A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution

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Androgenetic alopecia
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Brief Title

A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution

Official Title

An Open-Label Safety, Tolerability, and Efficacy Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution

Brief Summary

      Open label study to assess safety, tolerability, and efficacy of ATI-50002 in male and female
      subjects with androgenetic alopecia.

Detailed Description

      This is an open-label study designed to evaluate the safety and efficacy of ATI-50002 Topical
      Solution in male and female subjects with androgenetic alopecia.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Mean Change From Baseline in Target Area Hair Count (TAHC)

Secondary Outcome

 Mean Change From Baseline in Target Area Hair Count (TAHC)

Condition

Androgenetic Alopecia

Intervention

ATI-50002

Study Arms / Comparison Groups

 ATI-50002 Topical Solution
Description:  This is an open-label phase 2 study designed to evaluate the safety and efficacy of ATI- 50002 Topical Solution, 0.46% in male and female subjects with androgenetic alopecia.
Subjects will be required to apply ATI-50002 study medication to their scalp twice a day for a total of 26 weeks.

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

31

Start Date

March 22, 2018

Completion Date

October 30, 2019

Primary Completion Date

October 15, 2019

Eligibility Criteria

        Inclusion Criteria:

        Male subjects and non-pregnant, non-nursing female subjects 18-50 years of age with a
        clinical diagnosis of androgenetic alopecia.

        Subjects willing to agree to have a small circle of hair clipped to approx. 1mm in length
        on their balding spot.

        Subjects willing to agree to have a permanent dot tattoo applied to their scalp to mark the
        center of the identified target area.

        Subjects must agree to maintain the same hair style and hair care regimen during the study.

        Exclusion Criteria:

        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.

        Clinical diagnosis of alopecia areata or other non AGA forms of alopecia. Scalp hair loss
        on the treatment area, due to disease, injury or medical therapy.

        Active skin disease of 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 or efficacy or safety.

Gender

All

Ages

18 Years - 50 Years

Accepts Healthy Volunteers

No

Contacts

Stuart Shanler, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03495817

Organization ID

ATI-50002-AGA-201

Responsible Party

Sponsor

Study Sponsor

Aclaris Therapeutics, Inc.

Study Sponsor

Stuart Shanler, MD, Study Chair, Aclaris Therapeutics, Inc.

Verification Date

November 2020