Clinical trial NCT03759340
Conditions: Alopecia Areata Alopecia Universalis Alopecia Totalis
Sponsor: Aclaris Therapeutics, Inc.
Start date: 2019-01-15; Completion date: 2019-09-11
Enrollment: 56 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label study of ATI-502 Topical Solution for the treatment of AA, AU, and AT with the following goals:

* To assess the safety, tolerability, and efficacy of ATI-502 Topical Solution in subjects with AA, AU or AT following 24 weeks of treatment with ATI-501 Oral Suspension or Placebo Suspension.
* To assess the ability of ATI-502 Topical Solution to maintain or improve hair regrowth in subjects previously treated with ATI-501 Oral Suspension or Placebo Suspension.

Detailed description:
This Phase 2, multicenter, open-label study will evaluate the safety, tolerability, efficacy, and durability of efficacy of ATI-502 Topical Solution, 0.46% for the treatment of alopecia areata (AA), alopecia universalis (AU) and alopecia totalis (AT) in adult subjects who completed 24 weeks of treatment with ATI-501 Oral Suspension or Placebo Suspension.

Subjects who complete 24 weeks of active treatment with ATI-501 Oral Suspension or Placebo Suspension in study ATI-501-AUAT-201 will be assessed for eligibility to enter the study. At Visit 9 in study ATI-501-AUAT-201, subjects who did not experience any adverse events (AEs), serious adverse events (SAEs), or tolerability issues that met study discontinuation criteria in study ATI-501-AUAT-201 and who in the opinion of the investigator are capable of re-growing or maintaining scalp hair and meet the entry criteria are eligible to enroll in this open-label study.

Enrolled subjects will apply ATI-502 Topical Solution, 0.46% BID to the entire scalp and if applicable, the eyebrow(s) and return for safety and efficacy assessments as detailed in the Schedule of Assessments (Table 3). Assessment of response to treatment will be performed at Week 4, Week 8, Week 16, Week 24, and post-treatment Week 28. Safety and tolerability will be evaluated at each study visit by assessment of adverse events, clinical laboratory tests, and vital signs, and at Week 24, and physical examination findings

Arms: arm 1: Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-week post-treatment follow up period.
Interventions: intervention 1: ATI 502 0.46% Topical Solution
Intervention descriptions: intervention 1: apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)

Protocol documents:
Prot_SAP_000.pdf: 
Protocol: ATI-502-AA-203 
Aclaris Therapeutics, Inc. 
Date: 09NOV2018, Version 1.0  
Page 1 of 80 
CONFIDENTAL 
CLINICAL STUDY PROTOCOL 
Open-Label Study of ATI-502 Topical Solution for the Treatment of Alopecia 
Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT) 
Compound: 
ATI-502 
US IND Number: 
134,064 
Protocol Number: 
ATI-502-AA-203 
Phase: 
2 
Sponsor 
Aclaris Therapeutics, Inc. 
640 Lee Road 
Suite 200 
Wayne, PA 19087 
Telephone: 484-324-7933 
Facsimile: 484-320-2344 
Medical Monitor 
Jeffrey Sugarman, MD, PhD 
Telephone: 707-545-4537 
Facsimile: 707-545-6723 
pediderm@yahoo.com  
Study Contact 
Sue Moran, RN, MSN 
Sr. Director, Clinical Development 
Aclaris Therapeutics, Inc. 
640 Lee Road 
Suite 200 
Wayne, PA 19087 
Telephone: 484-329-2129 
Cell:  484-999-7492 
E-mail:  
smoran@aclaristx.com
Safety Contact: 
ProPharma email:  
clinicalsafety@propharmagroup.com 
This document is a privileged and confidential communication of Aclaris Therapeutics, Inc. 
Acceptance of this document constitutes an agreement by the recipient that no unpublished 
information contained herein will be used, published or disclosed without prior written approval 
from Aclaris Therapeutics, Inc. 




Protocol: ATI-502-AA-203 
Aclaris Therapeutics, Inc. 
Date: 09NOV2018, Version 1.0  
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CONFIDENTAL 
INVESTIGATOR’S AGREEMENT 
I have received and read the Investigator’s Brochure for ATI-502.  I have read the ATI-502-AA-
203 protocol and agree to conduct the study as outlined.  I agree to maintain the confidentiality 
of all information received or developed in connection with this protocol. I will conduct the trial 
in accordance with the principles of ICH Good Clinical Practice and the Declaration of Helsinki. 
I will maintain as confidential all written and verbal information provided to me by the Sponsor, 
including but not limited to, the protocol, case report forms, investigator’s brochure, material 
supplied at investigator meetings, minutes of teleconferences, etc.  Such materials will only be 
provided as necessary to site personnel involved in the conduct of the trial, involved IRBs or 
local regulatory authorities. 
I will obtain written informed consent from each prospective trial subject or each prospective 
trial subject’s legal representative prior to conducting any protocol-specified procedures.  The 
Informed Consent Document used will have the approval of the IRB appropriate for my 
institution. 
I will maintain adequate source documents and record all observations, treatments and 
procedures pertinent to trial subjects in their medical records.  I will accurately complete the case 
report forms supplied by the Sponsor in a timely manner.  I will ensure that my facilities and 
records will be available for inspection by representatives of the Sponsor, the IRB, and/or local 
regulatory authorities.  I will ensure that I and my staff are available to meet with Sponsor 
representatives during regularly scheduled monitoring visits. 
I will notify the Sponsor within 24 hours of any serious adverse events.  Following this 
notification, an initial written report describing the serious adverse event will be provided to the 
Sponsor within 24 hours of Investigator awareness of the event. 
Printed Name of Investigator 
Signature of Investigator 
        Date 


Protocol: ATI-502-AA-203 
Aclaris Therapeutics, Inc. 
Date: 09NOV2018, Version 1.0  
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CONFIDENTAL 
SYNOPSIS 
Name of Sponsor/Company: Aclaris Therapeutics, Inc. 
Name of Investigational Product: ATI-502 Topical Solution 
Name of Active Ingredient: ATI-502 
Title of Study: Open-Label Study of ATI-502 Topical Solution for the Treatment of 
Alopecia Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT) 
Study center(s): Approximately 25 US study centers 
Studied period (years):  
Estimated date first patient enrolled: December 2018 
Estimated date last patient completed: January 2020 
Phase of development: 2 
Objectives: 
•
To assess the safety, tolerability, and efficacy of ATI-502 Topical Solution in subjects
with AA, AU or AT following 24 weeks of treatment with ATI-501 Oral Suspension or
Placebo Suspension.
•
To assess the ability of ATI-502 Topical Solution to maintain or improve hair regrowth in
subjects previously treated with ATI-501 Oral Suspension or Placebo Suspension.
Methodology: 
This Phase 2, multicenter, open-label study will evaluate the safety, tolerability, efficacy, and 
durability of efficacy of ATI-502 Topical Solution, 0.46% for the treatment of alopecia areata 
(AA), alopecia universalis (AU) and alopecia totalis (AT) in adult subjects who completed 24 
weeks of treatment with ATI-501 Oral Suspension or Placebo Suspension.   
Subjects who complete 24 weeks of active treatment with ATI-501 Oral Suspension or 
Placebo Suspension in study ATI-501-AUAT-201 will be assessed for eligibility to enter the 
study.  At Visit 9 in study ATI-501-AUAT-201, subjects who did not experience any adverse 
events (AEs), serious adverse events (SAEs), or tolerability issues that met study 
discontinuation criteria in study ATI-501-AUAT-201 and who in the opinion of the 
investigator are capable of regrowing or maintaining scalp hair and meet the entry criteria are 
eligible to enroll in this open-label study. 
Enrolled subjects will apply ATI-502 Topical Solution, 0.46% BID to the entire scalp and if 
applicable, the eyebrow(s) and return for safety and efficacy assessments as detailed in the 
Schedule of Assessments (Table 3).  Assessment of response to treatment will be performed 
at Week 4, Week 8, Week 16, Week 24, and post-treatment Week 28.  Safety and tolerability 
will be evaluated at each study visit by assessment of adverse events, clinical laboratory tests, 
and vital signs, and at Week 24, and physical examination findings. 
Number of patients (planned): approximately 80 


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CONFIDENTAL 
Diagnosis and main criteria for inclusion: A clinical diagnosis of AA, AU or AT and 
completion of the active treatment phase of ATI-501-AUAT-201.   
Inclusion Criteria: 
Subjects must meet the following criteria to be eligible for participation in the study: 
1. Subject must be able to comprehend and willing to sign the Informed Consent Form
(ICF).
2. Male or non-pregnant, non-nursing female ≥ 18 years old at the time of informed
consent.
3. Subject has completed 24 weeks of treatment and the assessments for Visit 9 in study
ATI-501-AUAT-201.
4. Subject has not experienced any AEs, SAEs or tolerability issues that met study
discontinuation criteria in ATI-501-AUAT-201.
5. Subject is capable of regrowing scalp hair or maintaining prior scalp hair regrowth
from ATI-501-AUAT-201 in the opinion of the investigator.
6. If a woman of childbearing potential (WOCBP), must have a negative urine
pregnancy test at Visit 1 and agree to: use a highly effective method of birth control
for the duration of the study; not be planning a pregnancy during the study duration
and use contraception for 30 days after last application of study medication. (Refer to
Section 8.4).
7. Be in good general health and free of any known disease state or physical condition
which, in the investigator’s opinion, might impair evaluation of the subject or which
might expose the subject to an unacceptable risk by study participation.
8. Be willing to maintain the same general hair style throughout the study period. Subjects
who shave their scalp must be willing to refrain from shaving their scalp for at least
one week or longer prior to each study visit, as determined by the investigator based on
visible scalp hair growth. Hair trimming outside the treatment areas to maintain the
current hair style is permitted.
9. Be willing and able to follow all study instructions and to attend all study visits.
10. Sexually active male subjects must agree to use a barrier method of contraception
from the first application of study medication to at least 30 days after the last
application of study medication.
Exclusion Criteria: 
Subjects are excluded from this study if any 1 or more of the following criteria is met: 
1. Any study medication discontinuation criteria are met during participation in study
ATI-501-AUAT-201.
2. Females who are nursing, pregnant, or planning to become pregnant for the duration
of the study and up to 30 days after the last application of study medication.
3. The presence of a permanent or difficult to remove hairpiece or wig that will, in the
opinion of the investigator, interfere with study assessments if not removed at each
visit.
4. Sensitivity to any of the ingredients in the study medications.
5. Unwillingness to refrain from weaves, hair extensions, or shaving of the scalp for at
least one week or longer prior to each study visit, as determined by the investigator
based on visible scalp hair growth the duration of the study.


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Date: 09NOV2018, Version 1.0  
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CONFIDENTAL 
Investigational product, dosage and mode of administration: 
ATI-502 Topical Solution, 0.46% 
Duration of treatment:  
Subjects will apply ATI-502 Topical Solution, 0.46%, BID to the entire scalp and if 
applicable, eyebrows for 24 weeks followed by a 4-week post-treatment follow up period.  
Reference therapy, dosage and mode of administration: 
None 
Criteria for evaluation: 
The efficacy endpoints will compare the assessment (specified below) from the Baseline visit 
from both ATI-501-AUAT-201 and ATI-502-AA-203 to the applicable post-baseline visits. 
 Primary Efficacy Endpoint: 
The primary efficacy endpoint will be the mean relative percent change from the original 
baseline visit in study ATI-501-AUAT-201 in the Severity of Alopecia Tool (SALT) score to 
Visit 6 (Week 24 on study ATI-502-AA-203).  This represents the percentage of hair 
regrowth.  It will be calculated as the mean of the changes from baseline SALT score to the 
SALT score at Visit 6 (Week 24 on study ATI-502-AA-203), divided by baseline SALT 
score and expressed as a percentage.   
Secondary Efficacy Endpoints: 
•
Proportion of subjects achieving a SALT50, SALT 75 (defined as a ≥ 50%, ≥ 75%
improvement from baseline in SALT) by visit.
•
Durability of response:  Proportion of subjects achieving a SALT 50 or SALT 75 at
Week 24 (study ATI-501-AUAT-201) and maintaining response at post-baseline
visits in ATI-502-AA-203.
•
Mean Relative Percent Change from Baseline (from the current study ATI-502-AA-
203) in Severity of Alopecia Tool (SALT) by visit.
•
Mean Relative Percent Change from Baseline in Alopecia Density and Extent Score
(ALODEX) score by visit.
•
Mean Change from Baseline in SALT and ALODEX score by visit.
•
Change from Baseline in the Alopecia Scalp Appearance Assessment (ASAA)
(Patient-reported outcome [PRO]) by visit.
•
Change from Baseline in the Alopecia Scalp Appearance Assessment (ASAA)
(Clinician-reported outcome [ClinRO]) by visit.
•
Change from Baseline in the Physician Global Impression of Severity (PhGIS) by
visit.
•
Change from Baseline in Alopecia Facial Hair Appearance Assessment (AFHA)
(Clinician and Subject) by visit.
•
Change from Baseline in the Subject Global Impression of Severity (SGIS) by visit.


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CONFIDENTAL 
•
Change from Baseline in the subject reported Alopecia Impact Assessment (AIA) by
visit.
•
Subject Global Impression of Treatment Satisfaction (SGITS) by visit.
•
Change from Baseline in the Subject Global Satisfaction with Hair Quality (SGSHQ)
by visit.
•
Global Impression of Change (Clinician and Subject) at Week 24 of ATI-502-AA-
203.
Safety Endpoints: 
Safety variables to be assessed include: adverse events, clinical laboratory tests (hematology, 
clinical chemistry, and urinalysis), vital sign measurements (systolic and diastolic blood 
pressures, respiration rate, heart rate, and oral or ear body temperature), and 
electrocardiograms. 
Other Assessments: 
•
Hair quality assessment including normalization of exclamation point hairs and hair
shedding will be described.
•
Vellus and Indeterminate scalp hair will be described.
•
Non-scalp hair assessments (body and nasal hair) will be described.
Statistical Methods: 
Sample Size/ Power Calculations 
The planned sample size 80 enrolled is based on an estimated completion rate from study 
ATI-501-AUAT-201. 
Statistical Methods 
Subject demographic and baseline characteristics, including medical and alopecia history, 
prior medications and therapies and physical examination findings will be summarized using 
descriptive statistics. 
Summary descriptive statistics (N, mean, median, SD) by visit will be provided for all safety 
and efficacy parameters. The Intent to Treat population will be used for all efficacy 
assessments and the Safety population will be used for all safety assessments. No data 
imputation will be used. 
No inferential analyses are planned. For all efficacy evaluations described below, summary 
statistics will be provided for all treated subjects pooled, and also for each of two sub-groups 
of subjects based on the treatment they previously received in study ATI-501-AUAT-201. 
Primary Efficacy Analyses 
For the primary endpoint, the primary efficacy variable will be the mean relative percent 
change from the original baseline visit in study ATI-501-AUAT-201 in the SALT score to 
Visit 6 (Week 24).  This represents the percentage of hair regrowth.  It will be calculated as 
the mean of the changes from baseline SALT score to the SALT score at Visit 6 (Week 24), 
divided by baseline SALT score and expressed as a percentage. 


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Date: 09NOV2018, Version 1.0  
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CONFIDENTAL 
Secondary Efficacy Analyses 
The secondary efficacy endpoints will be calculated using both the current study baseline 
scores and the baseline scores from study ATI-501-AUAT-201. These endpoints will be 
evaluated at each visit and will include: the mean relative percent change from baseline in the 
ALODEX score (percent regrowth); the mean change from baseline in SALT and the mean 
change from baseline in ALODEX, the proportion of subjects achieving a ≥ 50% and ≥ 75% 
hair regrowth compared with baseline; change from baseline in the ASAA (Clinician and 
Subject), PhGIS, AFHA, SGIS, AIA, and treatment satisfaction questionnaires.  The mean 
relative percent change in ALODEX score analysis will use the same methodology as 
specified for the primary efficacy analysis.  Other parameters will be summarized as detailed 
in the statistical analysis plan.  
Safety Data 
Safety analyses will include descriptive statistics calculated on the safety parameters using 
the safety population. The proportion of subjects with treatment-emergent adverse events will 
be tabulated and presented by Medical Dictionary for Regulatory Activities (MedDRA) 
System Organ Class. Vital signs and clinically significant abnormal laboratory results will 
also be tabulated and presented.  
Data from enrolled subjects will be presented and summarized. Safety summaries will 
include listings by study medication of adverse events incidences within each MedDRA 
System Organ Class, and changes from pre-dose values in vital signs. Adverse event 
summaries will be presented showing the proportion of subjects experiencing adverse events, 
both overall and by MedDRA System Organ Class.  


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CONFIDENTAL 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES 
INVESTIGATOR’S AGREEMENT ...............................................................................................3 
SYNOPSIS ......................................................................................................................................4 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES ....................................9 
LIST OF TABLES .........................................................................................................................13 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ................................................14 
1.
INTRODUCTION ......................................................................................................16 
1.1. 
Overview of Alopecia Areata .....................................................................................16 
1.2. 
Immunopathology & Pathophysiology of AA ............................................................17 
1.3. 
Previous Clinical Study Experience with ATI-501 ....................................................18 
1.4. 
Clinical Study Experience with ATI-502 Topical Solution .......................................19 
1.5. 
Study Rationale ...........................................................................................................19 
1.6. 
Study ATI-501-AUAT-201 ........................................................................................20 
2.
TRIAL OBJECTIVES AND ENDPOINTS ...............................................................21 
2.1. 
Objectives ...................................................................................................................21 
2.2. 
Efficacy Endpoints ......................................................................................................21 
2.2.1. 
Primary Efficacy Endpoint .........................................................................................21 
2.2.2. 
Secondary Efficacy Endpoints: ...................................................................................21 
2.3. 
Safety Endpoints .........................................................................................................22 
2.4. 
Other Assessments ......................................................................................................22 
3.
INVESTIGATIONAL PLAN .....................................................................................23 
3.1. 
Overall Study Design ..................................................................................................23 
3.2. 
Number of Subjects ....................................................................................................23 
3.3. 
Treatment Assignment ................................................................................................23 
3.4. 
Dose Adjustment Criteria ...........................................................................................23 
3.4.1. 
Safety Criteria for Adjustment or Stopping Doses .....................................................24 
3.4.1.1. 
Study Medication Interruption ....................................................................................24 
3.4.1.2. 
Study Medication Discontinuation .............................................................................24 
3.5. 
Criteria for Study Termination ...................................................................................25 
3.6. 
Study Procedures ........................................................................................................25 
4.
SELECTION AND WITHDRAWAL OF SUBJECTS ..............................................29 
4.1. 
Subject Inclusion Criteria ...........................................................................................29 


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CONFIDENTAL 
4.2. 
Subject Exclusion Criteria ..........................................................................................29 
4.3. 
Subject Withdrawal Criteria .......................................................................................30 
5.
TREATMENT OF SUBJECTS ..................................................................................31 
5.1. 
Study Medication Administration...............................................................................31 
5.2. 
Concomitant Medications ...........................................................................................31 
5.3. 
Grooming ....................................................................................................................32 
5.4. 
Prohibited Medications ...............................................................................................32 
5.5. 
Treatment Compliance ................................................................................................33 
5.6. 
Blinding ......................................................................................................................33 
6.
STUDY MEDICATION MATERIALS AND MANAGEMENT .............................34 
6.1. 
Study Medication ........................................................................................................34 
6.2. 
Packaging and Labeling ..............................................................................................34 
6.3. 
Study Medication Storage ...........................................................................................34 
6.4. 
Study Medication Accountability and Disposal .........................................................34 
7.
ASSESSMENT OF EFFICACY ................................................................................36 
7.1. 
Subject Reported Outcome Assessments ....................................................................36 
7.1.1. 
Alopecia Scalp Appearance Assessment (ASAA) .....................................................37 
7.1.2. 
Alopecia Facial Hair Appearance Assessment (AFHA) for AA, AT and AU: 
Subject Rating (SR) (AFHA: SR)...............................................................................37 
7.1.3. 
Subject Global Impression of Severity (SGIS) ...........................................................37 
7.1.4. 
Alopecia Impact Assessment (AIA):  Subject Rating ................................................37 
7.1.5. 
Subject Global Impression of Change (SGIC) ...........................................................37 
7.1.6. 
Subject Global Impression of Treatment Satisfaction (SGITS) .................................37 
7.1.7. 
Subject Global Satisfaction with Hair Quality (SGSHQ) ...........................................38 
7.2. 
Investigator Efficacy Assessments .............................................................................38 
7.2.1. 
Alopecia Scalp Appearance Assessment (ASAA) Clinician Rating (CR) .................38 
7.2.1.1. 
Alopecia Scalp Appearance Assessment (ASAA) for Patchy AA: Clinician 
Rating (CR) (ASAA-AAP: CR) .................................................................................39 
7.2.1.2. 
Alopecia Scalp Appearance Assessment (ASAA) for AT and AU: Clinician 
Rating (CR) (ASAA-AT/AU: CR) .............................................................................39 
7.2.2. 
Alopecia Facial Hair Appearance Assessment (AFHA) for AA, AT and AU: 
Clinician Rating (CR) (AFHA: CR) ...........................................................................40 
7.2.3. 
Non-Scalp Hair Loss Assessment (NSHA) ................................................................42 


