Phase 2
N=244
A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)
Alopecia · Alopecia, Androgenetic · Baldness
Bottom Line
View on ClinicalTrials.gov: NCT01904721 ↗Enrolled (actual)
244
Serious AEs
1.2%
Results posted
Dec 2015
Primary outcome: Primary: Change From Baseline in Target Area Hair Count (TAHC) — 131.3; 140.4; 129.0; 9.3 terminal hairs/cm2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bimatoprost Solution 1 (Drug); Bimatoprost Solution 2 (Drug); Bimatoprost Vehicle (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Allergan
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Target Area Hair Count (TAHC) |
131.3; 140.4; 129.0; 9.3; 12.7; 5.8 | — |
| PRIMARY Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score |
4.8; 6.5; 0.0; 25.4; 14.5; 6.7 | — |
| SECONDARY Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score |
4.8; 11.3; 0.0; 22.2; 17.7; 3.3 | — |
| SECONDARY Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score |
1.6; 3.3; 0.0; 9.7; 15.0; 0.0 | — |
| SECONDARY Change From Baseline in Target Area Hair Width (TAHW) |
7.32; 7.82; 7.30; 0.67; 0.92; 0.05 | — |
| SECONDARY Change From Baseline in Target Area Hair Darkness (TAHD) |
113.77; 115.76; 115.22; -1.63; -6.31; -1.62 | — |
Summary
This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).
Eligibility Criteria
Inclusion Criteria
- Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
- Willingness to maintain same hair style, length and hair color during study
- Willingness to have micro-dot-tattoo applied to scalp (Stage 2 only)
Exclusion Criteria
- Drug or alcohol abuse within 12 months
- HIV positive
- Received hair transplants or had scalp reductions
- Use of hair weaves, hair extensions or wigs within 3 months
- Use of minoxidil (oral or topical) and/or low level light treatment "combs" for hair growth within the last 6 months, or expected use during the study
- Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
Data sourced from ClinicalTrials.gov (NCT01904721). 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.