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