NCT01325337

Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Allergan · Industry
• Sex: Male
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alopecia
• Alopecia, Androgenetic
• Baldness

Interventions

Type	Name	Description
DRUG	bimatoprost Formulation A	Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
DRUG	bimatoprost Formulation B	Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
DRUG	bimatoprost Formulation C	Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
DRUG	bimatoprost vehicle solution	Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
DRUG	minoxidil 5% solution	Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-08-01
• Completion: 2012-09-01
• First posted: 2011-03-29
• Last updated: 2014-04-10
• Results posted: 2014-04-10

Locations

2 sites across 2 countries: United States, Germany