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A Phase 3 Multi-Center Parallel Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam vs. Vehicle in Females for the Treatment of Female Pattern Hair Loss (Androgenetic Alopecia)
This is a six month clinical trial to evaluate the effectiveness and safety in women with Female Pattern Hair Loss (FPHL), comparing a 5% minoxidil topical foam (MTF) formulation applied once a day versus a topical foam vehicle (placebo) formulation applied once a day.
Details
| Lead sponsor | Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 404 |
| Start date | 2010-09 |
| Completion | 2011-08 |
Conditions
- Androgenetic Alopecia
Interventions
- 5% Minoxidil Topical Foam
- Vehicle Topical Foam
Primary outcomes
- Target Area Hair Count — Baseline to Week 24
Number of hairs in the area being examined as measured by macrophotography. - Subject Assessment of Scalp Coverage — Week 24
Subject assessment of scalp coverage at Week 24 was measured as change from Baseline on a 7-point scale where 0 meant no perceived change in scalp coverage, +1 to +3 indicated progressively increased levels of scalp coverage, and -1 to -3 indicated progressively decreased levels.
Countries
United States, France, Germany, United Kingdom