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7.2.4. 
PHYSICIAN GLOBAL IMPRESSION OF SEVERITY (PhGIS) ............................42 
7.2.4.1. 
PHYSICIAN GLOBAL IMPRESSION OF SEVERITY (PhGIS-AAP) ...................43 
7.2.4.2. 
PHYSICIAN GLOBAL IMPRESSION OF SEVERITY (PhGIS-AT/AU) ...............43 
7.2.5. 
Physician Global Impression of Change (PhGIC) ......................................................43 
7.2.6. 
Hair Quality Assessments ...........................................................................................44 
7.2.6.1. 
Hair Pull Test ..............................................................................................................44 
7.2.7. 
Severity Alopecia Tool (SALT) Score .......................................................................44 
7.2.8. 
Alopecia Density and Extent Score (ALODEX) ........................................................44 
7.2.9. 
Vellus and Indeterminate Hair Assessment ................................................................44 
7.3. 
Photographic Assessment ...........................................................................................45 
8.
ASSESSMENT OF SAFETY .....................................................................................46 
8.1. 
Safety Parameters .......................................................................................................46 
8.1.1. 
Demographic/Medical History/ Alopecia Areata History ..........................................46 
8.1.2. 
Vital Signs ..................................................................................................................46 
8.1.3. 
Physical Examination .................................................................................................46 
8.1.4. 
Electrocardiogram (ECG) ...........................................................................................47 
8.1.5. 
Clinical Laboratory Assessments ...............................................................................47 
8.1.6. 
Pregnancy Testing ......................................................................................................48 
8.2. 
Adverse and Serious Adverse Events .........................................................................48 
8.2.1. 
Definition of Adverse Events .....................................................................................48 
8.2.1.1. 
Adverse Event (AE) ....................................................................................................48 
8.2.1.2. 
Serious Adverse Event (SAE) ....................................................................................49 
8.2.1.3. 
Unexpected adverse event ..........................................................................................49 
8.3. 
Reporting Adverse Events ..........................................................................................49 
8.3.1. 
Adverse event reporting period ..................................................................................49 
8.3.2. 
Severity .......................................................................................................................50 
8.3.3. 
Relationship to study medication ................................................................................50 
8.3.4. 
Procedures for reporting adverse events .....................................................................50 
8.3.5. 
Procedure for reporting a serious adverse event .........................................................50 
8.4. 
PREGNANCY ............................................................................................................51 
8.4.1. 
Definition of Women of Child Bearing Potential (WOCBP) .....................................51 
8.4.2. 
Highly Effective Methods of Birth Control ................................................................51 


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9.
STATISTICS ..............................................................................................................54 
9.1. 
Sample Size and Power Calculations .........................................................................54 
9.2. 
Analysis Populations ..................................................................................................54 
9.3. 
Demographic and Baseline Characteristics ................................................................54 
9.4. 
Efficacy Analyses .......................................................................................................54 
9.4.1. 
Primary Efficacy Analyses .........................................................................................54 
9.4.2. 
Secondary Efficacy Analyses .....................................................................................54 
9.5. 
Safety Analyses ..........................................................................................................55 
10.
TRAINING, DATA HANDLING AND RECORD KEEPING .................................56 
10.1. 
Training .......................................................................................................................56 
10.2. 
Data Collection ...........................................................................................................56 
10.3. 
Data Management .......................................................................................................56 
10.4. 
Study Monitoring ........................................................................................................56 
10.5. 
Source Documentation ................................................................................................57 
10.6. 
Inspection of Records .................................................................................................57 
10.7. 
Retention of Records ..................................................................................................57 
11.
QUALITY CONTROL AND QUALITY ASSURANCE .........................................58 
12.
ETHICS ......................................................................................................................59 
12.1. 
Ethics Review .............................................................................................................59 
12.2. 
Ethical Conduct of the Study ......................................................................................59 
12.3. 
Written Informed Consent ..........................................................................................59 
12.4. 
Study Conduct and Protocol Amendments .................................................................59 
12.5. 
Regulatory Documents ...............................................................................................60 
12.6. 
Contractual Requirements ..........................................................................................60 
13.
LIST OF REFERENCES ............................................................................................61 
APPENDIX 1. ALOPECIA AREATA HISTORY .....................................................................63 
APPENDIX 2. ALOPECIA SCALP APPEARANCE ASSESSMENT FOR PATCHY 
AA: SUBJECT RATING (ASAA-AAP:SR) ..............................................................64 
APPENDIX 3. ALOPECIA FACIAL HAIR APPEARANCE ASSESSMENT: 
SUBJECT RATING (AFHA:SR) ...............................................................................65 
APPENDIX 4. SUBJECT GLOBAL IMPRESSION OF SEVERITY FOR PATCHY 
AA (SGIS-AAP) .........................................................................................................67 
APPENDIX 5. ALOPECIA IMPACT ASSESSMENT ..............................................................68 


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APPENDIX 6. SUBJECT GLOBAL IMPRESSION OF TREATMENT 
SATISFACTION FOR AA PATCHY (SGITS-AAP) ...............................................70 
APPENDIX 7. SUBJECT GLOBAL SATISFACTION WITH HAIR QUALITY 
(SGSHQ-AAP) ...........................................................................................................71 
APPENDIX 8. ALOPECIA SCALP APPEARANCE ASSESSMENT FOR AT AND 
AU: SUBJECT RATING (ASAA-AT/AU:SR) .........................................................72 
APPENDIX 9. SUBJECT GLOBAL IMPRESSION OF SEVERITY FOR AT/AU 
(SGIS-AT/AU) ...........................................................................................................73 
APPENDIX 10. SUBJECT GLOBAL IMPRESSION OF TREATMENT 
SATISFACTION FOR AT/AU (SGITS-AT/AU)......................................................74 
APPENDIX 11. SUBJECT GLOBAL SATISFACTION WITH HAIR QUALITY FOR 
AT/AU (SGSHQ-AT/AU) ..........................................................................................75 
APPENDIX 12. SUBJECT GLOBAL IMPRESSION OF CHANGE (SGIC) ...........................76 
APPENDIX 13. SUBJECT INSTRUCTIONS FOR STUDY MEDICATION 
APPLICATION TO THE ENTIRE SCALP ..............................................................77 
APPENDIX 14. SUBJECT INSTRUCTIONS FOR STUDY MEDICATION 
APPLICATION TO THE EYEBROWS.......................................................................79
LIST OF TABLES 
Table 1: 
Abbreviations and Specialist Terms ...........................................................................14 
Table 2: 
Study Medication Interruption Criteria ......................................................................24 
Table 3: 
Schedule of Assessments ............................................................................................26 
Table 4: 
Investigational Product ...............................................................................................34 
Table 5: 
Subject Assessments ...................................................................................................36 
Table 6: 
Investigator Assessments ............................................................................................38 


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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
The following abbreviations and specialist terms are used in this study protocol. 
Table 1: 
Abbreviations and Specialist Terms  
Abbreviation or Specialist 
Term 
Explanation 
AA 
Alopecia Areata 
AAP 
Alopecia Areata Patchy 
AE 
Adverse Event 
AFHA 
Alopecia Facial Hair Appearance Assessment 
AGA 
Androgenic Alopecia 
AIA 
Alopecia Impact Assessment 
ALADIN 
Alopecia Areata Disease Activity Index 
ALODEX 
Alopecia Density and Extent Score 
ALT 
Alanine aminotransferase 
ANOVA 
Analysis of Variance 
ASAA 
Alopecia Scalp Appearance Assessment 
AST 
Aspartate Aminotransferase 
AT 
Alopecia Totalis 
AU 
Alopecia Universalis 
BID, b.i.d. 
Twice-daily 
BUN 
Blood Urea Nitrogen 
°C 
Degrees Centigrade 
CD 
Cluster of Differentiation 
CI 
Confidence Interval 
ClinRO 
Clinician Reported Outcome 
CMV 
Cytomegalovirus 
CR 
Clinician’s Rating 
CRA 
Clinical Research Associate 
CRO 
Contract Research Organization 
CS 
Clinically Significant 
CTL 
Cytotoxic T-lymphocytes 
DMARDs 
Disease Modifying Anti-Rheumatic Drugs 
DPCP 
Diphenylcyclopropenone 
e.g.
for example (Latin; exempla gratia) 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form 
°F 
Degrees Fahrenheit 
FACS 
Fluorescence Acquisition Cell Sorting 
FDA 
Food and Drug Administration 
G/g 
Gram 
GCP 
Good Clinical Practice 
HCl 
Hydrochloride 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HIV 
Human Immunodeficiency Virus 
H&E 
Hematoxylin and Eosin 
HLA-DR 
Human Leukocyte Antigen- antigen D Related 
ICAM-1 
Intercellular Adhesion Molecule 1 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 


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Abbreviation or Specialist 
Term 
Explanation 
i.e.  
that is (Latin; id est) 
IFN 
Interferon 
IHC 
Immunohistochemical  
IL 
Interleukin 
ITT 
Intent-to-Treat 
IRB 
Institutional Review Board 
JAK 
Janus Kinase  
KER 
Hair keratin panel 
KRT 
Hair Keratin 
LDH 
Lactate dehydrogenase 
MedDRA 
Medical Dictionary for Regulatory Activities 
MHC 
Major Histocompatibility Complex 
mL 
Milliliter 
mm 
Millimeter 
NCS 
Not Clinically Significant 
NK/ NKG 
Natural Killer/ Natural Killer Group 
NMSC 
Nonmelanoma Skin Cancer 
OTC 
Over-The-Counter 
PDT 
Photodynamic Therapy 
PhGIC 
Physician Global Impression of Change 
PhGIS 
Physician Global Impression of Severity 
PP 
Per-protocol 
PRO 
Patient-Reported Outcome 
PUVA 
Psoralen and Ultraviolet A 
SADBE 
Squaric Acid Dibutyl Ester 
SAE 
Serious Adverse Event 
SALT 
Severity of Alopecia Tool 
SALT50 
50% Absolute Change in SALT (Hair Loss at Baseline – Hair loss At Follow-up) 
SALT50 
50% Change in Hair Loss or 50% regrowth 
SGIC 
Subject Global Impression of Change 
SGIS 
Subject Global Impression of Severity 
SGSHQ 
Subject Global Satisfaction with Hair Quality 
SGITS 
Subject Global Impression of Treatment Satisfaction 
SI 
Subject identifier 
SN 
Subject Number 
SOP 
Standard Operation Procedure 
SR 
Subject’s Rating 
STAT 
Signal Transducer and Activator of Transcription 
TEAE 
Treatment Emergent Adverse Event 
Th1 
Type 1 Helper T Cell 
TNK 
Tumor Necrosis Factor 
Tyk2 
Tyrosine Kinase 2 
UPT 
Urine Pregnancy Test 
US 
United States 
UVA 
Ultraviolet A  
UVB 
Ultraviolet B 
WOCBP 
Women of childbearing potential  


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1. 
INTRODUCTION 
Aclaris Therapeutics, Inc. is developing ATI-502 for the topical treatment of alopecia areata, 
alopecia universalis, and alopecia totalis.  ATI-502 is a potent highly selective inhibitor of Janus 
kinase 1 (JAK1) and Janus kinase 3 (JAK3). 
1.1. 
Overview of Alopecia Areata 
Alopecia areata (AA) is an autoimmune dermatologic condition, which, in its mildest form, is 
typically characterized by patchy non-scarring hair loss on the scalp and/or body.  More severe 
forms of AA include total scalp hair loss, known as alopecia totalis (AT), and total loss of all the 
hair on the scalp and body- importantly, including loss of eyebrows, eyelashes, and intranasal 
hair- known as alopecia universalis (AU).  While spontaneous regrowth of hair is common in the 
milder form of AA (patchy), where the hair loss may wax and wane, in patients with the 
extensive hair loss of AT or AU, spontaneous hair regrowth is rare.  AA affects both males and 
females across all ethnic groups and ages, and with a lifetime risk of 1.7% (Safavi 1995).  About 
two-thirds of affected individuals are 30 years old or younger at the time of disease onset.  
The course of AA is unpredictable and while up to 50% of patients may recover within 1 year 
even without treatment, most patients will have more than one episode of hair loss (Price 2008).   
Factors portending a poorer prognosis for regrowth are more extensive hair loss presentations 
(extensive AA, AT, AU), an ophiasis pattern of hair loss, a long duration of hair loss, a positive 
family history, the presence of other autoimmune diseases, nail involvement, and young age of 
first onset (Tosti 2006, Weise 1996).  In children, the disease may have a tendency towards 
worsening with time even if the initial presentation was mild, and the progressively disfiguring 
nature of the disease can be psychologically devastating. AA is highly associated with numerous 
psychiatric comorbidities including adjustment disorders, anxiety disorders and depression in 
both children and adults, and an effective treatment for AT and AU, the more severe forms of the 
disease, represents a significant unmet medical need (Bilgic 2014, Ruiz-Doblado 2003, 
Alkhalifah 2010).  
The clinical development of innovative therapies in AA has lagged far behind other autoimmune 
conditions and there are currently no evidence-based treatments for AA. A Cochrane database 
review highlighted that few therapies for AA have been comprehensively evaluated in 
randomized clinical trials and that no treatment has demonstrated significant benefit compared to 
placebo according to evidence-based assessments (Delamere, 2008).  This lack of good 
evidence-based data remains a challenge for physicians attempting to select efficacious 
treatments for their patients and, as a result, numerous approaches to treatment exist and are 
typically based on considerations such as the age of the patient, the extent and/or duration of the 
disease, patient expectations, cost considerations (both time and financial resources) and 
physician preferences and experience. 
Common treatments for the less severe (patchy) form of AA include corticosteroids, either 
topically applied or injected intralesionally into the alopecic areas, or the induction of an allergic 
reaction at the site of hair loss using a topical contact sensitizing agent- an approach known as 
topical immunotherapy- typically with the topical contact sensitizers diphenylcyclopropenone 
(DPCP), squaric acid dibutyl ester (SADBE), or treatment with topical anthralin.  While these 
same treatment options may be utilized for the more severe forms of AA, their use in the more 


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severe forms of AA is limited not only due to limited efficacy, but also because of the 
impracticality of using them over extensive body surface areas.  Additional treatments used for 
extensive forms of AA (AT, AU) have included systemic steroids (pulsed or chronically 
administered), immunosuppressive agents such as cyclosporine or methotrexate, phototherapy 
with psoralen +UVA (PUVA), narrow-band UVB, photodynamic therapy (PDT), laser therapy 
(e.g., excimer laser, fractional photothermolysis lasers), prostaglandin analogs, etanercept, 
bexarotene and others, all with varying degrees of success and each with its inherent risk of 
adverse effects and unproven efficacy (Alkhalifah 2010, Price 1999, Hordinsky 2015, Strober 
2005).  Most recently, however, a breakthrough in the understanding of the pathophysiology of 
AA and several case reports in the literature have suggested that a group of inhibitors of the 
JAK-STAT pathway, the Janus Kinase (JAK) inhibitors, or “jakinibs” may be efficacious in the 
treatment of AA even in its most severe phenotypes, AT and AU (Jabbari, 2015, Pieri, 2015, 
Xing 2014).  
The JAKs are members of a family of tyrosine kinases that are involved in cytokine receptor 
signaling.  The JAK family of enzymes (JAK1, JAK2, JAK3, Tyk2) plays an essential role in 
regulating the signaling process of most cytokines in cells by linking the cytokine-induced 
signaling from the cell surface membrane receptors to signal transducers and activators of 
transcription, or STATs, within the cells. Once these JAK receptors are activated by the binding 
of a cytokine to the appropriate receptor, they initiate a JAK-STAT signaling pathway which can 
modify gene expression and modulate important regulatory functions in the cell, including 
regulating immune and inflammatory responses.  JAK1 and JAK3 are constitutively associated 
with the alpha chain and the common gamma chain (γc), respectively, of the receptors for 
interleukin-2 (IL2), interleukin-4 (IL-4), interleukin-7 (IL-7) interleukin-9 (IL-9), interleukin-15 
(IL-15), and interleukin-21 (IL-21).  When these cytokines bind to their respective receptors, 
JAK1 and JAK3 are activated and initiate a signaling cascade that drives key inflammatory 
events, including lymphocyte activation and proliferation. The JAK inhibitors can block the 
cytokine receptor signaling pathways, (in this instance JAK1 and JAK3) blocking JAK-STAT 
transcription activation, and can therefore modulate inflammatory or immune responses, which 
can be beneficial in a variety of disease states, particularly, as recently reported, AA (Xing 
2014).   In that report, pharmacologic inhibition of JAK kinase signaling (JAK-STAT signaling) 
was reported to promote hair growth in both genetic mouse models of alopecia and in human 
patients. 
1.2. 
Immunopathology & Pathophysiology of AA 
Alopecia areata (AA) results from an autoimmune attack on the hair follicles that results in 
growing anagen-phase terminal hairs being induced to prematurely enter the telogen-phase and 
then shed.  In its most acute state, AA demonstrates a histopathologically characteristic white 
cell infiltrate- the so called “swarm of bees”- encircling the human hair follicle, though more 
chronic forms typically demonstrate a sparser infiltrate (Jabbari 2016, Whiting 2003). Though 
the exact autoantigens expressed in the perifollicular epithelium that allow these specific T-cells 
to infiltrate the normally immunologically privileged hair follicle have been previously 
unknown, the T-cells that home to the hair follicle have been demonstrated to consist of both 
CD4 and CD8 cells.  Most recent studies have further characterized a specific subpopulation of 
activated NKG2D-bearing CD8+ T-cells as being prominent in the peribulbar infiltrate, and it is 


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now currently felt that these CD8+NKG2D+ effector T-cells preferentially localize to dermal 
sheath cells aberrantly expressing high levels of major histocompatibility complex (MHC) 
molecules and NKG2D ligands.  Interferons, as key activators of the MHC locus and of the 
cellular immune response, appear to play a key role in eliminating the immunologic privilege of 
the hair follicle and in inducing and maintaining the pathologic inflammatory response in AA.  
This is also seen in the C3H-HeJ mouse model of AA, in which IFN-γ is required for 
pathogenesis, and in which administration of IFN-γ accelerates disease. (Gilhar 2005, Hirota 
2003). 
AA has been viewed as a Th1-driven disease and, consistent with a pathogenic cellular immune 
response, elevated Th1 cytokines/ chemokines (IFN-induced chemokines [IP-10/CXCL10]) are 
seen in the peripheral blood of AA patients and IFN-inducible gene signatures have been 
described in the skin of AA patients and may correlate with disease activity (Arca 2004, 
Barahmani 2009, Kuwano 2007).  Additionally, transcriptional profiles in human AA patients 
have shown a Type I IFN response in lesional biopsies and Th1 skewing and elevated IFN 
response cytokines/chemokines in both the peripheral blood and in reviewed scalp biopsies 
(Jabbari 2015, Xing 2014, Jabbari 2016).  The cellular source of IFN-γ is hypothesized to be the 
T-cells, as in the AA mouse model IFN-gamma producing CD8+NKG2D+ cells dominate the 
dermal hair follicle infiltrate, and in human AA, IFN-γ producing cells were identified in 4 of 5 
dermal crawl-out assays (Christiano 2016).  Additionally, data implicate IL- 15 in driving 
activation of IFN-producing CD8 T-cells (Xing 2014).  
Thus, preclinical and preliminary clinical information, as discussed above, strongly suggests that 
the primary pathophysiologic mechanism in AA (including AT and AU) is a cytokine mediated 
(primarily through T-lymphocyte induced upregulation of IL-15 and IFN gamma) induction of 
and prolonged maintenance of the telogen stage of the hair cycle.  Inhibitors of the JAK/STAT 
pathway, particularly JAK1 and JAK3, are known to downregulate the effects of both IFN-
gamma (through the inhibition at JAK1), and IL-15 (through inhibition at both JAK1 and JAK 
3).  As ATI-502 is a potent inhibitor at JAK 1 and JAK 3, it is strongly suggested that ATI-502 
may be effective in the treatment of AA. 
1.3. 
Previous Clinical Study Experience with ATI-501 
Eight Phase 1 clinical studies were conducted with ATI-501 oral doses ranging from single 
ascending doses of ATI-501 of 50 mg to 500 mg and multiple ascending doses of 200, 400 mg, 
600 mg and 800 mg BID for 14 days. A total of 186 healthy volunteers were exposed to oral 
doses of ATI-501.  Single and twice-daily doses of ATI-501 were well-tolerated.  There were no 
SAEs reported in the eight completed clinical studies.   
In study ATI-50001-AUAT-106, the multiple ascending dose study, 54 subjects received doses 
up to 800 mg BID for 14 days.  The most frequently reported treatment related adverse events 
(TRAE) reported in more than 1 subject were:  headache (14.8%), abdominal discomfort (9.3%), 
decreased appetite (9.3%), dizziness (7.4%), somnolence (7.4%), diarrhea (5.6%), dry skin 
(5.6%), nausea (5.6%), constipation (3.7%), dyspepsia (3.7%), feeling hot (3.7%) and paresthesia 
(3.7%). 
No clinically significant laboratory abnormalities were observed.  There were no clinically 
significant findings from 12-lead ECGs.  One subject experienced a transient elevation in blood 


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pressure (pre-dose 126/85mmHg, 4 hours post dose 142/104 mm/Hg) which was assessed as 
clinically significant by the investigator.  The subjects blood pressure returned to within normal 
limits at all other assessed timepoints throughout the study.   There were no other clinically 
significant findings from vital signs assessments.   
In study, ATI-50001-AUAT-106, ATI-501 was not detected in plasma and there was a dose-
related increase in plasma of the active metabolite ATI-502.  Systemic levels of ATI-502, 
following oral doses of ATI-501 in healthy volunteers transiently reduced pSTAT5 activity in ex 
vivo IL-2 stimulated lymphocytes, indicating inhibition of the JAK signaling pathway.  Upon 
multiple dosing, pSTAT5 activity showed a more sustained inhibition during the dosing period.   
Non-clinical studies conducted with topical administration of ATI-502 support the topical 
administration of ATI-502 (ATI-502 Investigator Brochure).   
1.4. 
Clinical Study Experience with ATI-502 Topical Solution 
Seven Phase 2 clinical studies are ongoing with ATI-502 Topical Solution 0.46%, 0.12% or 
placebo solution.  ATI-50002-AA-201 is a randomized, double-blind vehicle-controlled study in 
subjects with stable patchy alopecia areata.  ATI-50002-AA-202 is a randomized double-blind, 
vehicle-controlled study in subjects with alopecia universalis or alopecia totalis.  ATI-50002-
AUATB-201 is an open-label pilot study of the safety, tolerability and efficacy of ATI-50002 
topical solution administered twice-daily in adult subjects with eyebrow loss due to alopecia 
areata, alopecia universalis or alopecia totalis. ATI-50002-AAB-201 is an open-label pilot study 
of the safety, tolerability and efficacy of ATI-50002 topical solution administered twice-daily in 
adult subjects with eyebrow loss due to alopecia areata, alopecia universalis or alopecia totalis.  
ATI-50002-VITI-201 is an open-label pilot study of the safety, tolerability and efficacy of ATI-
50002 Topical Solution Administered Twice-Daily in adult subjects with non-segmental facial 
vitiligo. ATI-50002-AGA-201 is an open-label safety, tolerability, and efficacy study in male 
and female subjects with androgenetic alopecia treated with ATI-50002 Topical Solution.  ATI-
502-AD-201 is a phase 2a safety study of ATI-502 Topical Solution in subjects with moderate to 
severe atopic dermatitis.   
As of July 2018, 141 subjects have applied ATI-502 Topical Solution 0.46%, 0.12% or Placebo 
solution bid for up to 6 months or longer.  Two unrelated serious adverse events were reported in 
one subject each: laceration and depression.  The studies are ongoing, adverse events reported to 
date have been primarily transient and mild in severity.  Local application site reactions 
occurring in one subject in the individual studies have included administration site pain, 
application site pruritus, application site erythema, application site swelling, erythema, pain of 
skin, pityriasis rosea, rash, acne, alopecia, and in two subjects; pruritus.   
1.5. 
Study Rationale  
Several published case reports have demonstrated the potential for JAK1/3 inhibitors to induce 
hair growth in patients with AA (Kim 2017, Craiglow 2014 and 2017, Gupta 2016, Scheinberg 
2016).  These AA case reports have shown promising results with oral tofacitinib and ruxolitinib 
treatment. However, so far, JAK inhibitors have not been shown to provide long-term efficacy 
after ending oral treatment. Hair shedding and substantial hair loss have been reported soon after 
cessation of treatment with oral JAK inhibitors (Mackay-Wiggan 2016).  


