A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis
Phase: PHASE2
Conditions: Seborrheic Dermatitis
Sponsor: Arcutis Biotherapeutics, Inc.



Protocol ARQ-154-203 
Arcutis, Inc. 
Amendment 1 
 
07 January 2020 
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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 
stated.  

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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