Safety, Tolerability, and Pharmacokinetics of Bimatoprost in Men With Androgenetic Alopecia (AGA)
- Registration Number
- NCT02676310
- Lead Sponsor
- Allergan
- Brief Summary
This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (AGA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 53
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2: Bimatoprost 1% (Formulation A) Bimatoprost 0.25 mL of bimatoprost 1% (Formulation A) applied onto pre-specified area on the scalp once daily for 28 days. Cohort 1: Bimatoprost 0.3% (Formulation B) Bimatoprost 0.25 mL of bimatoprost 0.3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. Cohort 2: Bimatoprost 1% (Formulation B) Bimatoprost 0.25 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. Cohort 3: Bimatoprost 1% (Formulation B) Bimatoprost 1 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. Cohort 4: Bimatoprost 3% (Formulation B) Bimatoprost 1 mL of bimatoprost 3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) 42 Days Change from Baseline in Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale Baseline, 42 Days Maximum plasma level (Cmax) of bimatoprost and its acid metabolite 31 Days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
J&S Studies Inc.
🇺🇸College Station, Texas, United States
E&R Research Foundation
🇺🇸Lynchburg, Virginia, United States
DermResearch, LLC
🇺🇸Austin, Texas, United States