Phase 2
N=307
Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
Alopecia · Alopecia, Androgenetic · Baldness
Bottom Line
View on ClinicalTrials.gov: NCT01325337 ↗Enrolled (actual)
307
Serious AEs
1.0%
Results posted
Apr 2014
Primary outcome: Primary: Change From Baseline in Target Area Hair Count (TAHC) — 135.0; 145.7; 151.5; 143.7 terminal hairs/cm^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bimatoprost Formulation A (Drug); bimatoprost Formulation B (Drug); bimatoprost Formulation C (Drug); bimatoprost vehicle solution (Drug); minoxidil 5% solution (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Allergan
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Target Area Hair Count (TAHC) |
135.0; 145.7; 151.5; 143.7; 132.7; 13.1 | — |
| PRIMARY Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score |
0.0; 1.7; 0.0; 1.7; 5.2; 8.6 | — |
| SECONDARY Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score |
0.0; 5.1; 0.0; 0.0; 8.6; 12.1 | — |
| SECONDARY Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score |
0.0; 0.0; 0.0; 0.0; 0.0; 3.5 | — |
| SECONDARY Change From Baseline in Target Area Hair Width (TAHW) |
7.83; 8.34; 8.59; 8.35; 7.82; 0.76 | — |
| SECONDARY Change From Baseline in Target Area Hair Darkness (TAHD) |
106.88; 103.85; 100.81; 104.03; 99.57; 1.19 | — |
Summary
This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.
Eligibility Criteria
Inclusion Criteria
- Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
- Willingness to have micro-dot-tattoo applied to scalp
- Willingness to maintain same hair style, length and hair color during study
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
- Oral or topical minoxidil treatment within 6 months
- Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
Data sourced from ClinicalTrials.gov (NCT01325337). 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.