A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution
Androgenetic Alopecia
Bottom Line
View on ClinicalTrials.gov: NCT03495817 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ATI-50002 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aclaris Therapeutics, Inc.
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Target Area Hair Count (TAHC) |
1.6 | — |
| SECONDARY Mean Change From Baseline in Target Area Hair Count (TAHC) |
1.6 | — |
| SECONDARY Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW) |
35.28 | — |
| SECONDARY Mean Change From Baseline in Cumulative Target Area Hair Width (TAHW) |
35.28 | — |
| SECONDARY Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale |
8 | — |
| SECONDARY Investigator Global Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale |
8 | — |
| SECONDARY Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale |
13 | — |
| SECONDARY Subject Self-Assessment: Total Subjects With Slightly Increased Hair Growth or Better Using a Seven-point Rating Scale |
13 | — |
| SECONDARY Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale |
1; 1; 1; 1; 1; 9 | — |
| SECONDARY Change From Baseline in Androgenetic Alopecia (AGA) Using the Norwood-Hamilton Scale |
1; 1; 1; 1; 1; 9 | — |
| SECONDARY Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale |
1; 1; 1 | — |
| SECONDARY Change From Baseline in Androgenetic Alopecia (AGA) Using the Sinclair Scale |
1; 1; 1 | — |
Summary
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.
Data sourced from ClinicalTrials.gov (NCT03495817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.