Trial Outcomes & Findings for A Study of ATI-50002 Topical Solution for the Treatment of Alopecia Areata (NCT NCT03354637)

NCT ID: NCT03354637

Last Updated: 2020-06-05

Results Overview

The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth. The primary efficacy variable was the percent change from baseline in SALT score at Week 24. This was calculated as the mean of the changes from Baseline (Visit 2) SALT score to Week 24 (Visit 10) SALT score, divided by Baseline SALT score and expressed as a percentage.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 129 participants
• Primary outcome timeframe: Baseline - Week 24
• Results posted on: 2020-06-05

Participant Flow

Participant milestones

Measure	Vehicle Topical Solution Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution ATI-50002 0.46% Topical Solution applied twice daily.
Double-blind Period STARTED	43	44	42
Double-blind Period COMPLETED	26	31	35
Double-blind Period NOT COMPLETED	17	13	7
Open Label Extension STARTED	0	0	61
Open Label Extension COMPLETED	0	0	33
Open Label Extension NOT COMPLETED	0	0	28

Reasons for withdrawal

Measure	Vehicle Topical Solution Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution ATI-50002 0.46% Topical Solution applied twice daily.
Double-blind Period Protocol Violation	2	0	0
Double-blind Period Adverse Event	1	2	0
Double-blind Period Lost to Follow-up	3	4	3
Double-blind Period Withdrawal by Subject	10	6	4
Double-blind Period Incomplete Efficacy Data Collection	1	1	0
Open Label Extension Adverse Event	0	0	1
Open Label Extension Lost to Follow-up	0	0	2
Open Label Extension Withdrawal by Subject	0	0	5
Open Label Extension Study Terminated by Sponsor	0	0	17
Open Label Extension Subject Noncompliance	0	0	1
Open Label Extension Lack of Efficacy	0	0	1
Open Label Extension Physician Decision	0	0	1

Baseline Characteristics

A Study of ATI-50002 Topical Solution for the Treatment of Alopecia Areata

Baseline characteristics by cohort

Measure	Vehicle Topical Solution n=43 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=44 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=42 Participants ATI-50002 0.46% Topical Solution applied twice daily.	Total n=129 Participants Total of all reporting groups
Age, Categorical <=18 years	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	40 Participants n=7 Participants	37 Participants n=5 Participants	113 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Age, Continuous	42.0 years STANDARD_DEVIATION 16.58 • n=5 Participants	42.1 years STANDARD_DEVIATION 13.92 • n=7 Participants	40.5 years STANDARD_DEVIATION 14.99 • n=5 Participants	41.5 years STANDARD_DEVIATION 15.09 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants	46 Participants n=4 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	31 Participants n=7 Participants	24 Participants n=5 Participants	83 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	26 Participants n=7 Participants	23 Participants n=5 Participants	72 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	38 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	28 Participants n=4 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	29 Participants n=7 Participants	31 Participants n=5 Participants	92 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment United States	43 participants n=5 Participants	43 participants n=7 Participants	43 participants n=5 Participants	129 participants n=4 Participants
Fitzpatrick Skin Type I - Always Burns	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Fitzpatrick Skin Type II - Burns Easily	12 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	42 Participants n=4 Participants
Fitzpatrick Skin Type III - Burns Moderately	13 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	31 Participants n=4 Participants
Fitzpatrick Skin Type IV - Burns Minimally	6 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	20 Participants n=4 Participants
Fitzpatrick Skin Type V - Rarely Burns	6 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 Participants
Fitzpatrick Skin Type VI - Never Burns	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Duration of Current Episode of Alopecia Areata	127.8 weeks STANDARD_DEVIATION 104.13 • n=5 Participants	160.7 weeks STANDARD_DEVIATION 140.67 • n=7 Participants	156.3 weeks STANDARD_DEVIATION 140.95 • n=5 Participants	148.3 weeks STANDARD_DEVIATION 129.55 • n=4 Participants
Duration of Alopecia Areata	6.9 years STANDARD_DEVIATION 7.92 • n=5 Participants	12.9 years STANDARD_DEVIATION 12.25 • n=7 Participants	9.9 years STANDARD_DEVIATION 10.43 • n=5 Participants	9.9 years STANDARD_DEVIATION 10.59 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline - Week 24

Population: This primary analysis utilized the SALT score with imputation for last observation carried forward (LOCF) and was based on the intent-to-treat population.

