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

NCT ID: NCT01904721

Last Updated: 2016-03-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Alopecia Alopecia, Androgenetic Baldness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Stage 1: Bimatoprost Solution 1 Twice Daily

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

Group Type EXPERIMENTAL

Bimatoprost Solution 1

Intervention Type DRUG

Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Stage 1: Bimatoprost Solution 1 Once Daily

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

Group Type EXPERIMENTAL

Bimatoprost Solution 1

Intervention Type DRUG

Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Bimatoprost Vehicle

Intervention Type DRUG

Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Stage 1: Bimatoprost Solution 2 Twice Daily

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

Group Type EXPERIMENTAL

Bimatoprost Solution 2

Intervention Type DRUG

Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Stage 1: Bimatoprost Solution 2 Once Daily

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

Group Type EXPERIMENTAL

Bimatoprost Solution 2

Intervention Type DRUG

Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Bimatoprost Vehicle

Intervention Type DRUG

Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Stage 2: Bimatoprost Solution 1 Twice Daily

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

Group Type EXPERIMENTAL

Bimatoprost Solution 1

Intervention Type DRUG

Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Stage 2: Bimatoprost Solution 2 Twice Daily

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

Group Type EXPERIMENTAL

Bimatoprost Solution 2

Intervention Type DRUG

Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Stage 2: Bimatoprost Vehicle Twice Daily

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

Group Type PLACEBO_COMPARATOR

Bimatoprost Vehicle

Intervention Type DRUG

Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Interventions

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Bimatoprost Solution 1

Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Intervention Type DRUG

Bimatoprost Solution 2

Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Intervention Type DRUG

Bimatoprost Vehicle

Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Fridley, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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192024-084

Identifier Type: -

Identifier Source: org_study_id

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