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Among patients with AA, patients with higher disease burdens are unlikely to have satisfactory 
outcomes with current therapies. Aclaris Therapeutics, Inc. is developing ATI-502 as a treatment 
for stable patchy AA, AU or AT.  ATI-501 is an oral prodrug that is rapidly converted 
presystemically to ATI-502, a potent highly selective inhibitor of Janus kinase 1 (JAK1) and 
Janus kinase 3 (JAK3).  This study will evaluate the safety and efficacy of ATI-502 Topical 
Solution in the treatment of subjects with AA, AU or AT.  In addition, the study will assess 
whether topical treatment with ATI-502 Topical Solution will maintain hair regrowth in subjects 
who completed 24 weeks of treatment with ATI-501 Oral Suspension or Placebo Suspension in 
study ATI-501-AUAT-201. 
1.6. 
Study ATI-501-AUAT-201 
Study ATI-501-AUAT-201 is an ongoing Phase 2, multicenter, randomized study designed to 
evaluate the safety, tolerability and efficacy of ATI-501 for the treatment of AA, AU, or AT in 
adult subjects. During the screening period, subjects were assessed for eligibility into the study. 
Eligible subjects were male and non-pregnant, non-nursing females ≥ 18 years of age, who were 
in good general health and free of any known disease or physical condition which might impair 
evaluation of the subject.  Subjects were excluded from enrollment if they had a history of or 
current systemic or cutaneous malignancy (except for adequately treated and well healed, and 
completely cleared non-melanoma skin cancers), had evidence of active or latent bacterial or 
viral infections (including herpes zoster or disseminated herpes zoster or disseminated herpes 
simplex), a history of a serious local infection within 3 months prior to baseline or were positive 
for active tuberculosis, HIV, Hepatitis B or C infection. Subjects with serologic evidence of 
Hepatitis B vaccination were allowed to participate.     
 
Enrolled subjects were required to have a clinical diagnosis of stable AA, AU, or AT with 30% 
to 100% total scalp hair loss (based on SALT score at baseline) for a duration of at least 6 
months up to and including 12 years.  Subjects who met the entry criteria were randomized to 
take ATI-501 Oral Suspension, 400 mg, 600 mg, 800 mg or placebo suspension twice-daily for 
24 weeks. Assessment of response to treatment is being performed at Week 4, Week 8, Week 12, 
Week 16, Week 20, Week 24, and post-treatment Week 28.  
Subjects who complete ATI-501-AUAT-201 study visits up to and including Week 24 (Visit 9) 
are eligible to enter this study.  At Visit 9 (in study ATI-501-AUAT-201), subjects who agree to 
participate in study ATI-502-AA-203, must sign consent prior to first application of topical study 
medication.  The assessments completed at Visit 9 (study ATI-501-AUAT-201) will be entered 
into the source documentation for Visit 1 in study ATI-502-AA-203.  Subjects who meet the 
ATI-502-AA-203 entry criteria will apply ATI-502 Topical Solution, 0.46% BID for 24 weeks 
followed by a 4-week post-treatment follow up visit. 
 


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2. 
TRIAL OBJECTIVES AND ENDPOINTS 
2.1. 
Objectives 
The primary objective is to assess the safety, tolerability, and efficacy of ATI-502 Topical 
Solution in subjects with AA, AU or AT following 24 weeks of treatment with ATI-501 Oral 
Suspension or Placebo Suspension in Study ATI-501-AUAT-201. 
An additional objective is to assess the ability of ATI-502 Topical Solution to maintain or 
improve hair regrowth in subjects with AA, AU or AT following 24 weeks of treatment with 
ATI-501 Oral Suspension or Placebo Suspension Study ATI-501-AUAT-201. 
2.2. 
Efficacy Endpoints 
The efficacy endpoints will evaluate the assessment (specified in Section 2.2.1 and Section 2.2.2) 
from the Baseline visit from both ATI-501-AUAT-201 and ATI-502-AA-203 compared to the 
applicable post-baseline visits. 
2.2.1. 
Primary Efficacy Endpoint 
The primary efficacy endpoint will be the mean relative percent change from the original 
baseline visit in study ATI-501-AUAT-201 in the SALT score at Visit 6 (Week 24 on study ATI-
502-AA-203).  This represents the percentage of hair regrowth.  It will be calculated as the mean 
of the changes from baseline SALT score to the SALT score at Visit 6 (Week 24 on study ATI-
502-AA-203), divided by baseline SALT score and expressed as a percentage. 
2.2.2. 
Secondary Efficacy Endpoints: 
• Proportion of subjects achieving a SALT 50, SALT 75 (defined as a ≥ 50%, ≥ 75% 
improvement from baseline in SALT) by visit. 
• Durability of response:  Proportion of subjects achieving a SALT 50 or SALT 75 at 
Week 24 (study ATI-501-AUAT-201) and maintaining response at post-baseline visits in 
ATI-502-AA-203. 
• Mean Relative Percent Change from Baseline (from the current study ATI-502-AA-203) 
in Severity of Alopecia Tool (SALT) by visit.   
• Mean Relative Percent Change from Baseline in Alopecia Density and Extent Score 
(ALODEX) score by visit.   
• Mean Change from Baseline in SALT and ALODEX score by visit. 
• Change from Baseline in the Alopecia Scalp Appearance Assessment (ASAA) (Patient-
reported outcome [PRO]) by visit. 
• Change from Baseline in the Alopecia Scalp Appearance Assessment (ASAA) (Clinician-
reported outcome [ClinRO]) by visit. 
• Change from Baseline in the Physician Global Impression of Severity (PhGIS) by visit. 
• Change from Baseline in Alopecia Facial Hair Appearance Assessment (AFHA) 
(Clinician and Subject) by visit. 
• Change from Baseline in the Subject Global Impression of Severity (SGIS) by visit. 
• Change from Baseline in the subject reported Alopecia Impact Assessment (AIA) by 
visit. 


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• Subject Global Impression of Treatment Satisfaction (SGITS) by visit. 
• Change from Baseline in the Subject Global Satisfaction with Hair Quality (SGSHQ) 
by visit. 
• Global Impression of Change (Clinician and Subject) at Week 24 of ATI-502-AA-
203. 
 
2.3. 
Safety Endpoints 
Safety variables to be assessed include: adverse events, clinical laboratory tests (hematology, 
clinical chemistry, and urinalysis), vital sign measurements (systolic and diastolic blood 
pressures, respiration rate, heart rate, and oral or ear body temperature), physical exam, and 
electrocardiograms. 
2.4. 
Other Assessments 
• Hair quality assessment including normalization of exclamation point hairs and hair 
shedding will be described. 
• Vellus and Indeterminate scalp hair will be described.  
• Non-scalp hair assessments (body and nasal hair) will be described. 
 
 


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3. 
INVESTIGATIONAL PLAN 
3.1. 
Overall Study Design 
This Phase 2, multicenter, open-label study will evaluate the safety, efficacy, and durability of 
efficacy of ATI-502 Topical Solution, 0.46% for the treatment of alopecia areata (AA), alopecia 
universalis (AU) and alopecia totalis (AT) in adult subjects who completed 24 weeks of 
treatment with ATI-501 Oral Suspension or Placebo Suspension.   
Subjects who complete 24 weeks of active treatment with ATI-501 Oral Suspension or Placebo 
Suspension in study ATI-501-AUAT-201 will be assessed for eligibility to enter the study.  At 
Visit 9 in study ATI-501-AUAT-201, subjects who did not experience any adverse events (AEs), 
serious adverse events (SAEs), or tolerability issues that met study discontinuation criteria in 
study ATI-501-AUAT-201 and who in the opinion of the investigator are capable of regrowing 
scalp hair or maintaining prior regrowth experienced in ATI-501-AUAT-201 and meet the other 
entry criteria are eligible to enroll in this open-label study. 
Enrolled subjects will apply ATI-502 Topical Solution, 0.46% BID to the entire scalp and if 
applicable, the eyebrow(s) and return for safety and efficacy assessments as detailed in the 
Schedule of Assessments (Table 3).  Assessment of response to treatment and durability of 
response will be performed at Week 4, Week 8, Week 16, Week 24, and post-treatment Week 
28.  Safety and tolerability will be evaluated at each study visit by assessment of adverse events, 
clinical laboratory tests, and vital signs, and at Week 24, and physical examination findings. 
3.2. 
Number of Subjects 
Approximately 80 subjects will be enrolled at approximately 25 US sites. 
3.3. 
Treatment Assignment 
Subjects will apply ATI-502 Topical Solution, 0.46% twice-daily for 24 weeks followed by a 4-
week post-treatment follow up period. 
3.4. 
Dose Adjustment Criteria 
Subjects should not modify the study medication dosage or frequency without the investigator’s 
prior approval. All study medication modifications must be reported on the appropriate eCRF.  If 
study medication intolerance or safety issue occurs, after consulting with the Aclaris 
Therapeutics, Inc. Medical Monitor (see page 1), the investigator or designee may direct the 
subject to modify the study medication frequency from twice-daily to once-a-day. If the subject 
cannot apply the study medication twice-daily for more than 4 consecutive days, other dose 
modifications and continuation in the study must be reviewed with the Medical Monitor. 


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3.4.1. 
Safety Criteria for Adjustment or Stopping Doses 
3.4.1.1. 
Study Medication Interruption 
Treatment with ATI-502 Topical Solution should be temporarily interrupted in the event of 
severe adverse events considered related to ATI-502, or in the event of one or more of the 
abnormal laboratory values listed in Table 2.  
Table 2: Study Medication Interruption Criteria 
Laboratory Test 
Hold Study Medication if: 
Resume Study Medication if: 
WBC count 
< 2 x 103/µL 
≥ 2.5 x 103/µL 
ANC 
< 1 x 103/µL 
≥ 1.5 x 103/µL 
Lymphocyte count < 0.5 x 103/µL 
≥ 0.75 x 103/µL 
Platelet count 
< 75 x 103/µL 
Returns to Baseline values 
Hemoglobin 
< 8 g/dL or a decrease > 2g/dL 
(from baseline value on ATI-
501-AUAT-201) 
≥ 10 g/dL 
AST or ALT 
> 3 x ULN 
< 2 x ULN or within 20% of Baseline values 
Serum creatinine 
>2 x ULN 
<1.5 x ULN or within 10% of Baseline value 
 
Subjects with one or more of laboratory values meeting the Study Medication Interruption 
Criteria found in Table 2 must have repeat lab testing performed with results meeting the 
minimum criteria for resumption in order to initiate treatment  
 
During treatment, if a subject has one or more of the abnormal laboratory values noted in 
Table 2, the investigator or designee upon receipt and review of the central laboratory report 
should instruct the subject to hold study medication dosing. The investigator or designee should 
ask the subject about symptoms, concomitant illnesses and medications and repeat the test(s) as 
soon as possible.  The Medical Monitor must be notified of dose interruptions due to SAEs 
considered related to study medication or laboratory abnormalities noted in Table 2.  
 
If the retest confirms the abnormal laboratory value, then the study medication should continue 
to be held followed by repeat testing once a week or sooner at the discretion of the investigator.  
The subject should be followed until the laboratory abnormality(s) returns to normal or to 
Baseline (Visit 1) values.    
3.4.1.2. 
Study Medication Discontinuation 
Study medication should be permanently discontinued in the event of any of the following: 
• Severe infection requiring parenteral antimicrobial therapy or hospitalization 
• Symptomatic herpes zoster 
• Malignancy  
• Anaphylactic or severe allergic reaction 


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• WBC Count: < 1 x 103/µL or second occurrence of < 2 x 103/µL  
• ANC: < 0.5 x 103/µL or second occurrence of < 1 x 103/µL  
• Lymphocyte count: < 0.3 x 103/L or second occurrence of < 0.5 x 103/µL  
  
• Platelet count: < 50 x 103/µL or second event of < 75 x 103/µL – in each case, value should 
be confirmed by retesting before treatment discontinuation 
• Hemoglobin: < 6.5 g/dL or second occurrence of < 8 g/dL – in each case, value should be 
confirmed by retesting before treatment discontinuation 
• AST or ALT:  
o > 5 x ULN persisting for 2 weeks of study medication interruption or second 
event of > 5 x ULN 
o > 3 x ULN with total bilirubin >2 x ULN or symptoms of hepatocellular  
injury [fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, 
rash and/ or eosinophilia (>5%)].  
 
• Serum creatinine:  > 2 x ULN persisting for >2 weeks of treatment discontinuation or 
second occurrence of > 2 x ULN 
The continued treatment of subjects who experience other serious or severe adverse events 
considered related to study treatment should be discussed with the Sponsor’s medical monitor. 
Site staff must perform protocol-required procedures for trial discontinuation and follow-up. 
3.5. 
Criteria for Study Termination 
This study may be terminated prematurely in whole or in part due to a change in the benefit/risk 
profile for ATI-502 Topical Solution such that continuation of the study would not be justified 
on medical or ethical grounds.  This determination may be made by the Study Investigators in 
conjunction with the Sponsor, or by IRB or the U.S. Food and Drug Administration (FDA).  The 
Sponsor may also elect to terminate the study if ATI-502 development is discontinued. 
If the study is terminated prematurely, the Sponsor will notify the Study Investigators and the 
FDA. The Investigator must promptly notify all enrolled subjects and the IRB of study 
termination. 
3.6. 
Study Procedures 
The investigator, a designated and appropriately trained staff member, or the subject will 
perform the study assessments according to the Schedule of Assessments (Table 3). The same 
staff member should perform the assessments for a given subject throughout the study. If this 
becomes impossible, an appropriate designee with overlapping experience with the subject and 
study should perform the assessments. The same lighting conditions and subject positioning 
should be used for all evaluations for a given subject.      


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Table 3: 
Schedule of Assessments 
 
 
 
 
Assessments 
Visit 91  
from Study 
ATI-501-
AUAT-201  
 
Post-
Treatment 
Visit 11 
 
Visit 2 
 
Visit 3 
 
Visit 4 
 
Visit 5 
Visit 6 
(ET) 
 
Visit 7 
 
Week 
NA 
0 
2 
4 
8 
16 
24 
28 
Treatment Day 
NA 
1 
15 
29 
57 
113 
169 
197 
Treatment Window(days) 
N/A 
N/A 
± 3 
± 3 
± 3 
± 3 
± 3 
± 7 
Informed consent2 
 
X 
 
 
 
Inclusion/exclusion criteria  
 
X 
 
 
 
 
 
 
Physical exam3 
 
(X)^ 
 
 
 
 
X 
 
Demographics and Medical History Update 
 
X 
 
 
 
 
 
 
Alopecia Areata History (Transcribe) 
 
X 
 
 
 
 
 
 
Vital signs4  
 
(X)^ 
X 
X 
X 
X 
X 
Clinical CBC, Chemistry, Urinalysis 
 
X 
X 
X 
X 
X 
Urine pregnancy test5 
 
(X)^ 
 
X 
X 
X 
X 
X 
ECG  
 
 
Subject6 
Alopecia Scalp Appearance Assessment (ASAA-
AAP: SR or ASAA-AT/AU: SR)   
 
(X)^ 
 
 
X 
 
X 
X 
Alopecia Facial Hair Appearance Assessment (AFHA: 
SR) 
 
(X)^ 
 
 
X 
 
X 
X 
Subject Global Impression of Severity (SGIS-AAP or 
SGIS-AT/AU)  
 
(X)^ 
 
 
X 
 
X 
 
Alopecia Impact Assessment (AIA):  Subject Rating 
 
(X)^ 
 
 
X 
 
X 
 
Subject Global Impression of Change (SGIC)7 
 
 
 
 
 
 
X 
 
Subject Global Impression Treatment Satisfaction 
(SGITS-AAP or SGITS-AT/AU)8 
 
(X)^ 
 
 
X 
 
X 
 
Subject Global Satisfaction with Hair Quality 
(SGSHQ-AAP or SGSHQ-AT/AU) 
 
(X)^ 
 
 
X 
 
X 
 
Investigator6 
Alopecia Scalp Appearance Assessment (ASAA: -
AAP:CR of ASAA-AT/AU:CR)  
 
(X)^ 
 
 
X 
 
X 
X 
Alopecia Facial Hair Appearance Assessment (AFHA: 
CR) 
 
(X)^ 
 
 
X 
 
X 
X 
Non-Scalp Hair Loss Assessment (NSHA) 
 
(X)^ 
 
 
X 
 
X 
 
Physician Global Impression of Severity (PhGIS-AAP 
or PHGIS-AT/AU) 
 
(X)^ 
 
 
X 
 
X 
 
Physician Global Impression of Change (PhGIC) 
 
(X)^ 
 
 
 
 
X 
 
Hair Quality Assessment (Patchy AA Subjects Only)9 
 
(X)^ 
 
 
X 
 
X 
X 


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Assessments 
Visit 91  
from Study 
ATI-501-
AUAT-201  
 
Post-
Treatment 
Visit 11 
 
Visit 2 
 
Visit 3 
 
Visit 4 
 
Visit 5 
Visit 6 
(ET) 
 
Visit 7 
 
SALT Score (prior to ALODEX)10 
 
(X)^ 
 
X 
X 
X 
X 
X 
ALODEX Score (after SALT)11 
 
(X)^ 
 
X 
X 
X 
X 
X 
Vellus and Indeterminate Hair Assessment 
 
(X)^ 
 
X 
X 
X 
X 
X 
Photography (complete scalp)  
 
(X)^ 
 
X 
X 
X 
X 
 
Subject instructions12 
 
X 
X 
X 
X 
X 
 
 
In office study medication application 
 
X 
 
 
 
 
 
 
Dispense study medication13  
 
X 
X 
X 
X 
X 
 
Collect study medication and assess compliance14  
 
 
X 
X 
X 
X 
X 
 
Concomitant therapies 
 
(X)^ 
X 
X 
X 
X 
X 
X 
Adverse events  
 
(X)^ 
X 
X 
X 
X 
X 
X 
Abbreviations: CR= Clinician Rating; ET= Early termination Visit; SR= Subject Rating  
1Visit 1 will occur on the same day as Visit 9 of study ATI-501-AUAT-201.  Visit 9 procedures for study ATI-501-AUAT-201 must be completed prior to initiation of 
any study related activity for ATI-502-AA-203. Eligible subjects must sign consent prior to first application of topical study medication.  The assessments performed 
for Visit 9 in study ATI-501-AUAT-201 will be entered into the source document and eCRF for Visit 1 in study ATI-502-AA-203.  ATI-502-AA-203 enrollment may 
not be open at the time of a subject’s ATI-501-AUAT-201 Visit 9. If this scenario occurs, the subject may be brought back to the clinic prior to their ATI-501-AUAT-
201 Visit 10. At this visit, the subject will then be given topical treatment.  Assessments marked as (X)^ represent repeat assessments that would need to be performed 
if the subject cannot enroll directly at Visit 9 (or within 14 calendar days of Visit 9) from study ATI-501-AUAT-201. 
2A written, signed ICF must be obtained from each subject prior to performing any study related procedure. 
3A physical examination includes:  General appearance, examination of the head, eyes, ears, nose and throat, respiratory, cardiovascular, abdominal, extremities, 
musculoskeletal, lymphatic, skin (other than AA) and neurological assessment.   
4Vital signs include oral or ear temperature, blood pressure, heart rate, respiration rate. 
5 For WOCBP, the UPT performed at Visit 9 in study ATI-501-AUAT-201 must be negative prior to study medication application. UPT 
in WOCBP must also be obtained at Visits 3, 4, 5, 6, and 7 and must be negative for the subject to continue in the study. 
6 The subject should perform assessments prior to the Investigator assessments. The investigator may assist the subject in locating a Target Patch.  
7The subject should refer to the Baseline (Visit 2 from ATI-501-AUAT-201 and Visit 1 from ATI-502-AA-203) photographs when assessing the change over time. 
8The study staff should remind the subject that this question is in relation to the satisfaction with the result of the hair regrowth.  
9In subjects with patchy AA, the assessment of hair quality will be performed at the edge of the target patch. For subjects with AU/AT, the assessment of hair quality 
will be recorded as Not Applicable in the source document and eCRF. At Baseline (Visit 1), the assessment should be determined prior to the first dose of study 
medication.  
10SALT score must be determined prior to ALODEX using device provided.  
11ALODEX score determined after SALT score using device provided.  
12The study staff must instruct the subject to apply study medication according to the instructions in Appendix 13 and Appendix 14.  


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Assessments 
Visit 91  
from Study 
ATI-501-
AUAT-201  
 
Post-
Treatment 
Visit 11 
 
Visit 2 
 
Visit 3 
 
Visit 4 
 
Visit 5 
Visit 6 
(ET) 
 
Visit 7 
 
13Each study medication bottle contains approximately 100 ml of ATI-502- Topical Solution.  The study staff should dispense a number of bottles to each subject based 
on the quantity applied at the first visit.   
14Staff should review the usage based on the number of used and unused bottles, weight of the bottle and counsel the subject as necessary.  
 


