area (Lower Limbs)
XX 
Coverage Area (Upper Limbs)
XX 
Coverage Area (Trunk)
XX.X 
Area Unaffected (Head)
XX.X 
Area Unaffected (Lower Limbs)
XX.X 
Area Unaffected (Upper Limbs)
XX.X 
Area Unaffected (Trunk)
XX.X 
BSA Result [1]
XX.X %
BSA CRF [2]
XX.X %
Abbreviation: COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of the first application of study drug.
[1] BSA result is calculated as sum of coverage areas of head, lower limbs, upper limbs and trunk. This is derived in the ERT.
[2] BSA captured in the CRF data.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 135 of 161
Listing 16.2.7.1
Adverse Events
All Subjects
Subject 
ID
Treatment 
Received
TEAE?
System Organ Class/
   Preferred Term/
      Verbatim Term
Start Date/Time (Study Day)/
   End Date/Time (Study Day)
CTCAE Toxicity Grade/
   Relationship
Outcome/
   Action Taken/
      Other Action Taken
Serious?/
  Criteria Met
AE Lead to Study 
D/C?
XXXXX
XXXXXX
XXX
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXXX
  XXXXXXXXXX
DDMMMYYYY/hh:mm (X)/
   DDMMMYYYY/ hh:mm (X)
XXXXXXXXX/
   XXXXXXXXXX
XXXXXXXXX/
   XXXXXXXXXX/
       XXXXXXXXXX  
XX
XX
XXXXX
XXXXXX
XXX
XXXXXXXXXXXXXX/
   XXXXXXXXXXXX
  XXXXXXXXXXXXX
DDMMMYYYY/ hh:mm (X)/
   DDMONYYYY/ hh:mm (X)
XXXXXXXXX/
   XXXXXXXXXX
XXXXXXXXX/
   XXXXXXXXXX/
       XXXXXXXXXX  
XX
XX
XX
XXXXXXXXXXXXXX/
   XXXXXXXXXXXXX
      XXXXXXXXXXXXX
DDMONYYYY/ hh:mm (X)/
   Ongoing
XXXXXXXXX/
   XXXXXXXXXX
XXXXXXXXX/
   XXXXXXXXXX/
      XXXXXXXXXX   
XXX/
   XXXXXXX
XXX
Abbreviations: COVID-19 = novel coronavirus disease; CTCAE = common terminology criteria for adverse events; D/C = discontinue; IP = investigational product; MedDRA = 
Medical Dictionary for Regulatory Activities; TEAE = Treatment emergent adverse event.
Note: Study day is calculated relative to the date of first application of study drug. AEs were coded using MedDRA version 23.0. All AEs that occur after the date/time of first 
application of IP will be considered TEAEs. 
Programming note: If time missing, display “- -:- -”. If Serious? is Yes, concatenate all serious criteria marked as Yes with a semicolon. “Other Action Taken” will be either None, 
Concomitant Medication, Non-drug Therapy, Hospitalization or Prolongation of Hospitalization, Discontinued Study or Other; if specify text is needed, concatenate “Concomitant 
Medication:” or “Other:” with the text. If no events meet the criteria for display, present “No events are reported.” SOC & PT text should be presented as is from the dataset.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 136 of 161
Listing 16.2.8.1.1
Clinical Laboratory Data: Clinical Chemistry
All Subjects
Subject
ID
Study
Visit
Date/Time of
Assessment
(Study Day)
Standard
Results
Reference
Range
[1]
Treatment
Received
Parameter (unit)
Reference 
Range
Flag
Result 
Interpretation; 
Specify CS 
Finding
Accession
Number
Comments/
Reason not Done
XXXXX
XXXXX
Alanine 
Aminotransferase (U/L)
XXXXX
DDMMMYYYY/hh:mm 
(XX)
XX
XX – YY
High
Normal
XXXXX
XXXXX
DDMMMYYYY/hh:mm 
(XX)
XX
XX – YY
Abnormal, 
NCS
XXXX
XXXXX
DDMMMYYYY/hh:mm 
(XX)
XX
XX – YY
Low
Normal
XXXXX
XXXXX
DDMMMYYYY/hh:mm 
(XX)
XX
XX – YY
Normal
XXXXX
XXXXX
DDMMMYYYY/hh:mm 
(XX)
XX
XX – YY
Abnormal, CS; 
XXXXXXX
XXXXX
Alkaline 
Phosphatase (U/L)
XXXXX
DDMMMYYYY/hh:mm 
(XX)
XX
XX – YY
Low
XXXXX
XXXXX
XXXXX
DDMMMYYYY/hh:mm 
(XX)
XX
XX – YY
XXXXX
XXXXX
XXXXX
ND
XXXXXXX
XXXXX
DDMMMYYYY/hh:mm 
(XX)
XX
XX – YY
High
XXXXXX
XXXXX
Abbreviations: CS = clinically significant; NCS = not clinically significant; ND = not done.
Note: Study day is calculated relative to the date of first application of study drug. Time is collected in the ACM.
[1] Reference range is used to identify potentially clinically significant laboratory values.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 137 of 161
Listing 16.2.8.1.2
Clinical Laboratory Data: Hematology
All Subjects
(Same shell as Listing 16.2.8.1.1)
Listing 16.2.8.1.3
Clinical Laboratory Data: Urinalysis
All Subjects
(Same shell as Listing 16.2.8.1.1)