The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth. The primary efficacy variable was the percent change from baseline in SALT score at Week 24. This was calculated as the mean of the changes from Baseline (Visit 2) SALT score to Week 24 (Visit 10) SALT score, divided by Baseline SALT score and expressed as a percentage.

Outcome measures

Measure	Vehicle Topical Solution n=43 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=44 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=42 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Percent Change From Baseline in the Severity of Alopecia Tool Score at Week 24	-18.54 score on a scale Standard Error 4.705	-4.66 score on a scale Standard Error 4.707	-9.22 score on a scale Standard Error 4.784

SECONDARY outcome

Timeframe: Baseline - Week 24

Population: Intent-to-treat population using LOCF to address missing data.

The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.

Outcome measures

Measure	Vehicle Topical Solution n=43 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=44 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=42 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Percent Change From Baseline in the Alopecia Density and Extent Score at Week 24	-14.75 score on a scale Standard Error 4.508	-8.15 score on a scale Standard Error 4.511	-11.52 score on a scale Standard Error 4.584

SECONDARY outcome

Timeframe: Baseline - Week 24

Population: Intent-to-treat population using LOCF to address missing data.

The Severity of Alopecia Tool (SALT) score is a physician administered scale measuring the amount of scalp without any terminal hair. Possible scores range from 0 (no scalp hair loss) to 100 (complete scalp hair loss). A negative change in the SALT score over time represents hair regrowth.

Outcome measures

Measure	Vehicle Topical Solution n=43 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=44 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=42 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Mean Change From Baseline in Severity of Alopecia Tool Score at Week 24	-6.47 score on a scale Standard Error 2.071	-1.95 score on a scale Standard Error 2.074	-2.94 score on a scale Standard Error 2.107

SECONDARY outcome

Timeframe: Baseline - Week 24

Population: Intent-to-treat population using LOCF to address missing data.

The Alopecia Density and Extent (ALODEX) score is a measurement of the amount of scalp with terminal hair loss assessed by the investigator at Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24. ALODEX breaks the scalp up into a grid of 1% scalp surface areas and assigns density rating in each area on a 10 point scale of hair loss (0= no hair loss to 10 = complete baldness). Summation of scores from each 1% scalp surface area provides an overall score which may range from 0 (no scalp hair loss) to 100 (complete baldness). A negative change in the ALODEX score over time represents hair regrowth.

Outcome measures

Measure	Vehicle Topical Solution n=43 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=44 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=42 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Mean Change From Baseline in Alopecia Density and Extent Score at Week 24	-4.91 score on a scale Standard Error 2.129	-3.36 score on a scale Standard Error 2.131	-4.98 score on a scale Standard Error 2.165

SECONDARY outcome

Timeframe: Baseline - Week 24

Population: Intent-to-treat population using LOCF to address missing data.

A summary of the proportion of subjects in each treatment arm achieving ≥50% hair regrowth compared with baseline using Severity of Alopecia Tool scores at Week 24 is presented.

Outcome measures

Measure	Vehicle Topical Solution n=43 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=44 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=42 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Severity of Alopecia Tool Scores at Week 24	5 Participants	7 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline - Week 24

Population: Intent-to-treat population using LOCF to address missing data.

A summary of the proportion of subjects in each treatment arm achieving ≥50% hair regrowth compared with baseline using Alopecia Density and Extent scores at Week 24 is presented.

Outcome measures

Measure	Vehicle Topical Solution n=43 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=44 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=42 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Proportion of Subjects Achieving ≥50% Hair Regrowth Based on Alopecia Density and Extent Scores at Week 24	6 Participants	8 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline - Week 24

Population: Intent-to-treat population using LOCF to address missing data.

The Scalp Patient Reported Outcome for Target Patch assesses the appearance of the subject's target patch (identified by the subject as his or her most bothersome area of scalp hair loss at Baseline) and was completed by subjects at Baseline, Week 4, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, scalp of the target patch completely covered with hair" to "no hair, scalp of the target patch completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. A summary of the proportion of subjects with ≥2 point improvement in Subject Target Patch assessment at Week 24 compared to baseline is presented.

