Clinical trial NCT03495817: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Androgenetic Alopecia
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Change From Baseline in Target Area Hair Count (TAHC)
timeFrame: Baseline to 26 Weeks
Secondary outcomes:
measure: Mean Change From Baseline in Target Area Hair Count (TAHC)
timeFrame: Baseline to 52 Weeks
measure: Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW)
timeFrame: Baseline to 26 Weeks
measure: Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW)
timeFrame: Baseline to 52 Weeks
measure: Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
timeFrame: Baseline to 26 Weeks
measure: Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
timeFrame: Baseline to 52 Weeks
measure: Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
timeFrame: Baseline to 26 Weeks
measure: Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale
timeFrame: Baseline to 52 Weeks
measure: Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
timeFrame: Baseline to 26 Weeks
measure: Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale
timeFrame: Baseline to 52 Weeks
measure: Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
timeFrame: Baseline to 26 Weeks
measure: Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale
timeFrame: Baseline to 52 Weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Aclaris Investigational Site
state: Colorado
city: Portland
country: United States
facility: Aclaris Investigational Site
state: Oregon
city: Austin
country: United States
facility: Aclaris Investigational Site
state: Texas
Study officials:
affiliation: Aclaris Therapeutics, Inc.
name: Stuart Shanler, MD
role: STUDY_CHAIR
References: