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

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Brief Title

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

Official Title

A Randomized, Double-Blind, Vehicle-Controlled Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ATI-50002 Topical Solution Administered Twice-Daily for 6 Months in Adolescents and Adult Subjects With Stable Patchy Alopecia Areata With Optional Long-Term Open-Label Extension

Brief Summary

      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
    

Detailed Description

      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
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Percent Change From Baseline in the Severity of Alopecia Tool Score at Week 24

Secondary Outcome

 Percent Change From Baseline in the Alopecia Density and Extent Score at Week 24

Condition

Alopecia Areata

Intervention

ATI-50002 high dose

Study Arms / Comparison Groups

 ATI-50002 high dose Topical Solution
Description:  High dose active

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

129

Start Date

November 29, 2017

Completion Date

September 10, 2019

Primary Completion Date

April 18, 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Have a clinical diagnosis of stable patchy alopecia areata (AA) defined as no current
             areas of spontaneous regrowth.

          2. 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.

          3. Have a duration of the current episode of scalp hair loss of a minimum of 6 months and
             a maximum of 12 years.

          4. 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.

        Exclusion Criteria:

          1. 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.

          2. Diffuse alopecia areata.

          3. Concomitant hair loss disorder (by history or physical exam) such as androgenetic
             alopecia or scarring alopecia (e.g., cicatricial alopecia, frontal fibrosing alopecia,
             etc.).

          4. 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.

          5. 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.

          6. 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.
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03354637

Organization ID

ATI-50002-AA-201


Responsible Party

Sponsor

Study Sponsor

Aclaris Therapeutics, Inc.


Study Sponsor

, , 


Verification Date

May 2020