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4. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
Male and female subjects, 18 years of age or older, with a clinical diagnosis of AA, AU or AT of 
the scalp, who meet all the inclusion criteria and none of the exclusion criteria, will be eligible to 
enroll in this study.  
4.1. 
Subject Inclusion Criteria 
 
Subjects must meet the following criteria to be eligible for participation in the study: 
1. Subject must be able to comprehend and willing to sign the Informed Consent Form 
(ICF). 
2. Male or non-pregnant, non-nursing female ≥ 18 years old at the time of informed consent. 
3. Subject has completed 24 weeks of treatment in study ATI-501-AUAT-201. 
4. Subject has not experienced any clinically significant AEs, SAEs or tolerability issues 
that met study discontinuation criteria in ATI-501-AUAT-201. 
5. Subject is capable of regrowing scalp hair or maintaining prior scalp hair regrowth from 
ATI-501-AUAT-201 in the opinion of the investigator. 
6. If a woman of childbearing potential (WOCBP), must have a negative urine pregnancy 
test at Visit 1 and agree to: use a highly effective method of birth control for the duration 
of the study; not be planning a pregnancy during the study duration and use contraception 
for 30 days after last application of study medication. (Refer to Section 8.4). 
7. Be in good general health and free of any known disease state or physical condition 
which, in the investigator’s opinion, might impair evaluation of the subject or which 
might expose the subject to an unacceptable risk by study participation. 
8. Be willing to maintain the same hair style throughout the study period. Subjects who shave 
their scalp must be willing to refrain from shaving their scalp for at least one week or longer 
prior to each study visit, as determined by the investigator based on visible scalp hair 
growth. Hair trimming outside the treatment areas to maintain the current hair style is 
permitted. 
9. Be willing and able to follow all study instructions and to attend all study visits. 
10. Sexually active male subjects must agree to use a barrier method of contraception from 
the first application of study medication to at least 30 days after the last application of 
study medication. 
4.2. 
Subject Exclusion Criteria 
Subjects are excluded from this study if any 1 or more of the following criteria is met: 
1. Any study medication discontinuation criteria are met during participation in study ATI-
501-AUAT-201. 
2. Females who are nursing, pregnant, or planning to become pregnant for the duration of 
the study and up to 30 days after the last application of study medication. 
3. The presence of a permanent or difficult to remove hairpiece or wig that will, in the opinion 
of the investigator, interfere with study assessments if not removed at each visit.   
4. Sensitivity to any of the ingredients in the study medications. 


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5. Unwillingness to refrain from weaves, hair extensions, or shaving of the scalp for at least 
one week or longer prior to each study visit, as determined by the investigator based on 
visible scalp hair growth the duration of the study. 
4.3. 
Subject Withdrawal Criteria 
Subjects will be informed that they are free to withdraw from the study at any time and for any 
reason. The investigator may remove a subject from the study if, in the investigator’s opinion, it 
is not in the best interest of the subject to continue the study. Examples of other reasons subjects 
may be discontinued from the study are: a change in compliance with an inclusion or exclusion 
criterion, occurrence of AEs, occurrence of pregnancy, use of a prohibited therapy or subject is 
unwilling or refuses to continue with the protocol defined study visits and/or subject withdraws 
consent (Refer to Section 3.4.1.2 for study medication discontinuation or termination criteria).  
In case of premature discontinuation from study participation, all efforts will be made to perform 
all Week 24 (Visit 6) assessments. The date the subject is withdrawn from the study and the 
reason for discontinuation must be recorded in the subject’s electronic case report forms 
(eCRFs). All withdrawn subjects with ongoing AEs will be followed until the event has resolved 
or stabilized, until the subject is referred to the care of a local health care professional, or until a 
determination of a cause unrelated to the study medication or study procedures is made. 


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5. 
TREATMENT OF SUBJECTS 
5.1. 
Study Medication Administration 
Study medication will be applied by the subject.  Subjects will be instructed to apply a thin film 
of ATI-502 Topical Solution up to 4-mLs, twice-daily; once in the morning and approximately 
12 hours later to the entire scalp and eyebrows (if applicable) following the instructions in 
Appendix 13 and Appendix 14 (if applicable).  The subject must wash her/his hands thoroughly 
before and after each study drug application. At each study visit, subjects should bring the study 
medication including unused bottles back to the site.  The disposable droppers and applicators 
should be disposed of at the subject’s home. 
Following review of study medication instructions, subjects will apply the first dose of study 
medication in the office under the instruction and supervision of the study staff.   
During Visit 1, the study staff member will: 
• Dispense the appropriate study medication bottle. 
• Weigh the bottle with the cap prior to the first study medication application. 
• Instruct the subject on the appropriate application technique following instructions in 
Appendix 13 and Appendix 14 (if applying study medication to the eyebrow area). 
• Observe the subject’s first study medication application to ensure proper coverage and 
monitor the subject for at least 20 minutes after application.   
• Record the quantity in mLs of study medication the subject applied to cover the entire scalp 
in the source document, eCRF and on the subject instruction sheet. 
• After the first application, the study staff should weigh the study bottle with the cap.   
• Provide feedback on the application procedure, if needed.  
 
The investigational site staff will dispense a sufficient supply of study medication at the visits  
detailed in the Schedule of Assessments (Table 3) and will review the study medication 
instructions as detailed in Appendix 13 and Appendix 14.  At each study visit, subjects should 
bring the study medication including used and unused bottles and the completed compliance 
record.  The study staff will review the compliance record, used and unused bottles and the study 
medication instructions.  
5.2. 
Concomitant Medications 
Concomitant therapies are any new or existing therapies received from Visit 1 until discharge 
from the study.  Concomitant therapies include drug (e.g. prescription and over the counter 
[OTC]), and non-drug (e.g., chiropractic, physical therapy, energy-based treatments).  
Subjects will be allowed to take medications not restricted by the protocol as long as they have 
been reviewed by the investigator and will not affect efficacy or safety.  Vitamins, minerals, and 
dietary supplements are permitted while on study if the subject has been on a stable dose prior to 
study entry and, in the opinion of the Investigator, will not affect the safety or efficacy of the 
subject during the study.  Topical hair and scalp products (shampoos, conditioners, styling 
products) should be reviewed by the Investigator and are permitted if, in the Investigator’s 
opinion, they will not affect the safety or efficacy of the subject during the study. Use of hair 
dyes is permitted during the study if the subject uses the same hair dye throughout the study.  If 


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in the opinion of the Investigator, the hair dye interferes with study assessments the subject may 
be directed to wait until after the study visit to dye his or her hair.  Efforts should be made to 
keep the hair care regimen the same throughout the duration of the study. 
Topical therapies such as topical corticosteroids are permitted if they are not applied on or near 
the scalp and if applicable the eyebrow(s) and are not used for hair growth in other areas. Inhaled 
or intranasal corticosteroids are allowed in the study. 
Prior permitted concomitant medications taken within 30 days of beginning treatment with ATI-
502 Topical Solution will be documented in the subject’s source document and eCRF.  In 
addition, any new permitted medications administered during protocol treatment and through 
Week 28 (Visit 7?) will be documented in the subject’s source document and eCRF.   
5.3. 
Grooming 
Routine shaving of the scalp and beard is allowed during the study if the subject refrains from 
shaving for a period sufficient to show hair growth prior to Visits 4 and 6.  Subjects who shave 
their scalp must be willing to refrain from shaving their scalp for at least one week or longer 
prior to each study visit, as determined by the investigator based on visible scalp hair growth.  
Hair trimming outside the treatment areas to maintain the current hair style is permitted.  
Subjects are allowed to grow their hair longer than the length at the baseline visit (Visit 1), as 
long as the investigator can assess hair loss and regrowth during the study and hair regrowth is 
pinned out of the way to show the areas with hair loss at baseline for photographs.   
5.4. 
Prohibited Medications 
Any medication, shampoo or hair product known to affect hair growth in AA, AU or AT is 
prohibited throughout the study period.  Subjects who are on a chronic stable dose of finasteride 
for benign prostatic hypertrophy for greater than 1 year are eligible for enrollment in the study as 
long as they maintain the same stable dose throughout the study.  Treatment with finasteride for 
alopecia during the study is prohibited.   
The following medications and therapies are not permitted during the study:   
• Disease Modifying Anti-Rheumatic Drugs (DMARDS), Biologics or 
immunosuppressants, including but not limited to: anakinra, adalimumab, azathioprine, 
corticosteroids, cyclosporine, etanercept, infliximab, methotrexate, TNF inhibitors, 
ustekinumab, and Plaquenil. 
• JAK inhibitors (oral or topical) other than ATI-502 Topical Solution. 
• Intralesional steroids or platelet rich plasma treatment in the scalp. 
• Topical treatments on the scalp with anthralin, bimatoprost, corticosteroids, 
diphencyprone, diphenylcyclopropenone (DPCP), squaric acid dibutylester (SADBE), 
minoxidil, pimecrolimus, or tacrolimus. 
• Phototherapy (narrow band Ultraviolet B [NB UVB] or broadband therapy). 
 


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Any prohibited medications taken by a subject in violation of the protocol requirements will be 
documented in the source record and eCRF.  Discussion with the Sponsor’s Medical Monitor 
must also take place to determine if the subject’s continuation in the study is allowed. 
5.5. 
Treatment Compliance 
The investigator or designee will be responsible for monitoring subject compliance through 
questioning the subject, reviewing the subject completed compliance record and documenting 
missed doses, if any, and visual inspection of the study medication bottles (used and unused).  
Study staff will counsel the subjects, as required to make sure subjects are compliant with study 
medication dosing. 
5.6. 
Blinding 
This is an open-label study. 


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6. 
STUDY MEDICATION MATERIALS AND MANAGEMENT 
6.1. 
Study Medication 
The study medication for this study is ATI-502 Topical Solution, 0.46%. The study medication is 
formulated as a thin clear solution.  The inactive ingredients include: water, transcutol P, 
propylene glycol, PEG400, dimethyl sulfoxide (DMSO), kolliphor CS 20, benzyl alcohol, 
poloxamer 188, and povidone K30. 
 
Table 4: 
Investigational Product 
STUDY MEDICATION INFORMATION 
Study medication name 
ATI-502 Topical Solution 
Dosage Strength 
0.46% 
Manufacturer 
PMRS, Horsham, PA 
Pharmaceutical Form 
Topical Solution 
Container 
Amber Glass Bottle, 120 mL (100 mL fill) with screw cap  
Storage Conditions 
59°F to 77°F (15°C to 25°C) 
Dose regimen 
Route 
Topical to the scalp, and if applicable, eyebrows 
Frequency 
Twice-daily 
Duration of administration 
24 weeks 
Other supplies 
Disposable, single-use droppers, and applicators will be 
provided. 
6.2. 
Packaging and Labeling 
The study medication must be used by the study subjects only.  The study medication will be 
supplied in amber glass 120 mL bottles with each bottle packaged in a carton.  Disposable 
droppers with 1 mL calibration mark and applicators will be provided   Each carton and bottle 
will be labeled with a single panel label.   
Investigational site staff will explain the administration of study medication to subjects.  Study 
medication will be provided by Aclaris Therapeutics, Inc. and labeled according to regulations as 
detailed in the Pharmacy Manual.   
6.3. 
Study Medication Storage 
Study medications must be stored in a secure area with limited access under appropriately 
controlled and monitored storage conditions.  Study medication should be stored at controlled 
room temperature 59°F – 77°F (15°C – 25°C).  Subjects will be instructed to store the study 
medication in the carton at room temperature, away from heat, moisture, direct light, and to keep 
it from freezing and out of the reach of children. 
6.4. 
Study Medication Accountability and Disposal 
The Principal Investigator or designee is responsible for ensuring accountability for the 
investigational agent, including reconciliation of medications and maintenance of medication 


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records.  Upon receipt of study medication, the clinical site will check for accurate delivery and 
acknowledge receipt by signing (or initialing) and dating the documentation provided.  A copy of 
this document will be submitted to Aclaris Therapeutics, Inc. (or designee) by facsimile or e-mail 
(scanned copy) and the original will be maintained in the study file. In addition, an accurate 
study medication disposition record will be kept, specifying the amount dispensed for each 
subject and the date of dispensing. This inventory record will be available for inspection at any 
time. At the completion of the study, the original inventory record will be available for review by 
Aclaris Therapeutics, Inc. upon request.  Final medication accountability will be performed by 
the study monitor at the completion of the study and all used and unused study medication 
bottles will be disposed of as detailed in the Pharmacy Manual. 


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7. 
ASSESSMENT OF EFFICACY 
Note that all subject assessments should be performed in the order detailed in Table 5 prior to 
any investigator assessments.  For the purposes of the ATI-502-AA-203 study, subjects will 
retain their original disease classification (AA, AT, or AU) from the ATI-501-AUAT-201 study.  
For subjects classified with AA (30%-95% scalp hair loss at Baseline in study ATI-501-AUAT-
201), the investigator may assist the subject in determining the location of the target patch by 
showing him/her baseline photography of the original target patch from the ATI-501-AUAT-201 
study. Investigators should not review the subject’s completed assessments prior to completing 
the investigator assessments.  The investigator should perform the assessments in the order 
detailed in Table 6.  Detailed instructions for completing the subject and investigator assessments 
will be provided to the investigational center prior to the initiation of subject enrollment. 
7.1. 
Subject Reported Outcome Assessments 
The subject will complete the assessments (questionnaires) in the order detailed in Table 5.  The 
subject must sign/initial and date the completed questionnaire to indicate he/she performed the 
assessment as instructed.  The staff member administering the questionnaires must document 
proper completion of the assessments in the subject’s source notes. 
 
Table 5: Subject Assessments 
Order Subjects with Patchy AA  
(30% – 95% scalp hair loss at 
Baseline in study ATI-501-AUAT-
201) 
Subjects with AU or AT (>95% scalp hair 
loss at Baseline in study ATI-501-AUAT-
201) 
1. 
Alopecia Scalp Appearance Assessment 
for Patchy AA:  Subject Rating (ASAA-
AAP: SR) Appendix 2  
Alopecia Scalp Appearance Assessment for 
AT/AU:  Subject Rating (ASAA-AT/AU: SR) 
Appendix 8  
2. 
Alopecia Facial Hair Appearance Assessment:  Subject Rating (AFHA: SR) Appendix 3  
3. 
Subject Global Impression of Severity 
for Patchy AA (SGIS-AAP) Appendix 4 
Subject Global Impression of Severity for 
AT/AU (SGIS-AT/AU) Appendix 9  
4. 
Alopecia Impact Assessment (AIA) Appendix 5  
5. 
Subject Global Impression of Change (SGIC)* Appendix 12   
6. 
Subject Global Impression of Treatment 
Satisfaction for Patchy AA (SGITS-
AAP) Appendix 6  
Subject Global Impression of Treatment 
Satisfaction for AT/AU (SGITS-AT/AU) 
Appendix 10  
7. 
Subject Global Satisfaction with Hair 
Quality (SGSHQ-AAP) Appendix 7 
Subject Global Satisfaction with Hair Quality 
(SGSHQ_AT/AU) Appendix 11  
*Only assessed at final study treatment visit 


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7.1.1. 
Alopecia Scalp Appearance Assessment (ASAA)  
Subjects with patchy AA (30 – 95% scalp hair loss at Baseline in study ATI-501-AUAT-201), 
will assess appearance of hair loss in the target scalp patch and the whole scalp by completing 
Item 1 and 2 of the ASAA-AAP: SR at the visits detailed in Schedule of Assessments (Table 3). 
The scalp assessment for subjects (ASAA-AAP: SR) is in Appendix 2.   
Subjects with AU and AT (>95% scalp hair loss at Baseline in study ATI-501-AUAT-201) will 
assess the appearance of the whole scalp using the ASAA-AT/AU: SR by the subject at the visits 
listed in the Schedule of Assessments (Table 3).  The scalp appearance for the subjects (ASAA-
AT/AU: SR) is in Appendix 8.   
7.1.2. 
Alopecia Facial Hair Appearance Assessment (AFHA) for AA, AT and AU: 
Subject Rating (SR) (AFHA: SR) 
All subjects (AA, AT or AU) will complete the AFHA: SR.  An investigational staff member will 
instruct the subject to assess the facial hair areas (eyebrows, eyelashes and if male, beard), educate 
the subject on the AFHA: SR before each evaluation  at the visits detailed in Schedule of 
Assessments (Table 3). The staff member should not influence the subject’s assessment.  The 
AFHA: SR is in Appendix 3.   
7.1.3. 
Subject Global Impression of Severity (SGIS) 
The severity of the subject’s AA, AU or AT will be assessed by all subjects at the visits detailed 
in Schedule of Assessments (Table 3) using the Global Impression of Severity Questionnaire in 
Appendix 4 for subjects with AA or Appendix 9 for subjects with AT/AU. 
7.1.4. 
Alopecia Impact Assessment (AIA):  Subject Rating 
The Investigator or study staff will instruct subjects with AA, AT or AU to answer the AIA 
(Appendix 5) during the study visit at the visits detailed in the Schedule of Assessments (Table 
3).  
7.1.5. 
Subject Global Impression of Change (SGIC) 
The investigator or study staff will instruct subjects with AA, AU or AT to answer the SGIC 
questionnaire at their final study treatment visit to report their overall impression of change for 
their condition. Subjects will assess change in the severity of their condition on a 7-point scale 
from “Very much improved” to “Very much worse”; the SGIC can be found in Appendix 12.  
Subjects should be given the baseline photo prints from study ATI-501-AUAT-201 to review to 
complete this assessment. 
7.1.6. 
Subject Global Impression of Treatment Satisfaction (SGITS) 
The investigator or study staff will instruct subjects with AA, AU or AT to answer the SGITS 
questionnaire in relation to their satisfaction with the scalp hair regrowth.  Subjects will assess 
their satisfaction with the outcome of the study treatment on a 7-point satisfaction scale from 
“extremely satisfied” to “extremely dissatisfied” at the visits detailed in the Schedule of 
Assessments (Table 3).  Subjects with patchy AA (30%-95% scalp hair loss at Baseline in study 
ATI-501-AUAT-201) will complete the SGITS-AAP found in Appendix 6.   Subjects with AT or 


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AU (> 95% scalp hair loss at Baseline in study ATI-501-AUAT-201) will complete the SGITS-
AT/AU found in Appendix 10. 
7.1.7. 
Subject Global Satisfaction with Hair Quality (SGSHQ) 
The investigator or study staff will instruct the subject to answer the SGSHQ questionnaire in 
relation to their satisfaction with the quality of scalp hair right now.  Subjects will assess their 
satisfaction with the quality of their scalp hair on a 7-point satisfaction scale from extremely 
satisfied to extremely dissatisfied at the visits detailed in the Schedule of Assessments (Table 3).  
Subjects with patchy AA (30%-95% scalp hair loss at Baseline in study ATI-501-AUAT-201) 
will complete the SGSHQ-AAP found in Appendix 7.   Subjects with AT or AU (> 95% scalp 
hair loss at Baseline in study ATI-501-AUAT-201) will complete the SGSHQ-AT/AU found in 
Appendix 11. 
7.2. 
Investigator Efficacy Assessments 
The investigator will complete the assessments detailed in Table 6 in the order listed.   
Table 6: 
Investigator Assessments 
Order 
Subjects with Patchy AA (30% – 95% 
scalp hair loss at Baseline in study 
ATI-501-AUAT-201) 
Subjects with AU or AT (>95% scalp 
hair loss at Baseline in study ATI-501-
AUAT-201) 
1.  
Alopecia Scalp Appearance Assessment 
for Patchy AA:  Clinician Rating 
(ASAA-AAP: CR)  
Alopecia Scalp Appearance Assessment for 
AT/AU:  Clinician Rating (ASAA-AT/AU: 
CR) 
2.  
Alopecia Facial Hair Appearance Assessment:  Clinician Rating (AFHA: CR) 
3.  
Non-Scalp Hair Loss Assessment (NSHA) 
4.  
Physician Global Impression of Severity 
for Patchy AA (PhGIS-AAP) 
Physician Global Impression of Severity for 
AT/AU (PhGIS-AT/AU) 
5.  
Physician Global Impression of Change (PhGIC)* 
6.  
Hair Quality Assessment 
N/A 
7.  
SALT 
8.  
ALODEX 
9.  
Vellus and Indeterminate Hair Assessment 
*Only assessed at final study treatment visit 
 
7.2.1. 
Alopecia Scalp Appearance Assessment (ASAA) Clinician Rating (CR) 
The investigator will complete the ASAA-AAP: CR for subjects with patchy AA (30%-95% 
scalp hair loss at Baseline in study ATI-501-AUAT-201) or the ASAA-AT/AU: CR for subjects 


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with AT or AU (>95% scalp hair loss at Baseline in study ATI-501-AUAT-201) at the visits 
listed in Table 3, Schedule of Assessments.  
For subjects with patchy AA (30% to 95% scalp hair loss at Baseline in study ATI-501-AUAT-
201), the appearance of the target scalp patch and the whole scalp will be assessed by the 
Investigator by completing Items 1 and 2 of the ASAA-AAP:CR (Section 7.2.1.1).   
For subjects with AT or AU (scalp hair loss > 95% at Baseline in study ATI-501-AUAT-201), 
the appearance of the whole scalp will be assessed by the investigator by completing the ASAA-
AT/AU: CR (Section 7.2.1.2).  
7.2.1.1. 
Alopecia Scalp Appearance Assessment (ASAA) for Patchy AA: Clinician 
Rating (CR) (ASAA-AAP: CR) 
 
Instructions for item 1: Please mark an “X” in the box (
) that best describes the appearance 
of the subject’s target patch right now.  Please select the one response that best represents your 
answer. 
 Full hair, scalp of the target patch completely covered with hair 
 Most hair, scalp of the target patch mostly covered with hair 
 Some hair, scalp of the target patch somewhat covered with hair 
 A little hair, scalp of the target patch mostly exposed 
 No hair, scalp of the target patch completely exposed 
 
Instructions for item 2: Please mark an “X” in the box (
) that best describes the appearance 
of the subject’s whole scalp right now.  Please select the one response that best represents your 
answer. 
 Full hair, whole scalp completely covered with hair 
 Most hair, whole scalp mostly covered with hair 
 Some hair, whole scalp somewhat covered with hair 
 A little hair, whole scalp mostly exposed 
 No hair, whole scalp completely exposed 
7.2.1.2. 
Alopecia Scalp Appearance Assessment (ASAA) for AT and AU: Clinician 
Rating (CR) (ASAA-AT/AU: CR) 
 
Instructions: Please mark an “X” in the box (
) that best describes the appearance of the 
subject’s whole scalp right now.  Please select the one response that best represents your answer. 
 