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 138 of 161
Listing 16.2.8.1.4
Clinical Laboratory Data: Serum and Urine Pregnancy Test
Female Subjects
Subject ID
Treatment 
Received
Was Pregnancy 
Test Performed? 
Reason if No
Study Visit
Type of Test
Date/Time Performed
(Study Day)
Result
XXXXX
XXXXXX
Yes
XXXXXX
Serum
DDMMMYYYY (XX)
XXXXXXXX
Urine
DDMMMYYYY/hh:mm (XX) XXXXXXXXX
XXXXXX
Urine
DDMMMYYYY/hh:mm (XX) XXXXXXXXX
XXXXX
XXXXXX
Yes
XXXXXX
Serum
DDMMMYYYY (XX)
XXXXXXXXX
   
No: XXXXXXXXXX
XXXXXX
Urine
   
Note: Study day is calculated relative to the date of first application of study drug.
Programming note: If time missing, display only date. 


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 139 of 161
Listing 16.2.9.1
Investigator Local Tolerability Assessments 
All Subjects
Subject 
ID
Treatment 
Received
Tolerability
Assessment
Performed? 
Reason if No
If Visit 
Performed, 
COVID-19 
Disruption 
Contributed to 
Delay in 
Assessment
If Visit not 
Performed, 
COVID-19 
Disruption 
Contributed to 
Missed 
Assessment
Study Visit
Date/Time of 
Assessment (Study Day)
Dermal Response
Other Effects
XXXX
XXXXXX
Yes
No
No
XXXXXX
DDMMMYYYY/hh:mm 
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
Yes
No
No
XXXXXX
DDMMMYYYY/hh:mm 
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
Yes
No
No
XXXXXX
DDMMMYYYY/hh:mm 
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
XXXX
XXXXXX
Yes
No
No
XXXXXX
DDMMMYYYY/hh:mm 
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
Yes
No
No
XXXXXX
DDMMMYYYY/hh:mm 
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
Yes
No
No
XXXXXX
DDMMMYYYY/hh:mm 
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
XXXX
XXXXXX
Yes
No
No
XXXXXX
DDMMMYYYY/hh:mm 
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
Yes
No
No
XXXXXX
DDMMMYYYY/hh:mm 
(XX)
X = XXXXXXXXX
X = XXXXXXXXX
No: XXXXXXXXX
Yes
Yes
XXXXXX
Abbreviations: IP = investigational product; COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of the first application of study drug. This assessment will be conducted by the investigator prior to the application of IP in the 
study site.
Programming note:  Concatenate reason not done as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 140 of 161
Listing 16.2.9.2
Subject Local Tolerability Assessments 
All Subjects
Subject 
ID
Treatment 
Received
Tolerability
Assessment
Performed? 
Reason if No
If Visit Performed, 
COVID-19 Disruption 
Contributed to Delay 
in Assessment/
   Telemedicine 
If Visit not 
Performed, COVID-
19 Disruption 
Contributed to 
Missed Assessment
Study 
Visit
Date/Time of 
Assessment (Study 