Outcome measures

Measure	Vehicle Topical Solution n=43 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=44 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=42 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Proportion of Subjects With ≥2 Point Improvement in Scalp Patient Reported Outcome for Target Patch at Week 24	6 Participants	8 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline - Week 24

Population: Intent-to-treat population using LOCF to address missing data.

The Scalp Patient Reported Outcome for Entire Scalp assesses the appearance of the subject's whole scalp and was completed by subjects at Baseline, Week 4, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, whole scalp completely covered with hair" to "no hair, whole scalp completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. A summary of the proportion of subjects with ≥1 point improvement in Subject Entire Scalp assessment at Week 24 compared to baseline is presented.

Outcome measures

Measure	Vehicle Topical Solution n=43 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=44 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=42 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Proportion of Subjects With ≥1 Point Improvement in Scalp Patient Reported Outcome for Entire Scalp at Week 24	13 Participants	10 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline - Week 24

Population: Intent-to-treat population using LOCF to address missing data.

The Scalp Clinician Reported Outcome for Target Patch provides the investigator's assessment of the appearance of the subject's target patch (identified by the subject as his or her most bothersome area of scalp hair loss at Baseline) and was completed by investigators at Baseline, Week 4, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, scalp of the target patch completely covered with hair" to "no hair, scalp of the target patch completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. A summary of the proportion of subjects with ≥2 point improvement in Clinician Target Patch assessment at Week 24 compared to baseline is presented.

Outcome measures

Measure	Vehicle Topical Solution n=43 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=44 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=42 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Proportion of Subjects With ≥2-Point Improvement in Scalp Clinician Reported Outcome for Target Patch at Week 24	6 Participants	10 Participants	9 Participants

SECONDARY outcome

Timeframe: Baseline - Week 24

Population: Intent-to-treat population using LOCF to address missing data.

The Scalp Clinician Reported Outcome for Entire Scalp assesses the appearance of the subject's whole scalp and was completed by investigators at Baseline, Week 4, Week 12, and Week 24. The assessment has a recall period of "right now" and includes a five-point VRS ranging from "Full hair, whole scalp completely covered with hair" to "no hair, whole scalp completely exposed." The instrument produces a score of 1 to 5, with lower scores indicating more hair covering the subject's target patch. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

Outcome measures

Measure	Vehicle Topical Solution n=43 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=44 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=42 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 Better by 4 points	0 Participants	0 Participants	0 Participants
Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 Better by 3 points	0 Participants	0 Participants	1 Participants
Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 Better by 2 points	1 Participants	2 Participants	2 Participants
Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 Better by 1 points	11 Participants	9 Participants	8 Participants
Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 No change	27 Participants	27 Participants	23 Participants
Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 Worse by 1 point	4 Participants	5 Participants	7 Participants
Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 Worse by 2 point	0 Participants	1 Participants	1 Participants
Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 Worse by 3 point	0 Participants	0 Participants	0 Participants
Change From Baseline in Scalp Clinician Reported Outcome for Entire Scalp at Week 24 Worse by 4 point	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline - Week 24

Population: Intent-to-treat population using LOCF to address missing data.

The Physician Global Impression of Severity (PhGIS) is a 5-point descriptive scale completed by investigators at Baseline, Week 4, Week 12, and Week 24 and is used to capture the investigator's assessment of the subject's disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

Outcome measures

Measure	Vehicle Topical Solution n=43 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=44 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=42 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 Better by 4 points	0 Participants	0 Participants	0 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 Better by 3 points	0 Participants	0 Participants	0 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 Better by 2 points	5 Participants	4 Participants	4 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 Better by 1 point	9 Participants	10 Participants	12 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 No change	27 Participants	26 Participants	19 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 Worse by 1 point	1 Participants	3 Participants	5 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 Worse by 2 points	1 Participants	1 Participants	1 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 Worse by 3 points	0 Participants	0 Participants	1 Participants
Change From Baseline in the Physician Global Impression of Severity (PhGIS) of Patchy Alopecia Areata at Week 24 Worse by 4 points	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline - Week 24

Population: Intent-to-treat population using LOCF to address missing data.