 Full hair, whole scalp completely covered with hair 
 Most hair, whole scalp mostly covered with hair 
 Some hair, whole scalp somewhat covered with hair 


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 A little hair, whole scalp mostly exposed 
 No hair, whole scalp completely exposed 
7.2.2. 
Alopecia Facial Hair Appearance Assessment (AFHA) for AA, AT and AU: 
Clinician Rating (CR) (AFHA: CR) 
For subjects with AA, AU or AT, the appearance of the subject’s facial hair (eyebrows, 
eyelashes and if male, beard) will be assessed using the AFHA: CR by the investigator at the 
visits listed in the Schedule of Assessments (Table 3).   
The AFHA: CR is the investigator’s assessment of the subject’s facial hair (eyebrow(s), eyelashes, 
and if male, beard) at a particular point in time. The investigator should NOT refer to any other 
assessments to assist with these assessments. The investigator or designee will assess the affected 
facial hair areas (eyebrows, eyelashes and if male, beard) using the scales below and report the one 
response that best describes the amount of eyebrow, eyelash and if applicable beard hair present.  
Right and left eyebrow and eyelashes should be evaluated separately.  The AFHA is a tool to assess 
the presence of hair in expected areas of growth.  As such, unexpected hair growth (e.g. facial/beard 
hair in women) should be documented as an adverse event rather than on the AFHA. 
 
Instructions for item 1a: Please mark an “X” in the box (
) that best describes the appearance 
of the subject’s left eyebrow hair right now. Please select the one response that best represents 
your answer. 
 
 Full eyebrow hair 
 Most eyebrow hair 
 Some eyebrow hair 
 A little eyebrow hair 
 No eyebrow hair 
 
Instructions for item 1b: Please mark an “X” in the box (
) that best describes the appearance 
of the subject’s right eyebrow hair right now. Please select the one response that best represents 
your answer. 
 
 Full eyebrow hair 
 Most eyebrow hair 
 Some eyebrow hair 
 A little eyebrow hair 
 No eyebrow hair 


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Instructions for item 2a: Please mark an “X” in the box (
) that best describes the appearance 
of the subject’s left eyelashes right now. Please select the one response that best represents your 
answer. 
 
 Full eyelashes 
 Most eyelashes 
 Some eyelashes 
 A little eyelashes 
 No eyelashes 
 
Instructions for item 2b: Please mark an “X” in the box (
) that best describes the appearance 
of the subject’s right eyelashes right now.  Please select the one response that best represents 
your answer. 
 
 Full eyelashes 
 Most eyelashes 
 Some eyelashes 
 A little eyelashes 
 No eyelashes 
 
Instructions for item 3: Please mark an “X” in the box (
) that best describes the appearance 
of the subject’s beard hair right now. Beard hair can include hair on the chin, cheeks, neck, and 
above the upper lip. Please select the one response that best represents your answer. 
 
 Full beard hair 
 Most beard hair 
 Some beard hair 
 A little beard hair 
 No beard hair 
 
 
 
 
 


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7.2.3. 
Non-Scalp Hair Loss Assessment (NSHA) 
The investigator will assess body hair (axillary, truncal, genital, extremities) and facial hair 
including nasal hair using a 3-point scale; no hair loss, some hair loss and total hair loss.  Nasal 
hair will be assessed by presence or absence only. These assessments will be completed at the 
visits listed in the Schedule of Assessments (Table 3) (Olsen, 2011).   
 
Instructions: Please mark an “X” in the box (
) that best describes the appearance of the 
subject’s body hair loss right now. Please select the one response that best represents your 
answer. 
 
 
Mark “X” 
Body Hair Loss (axillary, truncal, genital, extremities) 
 
B0 
No body hair loss 
 
B1 
Some hair loss 
 
B2 
Total body hair loss 
 
 
Instructions: Please mark an “X” in the box (
) that best describes the appearance of the 
subject’s nasal hair loss right now. Please select the one response that best represents your 
answer. 
 
Mark “X” 
Nasal Hair Loss 
 
NH0 
No nasal hair loss 
 
NH1 
Some to total nasal hair loss 
 
7.2.4. 
PHYSICIAN GLOBAL IMPRESSION OF SEVERITY (PhGIS) 
The severity of the subject’s AA, AU or AT will be assessed at the visits detailed in Schedule of 
Assessments (Table 3), by the investigator using either the PhGIS-AAP for subjects with patchy 
AA (30% - 95% scalp hair loss at Baseline in study ATI-501-AUAT-201) (Section 7.2.4.1) or 
the PhGIS-AT/AU for subjects with AT or AU (> 95% scalp hair loss at Baseline in study ATI-
501-AUAT-201) (Section 7.2.4.2). 
 
 


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7.2.4.1. 
PHYSICIAN GLOBAL IMPRESSION OF SEVERITY (PhGIS-AAP) 
Please mark an “X” in the box (
) that best describes the severity of the subject’s patchy 
alopecia areata right now. 
Overall, how severe is the subject’s patchy alopecia areata right now? 
 Mild 
 Moderate 
 Severe 
 Very Severe 
 Extremely Severe 
7.2.4.2. 
PHYSICIAN GLOBAL IMPRESSION OF SEVERITY (PhGIS-AT/AU) 
Please mark an “X” in the box (
) that best describes the severity of the subject’s alopecia 
totalis or alopecia universalis right now. 
Overall, how severe is the subject’s alopecia totalis or alopecia universalis right now? 
 Mild 
 Moderate 
 Severe 
 Very Severe 
 Extremely Severe 
7.2.5. 
Physician Global Impression of Change (PhGIC) 
The investigator will assess the global impression of change in the subject’s hair loss (AA, AT or 
AU) at Week 24 (Visit 6) using the PhGIC detailed below and referencing the baseline photos 
from study ATI-501-AUAT-201. 
Compared to the subject’s hair loss at Baseline [prior to study medication initiation on study 
ATI-501-AUAT-201], the subject’s AA, AT or AU is (Please mark an “X” in the box 
):  
  
1=Very much improved since the initiation of treatment;  
  
2=Much improved;  
  
3=Minimally improved;  
  
4=No change from baseline (the initiation of treatment);  
  
5=Minimally worse;  
  
6= Much worse;  
  
7=Very much worse since the initiation of treatment. 


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7.2.6. 
Hair Quality Assessments 
Hair quality will be assessed by the investigator using the hair pull test including the presence of 
exclamation point hairs at the visits detailed in Schedule of Assessments (Table 3).  For subjects 
with AU or AT (>95% scalp hair loss at Baseline in study ATI-501-AUAT-201), the hair pull 
test will not be conducted. 
7.2.6.1. 
Hair Pull Test 
The hair pull test is performed at the edge of the alopecic (target) patch as follows: 
• Pinch 25 to 50 hairs between non-gloved thumb and forefinger and exert slow, 
gentle traction while sliding fingers up. 
• Resulting extracted hairs should be examined with magnification and counted. 
 
Normal: 1 to 2 hairs dislodged 
 
Abnormal: >2 hairs dislodged 
 
Broken hairs (structural disorder) 
 
Broken-off hair at the borders of an alopecic patch that are easily removable 
(in alopecia areata) (exclamation point hair) 
7.2.7. 
Severity Alopecia Tool (SALT) Score 
The SALT score is a measurement of the amount of terminal scalp hair loss. The investigator 
will assess the SALT score using an iPad provided by Aclaris at the visits detailed in Schedule of 
Assessments (Table 3).  The SALT score must be determined prior to the ALODEX score.  
Equipment, supplies, training and the detailed Reference Guide will be provided to the 
investigational site prior to the initiation of subject enrollment. 
7.2.8. 
Alopecia Density and Extent Score (ALODEX) 
The ALODEX score is a measurement of the amount of terminal scalp hair loss.  The 
investigator will calculate the ALODEX score using the iPad provided by Aclaris at the visits 
detailed in Schedule of Assessments (Table 3).  The ALODEX score must be determined after 
the SALT score.  Equipment, supplies, training and the detailed Reference Guide will be 
provided to the investigational site prior to the initiation of subject enrollment. 
7.2.9. 
Vellus and Indeterminate Hair Assessment 
The investigator will assess if vellus and indeterminate hair are present on the scalp by 
completing the question: 
Is vellus hair present in the areas of hair loss? Y, N 
Is indeterminate hair present in the areas of hair loss?  Y, N 
Hair types are characterized by the diameter and length of the hair shafts.  Vellus hair is soft, 
hypopigmented, unmedullated and less than 0.03 mm in diameter and less than 1 cm in length.  
Terminal hair is longer, coarser, often medullated, pigmented, and > 0.06 mm in diameter and > 
1 cm in length.  Indeterminate hairs are intermediate in size between terminal and vellus hairs 
(>0.03 mm and <0.06 mm in diameter).   


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7.3. 
Photographic Assessment 
A qualified investigational staff member will take standardized photographs of the scalp at the 
visits detailed in Schedule of Assessments (Table 3).  The photographs are to document loss, 
maintenance, or increase of hair growth during treatment.  Photography is a required element of 
the study procedures and is not considered optional.  During initial study discussion as part of 
consent procedures, site staff should ensure that subjects are fully aware of this aspect of study 
participation.  
Subjects should be instructed to maintain the same hairstyle and color throughout the study.  It is 
important for the staff member to clip the hair as detailed in the instructions provided, so the 
areas of hair loss and possible regrowth are visible at the post-baseline study visits.  Equipment, 
supplies, training and detailed instructions for obtaining and managing photographs and clipping 
the hair will be provided to the investigational center prior to the initiation of subject enrollment. 
 
 


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8. 
ASSESSMENT OF SAFETY 
8.1. 
Safety Parameters 
Safety will be assessed throughout the study by the investigator or a designated and appropriately 
trained staff member. 
8.1.1. 
Demographic/Medical History/ Alopecia Areata History 
The study site staff will review and if necessary, update the demographic, medical history and 
alopecia history obtained in study ATI-501-AUAT-201 and record into the source document and 
eCRF for study ATI-502-AA-203. Any adverse events that were ongoing at completion of Visit 
9 in ATI-501-AUAT-201 will be recorded as medical history in the ATI-502-AA-203 eCRF.  
Adverse Events that started and resolved during the course of study ATI-501-AUAT-201 do not 
need to be reported as medical history unless the investigator considers the event(s) to be 
clinically significant in relation to the subject’s continuation in study ATI-502-AA-203. The 
medical history of women who are not of childbearing potential should reflect the reason e.g. 
post-menopausal for 1 year or greater, bilateral tubal ligation, or hysterectomy.  The subject’s 
alopecia history (Appendix 1) is captured on a separate source document and eCRF and is not 
documented as part of the subject’s general medical history. 
8.1.2. 
Vital Signs 
Vital signs will be measured at each visit during the study. The following items will be 
measured: 
• Body temperature 
• Pulse rate 
• Respiration rate 
• Blood pressure (systolic and diastolic) after the subject sits quietly for at least 5 
minutes 
Any measure that is, in the opinion of the investigator, abnormal AND clinically significant (CS) 
must be recorded as medical history if found prior to the first study medication administration, or 
as an AE if found after the first dose of study medication.  
A systolic blood pressure >140mm Hg or a diastolic blood pressure >90 mmHg is considered 
abnormal and therefore must be defined as CS or not clinically significant (NCS) in the eCRF.   
8.1.3. 
Physical Examination 
The investigator or designee will perform a physical examination for all body systems at the end 
of treatment Week 24 (Visit 6).  A physical examination may also be performed at Visit 1 if the 
Visit 1 did not occur at Visit 9 of the ATI-501-AUAT-201 study.  The skin assessment portion of 
the Physical Examination does not require documentation of alopecia as an abnormality since it 
is the indication of interest for this study and required for participation.  In the absence of any 
other abnormalities, skin should be considered “Normal” for these subjects. 


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8.1.4. 
Electrocardiogram (ECG) 
Any abnormalities arising from ECGs collected during the ATI-501-AUAT-201 study that are, 
in the opinion of the investigator, clinically significant, must be reported as medical history on 
the ATI-502-AA-203 study.   
8.1.5. 
Clinical Laboratory Assessments 
A qualified staff member will collect non-fasting samples for clinical laboratory analysis at the 
visits detailed in Schedule of Assessments (Table 3).  Samples will be sent to a central laboratory 
for analysis.  Refer to the study specific laboratory manual for handling and shipping 
instructions. The following tests will be conducted: 
 
Chemistry Panel 
Complete Blood Count 
Albumin 
Hematocrit 
Alkaline phosphatase 
Hemoglobin 
Alanine aminotransferase (ALT) 
Platelet count 
Aspartate aminotransferase (AST) 
Red blood cell morphology 
Blood urea nitrogen (BUN) 
Red blood cell count 
Bicarbonate 
White blood cell count 
Calcium 
White blood cell differential 
Chloride 
    % & absolute 
Creatinine 
    Basophils 
Glucose 
    Eosinophils 
Lactate dehydrogenase (LDH) 
    Lymphocytes 
Phosphorus 
    Monocytes 
Potassium 
    Neutrophils 
Sodium 
 
Total bilirubin 
Urinalysis 
Total protein 
 
Uric acid 
CPK 
Total cholesterol, LDL, HDL, 
Triglycerides  
 
Urine Pregnancy Test for WOCBP 
(At the visits detailed in Schedule of 
Assessments (Table 3)). 
 
 
 
Total cholesterol, LDL, HDL and Triglycerides will be assessed at all visits. The results of the 
clinical laboratory tests will be reported on the central laboratory’s standard reports. The 
investigator must note NCS or CS to define the clinical relevance of any result that is outside the 
normal range for the laboratory. The investigator must date and initial every laboratory report.  


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The investigator or subinvestigator must review all the laboratory test results against the study 
entry criteria and the Study Medication Interruption Criteria Table 2 for each subject. Subjects 
with laboratory values meeting the Study Medication Interruption Criterial found in Table 2 must 
have repeat laboratory testing performed with results meeting the minimum criteria for 
resumption.   
The investigator must report all laboratory results from samples collected on the ATI-502-AA-
203 study that are BOTH outside the normal range for the laboratory AND, in the opinion of the 
investigator, CS as an AE. Laboratory results from samples collected at V9 on the ATI-501-
AUAT-201 study that are BOTH outside the normal range for the laboratory AND, in the 
opinion of the investigator, CS must be reported as medical history on the ATI-502-AA-203 
study eCRF. The investigator must review all laboratory reports in a timely manner. 
8.1.6. 
Pregnancy Testing 
The investigator or designee will perform a urine pregnancy test for subjects who are WOCBP at 
the visits detailed in Schedule of Assessments (Table 3). The UPT kits provided by the Central 
lab have a minimum sensitivity of 25-mIU ß-HCG/milliliter (mL) of urine. If the result of any 
post-treatment urine pregnancy test is positive, the subject will be withdrawn from the study and 
the subject’s pregnancy documented and followed. 
8.2. 
Adverse and Serious Adverse Events 
Adverse events will be monitored throughout the study and reported on the appropriate Aclaris 
Therapeutics, Inc. AE eCRF. 
8.2.1. 
Definition of Adverse Events 
8.2.1.1. 
Adverse Event (AE) 
An AE is the development of an undesirable medical condition or the deterioration of a pre-
existing medical condition following or during exposure to a pharmaceutical product, whether or 
not considered casually related to the product.   
The investigator should, when certain, report a diagnosis rather than the signs, symptoms or 
clinically significant abnormal laboratory values associated with the AE. Otherwise, signs, 
symptoms or abnormal laboratory values may be used to describe the AE. 
Every new episode or clinically significant worsening of a chronic condition (e.g., headaches, 
seasonal allergies, depression, or hypertension) should be reported as a separate AE, even if the 
condition is reported in the subject’s medical history.  Hair growth in unexpected areas, such as 
facial hair in women, should be reported as an adverse event. 
Any CS abnormality discovered prior to the first study medication treatment (e.g. laboratory or 
ECG results from Visit 9 in study ATI-501-AUAT-201) should be reported as medical history, 
not as an AE. 
All AEs that occur after any subject has been enrolled, before treatment, during treatment, or 
within 30 days following the cessation of treatment, whether or not they are related to the study, 
must be recorded in the subject’s source documents and in the Aclaris’ electronic case report 


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form (eCRF).  Changes to a subject’s medical condition that occur between signing an ICF and 
beginning treatment should be captured in the medical history. 
8.2.1.2. 
Serious Adverse Event (SAE) 
A serious adverse event is an AE occurring during any study phase (i.e., Baseline, Treatment, 
Washout, or Follow-up), and at any dose of the investigational product, comparator or placebo, 
that fulfills one or more of the following: 
• Results in death 
• It is immediately life-threatening 
• It requires in-patient hospitalization or prolongation of existing hospitalization 
• It results in persistent or significant disability or incapacity 
• Results in a congenital abnormality or birth defect 
• It is an important medical event that may jeopardize the patient or may require medical 
intervention to prevent one of the outcomes listed above. 
The term “life threatening” refers to an event in which the subject was at risk of death at the time 
of event; it does not refer to an event that hypothetically might have caused death if it were more 
severe. 
 
Important medical events are those that may not be immediately life threatening, result in death 
or hospitalization, but are clearly of major clinical significance and may jeopardize the subject or 
require intervention to prevent one of the outcomes listed in the SAE definition above. These 
should also usually be considered serious. 
All SAEs that occur from the time of informed consent until 30 days following the cessation of 
study medication dosing, whether or not they are related to the study, must be recorded on the 
SAE forms provided by Aclaris Therapeutics, Inc. 
8.2.1.3. 
Unexpected adverse event 
An AE is considered unexpected if it is not listed in the Investigator’s Brochure or is not listed at 
the specificity or severity that has been observed. 
8.3. 
Reporting Adverse Events 
8.3.1. 
Adverse event reporting period 
The investigator must start reporting non-serious AEs from the time of the subject’s first dose of 
study medication until 30 days after the last dose of study medication. Reporting for SAEs must 
start when the subject signs the ICF and continue until 30 days past the subject’s last dose of 
study medication, whether or not they are related to the study. 
Any adverse events that were ongoing at the time of completion from study ATI-501-AUAT-
201, will be recorded in the medical history at Visit 1. 


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8.3.2. 
Severity 
The investigator is to define the severity of each AE using the following definitions as a 
guideline. The investigator will consider the range of the possible severity of the event and 
identify the severity that is the most appropriate according to her/his medical judgment. 
 
Mild – Awareness of signs or symptom, but easily tolerated 
Moderate – Discomfort, enough to cause interference with usual activity 
Severe – Incapacitating with inability to perform usual activity 
8.3.3. 
Relationship to study medication 
The investigator will determine if there is a reasonable causal relationship between the study 
medication and an AE or not. The investigator will use her/his best medical judgment and 
consider all relevant factors (e.g., temporal relationship, location of the event, the subject’s 
relevant medical history, concomitant therapies and concurrent conditions) to determine the 
relationship of the AE to the study medication. The investigator will define the relationship of an 
AE to the study medication by selecting one of the following categories: 
Related – There is a reasonable causal relationship between the study medication and the AE. 
Not Related – There is not a reasonable causal relationship between the study medication and 
the AE. 
The expression “reasonable causal relationship” is meant to convey in general that there are facts 
(evidence) or arguments to suggest a causal relationship (International Conference on 
Harmonization [ICH] E2A). 
8.3.4. 
Procedures for reporting adverse events 
At each post-enrollment visit, the investigator will question the subject to elicit AEs using a non-
directive question such as “Has there been any change in your health since the previous study 
visit?”  If appropriate, based on the subject’s response to non-directed questioning to elicit AEs, 
the investigator will follow-up with directed questions and appropriate evaluations.  
Any AE noted during the reporting period must be reported in the source documents and on the 
appropriate AE eCRF. AEs that are defined as “Not Related” to the study medications will be 
followed until they are resolved or until the subject’s last study visit. AEs that are defined as 
“Related” to the study medications will be followed until they are resolved or, if not resolved 
after the subject’s last study visit, until in the opinion of the investigator, the AE reaches a 
clinically stable outcome with or without sequelae. 
8.3.5. 
Procedure for reporting a serious adverse event 
Upon becoming aware of a SAE occurring during the SAE reporting period, whether or not 
related to the study medications, the investigator must: 
1. Take the appropriate medical action to ensure the subject’s safety. 


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2. Immediately inform the Safety Monitor of the SAE by email, ensuring that the subject 
information is deidentified (only subject initials and subject number) to: ProPharma, 
Email: clinicalsafety@propharmagroup.com. 
3. Print a copy of the email confirmation from ProPharma and place in the study file. 
4. Within 24-hours complete, as fully as possible, an AE eCRF and an SAE form; e-mail the 
forms and any other relevant information (e.g., concomitant medication eCRF, medical 
history eCRF, laboratory test results) to ProPharma (Aclaris Therapeutics, Inc. Safety 
Monitor). 
5. Monitor and document the progress of the SAE until it resolves or, if not resolved after 
the subject’s last study visit, until in the opinion of the investigator the SAE reaches a 
clinically stable outcome with or without sequelae AND the investigator and Aclaris 
Therapeutics, Inc.  Safety and Medical Monitor agree that the SAE is satisfactorily 
resolved. 
6. Inform the Aclaris Therapeutics, Inc. Safety Monitor of SAE updates, via telephone, 
followed by an SAE form update sent by e-mail. 
7. Comply with the appropriate regulatory requirements and Aclaris Therapeutics, Inc. 
instructions regarding reporting of the SAE to the responsible Institutional Review Board 
(IRB) or Ethics Committee (EC). 
8.4. 
PREGNANCY 
8.4.1. 
Definition of Women of Child Bearing Potential (WOCBP) 
WOCBP includes any female who has experienced menarche and who has not undergone 
successful surgical sterilization (e.g., hysterectomy, bilateral tubal ligation, or bilateral 
oophorectomy) or is not postmenopausal. Postmenopausal is defined as ≥12 months with no 
menses without an alternative medical cause.  WOCBP must have a negative UPT at Visit 9 
(study ATI-501-AUAT-201)/Visit 1 (study ATI-502-AA-203) prior to dispensing study 
medication. 
8.4.2. 
Highly Effective Methods of Birth Control 
The Investigator or subinvestigator will discuss the potential risk factors associated with 
pregnancy and the importance of maintaining a highly effective method of contraception 
throughout the study with all WOCBP (for example, those which result in a low failure rate - i.e., 
less than 1% per year- when used consistently and correctly).  All WOCBP must use a highly 
effective method of birth control during the study and for 30 days after the final dose of study 
medication in a manner such that risk of failure is minimized.   
 
