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

NCT03495817 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ATI-50002-AGA-201
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

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

  Target Area Hair Count will measure the hairs/cm2 on a subject's head. Higher values represent better outcomes.

  Baseline to 26 Weeks

Secondary Outcomes (11)

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

  Baseline to 52 Weeks

• Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW)

  Baseline to 26 Weeks

• Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW)

  Baseline to 52 Weeks

• Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale

  Baseline to 26 Weeks

• Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale

  Baseline to 52 Weeks

Study Arms (1)

ATI-50002 Topical Solution

EXPERIMENTAL

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.

Drug: ATI-50002

Interventions

ATI-50002 DRUG

ATI-50002 Topical Solution

ATI-50002 Topical Solution

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aclaris Therapeutics, Inc.: lead

Study Sites (3)

Aclaris Investigational Site

Denver, Colorado, 80210, United States

Location

Aclaris Investigational Site

Portland, Oregon, 97210, United States

Location

Aclaris Investigational Site

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Aclaris Clinical Operations
• Organization: Aclaris Therapeutics, Inc.

clinicaloperations@aclaristx.com

1-833-225-2747

Study Officials

• Stuart Shanler, MD

  Aclaris Therapeutics, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 12, 2018
• Study Start: March 22, 2018
• Primary Completion: October 15, 2019
• Study Completion: October 30, 2019
• Last Updated: December 9, 2020
• Results First Posted: December 9, 2020

Record last verified: 2020-11

Locations

US (3)