Safety, Tolerability, and Pharmacokinetics of Bimatoprost in Men With Androgenetic Alopecia (AGA)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-03-31

Brief Summary

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This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic 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

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Bimatoprost

Intervention Type DRUG

Other Intervention Names

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Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.

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

Exclusion Criteria

* History of Paget's disease, osteoporosis, or bone malignancy
* History of bone fracture within the previous 12 months, except for metatarsal, metacarpal, or skull fractures
* Patient is currently undergoing radiation therapy or anticipates undergoing radiation therapy at any time during the study
* 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
* Application of topical medications, minoxidil 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