Highly effective methods include: 
• Combined (estrogen and progestogen containing) hormonal contraception associated with 
inhibition of ovulation: 
o oral 
o intravaginal 


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o transdermal 
• Progestogen-only hormonal contraception associated with inhibition of ovulation: 
o oral 
o injectable 
o implantable 
• intrauterine device (IUD) 
• intrauterine hormone-releasing system (IUS) 
• vasectomized partner1 
• sexual abstinence2 
1Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner 
of the WOCBP trial participant and that the vasectomized partner has received medical assessment of the 
surgical success.  
2 Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual 
intercourse during the entire period of risk associated with the study treatments. The reliability of sexual 
abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual 
lifestyle of the subject. 
 
WOCBP must be on a highly effective method of birth control for the following timeframes prior 
to study entry:  
• Implants (on a stable dose for ≥30 days) 
• Injectables (on a stable dose for ≥30 days) 
• Patches (on a stable dose for ≥30 days) 
• Combined oral contraceptives (on a stable dose for ≥30 days) 
• Intrauterine devices (inserted for ≥30 days). 
Prior to trial enrollment, WOCBP must be advised of the importance of avoiding pregnancy 
during trial participation and of the potential risk factors associated with pregnancy while in the 
study.  The subject must sign an informed consent form documenting this discussion.  During the 
trial, all WOCBP will be instructed to contact the investigator immediately if they suspect they 
might be pregnant (e.g., missed or late menstrual period). 
If a subject or investigator suspects that the subject may be pregnant prior to study medication 
administration, the study medication must be withheld until the results of a pregnancy test are 
available.  If pregnancy is confirmed, the subject must not receive study medication and must be 
discharged from the study.  
If, following study medication administration, it is determined that the subject or partner of a 
male subject may have been or was pregnant at the time of study medication exposure (including 
30 days after study medication administration) the investigator must immediately notify the 
Aclaris Therapeutics, Inc. Medical Monitor and record the event on a pregnancy surveillance 
form. While not an AE or SAE, the investigator must report every pregnancy using a pregnancy 
surveillance form and follow the reporting procedures described for SAE reporting. 
Protocol-required procedures for trial discontinuation and follow-up must be performed on the 
subject unless contraindicated by pregnancy (e.g., x-ray studies). Other appropriate pregnancy 
follow-up procedures should be considered if indicated. In addition, the investigator must report 
to Aclaris Therapeutics, Inc.’s Medical Monitor on the pregnancy surveillance form, follow-up 


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information regarding the course of the pregnancy, including perinatal and neonatal outcome. 
Infants should be followed for a minimum of six weeks. 
  
 
 


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9. 
STATISTICS 
9.1. 
Sample Size and Power Calculations 
The planned sample size is 80 enrolled subjects.   
9.2. 
Analysis Populations 
The Safety analysis population will be comprised of all subjects who received at least one dose 
of study medication.  The Efficacy analysis population will include all subjects who received at 
least one dose of study medication using observed cases with no imputation for missing data. 
9.3. 
Demographic and Baseline Characteristics 
Subject demographic and baseline characteristics, including medical and alopecia history, prior 
medications and therapies and physical examination findings will be summarized using 
descriptive statistics. 
For continuous variables, descriptive statistics (number, mean, standard deviation, standard error, 
median, minimum, and maximum) will be provided.  For categorical variables, subject counts 
and percentages will be provided.  Categories for missing data will be presented, if necessary. 
9.4. 
Efficacy Analyses 
Hair regrowth is determined based on both percent scalp hair regrowth (Baseline SALT – 
Follow-up SALT/Baseline SALT) and change in absolute percent scalp hair loss from baseline 
(Baseline SALT – Follow-up SALT).  A responder is a subject who achieves a SALT50 or 
SALT75 defined as ≥ 50%, ≥ 75% improvement in SALT score from baseline values in the ATI-
501-AUAT-201 study.  Durability of response will be assessed in subjects who achieved a 
SALT50 or SALT75 in study ATI-501-AUAT-201.  Results will be summarized using 
descriptive statistics. 
9.4.1. 
Primary Efficacy Analyses 
For the primary endpoint, the primary efficacy variable will be the mean relative percent change 
from the original baseline visit in study ATI-501-AUAT-201in the SALT score at Visit 6 (Week 
24 on study ATI-502-AA-203).  This represents the percentage of hair regrowth.  It will be 
calculated as the mean of the changes from baseline SALT score to the SALT score at each visit, 
divided by baseline SALT score and expressed as a percentage.   
9.4.2. 
Secondary Efficacy Analyses 
The secondary efficacy endpoints will be calculated using both the current study baseline scores 
and the baseline scores from study ATI-501-AUAT-201. These endpoints will be evaluated at 
each visit and will include: the mean relative percent change from baseline in the ALODEX 
score (percent regrowth); the mean change from baseline in SALT and the mean change from 
baseline in ALODEX, the proportion of subjects achieving a ≥ 50% hair regrowth compared 
with baseline; change from baseline in the AAA (Clinician and Subject), PhGIS, AFHA, SGIS, 
AIA, and treatment satisfaction questionnaires.  The mean relative percent change in ALODEX 


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score analysis will use the same methodology as specified for the primary efficacy analysis.  
Other parameters will be summarized as detailed in the statistical analysis plan.  
9.5. 
Safety Analyses 
Safety analyses will include descriptive statistics calculated on the safety parameters using the 
safety population. The proportion of subjects with treatment-emergent adverse events will be 
tabulated and presented by Medical Dictionary for Regulatory Activities (MedDRA) System 
Organ Class. Vital signs and clinically significant abnormal laboratory results will also be 
tabulated.  
Data from all enrolled subjects will be presented and summarized. Safety summaries will include 
listings of adverse events incidences within each MedDRA System Organ Class, and changes 
from pre-dose values in vital signs. Adverse event summaries will be presented showing the 
proportion of subjects experiencing adverse events, both overall and by MedDRA System Organ 
Class. 
 


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10. 
TRAINING, DATA HANDLING AND RECORD KEEPING 
10.1. 
Training 
For each investigational center, participants will be trained to the protocol, study specific 
procedures, and the eCRFs.  Those unable to attend the training must receive on-site training 
from an appropriately trained individual prior to participating in any of the procedures and 
evaluations in this study.  
Clinical Research Associates (CRAs) and other applicable personnel will be trained prior to 
study initiation to familiarize CRAs with the disease, the Standard Operating Procedures (SOPs), 
the protocol and other study specific items.  Team organization, communication and operational 
issues will also be discussed. 
Aclaris Therapeutics, Inc. or designee will provide an investigational center file to each center. 
10.2. 
Data Collection 
The Investigator must maintain required records for all study subjects.  Data for this study will 
be recorded in the subject's source document and on the eCRFs.  All data on these eCRFs should 
be recorded completely and promptly.  A copy of the completed eCRFs for each subject will be 
retained by the investigational center. 
Records of the subject’s participation in this study will be held confidential except as disclosure 
is required by law. The study doctor, the sponsor, persons working on behalf of the sponsor, and 
under certain circumstances, the United States Food and Drug Administration and the 
Institutional Review Board will be able to inspect and copy confidential study-related records 
that identify subjects by name. Therefore, absolute subject confidentiality cannot be guaranteed. 
If the results of this study are published or presented at meetings, the subject’s identity will not 
be revealed. 
10.3. 
Data Management 
Data-management activities of this study will be subcontracted.  Edit checks and review 
processes will be performed by the sub-contractor until all data clarifications are resolved. The 
data will be exported to be stored in SAS datasets (or equivalent) by the sub-contractor. After all 
data clarifications are resolved and subject’s evaluability is determined, the database will be 
locked. 
10.4. 
Study Monitoring 
During the study, a monitor from Aclaris Therapeutics, Inc. or representative will have regular 
contacts with the investigational site, for the following: 
• Provide information and support to the investigator(s) 
• Confirm that facilities remain acceptable 


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• Confirm that the investigational team is adhering to the protocol, that data are being 
accurately recorded in the case report forms, and that investigational product 
accountability checks are being performed 
• Perform source data verification.  This includes a comparison of the data in the case 
report forms with the patient’s medical records at the hospital or practice, and other 
records relevant to the study.  This will require direct access to all original records for 
each patient (e.g. clinic charts). 
• Record and report any protocol deviations not previously sent to Aclaris Therapeutics, 
Inc. 
• Confirm AEs and SAEs have been properly documented on CRFs and confirm any SAEs 
have been forwarded to Aclaris Therapeutics, Inc. and those SAEs that met criteria for 
reporting have been forwarded to the IRB. 
The monitor will be available between visits if the investigator(s) or other staff needs 
information or advice. 
10.5. 
Source Documentation 
Investigators must keep accurate separate records (other than the eCRFs) of all subjects' visits 
that include all pertinent study related information.  A statement should be made indicating that 
the subjects have been enrolled in this clinical study and have provided written informed 
consent.  Any AEs must be completely documented. Source documentation includes results of 
any diagnostic tests conducted during the study.   
10.6. 
Inspection of Records 
 
Aclaris or designee will be allowed to conduct site visits to the investigation facilities for the 
purpose of monitoring any aspect of the study. The Investigator agrees to allow the monitor to 
inspect the drug storage area, study medication stocks, drug accountability records, subject charts 
and study source documents, and other records relative to study conduct. 
10.7. 
Retention of Records 
The Principal Investigator must maintain all documentation relating to the study for a period of 2 
years after the last marketing application approval, or if not approved 2 years following the 
discontinuance of the test article for investigation. If it becomes necessary for Aclaris or the 
Regulatory Authority to review any documentation relating to the study, the Investigator must 
permit access to such records. 


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11. 
QUALITY CONTROL AND QUALITY ASSURANCE 
The study is conducted under the sponsorship of Aclaris Therapeutics, Inc. in compliance with 
the applicable regulatory requirements as well as applicable ICH guidelines, Declaration of 
Helsinki, and in respect of the Aclaris Therapeutics, Inc. and/or sub-contractor SOPs for study 
conduct and monitoring. 
Audits may be carried out by Aclaris Therapeutics, Inc. or Aclaris Therapeutics, Inc.’s 
representatives, and inspections may be performed by regulatory authorities or IRB/ECs before, 
during or after the study.  The investigator will provide the auditing/inspecting group direct 
access to all study records (e.g., eCRFs, subject medical records, study medication dispensing 
records) and the investigational center study facilities. The investigator and study staff will be 
available and will assist the auditing/inspecting groups as appropriate. 


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12. 
ETHICS 
12.1. 
Ethics Review 
This protocol, informed consent form, any information provided to subjects, subject-recruiting 
advertisements, and any amendments to these items will receive IRB/EC approval prior to use. 
The IRB/EC must receive a copy of the Investigator’s Brochure, all protocol amendments, safety 
reports and other study related information as required by regulation or the IRB/EC procedures. 
12.2. 
Ethical Conduct of the Study 
The rights, safety and well-being of the subjects are the most important considerations in this 
study and take priority over the interests of society and science.  
This study will be conducted in accordance with the ethical principles originating from the 
Declaration of Helsinki, the current ICH E6 GCP guideline, local regulatory requirements and, at 
US investigational centers, in compliance with the HIPAA. The study will be conducted in 
compliance with the IRB/EC approved version of the protocol and any applicable amendments. 
12.3. 
Written Informed Consent 
The Principal Investigator(s) at each center will ensure that the subject is given full and adequate 
oral and written information about the nature, purpose, possible risk and benefit of the study.  
Subjects must also be notified that they are free to discontinue from the study at any time.  The 
subject should be given the opportunity to ask questions and allowed time to consider the 
information provided. 
The subject’s signed and dated informed consent must be obtained before conducting any study 
procedures.  The Principal Investigator(s) must maintain the original, signed Informed Consent 
Form.  A copy of the signed Informed Consent Form must be given to the subject. 
12.4. 
Study Conduct and Protocol Amendments 
With the exception of eliminating an immediate hazard to a subject, the investigator should not 
deviate from the protocol or implement any changes without prior written approval from the 
Aclaris Therapeutics, Inc.’s representative or designee and prior review and documented 
approval from the IRB/EC. 
 
Changes that involve only logistical or administrative changes are allowed.  The investigator 
should document and explain any deviation from the protocol.  A protocol deviation is a non-
adherence to protocol-specific study procedures or schedules that does not increase the risk to a 
study subject and does not affect the scientific integrity of the study.   
 
A protocol violation is defined as any divergence from the protocol-specific study procedures or 
schedules that may results in an increased risk to a study subject or that affect the scientific 
integrity of the study.  All protocol violations must be reviewed by the Medical Monitor and 
reported to the IRB by the Investigator, as directed by the IRB-specific procedures. 
 


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12.5. 
Regulatory Documents 
The investigator must maintain a study file containing current and complete regulatory 
documentation in compliance with the current ICH E6 GCP guideline. This file will be reviewed 
as part of the routine monitoring for this study. 
 
12.6. 
Contractual Requirements 
A contractual agreement will be signed between Aclaris Therapeutics, Inc. and each investigator.  
This document will contain supplemental information, including financial terms, confidentiality, 
study schedule, third party responsibility, and publication rights. 
 
 
 


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13. 
LIST OF REFERENCES 
Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: Part II. 
Treatment. J Am Acad Dermatol. 2010;62(2):191-202. 
Arca E, Muşabak U, Akar A, Erbil AH, Taştan HB. Interferon-gamma in alopecia 
areata. Eur J Dermatol. 2004 Jan-Feb;14(1):33-6.  
Barahmani N, Schabath MB, Duvic M; National Alopecia Areata Registry. History  
of atopy or autoimmunity increases risk of alopecia areata. J Am Acad Dermatol. 
2009 Oct;61(4):581-91.  
Bilgiç Ö, Bilgiç A, Bahalı K, Bahali AG, Gürkan A, Yılmaz S. Psychiatric symptomatology and 
health-related quality of life in children and adolescents with alopecia areata. J Eu Acad 
Dermatol Venereol. 2014;28(11):1463-1468. 
Christiano, A.  2016.  Data on File.  
Craiglow BG, King BA. Killing Two Birds with One Stone: Oral Tofacitinib Reverses Alopecia 
Universalis in a Patient with Plaque Psoriasis. J Invest Dermatol. 2014;134(12):2988-2990. 
Craiglow BG, Liu LY, and King BA. Tofacitinib for the treatment of alopecia areata and variants in 
adolescents. J Am Acad Dermatol. 2017;76(1):29-32.  
Crispin MK et al. Safety and efficacy of the JAK inhibitor tofacitinib citrate in patients with 
alopecia areata.  JCI Insight. 2016;1(15):1-15. 
Delamere FM, Sladden MJ, Dobbins HM, Leonardi-Bee J. Interventions for alopecia areata. 
Cochrane Database Syst Rev. 2008;16(2). 
Gilhar A, Kam Y, Assy B, Kalish RS. Alopecia areata induced in C3H/HeJ mice by 
interferon-gamma: evidence for loss of immune privilege. J Invest Dermatol. 2005;124(1):288-9.  
Gupta AK. Efficacy of tofacitinib in treatment of alopecia universalis in two patients. J Eur Acad 
Dermatol Venereol. 2016;30(8):1373-1378. 
Hirota R, Tajima S, Yoneda Y, Okada M, Tashiro J, Ueda K, Kubota T, Yoshida R. 
Induction of hair regrowth in the alopecia site of IFN-gamma knockout mice by 
allografting and IFN-gamma injection into the transplantation site. J Interferon  
Cytokine Res. 2003 Aug;23(8):433-9. 
Hordinsky MK. Current Treatments for Alopecia Areata. J Investig Dermatol Symp Proc. 
2015;17(2):44-46. 
Jabbari A, Dai Z, Xing L, et al. Reversal of Alopecia Areata Following Treatment With the JAK1/2 
Inhibitor Baricitinib. EBioMedicine. 2015;2(4):351-355. 
Jabbari A, Cerise JE, Chen JC, Mackay-Wiggan J, Duvic M, Price V, Hordinsky M, Norris D, 
Clynes R, Christiano AM. Molecular signatures define alopecia areata 
subtypes and transcriptional biomarkers. EBioMedicine. 2016 May;7:240-7. 
Kim BY and Kim HS. Successful hair growth in a Korean patient with alopecia universalis 
following tofacitinib treatment. Singapore Med. J., 2017 May; 58(5): 279-280. 
Kuwano Y, Fujimoto M, Watanabe R, Ishiura N, Nakashima H, Ohno Y, Yano S, 
Yazawa N, Okochi H, Tamaki K. Serum chemokine profiles in patients with alopecia  
areata. Br J Dermatol. 2007:157(3):466-73.  
Mackay-Wiggan J, Jabbari A, Nguyen N et al.  Oral ruxolitinib induces hair regrowth in patients 
with moderate-to-severe alopecia areata.  JCI Insight 2016;1(15):e89790. 
Olsen EA.  Investigative guidelines for alopecia areata.  Dermatol Ther. 2011:24;311-319. 
Olsen EA and Canfield D.  SALT II: A New Take on the Severity of Alopecia Tool (SALT) for 
Determining Scalp Hair Loss.  J Am Acad Dermatol. 2016;75(6):1268-1270.  


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Olsen EA, Green C, Hordinsky M, Bergfeld W, McMichael A, Callender V, Washenik K, 
Cotsarelis G, Shapiro J, Roberts J, Wolfe S, Cherill D, Canfield D.  Alopecia Density and Extent 
(ALODEX):  A new method for assessing severity of hair loss in alopecia areata.  Submitted for 
publication. 
Pieri L, Guglielmelli P, Vannucchi AM. Ruxolitinib-induced reversal of alopecia universalis in a 
patient with essential thrombocythemia. Am J Hematol. 2015;90(1):82-83. 
Price VH. Treatment of Hair Loss. N Eng J Med. 1999;341(13):964-973. 
Price VH, Hordinsky MK, Olsen EA, et al. Subcutaneous efalizumab is not effective in the 
treatment of alopecia areata. J Am Acad Dermatol. 2008;58(3):395-402. 
Ruiz-Doblado S, Carrizosa A, García-Hernández MJ. Alopecia areata: psychiatric comorbidity and 
adjustment to illness. Int J Dermatol. 2003;42(6):434-437. 
Safavi KH, Muller SA, Suman VJ, Moshell AN, Melton Iii LJ. Incidence of Alopecia Areata in 
Olmsted County, Minnesota, 1975 Through 1989. Mayo Clinic Proc. 1995;70(7):628-633. 
Scheinberg M, and Ferreira SB. Reversal of Alopecia Universalis by Tofacitinib: A Case Report; 
Ann Intern Med.; 2016 Nov 15; 165(10): 750-751. doi: 10.7326/L16-0125. 
Strober BE, Siu K, Alexis AF, et al. Etanercept does not effectively treat moderate to severe 
alopecia areata: An open-label study. J Am Acad of Dermatol. 2005;52(6):1082-1084. 
Tosti A, Bellavista S, Iorizzo M. Alopecia areata: a long term follow-up study of 191 patients. J Am 
Acad Dermatol. 2006;55(3):438-441. 
Weise K, Kretzschmar L, John SM, Hamm H. Topical Immunotherapy in Alopecia areata: 
Anamnestic and Clinical Criteria of Prognostic Significance. Dermatology. 1996;192(2):129-
133. 
Whiting, D.A., 2003a. Histopathologic features of alopecia areata: a new look. Arch. 
Dermatol. 139, 1555–1559.  
Whiting, D.A., 2003b. Histopathologic features of alopecia areata. Arch. Dermatol. 139, 
1555–1559.  
Xing L, Dai Z, Jabbari A, et al. Alopecia areata is driven by cytotoxic T lymphocytes and is 
reversed by JAK inhibition. Nat Med. 2014;20(9):1043-1049. 
 
 
 
 
 


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APPENDIX 1. ALOPECIA AREATA HISTORY 
The following AA history will be obtained: 
 
1. Onset date of alopecia 
 
2. Onset date of current episode of AA, AU or AT 
 
3. Does the subject have AA, AU or AT? 
 
4. Does the subject have an ophiasis pattern of hair loss? 
a. Ophiasis only 
b. Ophiasis and AA 
 
5. Did the subject use previous therapies for AA, AU or AT? 
 
a. If Yes, indicate which therapies 
1. Topical immunotherapy 
2. Corticosteroids 
3. Systemic Steroids 
4. DMARDS 
5. Biologics or immunosuppressants 
6. Plaquenil 
7. PDT 
8. Janus kinase inhibitors 
9. Phototherapy 
10. Laser therapy 
11. Narrow-band UVB 
12. Other 
 


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APPENDIX 2. ALOPECIA SCALP APPEARANCE ASSESSMENT FOR 
PATCHY AA: SUBJECT RATING (ASAA-AAP:SR) 
 
Instructions for item 1: Please mark an “X” in the box (
) that best describes the appearance 
of the target patch right now.  Please select the one response that best represents your answer. 
 
 Full hair, scalp of the target patch completely covered with hair 
 Most hair, scalp of the target patch mostly covered with hair 
 Some hair, scalp of the target patch somewhat covered with hair 
 A little hair, scalp of the target patch mostly exposed 
 No hair, scalp of the target patch completely exposed 
 
 
Instructions for item 2: Please mark an “X” in the box (
) that best describes the appearance 
of your whole scalp right now.  Please select the one response that best represents your answer. 
 
