drugset / Trial / NCT01226459
Clinical Trial in Females for Female Pattern Hair Loss
Phase 3
Completed
404 enrolled
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.
Johnson & Johnson Consumer and Personal Products Worldwide · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2010-09
- Primary completion
- 2011-08
- Completion
- 2011-08
Outcome
Met primary endpoint
registry analysis (superiority or other test); Vehicle Foam vs Minoxidil Foam; p <0.0001; Mean Difference (Final Values) 9.1 (95% CI 5.0 to 13.1); ANCOVA NCT01226459 ↗
registry analysis (superiority or other test); Vehicle Foam vs Minoxidil Foam; p <0.0001; Mean Difference (Final Values) 0.69 (95% CI 0.35 to 1.04); ANCOVA NCT01226459 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Minoxidil | Small molecule | 5 % | Topical |
| Subject | Minoxidil | Small molecule | 1 g | Topical |