Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)

• Status: Completed
• Trial end date: 2019-06-20
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution compared to vehicle in subjects with AU and AT.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aclaris Therapeutics, Inc.
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Able to comprehend and willing to sign an Informed Consent Form (ICF).

• Male or non-pregnant, non-nursing female ≥18 years old at the time of informed consent.

• Have a clinical diagnosis of stable, clinically typical, AU or AT.

• Have a duration of the current episode of AU or AT for a minimum of 6 months and a maximum of seven years.

• Be willing and able to follow all study instructions and to attend all study visits.

Exclusion Criteria:

• Females who are nursing, pregnant, or planning to become pregnant for the duration of the study including 30 days after the last application of study medication.

• Patchy alopecia areata, diffuse alopecia areata or a history of an atypical pattern of Alopecia Areata (AA) (e.g., ophiasis, sisaihpo).

• 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 AU or AT 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.