The Subject Global Impression of Severity (SGIS) is a 5-point descriptive scale completed by subjects at Baseline, Week 4, Week 12, and Week 24 and is used to capture the subject's assessment of disease severity at a particular timepoint. Scores of 1 to 5 are assigned to responses Mild to Extremely Severe, respectively. Change status is categorized as 'Better by x points' when the score decreases from baseline by x points, and as 'Worse by x points' when the score increases by x points.

Outcome measures

Measure	Vehicle Topical Solution n=43 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=44 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=42 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 Better by 4 points	0 Participants	1 Participants	0 Participants
Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 Better by 3 points	1 Participants	2 Participants	3 Participants
Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 Better by 2 points	6 Participants	5 Participants	5 Participants
Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 Better by 1 point	9 Participants	4 Participants	9 Participants
Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 No change	11 Participants	20 Participants	17 Participants
Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 Worse by 1 point	14 Participants	8 Participants	7 Participants
Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 Worse by 2 points	2 Participants	4 Participants	1 Participants
Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 Worse by 3 points	0 Participants	0 Participants	0 Participants
Change From Baseline in the Subject Global Impression of Severity of Patchy Alopecia Areata at Week 24 Worse by 4 points	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline - Week 24

Population: Intent-to-treat population using LOCF to address missing data.

The Alopecia Impact Assessment (AIA) is a 13-item patient reported outcome questionnaire which measures the subject's experience with impacts related to alopecia areata in managing appearance, worry, sadness, loss of confidence, self-consciousness, embarrassment, feeling unattractive, limitation of social activities, limitation of physical activities, unwanted attention, sweat in eyes, debris in eyes, and debris in nose. The AIA was completed by subjects at Baseline, Week 4, Week 12, and Week 24 and has a recall period of "over the past seven days". An 11-point NRS with anchors "0 - Not at all [impact]" and "10 - Extremely [impact]" (e.g., "Not at all bothersome" and "Extremely bothersome"; "Not at all worried" and "Extremely worried") is utilized. The AIA produces single-item (0-10) and mean total (0-10) scores, with higher scores indicating higher levels of impact.

Outcome measures

Measure	Vehicle Topical Solution n=43 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=44 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=42 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Alopecia Impact Assessment Patient Reported Outcome Change From Baseline at Week 24	-0.8 score on a scale Standard Deviation 2.21	-0.8 score on a scale Standard Deviation 2.26	-1.0 score on a scale Standard Deviation 2.30

SECONDARY outcome

Timeframe: Week 24

Population: Intent-to-treat population using LOCF to address missing data.

The Subject Global Impression of Treatment Satisfaction (SGITS) is a 7-point descriptive scale completed by subjects at Week 12 and Week 24. Scale response options ranged from "1. Extremely Satisfied" to "7. Extremely Dissatisfied" and are used to capture how satisfied or dissatisfied they are with the study medication treatment received for their alopecia areata.

Outcome measures

Measure	Vehicle Topical Solution n=38 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=41 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=38 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Subject Global Impression of Treatment Satisfaction at Week 24 1. Extremely satisfied	5 Participants	8 Participants	9 Participants
Subject Global Impression of Treatment Satisfaction at Week 24 2. Moderately satisfied	6 Participants	5 Participants	7 Participants
Subject Global Impression of Treatment Satisfaction at Week 24 3. A little satisfied	5 Participants	7 Participants	3 Participants
Subject Global Impression of Treatment Satisfaction at Week 24 4. Neither satisfied or dissatisfied	5 Participants	8 Participants	6 Participants
Subject Global Impression of Treatment Satisfaction at Week 24 5. A little dissatisfied	3 Participants	4 Participants	2 Participants
Subject Global Impression of Treatment Satisfaction at Week 24 6. Moderately dissatisfied	5 Participants	3 Participants	4 Participants
Subject Global Impression of Treatment Satisfaction at Week 24 7. Extremely dissatisfied	9 Participants	6 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline - Week 24

Population: Intent-to-treat population using LOCF to address missing data.

The 10 question Dermatology Life Quality Index (DLQI) questionnaire was completed by subjects at Baseline, Week 4, Week 12, and Week 24. When completing the questionnaire, subjects were instructed to think of their hair loss in place of "skin problem" and "skin" as referenced in the questionnaire. Possible summary scores could range from 0 to 30 with higher scores indicating a worse outcome.

Outcome measures

Measure	Vehicle Topical Solution n=43 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=44 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=42 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Change in Dermatology Life Quality Index Total Score Between Baseline and Week 24	-0.5 score on a scale Standard Deviation 7.64	-1.1 score on a scale Standard Deviation 4.07	-2.2 score on a scale Standard Deviation 5.46

SECONDARY outcome

Timeframe: Week 24

Population: Intent-to-treat population using LOCF to address missing data.

The Physician Global Impression of Change (PhGIC) is a 7-point descriptive scale completed by investigators at Week 24. Scale response options ranged from "1. Very much improved" to "7. Very much worse" and are used to capture the investigator's overall impression of change for the subject's alopecia during the treatment period.

Outcome measures

Measure	Vehicle Topical Solution n=25 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=30 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=32 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Physician Global Impression of Change at Week 24 1. Very much improved	2 Participants	1 Participants	6 Participants
Physician Global Impression of Change at Week 24 2. Much improved	3 Participants	3 Participants	2 Participants
Physician Global Impression of Change at Week 24 3. A little improved	10 Participants	7 Participants	9 Participants
Physician Global Impression of Change at Week 24 4. No change	8 Participants	12 Participants	8 Participants
Physician Global Impression of Change at Week 24 5. A little worse	0 Participants	4 Participants	4 Participants
Physician Global Impression of Change at Week 24 6. Much worse	1 Participants	1 Participants	1 Participants
Physician Global Impression of Change at Week 24 7. Very much worse	1 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Week 24

Population: Intent-to-treat population using LOCF to address missing data.

The Subject Global Impression of Change (SGIC) is a 7-point descriptive scale completed by subjects at Week 24. Scale response options ranged from "1. Very much improved" to "7. Very much worse" and are used to capture the subject's overall impression of change for his/her alopecia during the treatment period.

Outcome measures

Measure	Vehicle Topical Solution n=25 Participants Vehicle Topical Solution applied twice daily.	ATI-50002 0.12% Topical Solution n=27 Participants ATI-50002 0.12% Topical Solution applied twice daily.	ATI-50002 0.46% Topical Solution n=33 Participants ATI-50002 0.46% Topical Solution applied twice daily.
Subject Global Impression of Change at Week 24 1. Very much improved	4 Participants	1 Participants	3 Participants
Subject Global Impression of Change at Week 24 2. Much improved	2 Participants	4 Participants	6 Participants
Subject Global Impression of Change at Week 24 3. A little improved	8 Participants	10 Participants	5 Participants
Subject Global Impression of Change at Week 24 4. No change	3 Participants	4 Participants	8 Participants
Subject Global Impression of Change at Week 24 5. A little worse	4 Participants	4 Participants	6 Participants
Subject Global Impression of Change at Week 24 6. Much worse	3 Participants	3 Participants	1 Participants
Subject Global Impression of Change at Week 24 7. Very much worse	1 Participants	1 Participants	4 Participants

Adverse Events

Vehicle Topical Solution (Double Blind Period)

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

ATI-50002 0.12% Topical Solution (Double Blind Period)

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

ATI-50002 0.46% Topical Solution (Double Blind Period)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

ATI-50002 0.46% Topical Solution (Open Label Extension Period)

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vehicle Topical Solution (Double Blind Period) n=43 participants at risk Vehicle Topical Solution applied twice daily during the double blind period of the study.	ATI-50002 0.12% Topical Solution (Double Blind Period) n=44 participants at risk ATI-50002 0.12% Topical Solution applied twice daily during the double blind period of the study	ATI-50002 0.46% Topical Solution (Double Blind Period) n=42 participants at risk ATI-50002 0.46% Topical Solution applied twice daily during the double blind period of the study	ATI-50002 0.46% Topical Solution (Open Label Extension Period) n=59 participants at risk ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
General disorders Application site laceration	0.00% 0/43 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	2.3% 1/44 • Number of events 1 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/59 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Nervous system disorders Polyneuropathy idiopathic progressive	0.00% 0/43 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	2.3% 1/44 • Number of events 1 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/59 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.