 Full hair, whole scalp completely covered with hair 
 Most hair, whole scalp mostly covered with hair 
 Some hair, whole scalp somewhat covered with hair 
 A little hair, whole scalp mostly exposed 
 No hair, whole scalp completely exposed 
 


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APPENDIX 3. ALOPECIA FACIAL HAIR APPEARANCE 
ASSESSMENT: SUBJECT RATING (AFHA:SR)  
 
Instructions for item 1a: Please mark an “X” in the box (
) that best describes the appearance 
of your left eyebrow hair right now. Please select the one response that best represents your 
answer. 
 Full eyebrow hair 
 Most eyebrow hair 
 Some eyebrow hair 
 A little eyebrow hair 
 No eyebrow hair 
 
Instructions for item 1b: Please mark an “X” in the box (
) that best describes the appearance 
of your right eyebrow hair right now. Please select the one response that best represents your 
answer. 
 
 Full eyebrow hair 
 Most eyebrow hair 
 Some eyebrow hair 
 A little eyebrow hair 
 No eyebrow hair 
 
Instructions for item 2a: Please mark an “X” in the box (
) that best describes the appearance 
of your left eyelashes right now. Please select the one response that best represents your answer. 
 
 Full eyelashes 
 Most eyelashes 
 Some eyelashes 
 A little eyelashes 
 No eyelashes 
 
 
 


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Instructions for item 2b: Please mark an “X” in the box (
) that best describes the appearance 
of your right eyelashes right now. Please select the one response that best represents your 
answer. 
 
 Full eyelashes 
 Most eyelashes 
 Some eyelashes 
 A little eyelashes 
 No eyelashes 
 
Instructions for item 3: Please mark an “X” in the box (
) that best describes the appearance 
of your beard hair right now. Beard hair can include hair on the chin, cheeks, neck, and above the 
upper lip. Please select the one response that best represents your answer. 
 
 Full beard hair 
 Most beard hair 
 Some beard hair 
 A little beard hair 
 No beard hair 
 N/A – Female  
 


Protocol: ATI-502-AA-203 
 
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Date: 09NOV2018, Version 1.0                    
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APPENDIX 4. SUBJECT GLOBAL IMPRESSION OF SEVERITY FOR 
PATCHY AA (SGIS-AAP) 
 
Please mark an “X” in the box (
) that best describes the severity of your patchy alopecia areata 
right now. 
 
Overall, how severe is your patchy alopecia areata right now? 
 
 Mild 
 Moderate 
 Severe 
 Very Severe 
 Extremely Severe 
 
 


Protocol: ATI-502-AA-203 
 
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Date: 09NOV2018, Version 1.0                    
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APPENDIX 5. ALOPECIA IMPACT ASSESSMENT 
Alopecia Impact Assessment (AIA) 
Instructions: The following questions are about your alopecia.  For each question, please select the box 
(☒) below the number that best describes your experience with alopecia during the past seven days.  
There are no right or wrong answers. 
1. During the past seven 
days, how bothersome 
was it to cover your hair 
loss (e.g., wearing a wig, 
using makeup to fill in 
eyebrows, wearing hats)? 
Not at all 
bothersome 
 
Extremely 
bothersome 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2. During the past seven 
days, how worried were 
you about your 
appearance due to your 
hair loss? 
Not at all 
worried 
 
Extremely 
worried 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3. During the past seven 
days, how sad did you feel 
due to your hair loss? 
Not at all  
sad 
 
Extremely  
sad 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4. During the past seven 
days, how much did your 
hair loss impact your 
confidence? 
Not at all 
impacted 
 
Extremely 
impacted 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5. During the past seven 
days, how self-conscious 
did you feel due to your 
hair loss (e.g., feeling 
uncomfortable with 
hair/hair loss in public)? 
Not at all self-
conscious 
 
Extremely 
self-
conscious 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6. During the past seven 
days, how embarrassed 
did you feel due to your 
hair loss (e.g., feeling 
awkward about, or 
ashamed of, hair loss)? 
Not at all 
embarrassed 
 
Extremely 
embarrassed 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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7. During the past seven 
days, how unattractive 
did you feel due to your 
hair loss? 
Did not feel 
unattractive at all 
 
Felt 
extremely 
unattractive 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. During the past seven 
days, how much did your 
hair loss limit your social 
activities (e.g., spending 
time with friends, going to 
a social event)? 
Not at all 
limited 
 
Extremely 
limited 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9. During the past seven 
days, how much did your 
hair loss limit your 
physical activities (e.g., 
going to the gym, 
swimming, playing 
sports)? 
Not at all 
limited 
 
Extremely 
limited 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10. During the past seven 
days, how bothersome 
was unwanted or negative 
attention from others due 
to your hair loss (e.g., 
staring, questions)? 
Not at all 
bothersome 
 
Extremely 
bothersome 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11. During the past seven 
days, how bothersome 
was your experience of 
getting sweat in your eyes 
due to your hair loss? 
Not at all 
bothersome 
 
Extremely 
bothersome 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
12. During the past seven 
days, how bothersome 
was your experience of 
getting debris in your eyes 
due to your hair loss? 
Not at all 
bothersome 
 
Extremely 
bothersome 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
13. During the past seven 
days, how bothersome 
was your experience 
getting debris in your 
nose due to your hair 
loss? 
Not at all 
bothersome 
 
Extremely 
bothersome 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Protocol: ATI-502-AA-203 
 
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Date: 09NOV2018, Version 1.0                    
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APPENDIX 6. SUBJECT GLOBAL IMPRESSION OF TREATMENT 
SATISFACTION FOR AA PATCHY (SGITS-AAP) 
 
Please mark an “X” in the box (
) that best describes how satisfied you are with the treatment 
for your patchy alopecia areata. 
 
How satisfied or dissatisfied are you with the treatment you received in this study for your 
patchy alopecia areata? 
 
 Extremely satisfied 
 Moderately satisfied 
 A little satisfied 
 Neither satisfied or dissatisfied 
 A little dissatisfied 
 Moderately dissatisfied 
 Extremely dissatisfied 
 


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APPENDIX 7. SUBJECT GLOBAL SATISFACTION WITH HAIR 
QUALITY (SGSHQ-AAP) 
Instructions: Please mark an “X” in the box (
) that best describes your satisfaction with your 
scalp hair quality (such as its color, texture, and thickness) right now. Please select the one 
response that best represents your answer. 
 
1. How satisfied or dissatisfied are you with your hair quality in the target patch right 
now? 
 
 Extremely satisfied 
 Moderately satisfied 
 A little satisfied 
 Neither satisfied or dissatisfied 
 A little dissatisfied 
 Moderately dissatisfied 
 Extremely dissatisfied 
 
2. How satisfied or dissatisfied are you with your hair quality in the all treated patchy 
areas right now? 
 
 Extremely satisfied 
 Moderately satisfied 
 A little satisfied 
 Neither satisfied or dissatisfied 
 A little dissatisfied 
 Moderately dissatisfied 
 Extremely dissatisfied 
 


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APPENDIX 8. ALOPECIA SCALP APPEARANCE ASSESSMENT FOR 
AT AND AU: SUBJECT RATING (ASAA-AT/AU:SR) 
 
Instructions: Please mark an “X” in the box (
) that best describes the appearance of your 
whole scalp right now.  Please select the one response that best represents your answer. 
 
 Full hair, whole scalp completely covered with hair 
 Most hair, whole scalp mostly covered with hair 
 Some hair, whole scalp somewhat covered with hair 
 A little hair, whole scalp mostly exposed 
 No hair, whole scalp completely exposed 
 
 


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APPENDIX 9. SUBJECT GLOBAL IMPRESSION OF SEVERITY FOR 
AT/AU (SGIS-AT/AU) 
 
Please mark an “X” in the box (
) that best describes the severity of your alopecia totalis or 
alopecia universalis right now. 
 
Overall, how severe is your alopecia totalis or alopecia universalis right now? 
 
 Mild 
 Moderate 
 Severe 
 Very Severe 
 Extremely Severe 
 
 


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APPENDIX 10. SUBJECT GLOBAL IMPRESSION OF TREATMENT 
SATISFACTION FOR AT/AU (SGITS-AT/AU) 
 
Please mark an “X” in the box (
) that best describes how satisfied you are with the treatment 
for your alopecia totalis or alopecia universalis. 
 
How satisfied or dissatisfied are you with the treatment you received in this study for your 
alopecia totalis or alopecia universalis? 
 
Extremely satisfied 
 
Moderately satisfied 
 
A little satisfied 
 
Neither satisfied or dissatisfied 
 
A little dissatisfied 
 
Moderately dissatisfied 
 
Extremely dissatisfied 
 
 
 


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Date: 09NOV2018, Version 1.0                    
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APPENDIX 11. SUBJECT GLOBAL SATISFACTION WITH HAIR 
QUALITY FOR AT/AU (SGSHQ-AT/AU) 
Instructions: Please mark an “X” in the box (
) that best describes your satisfaction with your 
scalp hair quality (such as its color, texture, and thickness) right now. Please select the one 
response that best represents your answer. 
 
1. How satisfied or dissatisfied are you with your scalp hair quality right now? 
 
Extremely satisfied 
 
Moderately satisfied 
 
A little satisfied 
 
Neither satisfied or dissatisfied 
 
A little dissatisfied 
 
Moderately dissatisfied 
 
Extremely dissatisfied 
 
 
 


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Date: 09NOV2018, Version 1.0                    
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APPENDIX 12. SUBJECT GLOBAL IMPRESSION OF CHANGE (SGIC) 
 (Please mark an “X” in the box (
):  
 
1. Compared to your hair loss at the beginning of the study [before starting study 
medication on study ATI-501-AUAT-201], your alopecia is? 
 
1=Very much improved since starting study medication 
 
2=Much improved 
 
3=A little improved 
 
4=No change since starting study medication 
 
5=A little worse 
 
6= Much worse 
 
7=Very much worse since starting study medication 
 
 
 
 
  
 
 
  
 
 
  
 
  
 
 
 
 


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Date: 09NOV2018, Version 1.0  
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APPENDIX 13. SUBJECT INSTRUCTIONS FOR STUDY MEDICATION 
APPLICATION TO THE ENTIRE SCALP 
Preparation and General Instructions: 
1.
Gather a clean washcloth and towel, the study medication bottle, disposable dropper and gloves
(parent application only).  Parents must wear gloves when applying study medication to their
child’s scalp.
2.
Hair and scalp should be clean (free of any hair and scalp styling products), and dry or at least
towel-dried before applying study medication.  Ensure that your scalp is as dry as possible.  A
clean scalp will allow the study medication to penetrate down into the scalp to ensure you are
getting the best application.  The scalp should be washed using your normal cleansing products at
least an hour prior to study medication application, at least once a day to prevent accumulation of
study medication on your skin.
3.
Wash your hands with soap and water before and after using this study medication.
4.
You will apply a thin layer of study medication to the entire scalp as instructed by the study
doctor or the study staff.  Once medication has been applied to all current patchy areas, part hair
into approximately 4 sections (from front to back). Take each section one by one and apply up to
1mL to the scalp part and massage the study medication into the scalp from the part to the sides
until the entire scalp is covered in a thin film of study medication.  Keep applying study
medication throughout the study, even if scalp hair is regrowing. If you experience new areas of
scalp hair loss (for example, areas of the scalp with active hair shedding and abnormal sensations
that in your experience is a sign of scalp hair loss) discuss these new areas with the study Doctor
so they can be appropriately documented.
5.
The amount of study medication you will apply during one treatment is a total of __ mL (__
-1mL droppers).
6.
Avoid study medication contact with the eye.  If the study medication gets on any part of your
body other than your scalp, rinse the area well with water.
7.
You will apply study medication twice-a-day, approximately 8 to 12 hours apart. Remember to
bring your study medication bottles both used and unused to each study visit.
Study Medication Application: 
1.
Draw up exactly 1 mL of study medication into the dropper. The medication level should be at the 
1mL line.
2.
During study medication application, keep your head tilted back to avoid any study medication 
running into your eyes.
3.
Section hair into approximately 4 sections (from front to back). Apply up to 1 mL to the scalp of 
each parted section from front to back and massage the study medication into the scalp from the 
part to extending to the sides until the entire scalp is covered in a thin film of study medication.
4.
Replace the screw top cap and make sure it is closed tightly.  Dispose of the used dropper(s).
5.
It is important to continue to apply study medication to the entire scalp throughout the study, even 
if there is hair growth.
6.
Wash your hands after using this product to prevent any residue being left on your hands.
7.
Allow the study medication to dry for at least 15 minutes before you apply any styling products to 
the hair.  All topical products applied to the hair and scalp must be reviewed and approved by 
your study doctor before use.
8.
If you missed a dose or doses, record on your subject compliance record and tell the study staff at 
your next visit.
9.
Do not wash your hair or scalp for at least 6 hours after applying study medication or participate 
in strenuous exercise that would cause profuse sweating for at least 6 hours.


Protocol: ATI-502-AA-203 
 
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Date: 09NOV2018, Version 1.0                    
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Wigs and Hairpieces 
1. Wigs and hairpieces may be worn while participating in the study but must be appropriately 
managed. 
2. Wigs or hairpieces should not be worn until the study medication is completely dry on the scalp.  
Thus, wigs or hairpieces should not be reapplied for at least 15 minutes after the study drug has 
been applied.  
3. Wigs and hairpieces will need to be removed at each study visit to allow the study doctor to 
evaluate your scalp and hair loss.  Any hairpieces that may be difficult to remove will prevent you 
from participating in the study.  Do not have semi-permanent or difficult to remove hairpieces 
placed during the study.  Hair “weaves” that only involve areas of the scalp that continue to have 
hair may be accepted on a case by case basis. 
4. If scalp irritation develops during the study, it may be necessary to temporarily stop wearing of a 
hairpiece or wig.  The study doctor will discuss this with you should scalp irritation develop. 
Missed Doses: If you miss a dose of this study medicine, apply it as soon as possible. However, if it is 
almost time for your next dose, skip the missed dose, and go back to your regular dosing schedule.  Tell 
the study staff about any missed doses at your next study visit. 
 
Storage: Store the medicine in the original glass bottle, in the carton provided, at room temperature, away 
from heat, moisture, and direct light. Keep from freezing.  Keep study medication and used droppers out 
of the reach of children. 
  


Protocol: ATI-502-AA-203 
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Date: 09NOV2018, Version 1.0  
Page 79 of 80 
CONFIDENTAL 
APPENDIX 14. SUBJECT INSTRUCTIONS FOR STUDY MEDICATION 
APPLICATION TO THE EYEBROWS
General Instructions: 
1. Before application of study medication, your eyebrow area should be clean (free of any
makeup, moisturizers, sunscreen, etc.), and dry. This will allow the study medication to
penetrate down into the skin to ensure you are getting the best application.
2. The study doctor will instruct you to apply study medication to one or both eyebrows.
You will apply the study medication to the entire eyebrow area, both with and without
eyebrow hair.
3. You will be asked to apply a thin layer of study medication to the affected eyebrow with
an applicator as instructed by the study doctor or the study staff. Keep applying study
medication to the affected eyebrow(s) throughout the study, even if hair is re-growing in
these areas.
4. You will want the tip of your applicator to be saturated but not too much as to cause
dripping.  An applicator should only be dipped in the bottle once and then disposed of.
5. Keep the study medication out of your eyes.  If the study medication gets in your eyes,
rinse the area well with water for up to 15 minutes.  Contact the study doctor for further
advice on managing the eye exposure.
6. You will apply study medication twice-a-day, approximately 8 to 12 hours apart.  Once
you apply study medication, do not wash your face and eyebrow area or participate in
strenuous exercise that would cause profuse sweating for at least 6 hours.
7. Remember to bring your study medication bottles, both used and unused, to each study
visit.
8. Avoid exposing your face to excessive natural or artificial ultraviolet radiation (e.g.,
sunlight, tanning beds) and use sunscreen on the face including the eyebrows, if
excessive sun exposure cannot be avoided.
9. Remove any products applied to the eyebrow area at least 1 hour before study visits.  Do
not apply study medication less than 6 hours before a study visit. If your visit is in the
morning you should wait until after the visit to apply your study medication.
10. Each bottle of study medication should be used for 60 days only, even if there is
remaining study medication.
Preparation for Study Medication Application 
1. Gather a clean, dry washcloth or towel, the study medication bottle, disposable
applicators and a mirror.
2. Wash your hands with soap and water before and after using this study medication.
3. Gently wash your eyebrow areas, ensuring your eyebrow areas are clean. Use your
normal cleansing regime as approved by your study doctor.  Do not use abrasive
cleansers or materials on your face and eyebrow area.
4. Pat your face dry with a clean towel and then let it air dry until it is completely dry to the
touch.


Protocol: ATI-502-AA-203 
 
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Date: 09NOV2018, Version 1.0                    
Page 80 of 80 
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Study Medication Application: 
1. Unscrew the cap from the bottle.  Place the open bottle on a stable, level surface.   
2. Dip a disposable applicator into the bottle of study medication for about 2 seconds. Tap 
the tip of the applicator twice inside the edge of the bottle to remove any excess study 
medication.  The applicator should be saturated, but not dripping.   
3. Tilt your head back and place your clean, dry washcloth over one eye. Swipe the 
applicator across your affected eyebrow ridge above the covered eye, applying a thin 
layer of study medication over the entire affected eyebrow area.  Your eyebrow area 
should be wet, but not dripping wet.  Dispose of the applicator.  Do not dip the same 
applicator in the study medication bottle more than once. 
4. If you need additional study medication to cover your entire affected eyebrow, use a new 
applicator and repeat the application process as described in #2 and #3.  
5. If you are instructed by the study doctor to treat both eyebrows, apply study medication 
to your other eyebrow following instructions in #2, #3, and #4. 
 
After Study Medication Application 
1. Securely close the study medication bottle and dispose of any used applicators.   
2. Wash your hands after using this product. 
3. Allow the study medication to completely dry for at least 10 minutes. 
4. Do not apply any products (moisturizers, sunscreens, cosmetics, etc.) to your eyebrow 
area until the study medication has completely dried, at least 30 minutes after applying 
study medication. 
5. Do not wash your face and eyebrow areas or participate in strenuous exercise that would 
cause profuse sweating for at least 6 hours after applying the study medication. 
 
Missed Doses 
If you miss a dose of this study medication, apply it as soon as possible. However, if it is almost 
time for your next dose, skip the missed dose, and go back to your regular dosing schedule.  Tell 
the study staff about any missed doses at your next study visit. 
 
Storage 
Store the study medication in the original glass bottle at room temperature, away from heat, 
moisture, and direct light. Do not refrigerate or freeze. Keep out of reach of children. 
 
 
 

ICF_001.pdf: 
Information and Consent Form 
Aclaris Therapeutics, Inc. 
ATI-502-AA-203 
 
Initials __________    Date __________ 
Version 1, dated 11/13/18 
Page 1 of 13 
INFORMATION AND CONSENT FORM 
 
Study Title: 
Open-Label Study of ATI-502 Topical Solution for the Treatment of Alopecia 
Areata (AA), Alopecia Universalis (AU) and Alopecia Totalis (AT) 
Study #: 
<<protocol number>> 
Sponsor: 
<<sponsor>> 
Study Doctor: 
<<investigator>> 
<<firm name>> 
<<street address>>, <<city>>, <<state>>  <<zip>> 
Telephone Number: <<000-000-0000>> 
After Office Hours: <<000-000-0000>> 
 
The study doctor wants to know if you would like to be part of a research study. 
If you have any questions about or do not understand something in this form, you should ask 
the study doctor or study staff.  You should also discuss your participation with anyone you 
choose in order to better understand this study and your options. 
Participating in a research study is not the same as getting regular medical care.  The purpose 
of regular medical care is to improve your health.  The purpose of a research study is to gather 
information. 
 
WHAT IS THIS STUDY ABOUT? 
You are currently participating in the ATI-501-AUAT-201 study to see if ATI-501 Oral 
Suspension can help regrow hair in people with stable alopecia areata (AA), alopecia 
universalis (AU), or alopecia totalis (AT).  You have now finished the portion of the study where 
you are taking ATI-501 Oral Suspension or Placebo twice daily and the researchers would like 
to provide you with the option to continue experimental treatment with a topical solution. 
Researchers want to find out more about an investigational drug called ATI-502 Topical 
Solution.  An “investigational” drug is a drug that is being tested as a potential treatment and is 
not approved for sale in the United States by the U.S. Food and Drug Administration (FDA). 
Currently, there is no proven treatment for AA or its more severe forms AU and AT.  Increases 
in the understanding of what causes AA has led to the development of the new drug ATI-502, 
which may help to stop the body from attacking the hair follicles, which causes hair to stop 
growing and fall out. 
The purpose of this study is to see whether ATI-502 Topical Solution (0.46%) is safe and well-
tolerated when applied to the scalp of those with AA, AU and AT.  Additionally, researchers 
want to find out if ATI-502 Topical Solution can maintain or improve hair regrowth in people who 
completed 24 weeks of treatment with ATI-501 Oral Suspension or Placebo Suspension.   
It is planned that about 80 people with stable AA, AU, or AT will be in this study. 


Information and Consent Form 
Aclaris Therapeutics, Inc. 
ATI-502-AA-203 
 
Initials __________    Date __________ 
Version 1, dated 11/13/18 
Page 2 of 13 
Be aware that this form refers to ATI-502 Topical Solution (0.46%) as “study drug”. 
 
HOW DOES ATI-502 TOPICAL SOLUTION WORK? 
ATI-502 Topical Solution is an investigational drug in a Topical Solution that is designed to allow 
hair growth to occur again.  ATI-502 Topical Solution has been used in several small studies in 
people with alopecia areata, but those studies are still ongoing and it is not yet known if ATI-502 
will work.   
 
IS THERE ANYTHING ELSE I CAN DO FOR MY ALOPECIA AREATA, ALOPECIA TOTALIS 
OR ALOPECIA UNIVERSALIS? 
You do not have to be in this study to get help for your alopecia areata.  Some other things you 
may be able to do are: 
• 
Corticosteroids (anti-inflammatory medications), either topically applied or injected into 
your scalp, 
• 
Immunosuppressive treatments (drugs that suppress your immune system) such as: 
o cyclosporine, methotrexate, or etanercept 
• 
Phototherapy (a treatment that uses ultraviolet light) such as: 
o phototherapy with psoralen + UVA (PUVA) 
o narrow-band UVB 
o photodynamic therapy (PDT) 
• 
Laser therapy 
• 
Diphenylcyclopropenone or squaric acid dibutyl ester – medications that are applied to 
your scalp to produce an allergic reaction (an approach known as topical 
immunotherapy), 
• 
Topical anthralin (a tar-like topical medication), 
• 
Topical minoxidil (a topical medication approved for male and female pattern baldness). 
Although many products are used for this condition, their effectiveness is uncertain. 
You should discuss your alternatives to participating in this research with the study doctor or 
study staff.  In addition, you may discuss your options with your regular health care provider. 
 
