Conditions: Alopecia Alopecia, Androgenetic Baldness
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 244
Healthy volunteers: no

Brief summary:
This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).

Detailed description:

Arms:
arm 1: Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days. arm 2: Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days. arm 3: Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days. arm 4: Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days. arm 5: Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months. arm 6: Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months. arm 7: Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.

Interventions: intervention 1: Bimatoprost Solution 1 intervention 2: Bimatoprost Solution 2 intervention 3: Bimatoprost Vehicle
Intervention descriptions: intervention 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months. intervention 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months. intervention 3: Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Protocol document: