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

Aclaris Therapeutics

Status and phase: Completed; Phase 2

Conditions: Alopecia Totalis (AT); Alopecia Universalis (AU)

Treatments: Drug: Vehicle; Drug: ATI-50002

Study type: Interventional

Funder types: Industry

Identifiers

NCT03315689

ATI-50002-AA-202

Details and patient eligibility

About

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.

Full description

This study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution in patients with Alopecia Universalis and Alopecia Totalis. Concentrations of ATI-50002 in the blood and skin will be assessed after 28 days of treatment with ATI-50002 Topical Solution.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11 participants in 2 patient groups, including a placebo group

Vehicle

Placebo Comparator group

Description:

Vehicle

Treatment:

Drug: Vehicle

Active

Experimental group

Description:

ATI-50002 Topical Solution

Treatment:

Drug: ATI-50002