WHO IS PAYING FOR THIS STUDY? 
A company called Aclaris Therapeutics, Inc., the sponsor of the study, is paying for this study. 
<<Quorum may add site-specific conflict-of-interest language to the form based on information 
the site reports to Quorum.>> 
 
WILL IT COST ANYTHING TO BE IN THIS STUDY? 
It will not cost you anything to participate in this study. 
 


Information and Consent Form 
Aclaris Therapeutics, Inc. 
ATI-502-AA-203 
 
Initials __________    Date __________ 
Version 1, dated 11/13/18 
Page 3 of 13 
HOW LONG WILL I BE IN THE STUDY? 
If you decide to be in this study and the study doctor says you can proceed, your participation 
will include 7 visits to the study center and will last about 28 weeks, up to a maximum of about 
200 days.  Your first visit for this study may occur on the same day as Visit 9 on the ATI-501-
AUAT-201 study. 
You will visit the study center to have the procedures and tests described in this form.  Ask the 
study doctor or study staff about your study visit schedule. 
 
WHAT WILL HAPPEN DURING THIS STUDY? 
The study doctor or study staff will give you study drug to put on your scalp.  You will apply up to 
4 mLs of the study drug 2 times a day (in the morning and evening approximately 12 hours 
apart) for 24 weeks. In addition, study participants with eyebrow loss may apply study 
medication to the entire eyebrows twice daily for 24 weeks. 
While you are in the study, you must: 
• 
Follow the instructions you are given. 
• 
Come to the study center for all visits with the study doctor or study staff. 
• 
Tell the study doctor or study staff about any changes in your health or the way you feel. 
• 
Tell the study doctor or study staff if you want to stop being in the study at any time. 
• 
Use birth control during the study and up to 30 days after the last application of study 
drug. 
 
What happens when I come for study visits? 
After you sign this form, the study doctor or study staff will perform the tests and procedures 
listed below when you come in for the study visits.  If you would like more information about 
which tests and procedures will be done at each study visit, ask the study doctor or study staff. 
• 
Demographic Questions:  Ask you to confirm personal information, such as your 
name, date of birth, sex at birth, and race/ethnicity. 
• 
Health and Medication Questions:  Ask you to answer questions about your health, 
your medical history, your alopecia areata history, and the medications you take. 
• 
Physical Exam:  The study doctor or a member of the study staff will examine your 
overall general appearance, head, eyes, ears, nose, throat, stomach, nervous system, 
muscles and bones, lymphatics, and skin, and will listen to your heart and lungs. 
• 
Vital Signs:  Check your blood pressure by putting a band around your arm (this will 
squeeze your arm for about a minute), check your pulse, listen to you breathe in and out, 
and take your temperature. 
• 
Blood Testing:  Take some blood through a needle in your arm to do safety and 
laboratory tests.  At visits where blood samples are collected, you will have 2 tubes of 
blood drawn. The maximum amount of blood you will have taken over 6 months is 
slightly more than 5 tablespoons for the safety testing.   
• 
Urine Testing:  You will have your urine tested. 


Information and Consent Form 
Aclaris Therapeutics, Inc. 
ATI-502-AA-203 
 
Initials __________    Date __________ 
Version 1, dated 11/13/18 
Page 4 of 13 
• 
Pregnancy Testing:  Test your urine to see if you are pregnant.  You will only have 
pregnancy testing if you are a woman and can have children. 
o The study doctor or study staff will tell you if the pregnancy test results are 
positive. 
o The results of the pregnancy testing must be negative in order for you to be 
enrolled in and continue in the study. 
• 
Other Questions:  You will be asked about any changes in your health and the 
medications you are taking since the previous study visit. 
• 
Scalp Examinations:  The study doctor or study staff will examine your scalp to 
determine the amount of hair loss, the quality of your hair (by gently pulling at hairs at 
the border of areas of hair loss), and the appearance and severity of your hair loss. 
• 
Questionnaires:  You will examine your scalp to determine and describe the 
appearance and severity of your hair loss and assess the impact of hair loss on your life.  
At Visit 4 (Day 57) and Visit 6 (Day 169), you will be asked to rate your satisfaction with 
the study drug results. 
• 
Photography:  The study doctor or study staff will take pictures of your head and scalp 
(your face will be included in these photographs) to document the hair loss. These 
photographs may be used for research purposes related to the study and for 
presentation to government health authorities, such as the U.S. Food and Drug 
Administration (FDA), at scientific meetings, for scientific publications, for general 
corporate purposes, and may be used for marketing purposes. Your identity will not be 
revealed in these photographs.  Your identifying features, (eyes, mouth, tattoos) will be 
hidden in the photographs.  You do not have to let the study doctor or study staff 
take photographs if you don’t want to; however, if you decline to have these 
pictures taken, you will not be allowed to participate in this study. 
• 
Study Drug:  You will be given a supply of study drug and instructions for how to apply 
the study drug. 
• 
Apply study drug in the office:  At visit 1 if the study doctor decides you are able to 
participate, the study staff will instruct you on how to apply the study drug.  You will 
apply the study drug in the office under the supervision and guidance of the study staff. 
• 
Subject Instruction Sheet:  You will be given a written instruction sheet. 
 
If you participate on the ATI-502-AA-203 study, your Visit 1 may be the same day as visit 9 in 
the ATI-501-AUAT-201 study.  If that is the case, you will have a short set of assessments 
completed as shown in the table below.  If the study doctor decides you may proceed, you will 
be given a supply of the active study medication and perform your first application in the 
doctor’s office.  If your Visit 1 for the ATI-502-AA-203 occurs more than 14 days after Visit 9 on 
study ATI-501-AUAT-201, some additional tests will need to be done in order for the study 
doctor to decide if you may continue on the ATI-502-AA-203 study.    


Information and Consent Form 
Aclaris Therapeutics, Inc. 
ATI-502-AA-203 
 
Initials __________    Date __________ 
Version 1, dated 11/13/18 
Page 5 of 13 
 
WILL BEING IN THIS STUDY HELP ME? 
The study drug may help your alopecia areata, but there is no guarantee that being in this study 
will help you.  Your alopecia areata might not get better or may even get worse while you are in 
this study.  Information from this study might help researchers to better understand alopecia 
areata or come up with new tests or medications to help others in the future. 
 
WHAT ARE THE RISKS TO ME IF I AM IN THIS STUDY? 
You must be careful to avoid having the study drug run into your eyes because it could cause 
irritation.   
Events and 
Tests 
Treatment Period 
Post-
Treatment 
Visit 1  
(same day as 
Visit 9 on ATI-
501-AUAT-
201) 
Visit 1  
(>14 days 
since Visit 9 
on ATI-501-
AUAT-201) 
Visit 2 
Visit 3 
 
Visit 4 
Visit 5 
 
Visit 6 
 
Visit 7 
 
Informed Consent 
 
 
 
 
 
 
 
 
Demographics, 
Health History and 
Medication Review 
 
 
 
 
 
 
 
 
Physical exam 
 
 
 
 
 
 
 
 
Vital signs3 
 
 
 
    
 
Blood for safety and 
urine test 
 
 
 
    
 
Urine test for 
pregnancy, if you are 
a woman and can 
have a baby 
 
 
 
    
 
Scalp examination 
and measurement of 
hair loss 
 
 
 
    
 
Questionnaire 
Completion 
 
 
 
 
 
 
 
 
Treatment 
Satisfaction 
Questionnaire 
 
 
 
 
 
 
 
 
Photographs of your 
head and scalp 
 
 
 
    
 
Receive study drug 
and instructions 
 
 
    
 
 
Return used study 
drug 
 
 
 
 
 
 
 
 
Apply study drug in 
office 
 
 
 
 
 
 
 
 
Other Questions 
 
 
     
 


Information and Consent Form 
Aclaris Therapeutics, Inc. 
ATI-502-AA-203 
 
Initials __________    Date __________ 
Version 1, dated 11/13/18 
Page 6 of 13 
In animal testing, the following temporary side effects occurred on the skin where ATI-502 was 
applied: 
• 
Redness 
• 
Swelling 
• 
Skin peeling 
Healthy volunteers took an oral form of ATI-502, and the most frequently reported drug-related 
side effects include: 
• 
Headache 
• 
Abdominal discomfort 
• 
Decreased appetite 
• 
Dizziness 
• 
Somnolence (Sleepiness) 
• 
Diarrhea 
• 
Dry Skin 
• 
Nausea 
• 
Constipation 
• 
Dyspepsia (Indigestion) 
• 
Feeling hot 
• 
Paresthesia (Pins and Needles sensation on the skin) 
People who took FDA-approved oral medications similar to ATI-502 experienced: 
• 
Infections (bacterial, viral, fungal, or other infections) 
• 
Abnormal blood tests (decreases in white blood cells and platelets, and increases in liver 
function tests) 
• 
Cancers 
• 
Increased lipids (total cholesterol, high-density lipoprotein cholesterol [also known as 
HDL, the good cholesterol], and low-density lipoprotein cholesterol [also known as LDL, 
the bad cholesterol]) 
Since ATI-502 Topical Solution is an investigational drug, there may be other risks that are 
unknown.  Please tell the study doctor or study staff right away if you have any side effects.  
Please tell them if you have any other problems with your health or the way you feel during the 
study, whether or not you think these problems are related to the study drug. 
It is possible that using ATI-502 Topical Solution may change how your regular medications, 
vaccines, or supplements work.  It is very important that you tell the study doctor about any 
medications, supplements, or vaccines before you take them during the study. 
 
Could I have an allergic reaction? 
Sometimes people have allergic reactions to drugs.  All drugs have a potential risk of an allergic 
reaction, which if not treated promptly, could become life-threatening.  Some things that happen 
during an allergic reaction that could be a sign or symptom of a life-threatening allergic reaction 
(anaphylaxis) are: 
• 
A rash 


Information and Consent Form 
Aclaris Therapeutics, Inc. 
ATI-502-AA-203 
 
Initials __________    Date __________ 
Version 1, dated 11/13/18 
Page 7 of 13 
• 
A fast pulse 
• 
Sweating 
• 
A feeling of dread 
• 
Swelling around the eyes and mouth 
• 
Swelling of the throat 
• 
Wheezing 
• 
Having a hard time breathing 
• 
A sudden drop in blood pressure (making you feel dizzy or lightheaded) 
• 
Inability to breathe without assistance 
You should get medical help and contact the study doctor or study staff, if you have any of these 
or any other side effects during the study. 
 
What are the risks of giving blood for this study? 
The study doctor or study staff will take your blood by sticking a needle in your arm.  Some 
problems you might have from this are: 
• 
Pain 
• 
Bruising 
• 
Dizziness 
• 
Infection 
 
Risks of study photography 
There are no expected physical risks if the study doctor or study staff takes photos of your head 
and scalp during the study.  It is possible that people who see the study photos will recognize 
you.  
 
Loss of confidentiality 
There is a risk of loss of confidentiality of your information.  You will read more about the 
protection of your information later in this form.  Please ask the study doctor or study staff if you 
would like to know more about how your information will be protected while you are in this study. 
 
What are the risks if I am pregnant or nursing a child during the study? 
If you are a woman who can have a baby, you must not get pregnant during the study or for 
30 days after the last study drug application.  In animal testing, there were potential toxic effects 
to both the embryo and fetus, indicating a risk to pregnancies.  If you are pregnant or nursing a 
child while using ATI-502 Topical Solution, there may be risks to you, the embryo, fetus, or 
nursing child.  Nobody knows what all the risks are right now. 
If you are a woman who can have children, the study doctor or study staff will talk to you about 
birth control you must use during the study and up to 30 days after the last application of study 


Information and Consent Form 
Aclaris Therapeutics, Inc. 
ATI-502-AA-203 
 
Initials __________    Date __________ 
Version 1, dated 11/13/18 
Page 8 of 13 
drug. If you are a sexually active male, you must agree to use a barrier method of contraception 
from the first application of study drug to at least 30 days after the last application of study drug. 
If you think you are pregnant during the study, you must tell the study doctor or study staff 
immediately. 
Women who become pregnant during the study will have to leave the study. The study doctor or 
study staff may ask for information about the pregnancy and the child’s health at birth, and for 
up to 6 weeks after the birth, and may share this information with the sponsor. 
 
What are the risks of fathering a child during the study? 
If you are a sexually active male, you must not father a child during the study or for 30 days 
after the last dose of study drug.  In animal testing, there were potential toxic effects to both the 
embryo and fetus, indicating a risk to pregnancies.  There may be risks to an unborn embryo or 
fetus that you father during or after the study.  Nobody knows what all the risks are right now. 
You must agree to use a barrier method of contraception from the first dose of study drug to at 
least 30 days after the last dose of study drug. 
If you think your partner is pregnant during the study, you must tell the study doctor or study 
staff immediately.  The study doctor or study staff may ask for information about the pregnancy 
and the child’s health at birth, and for up to 6 weeks after the birth, and may share this 
information with the sponsor. 
 
COULD I HAVE ANY OTHER PROBLEMS WITH MY HEALTH IF I AM IN THIS STUDY? 
It is possible that you could have problems and side effects of ATI-502 Topical Solution that 
nobody knows about yet, which include your alopecia areata getting worse. 
Ask the study doctor if you have questions about the signs or symptoms of any side effects that 
you read about in this consent form. 
 
WILL I RECEIVE ANY NEW INFORMATION DURING THE STUDY? 
If the study doctor or study staff learns any new information that might change your mind about 
continuing in the study, the study doctor or study staff will tell you about it. 
 
WHAT IF I GET HURT OR SICK WHILE I AM IN THIS STUDY? 
If, during the course of this study, any injury occurs to you as a direct result of the administration 
of the study drug or properly performed procedures, the Sponsor agrees to pay all medical 
expenses necessary to treat such injury: 1) to the extent you are not otherwise reimbursed by 
medical insurance; and 2) provided you have followed the directions of the study doctor. 
The compensation offered by the Sponsor for any injury which occurs to you as a direct result of 
the administration of the study drug or poorly performed procedures by the study doctor or study 


Information and Consent Form 
Aclaris Therapeutics, Inc. 
ATI-502-AA-203 
 
Initials __________    Date __________ 
Version 1, dated 11/13/18 
Page 9 of 13 
staff, will be paid after the Sponsor receives all appropriate documentation and completes its 
review, to its satisfaction, of all documentation regarding your claim for injury. 
You will not lose or give up any of your legal rights or release the Sponsor, the study doctor, the 
study staff, or study site from liability for negligence or intentional misconduct by signing this 
consent document. 
There are no plans to provide financial compensation for such things as lost wages, disability, or 
discomfort due to injury. 
Be aware that your health care payer/insurer might not cover the costs of study-related injuries 
or illnesses. 
 
WILL I RECEIVE PAYMENT? 
<<Quorum will add site-specific compensation language to the form based on information the 
site reports to Quorum.>> 
 
DO I HAVE TO BE IN THIS STUDY? 
Your participation in this study is voluntary.  You can decide not to be in the study and you can 
change your mind about being in the study at any time.  There will be no penalty to you, and you 
won’t lose any benefits except for benefits having to do with the study.  If you want to stop being 
in the study, tell the study doctor or study staff. 
The study doctor or study staff or sponsor can remove you from the study at any time, even if 
you want to stay in the study.  This could happen if, for example: 
• 
The study doctor or study staff believes it is best for you to stop being in the study. 
• 
You do not follow directions about the study. 
• 
The sponsor stops the study for any reason. 
If you stop being in the study early, the study doctor or study staff may ask you some questions 
about being in the study.  The study doctor or study staff may ask you to participate in some 
procedures or tests to help you leave the study safely and/or to collect more information for the 
study. 
If you leave the study, the study doctor and study staff will still be able to use your information 
that they have already collected. 
If you change your mind later, be aware that your samples may or may not be withdrawn from 
the research, depending on the sponsor’s policies. You can ask the study doctor or study staff 
about this. 
 
HOW WILL MY INFORMATION BE KEPT CONFIDENTIAL? 
Your identity will be protected as required by law and according to any policies the study center 
or sponsor may have.  Be aware that your study records (which include your medical records, 
your signed consent form, and other information) will be shared as needed for the study.  For 


Information and Consent Form 
Aclaris Therapeutics, Inc. 
ATI-502-AA-203 
 
Initials __________    Date __________ 
Version 1, dated 11/13/18 
Page 10 of 13 
example, the U.S. Food and Drug Administration (FDA), the sponsor, and Quorum Review may 
look at your study and medical records. 
Your blood and urine samples will not be labeled with your name or other directly identifying 
information.  Your samples will have a code (a unique subject identifier) instead.  The list that 
matches the code with your name will be stored separately from your samples.  Your samples 
will be kept only until we are able to complete the tests described in this form, and then your 
samples will be destroyed. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law.  This Web site will not include information that can identify you. At most, the Web site 
will include a summary of the results. You can search this Web site at any time. 
 
WHO CAN I TALK TO ABOUT THIS STUDY? 
In the event of an emergency, dial 911 immediately. 
If you require emergency care, be sure to tell the emergency care provider about your 
participation in this study.  Contact the study doctor or study staff as soon as possible. 
You can ask questions about the study at any time.  You can call the study doctor or study staff 
at any time if you have any concerns or complaints.  You should call the study doctor or study 
staff at the phone number listed on page 1 of this form if you have questions about the study 
procedures, study costs (if any), study payment (if any), or if you get hurt or sick during the 
study. 
Quorum Review reviewed this study.  Quorum Review is a group of people who review research 
studies to protect the rights and welfare of research participants.  Review by Quorum Review 
does not mean that the study is without risks.  If you have questions about your rights as a 
research participant, if you are not able to resolve your concerns with the study doctor or study 
staff, if you have a complaint, or if you have general questions about what it means to be in a 
research study, you can call Quorum Review or visit the Quorum Review website at 
www.QuorumReview.com. 
Quorum Review is located in Seattle, Washington. 
Office hours are 8:00 AM to 5:00 PM Pacific Time, Monday through Friday. 
Ask to speak with a Research Participant Liaison at 888-776-9115 (toll free). 
 
HOW WILL MY INFORMATION BE USED AND SHARED FOR THIS STUDY? 
This section explains who will use and share your health information if you agree to be in this 
study.  You must authorize this use and sharing of your information by signing this form or you 
cannot be in the study.  
The study doctor and study staff will collect, use, and share health information about you, 
including any information needed to do the study and other identifying information about you, 
such as your name, address, phone number, or social security number.  The information used 
and shared will include: 
• 
information from your medical records 


Information and Consent Form 
Aclaris Therapeutics, Inc. 
ATI-502-AA-203 
 
Initials __________    Date __________ 
Version 1, dated 11/13/18 
Page 11 of 13 
• 
information collected about you during the research, including study visits, notes, tests, 
procedures, photographs, etc. 
Your information may be used and shared with these people for the following purposes: 
• 
The study doctor and study staff to conduct this research. 
• 
The sponsor, Aclaris Therapeutics, Inc.; people who work with or for the sponsor; and 
other researchers involved in this study.  These people will use your information to 
review the study, to check the safety and results of the study drug, and to seek 
government approval of ATI-502 Topical Solution. 
• 
Others required by law to review the quality and safety of research, including the FDA, 
Department of Health and Human Services, Office for Human Research Protections, 
other government agencies in the United States and other countries, and Quorum 
Review. 
After your information is shared with the people and companies listed above, the law may not 
require them to protect the privacy of your information.   
To maintain the integrity of this research, you might not have access to any health information 
developed as part of this study until it is completed.  At that point, you generally would have 
access to your health information. 
You can cancel your authorization to use and share your information at any time by writing a 
letter to the study doctor.  If you cancel your authorization, you will not be able to continue in the 
study.   
If you cancel your authorization, the study doctor and study staff will still be able to use and 
share your information that they have already collected. 
This authorization to use and share your information expires in 50 years. 
 
 
 
 
 
Signature of Participant 
 
 
 
 
 
Date 
 
<<Quorum staff: Include the following for Indiana sites: 
In Indiana, you must complete the following information: 
 
 
 
 
 
 
 
Participant’s Street Address 
 
 
 
 
 
 
 
Participant’s City, State, ZIP>> 
 


Information and Consent Form 
Aclaris Therapeutics, Inc. 
ATI-502-AA-203 
 
Initials __________    Date __________ 
Version 1, dated 11/13/18 
Page 12 of 13 
REGULAR DOCTOR OR SPECIALIST NOTIFICATION OPTION 
For your safety, you or the study doctor should tell your regular health care provider that you are 
in this study.  This is recommended so that your primary care doctor may contact the study 
doctor if they have any concerns or questions about your care. 
Please indicate below whether you want us to notify your regular doctor or your specialist of 
your participation in this study. 
 
 
Yes, I want the study doctor to inform my regular doctor/specialist of my participation in 
this study: 
 
 
 
 
 
Name of Doctor 
 
 
 
 
 
 
Phone 
 
 
No, I do not want the study doctor to inform my regular doctor/specialist of my 
participation in this study. 
 
I do not have a regular doctor/specialist. 
 
The study doctor is my regular doctor/specialist. 


Information and Consent Form 
Aclaris Therapeutics, Inc. 
ATI-502-AA-203 
 
Initials __________    Date __________ 
Version 1, dated 11/13/18 
Page 13 of 13 
CONSENT 
I have read this form, and I have been able to ask questions about this study. The study doctor 
or study staff has talked with me about this study. They have answered all my questions.  
I voluntarily agree to be in this study. 
By signing this form, I do not give up any of my legal rights.  I will get a signed copy of this 
consent form. 
 
 
 
Printed Name of Participant 
 
 
 
 
 
Signature of Participant 
 
 
 
 
 
Date 
 
I attest that the individual providing consent had enough time to consider this information, had 
an opportunity to ask questions, and voluntarily agreed to participation in this study. 
 
 
 
Printed Name of Person Explaining Consent 
 
 
 
 
 
Signature of Person Explaining Consent 
 
 
 
Date 
 
 
I attest that I or my representative discussed this study with the individual providing consent. 
 
 
 
Signature of Principal Investigator or Sub-Investigator