A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)

Allergan

Status and phase: Completed; Phase 2

Conditions: Baldness; Alopecia, Androgenetic; Alopecia

Treatments: Drug: Bimatoprost Solution 1; Drug: Bimatoprost Solution 2; Drug: Bimatoprost Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01904721

192024-084

Details and patient eligibility

About

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

Enrollment: 244 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 maintain same hair style, length and hair color during study
• Willingness to have micro-dot-tattoo applied to scalp (Stage 2 only)

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
• Use of minoxidil (oral or topical) and/or low level light treatment "combs" for hair growth within the last 6 months, or expected use during the study
• 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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244 participants in 7 patient groups, including a placebo group

Stage 1: Bimatoprost Solution 1 Twice Daily

Experimental group

Description:

Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.

Treatment:

Drug: Bimatoprost Solution 1

Stage 1: Bimatoprost Solution 1 Once Daily

Experimental group

Description:

Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.

Treatment:

Drug: Bimatoprost Solution 1

Drug: Bimatoprost Vehicle

Stage 1: Bimatoprost Solution 2 Twice Daily

Experimental group

Description:

Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.

Treatment:

Drug: Bimatoprost Solution 2

Stage 1: Bimatoprost Solution 2 Once Daily

Experimental group

Description:

Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.

Treatment:

Drug: Bimatoprost Solution 2

Drug: Bimatoprost Vehicle

Stage 2: Bimatoprost Solution 1 Twice Daily

Experimental group

Description:

Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.

Treatment:

Drug: Bimatoprost Solution 1

Stage 2: Bimatoprost Solution 2 Twice Daily

Experimental group

Description:

Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.

Treatment:

Drug: Bimatoprost Solution 2

Stage 2: Bimatoprost Vehicle Twice Daily

Placebo Comparator group

Description:

Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.

Treatment:

Drug: Bimatoprost Vehicle