Other adverse events

Measure	Vehicle Topical Solution (Double Blind Period) n=43 participants at risk Vehicle Topical Solution applied twice daily during the double blind period of the study.	ATI-50002 0.12% Topical Solution (Double Blind Period) n=44 participants at risk ATI-50002 0.12% Topical Solution applied twice daily during the double blind period of the study	ATI-50002 0.46% Topical Solution (Double Blind Period) n=42 participants at risk ATI-50002 0.46% Topical Solution applied twice daily during the double blind period of the study	ATI-50002 0.46% Topical Solution (Open Label Extension Period) n=59 participants at risk ATI-50002 0.46% Topical Solution applied twice daily during the open label extension period of the study
Ear and labyrinth disorders Vertigo	0.00% 0/43 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/44 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	3.4% 2/59 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Gastrointestinal disorders Diarrhoea	4.7% 2/43 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	6.8% 3/44 • Number of events 3 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	3.4% 2/59 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
General disorders Application site exfoliation	0.00% 0/43 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/44 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	3.4% 2/59 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
General disorders Application site pruritis	7.0% 3/43 • Number of events 3 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	2.3% 1/44 • Number of events 1 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	9.5% 4/42 • Number of events 4 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	3.4% 2/59 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
General disorders Application site dermatitis	0.00% 0/43 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	4.5% 2/44 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/59 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
General disorders Application site dryness	0.00% 0/43 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	4.5% 2/44 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/59 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Infections and infestations Upper respiratory tract infection	0.00% 0/43 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	4.5% 2/44 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	9.5% 4/42 • Number of events 4 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	8.5% 5/59 • Number of events 5 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Infections and infestations Nasopharyngitis	4.7% 2/43 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	4.5% 2/44 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	2.4% 1/42 • Number of events 1 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	1.7% 1/59 • Number of events 1 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Infections and infestations Influenza	2.3% 1/43 • Number of events 1 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/44 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	4.8% 2/42 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	3.4% 2/59 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Infections and infestations Urinary tract infection	4.7% 2/43 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/44 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	2.4% 1/42 • Number of events 1 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/59 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/43 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	4.5% 2/44 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	1.7% 1/59 • Number of events 1 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Investigations White blood cells urine positive	7.0% 3/43 • Number of events 3 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	2.3% 1/44 • Number of events 1 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/59 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Investigations Alanine aminotransferase increased	0.00% 0/43 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	2.3% 1/44 • Number of events 1 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	2.4% 1/42 • Number of events 1 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	3.4% 2/59 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Investigations Blood creatine phosphokinase increased	0.00% 0/43 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/44 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	6.8% 4/59 • Number of events 4 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Investigations Blood uric acid increased	4.7% 2/43 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/44 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/59 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Investigations Blood cholesterol increased	0.00% 0/43 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/44 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	3.4% 2/59 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Investigations High density lipoprotein increased	0.00% 0/43 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/44 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	3.4% 2/59 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Investigations Low density lipoprotein increased	0.00% 0/43 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/44 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	3.4% 2/59 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Investigations Lymphocyte count decreased	4.7% 2/43 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/44 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/59 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Nervous system disorders Headache	0.00% 0/43 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	4.5% 2/44 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	1.7% 1/59 • Number of events 1 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Psychiatric disorders Depression	4.7% 2/43 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/44 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/42 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/59 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.
Vascular disorders Hypertension	4.7% 2/43 • Number of events 2 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	2.3% 1/44 • Number of events 1 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	2.4% 1/42 • Number of events 1 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.	0.00% 0/59 • Double blind period = 6 months; Open label extension period = 6 months; Reporting of non-serious AEs started with each subject's first study medication application and continued until the end of the subject's last study visit. Reporting for SAEs started when the subject signed the informed consent document and continued until the end of the subject's last visit.

Additional Information

Marco Cardillo, Clinical Trial Manager

Aclaris Therapeutics, Inc.

Phone: 484-540-6299

Email: mcardillo@aclaristx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place