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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Alopecia Areata

In brief

Primary: • To assess safety, tolerability and efficacy of 2 dose strengths of ATI-50002 Topical Solution, compared to vehicle in subjects with alopecia areata (AA) Secondary: • To evaluate key clinical outcome assessments

Key facts

Study ID

NCT03354637

Run by

Aclaris Therapeutics, Inc.

People needed

129

Starts

2017-11-29

Expected to finish

2019-09-10

Last updated by the study team

2020-06-05

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a clinical diagnosis of stable patchy alopecia areata (AA) defined as no current areas of spontaneous regrowth.
• Have a Severity of Alopecia Tool (SALT) score of at least 15% up to 95% total scalp hair loss determined by the study investigator at baseline.
• Have a duration of the current episode of scalp hair loss of a minimum of 6 months and a maximum of 12 years.
• If a woman of childbearing potential (WOCBP), must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2) 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.

You may not qualify if…

• 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.
• Diffuse alopecia areata.
• Concomitant hair loss disorder (by history or physical exam) such as androgenetic alopecia or scarring alopecia (e.g., cicatricial alopecia, frontal fibrosing alopecia, etc.).
• Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments of efficacy or safety.
• Active scalp trauma or other condition affecting the scalp that, in the investigator's opinion, may affect the course of AA or interfere with the study conduct or evaluations.
• 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.

Where it is running

• Aclaris Investigator Site — Encinitas, California, United States
• Aclaris Investigator Site — Laguna Hills, California, United States
• Aclaris Investigator Site — Redwood City, California, United States
• Aclaris Investigator Site — Washington D.C., District of Columbia, United States
• Aclaris Investigator Site — Boynton Beach, Florida, United States
• Aclaris Investigator Site — Miami, Florida, United States
• Aclaris Investigator Site — Boston, Massachusetts, United States
• Aclaris Investigator Site — Clinton Township, Michigan, United States
• Aclaris Investigator Site — Warren, Michigan, United States
• Aclaris Investigator Site — Fridley, Minnesota, United States
• Aclaris Investigator Site — Minneapolis, Minnesota, United States
• Aclaris Investigator Site — Omaha, Nebraska, United States
• Aclaris Investigator Site — New York, New York, United States
• Aclaris Investigator Site — Durham, North Carolina, United States
• Aclaris Investigator Site — Winston-Salem, North Carolina, United States
• Aclaris Investigator Site — Portland, Oregon, United States
• Aclaris Investigator Site — Fort Washington, Pennsylvania, United States
• Aclaris Investigator Site — Knoxville, Tennessee, United States
• Aclaris Investigator Site — Nashville, Tennessee, United States
• Aclaris Investigator Site — Austin, Texas, United States
• Aclaris Investigator Site — Austin, Texas, United States
• Aclaris Investigator Site — San Antonio, Texas, United States
• Aclaris Investigator Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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