Conditions: Alopecia Alopecia, Androgenetic Baldness
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 307
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. arm 2: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. arm 3: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. arm 4: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. arm 5: Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.

Interventions: intervention 1: bimatoprost Formulation A intervention 2: bimatoprost Formulation B intervention 3: bimatoprost Formulation C intervention 4: bimatoprost vehicle solution intervention 5: minoxidil 5% solution
Intervention descriptions: intervention 1: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. intervention 2: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. intervention 3: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. intervention 4: Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. intervention 5: Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.

Protocol document: