Trial Outcomes & Findings for Open Label Study of ATI-50002 Topical Solution Administered to Adult Subjects With Eyebrow Loss Due to Alopecia Areata (NCT NCT03551821)

Last Updated: 2019-12-11

Results Overview

Determination of the amount of hair in the affected area. Clinician's Eyebrow Assessment Grade Descriptor 0 No eyebrow hair: No terminal hairs are visible in the affected area(s) 1. A little eyebrow hair: Occasional terminal hairs are visible in the affected area(s) 2. Some eyebrow hair: Numerous terminal hairs are visible in the affected area(s) 3. Most eyebrow hair: Mostly complete eyebrow regrowth with terminal hair in the affected area(s) 4. Full eyebrow hair: Complete eyebrow regrowth with terminal hair in the affected area(s)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Six months

Results posted on

2019-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	ATI-50002 Topical Solution ATI-50002 Topical Solution
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open Label Study of ATI-50002 Topical Solution Administered to Adult Subjects With Eyebrow Loss Due to Alopecia Areata

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ATI-50002 Topical Solution n=1 Participants ATI-50002 Topical Solution ATI-50002: Topical Solution
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	50 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Six months

Outcome measures

Outcome measures
Measure	ATI-50002 Topical Solution n=1 Participants ATI-50002 Topical Solution
Clinician's Eyebrow Assessment	0 score on a scale

SECONDARY outcome

Timeframe: Six months

Determination of the amount of hair in the affected area. Subject's Eyebrow Assessment Grade Descriptor 0 No eyebrow hair: No thick, coarse hairs are visible in the affected area(s) 1. A little eyebrow hair: A few thick, coarse hairs are visible in the affected area(s) 2. Some eyebrow hair: Numerous thick, coarse hairs are visible in the affected area(s) 3. Most eyebrow hair: The majority of the affected area(s) of the eyebrow is covered in thick, coarse hairs 4. Full eyebrow hair: The affected area(s) of the eyebrow is fully covered in thick, coarse hairs

Outcome measures

Outcome measures
Measure	ATI-50002 Topical Solution n=1 Participants ATI-50002 Topical Solution
Subject's Eyebrow Assessment	0 score on a scale

Adverse Events

ATI-50002 Topical Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Executive Director Clinical Operations

Aclaris Therapeutics

Phone: 4843247933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place