Day)
Grade
Sensation Following the Application of 
IP
XXXX
XXXXXX
Yes
No
No
XXXX
DDMMMYYYY/hh:mm 
(XX)
0 = None
No sensation
Yes
No
No
XXXX
DDMMMYYYY/hh:mm 
(XX)
1 = Mild
Slight warm, tingling sensation; not 
really bothersome
Yes
No
No
XXXX
DDMMMYYYY/hh:mm 
(XX)
2 = Moderate
Definite warm, tingling sensation that is 
somewhat bothersome
XXXX
XXXXXX
Yes
No
No
XXXX
DDMMMYYYY/hh:mm 
(XX)
0 = None
No sensation
Yes
Yes/
   Yes
No
XXXX
DDMMMYYYY/hh:mm 
(XX)
3 = Severe
Hot tingling/stinging sensation that has 
caused definite discomfort
No: 
XXXXXXXX
Yes
Yes
XXXX
Abbreviations: IP = investigational product; COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of the first application of study drug. This assessment will be performed at baseline visit 10 to 15 minutes after the application of IP in the 
study site.
Programming note:  Concatenate reason not done as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 141 of 161
Listing 16.2.9.3
Pigmentation Assessment
All Subjects 
Subject
ID
Treatment 
Received
Assessment 
Performed? 
Reason if No
If Visit Performed, 
COVID-19 Disruption 
Contributed to Delay in 
Assessment
If Visit not Performed, 
COVID-19 Disruption 
Contributed to Missed 
Assessment
Study 
Visit
Date/Time of 
Assessment
(Study Day)
Result
Categorical Result
Category
XXXX
XXXXXX
Yes
No
No
XXXX
DDMMMYYYY/hh:mm 
(XX)
Hypopigmentation
0
None
Hyperpigmentation
1
Mild
Yes 
No
No
XXXX
DDMMMYYYY/hh:mm 
(XX)
Hypopigmentation
2
Moderate
Hyperpigmentation
3
Severe
No: XXXXXXX
Yes
Yes
XXXX
Abbreviation: COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of first application of study drug.
Programming note:  Concatenate reason not done as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 142 of 161
Listing 16.2.9.4.1
Vital Signs
All Subjects
Subject 
ID
Treatment 
Received
Vital Signs 
Collected? 
Reason if No
Study 
Visit
Date of 
Assessment
(Study Day)
Temp
(°C)
Heart 
Rate
(bpm)
Position
Blood
Pressure (mmHg)
Height
(cm)
Abnormal Findings/
Systolic
Diastolic
BMI
(kg/m2)
   Clinically Significant/
      Description of Finding
XXXX
XXXXXX
Yes
XXXXX
DDMMMYYYY 
(X)
XX.X
XX
XXXX
XX
XX
XXX
XX.X
XX
Yes
XXXXX
DDMMMYYYY 
(X)
XX.X
XX
XXXXX
XX
XX
No: XXXXXX
XXXXX
Yes
XXXXX
DDMMMYYYY 
(X)
XX.X
XX
XXXXX
XX
XX
XXX
XX.X
XXX/
  XXX/
     XXXXXXX
Note: Study day is calculated relative to the date of first application of study drug.
[1] BMI is derived as (weight in kg)/[(height in cm/100)2]. Weight is collected at all visits. For visits up to Week 4, baseline day 0 height is used for BMI derivation. Week 8 and 
Week 9 BMI is derived using Week 8 height. 


