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

Allergan

Status and phase: Completed; Phase 2

Conditions: Baldness; Alopecia, Androgenetic; Alopecia

Treatments: Drug: bimatoprost Formulation C; Drug: bimatoprost vehicle solution; Drug: minoxidil 5% solution; Drug: bimatoprost Formulation A; Drug: bimatoprost Formulation B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01325337

192024-057

2011-000379-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 307 patients

Sex: Male

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
• Willingness to have micro-dot-tattoo applied to scalp
• Willingness to maintain same hair style, length and hair color during study

Exclusion criteria

• Drug or alcohol abuse within 12 months
• HIV positive
• Received hair transplants or had scalp reductions
• Use of hair weaves, hair extensions or wigs within 3 months
• Oral or topical minoxidil treatment within 6 months
• Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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307 participants in 5 patient groups, including a placebo group

bimatoprost Formulation A

Experimental group

Description:

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

Treatment:

Drug: bimatoprost Formulation A

bimatoprost Formulation B

Experimental group

Description:

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

Treatment:

Drug: bimatoprost Formulation B

bimatoprost Formulation C

Experimental group

Description:

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

Treatment:

Drug: bimatoprost Formulation C

bimatoprost vehicle solution

Placebo Comparator group

Description:

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

Treatment:

Drug: bimatoprost vehicle solution

minoxidil 5% solution

Active Comparator group

Description:

Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.

Treatment:

Drug: minoxidil 5% solution