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 143 of 161
Listing 16.2.9.4.2
Vital Signs - Weight
All Subjects
Subject
ID
Treatment 
Received
Vital Signs 
Collected?
Reason if No
Study 
Visit
Date of 
Assessment
(Study Day)
Weight
(kg)
Percent
Change in 
Weight 
Since 
Baseline
Was Weight 
Loss 
Intentional?
Weight Loss 
due to 
Complications 
Associated with 
COVID-19
Underlying 
Reason for 
Weight Loss
Abnormal Findings/
   Clinically Significant/
      Description of Finding
XXXXX
XXXXXX
Yes
XXXXX
DDMMMYYYY (X)
XXX
XX
Yes
No 
Weight loss 
was a result of 
dieting
XX
Yes
XXXXX
DDMMMYYYY (X)
XXX
XX
Yes
No
Other: XXXXX
XXXXX
XXXXXX
No: 
XXXXXXXX
XXXXX
XXX/
  XXX/
     XXXXXXX
Abbreviation: COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of first application of study drug.
Programming note: If reason for weight loss is “Other”, concatenate reason as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 144 of 161
Listing 16.2.9.5
Physical Examination
All Subjects
Physical 
Examination 
Date of
Subject ID
Treatment 
Received
Performed? 
Reason if No
Study Visit
Assessment 
(Study Day)
Body System
Result
Abnormal Findings
Clinically Significant?
XXXXXX
XXXXXXX
Yes
XXXXXXX
DDMMMYYYY
(-X)
Skin
Normal
Lungs
Abnormal
XXXXXXXX
No
Heart
Normal
Yes
XXXXXXX
DDMMMYYYY
(-X)
Skin
Normal
Lungs
Abnormal
XXXXXXXX
No
Heart
Normal
No: XXXXXXX
XXXXXXX
Note: Study day is calculated relative to the date of first application of study drug.
Programming note:  Concatenate reason not done as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 145 of 161
Listing 16.2.9.6
Medical Photography
All Subjects 
Subject ID
Treatment 
Received
Photography 
Performed?
If Visit Performed, 
COVID-19 Disruption 
Contributed to Delay 
in Assessment
If Visit not Performed, 
COVID-19 Disruption 
Contributed to Missed 
Assessment
Study Visit
Date of Assessment
(Study Day)
XXXXXX
Yes
No
No
XXXXXX
DDMMMYYYY (XX)
Yes
No
No
XXXXXX
DDMMMYYYY (XX)
Yes
No
No
XXXXXX
DDMMMYYYY (XX)
Yes
No
No
XXXXXX
DDMMMYYYY (XX)
No: XXXXXXXX
Yes
Yes
XXXXXX
Abbreviation: COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of first application of study drug.
Programming note:  Concatenate reason not done as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 146 of 161
Listing 16.2.9.7
Prior and Concomitant Medications
All Subjects
Subject ID
Country
Treatment Received
Prior/
Concomitant
[1]
Indication 
ATC Class (Level 4)/
  Preferred Term/
     Verbatim Term
Start Date (Study Day)/
  End Date (Study Day)
Dose (unit)
Route/
  Frequency
XXXXXX
XXX
XXXXXX
Prior
XXXXXXXX
XXXXXXXXXXXXXXXXX/
   XXXXXXXXXXXXXX/
      XXXXXXXXXXXXX
DDMMMYYYY (X)/
   DDMMMYYYY (X)
XXX (XXX)
XXXXXXXX/
   XXXXXXX
  
Both
XXXXXXXX
XXXXXXXXX/
   XXXXXXXXXXXXXXX/
      XXXXXXXXXXX
DDMMMYYYY (X)/
   Ongoing
XXX (XXX)
XXXXXXXX/
   XXXXXXX
Concomitant
XXXXXXX
XXXXXXXXX/
   XXXXXXXXXXXXXX/
      XXXXXXXXXXXXX
DDMMMYYYY (X)/
   DDMMMYYYY (X)
XXX (XXX)
  
XXXXXXXX/
   XXXXXXX
Abbreviations: ATC = anatomic therapeutic chemical; NA = Not applicable; WHO-DDE = World Health Organization-Drug Dictionary Enhanced.
Note: Study day is calculated relative to the date of first application of study drug. Medications were coded using WHO-DDE Global B3 version September 2019.
[1] Prior indicates medication that was started and stopped prior to dosing of study drug. Concomitant indicates medication that started during the treatment period. Both indicates 
medication that was started prior to dosing of study drug and continued during the treatment period.
Programming note: If Dose unit, Route or Frequency is Other, display other specify text only (ie, do not display “Other: XXXXXX” but just “XXXXXX “). Sort by subject, start date, end 
date, ATC level 4 & PT. ATC & PT text should be presented as is from the dataset. 


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 147 of 161
Listing 16.2.9.8
Patient Health Questionnaire (PHQ-8)
All Subjects 
Subject 
ID
Treatment 
Received
Assessment 
Completed?
Reason If No
If Visit 
Performed, 
COVID-19 
Disruption 
Contributed to 
Delay in 
Assessment/
   Telemedicine 
If Visit not 
Performed, 
COVID-19 
Disruption 
Contributed to 
Missed 
Assessment
Study 
Visit
Date/Time of 
Assessment
(Study Day)
Result
Text Result
Question [1]
XXXX
XXXXXX
Yes
No
No
XXXX
DDMMMYYYY/
hh:mm (XX)
1. Little interest or pleasure in doing 
things
0
Not at all
2. Feeling down, depressed, or hopeless
1
Several days
3. Trouble falling or staying asleep, or 
sleeping too much
2
More than 
half the days
4. Feeling tired or having little energy
3
Nearly every 
day
5. Poor appetite or overeating
0
Not at all
6. Feeling bad about yourself, or that you 
are a failure, or have let yourself or your 
family down
1
Several days
7. Trouble concentrating on things, such 
as reading the newspaper or watching 
television
2
More than 
half the days
8. Moving or speaking so slowly that 
other people could have noticed. Or the 
opposite-being so fidgety or restless that 
you have been moving around a lot more 
than usual
3
Nearly every 
day
PHQ8 Total Score [2]
Total Score [3]
12
Moderate 
depression
Abbreviation: COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of the first application of study drug.
[1] These questions are based on the “Over the last 2 weeks, how often have you been bothered by any of the following problems?” prompt. 
[2] Score as collected in the CRF.
[3] The total score is calculated as sum of all the 8 questions. If more than 1 item is missing the total score should not be calculated.  If 1 item is missing, the total score is calculated 
as (sum of answered items*8)/number of answered items. If total score ranges between 0-4, it is categorized as None – Minimal depression; 5-9 = Mild depression; 10-14 = Moderate 
depression; 15-19 = Moderately severe depression; 20-24 = Severe depression.
Programming note:  Concatenate reason not done as shown in the shell.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 148 of 161
Listing 16.2.9.9
Columbia-Suicide Severity Rating Scale (C-SSRS) 
All Subjects 
Subject
ID
Treatment 
Received
Study Visit
Date/Time of
Assessment (Study 
Day)
Reference
Period
If Visit Performed, 
COVID-19 
Disruption 
Contributed to 
Delay in 
Assessment/
   Telemedicine
If Visit not 
Performed, COVID-
19 Disruption 
Contributed to 
Missed 
Assessment
Category
Assessment
Result
XXXXXX
XXXXXX
XXXXXX
DDMMMYYYY/hh:mm 
(XX)
Baseline/
Screening
No
No
Suicidal Ideation
1. Wish to be dead
XX
If yes, describe:
2. Non-Specific Active Suicidal 
Thoughts
XX
If yes, describe:
3. Active Suicidal Ideation with 
Any Methods (not Plan) without 
Intent to Act
ND
If yes, describe:
4. Active Suicidal Ideation with 
Some Intent to Act, without 
Specific Plan
XX
If yes, describe:
5. Active Suicidal Ideation with 
Specific Plan and Intent
XX
If yes, describe:
Intensity of Ideation
Most Severe Ideation Type # (1-5)
X
Description of Ideation
XXXXXXXXXXX
XXXX
Frequency
1 = Less than 
once a week
Duration
1 = Fleeting –
few seconds or 
minutes
Controllability
1 = Easily able to 
control thoughts
Programming note: Reference period will be either Baseline/Screening or Since Last Visit. Display the results following the order of C-SSRS questionnaire for all categories.
Abbreviation: COVID-19 = novel coronavirus disease.
Note: Study day is calculated relative to the date of first application of study drug. Time is collected in the ERT. Assessments that are marked as Not Done are not included in the listing.


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 149 of 161
Appendix 1: Premier Research Library of Abbreviations
Abbreviation
Definition
aCRF 
annotated case report form
AD
associated documents
ADR
adverse drug reactions
AE
adverse event
AESI
adverse events special interest
ANCOVA
analysis of covariance
ATC
anatomical therapeutic chemical
BLQ
beneath limit of quantification
BMI
body mass index
BRD
business requirements document
BSL
biostatistician lead


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 150 of 161
Abbreviation
Definition
CCGs
CRF completion guidelines
CD
compact disc
CDISC
clinical data interchange standards consortium
CEC
central ethics committee
CFR
code of federal regulations
CI
confidence intervals
CIOMS
council for international organizations of medical sciences
CIP
clinical investigational plan
CM
clinical manager
CMH
Cochran Mantel Haenszel
CMP
clinical monitoring plan
COV
close out visit
COVID-19
Novel coronavirus disease
CRA
clinical research associate


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 151 of 161
Abbreviation
Definition
CRF
case report form
CRO
contract research organization
CS
clinically significant
CSM
clinical supply manager
CSR
clinical study report
CTA
clinical trial administrator
CTM
clinical trial manager
CTMS
clinical trial management system
DB
database
DBL
database lock
DBP
diastolic blood pressure
DCRF
data change request form
DDE
drug dispensing error form
DEA
drug enforcement administration


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 152 of 161
Abbreviation
Definition
DIA
drug information association
DIS
data integration specification
DLT
dose limiting toxicity
DM
data management
DMB
data monitoring board
DMC
data monitoring committee
DML
data management lead
DMP
data management plan
DNA
deoxyribonucleic acid
DOB
date of birth
DS
document specialist
DSG
drug safety group
DSM
drug supply management (drug distributor)
DSMB 
data safety monitoring board


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 153 of 161
Abbreviation
Definition
DSP
data safety plan
DSUR
development safety update report
DTS
data transfer specification
DVD
digital video disk
EC
ethics committee
ECD
edit check and derivation specifications
ECG
electrocardiogram
eCRF
electronic case report form
EDC
electronic data capture
EMA
European medicines agency
eTMF
electronic trial master file
EU
European Union
FA
full analysis
FDA
food and drug administration


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 154 of 161
Abbreviation
Definition
FMP
file management plan
FPFV
first patient first visit
FPI
first patient in
GCP
good clinical practice
GMP
good manufacturing practices
GPV
global pharmacovigilance
HR
heart rate
IB
investigator’s brochure
IC or ICF
informed consent or informed consent form
ICH
international council for harmonization 
ID
identification
IDM
independent drug monitoring
IEC
independent ethics committee
IGA
investigator global assessment


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 155 of 161
Abbreviation
Definition
IM
investigator meeting
IMV
interim monitoring visit
IND
investigational new drug
INDSR
investigational new drug safety reports
IP
investigational product
IRB
institutional review board
IRF
inventory release file
IRR
infusion related reactions
IRT
interactive response technology
ISF
investigator site file
ITT
intent-to-treat
IVRS
interactive voice response system
IWRS
interactive web response system
IxRS
interactive voice/web response system


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 156 of 161
Abbreviation
Definition
KPI
key performance indicator
LAN
local area network
LDM
lead data manager
LMS
learning management system
LLOQ
lower limit of quantification
LPI
last patient in
LPLV
last patient last visit
LPO
last patient out
MAAP
medical affairs and pharmacovigilance teams
MAH
marketing authorization holder
MedDRA
medical dictionary for regulatory activities
MHRA
medicines and healthcare products regulatory agency
MM
medical monitor
MMP
medical monitoring plan


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 157 of 161
Abbreviation
Definition
MMRM
mixed effect model repeat measurement
MTD
maximum tolerated dose
MVR
monitoring visit report
N
number
NA
not applicable
NCS
non-clinically significant
NF
non-functional
PD
protocol deviation
PDGP
protocol deviation guidance plan
PE
physical examination
PHQ
patient health questionnaire
PI
principal investigator
PIN
personal identification number
PK
pharmacokinetic


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 158 of 161
Abbreviation
Definition
PKAP
pharmacokinetic analysis plan
PM
project manager
PMP
project management plan
PP
per-protocol
PRIMS 
Premier Research information management system
PS
project specialist
PV
pharmacovigilance
PVG
pharmacovigilance group
QA
quality assurance
QARC
quality assurance, risk and compliance
QC
quality control
QOL
quality of life
ROT
record of training
RR
respiratory rate or relative rate


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 159 of 161
Abbreviation
Definition
RSM
regional site monitor
SAE
serious adverse event
SAP
statistical analysis plan
SAS® 
a software system used for data analysis
SBP
systolic blood pressure
SC
study coordinator
SCR
software change request 
SD
standard deviation
SDS
study design specifications
SDTM 
study data tabulation model 
SDV
source data verification
SECC 
self-evident correction conventions 
SECP 
self-evident correction plan
SF
screen failure


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 160 of 161
Abbreviation
Definition
SFT or SFTP
secure file transfer or secure file transfer plan
SIV
site initiation visit
SLA
service level agreement
SMP
safety management plan
SOC
system organ class
SOP
standard operating procedure
SOW
statement of work
SQV
site qualification visit
SUA
start-up associate
SUSAR
suspected, unexpected, serious adverse (drug) reaction
TA
trial assistant
TEAE
treatment-emergent adverse event
TMF
trial master file
TOM
task ownership matrix


Statistical Analysis Plan, 
Sponsor Arcutis, Inc.
Protocol Number ARQ-154-203
PCN Number ARCU210100
AD-ST-33.05  Effective date: 22-Jan-2018
Version Final 1.0    |    08-Sep-2020    |    AD-PR-109.01  Effective date: 26-Jun-2017
Page 161 of 161
Abbreviation
Definition
UAT
user acceptance testing
USA
United States of America
UTC
universal coordinated time
WAN
wide area network
WAR
work at risk
WG
working guideline
WHO
world health organization
WHO-DD
world health organization drug dictionary
WI-NRS
worst itch – numeric rating scale