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

Study Overview
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Brief Summary
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This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (AGA).

Official Title
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Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Bimatoprost Topical Solution in the Treatment of Androgenetic Alopecia in Men

Conditions
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Alopecia, Alopecia, Androgenetic, Baldness

Intervention / Treatment
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* Drug: Bimatoprost


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Bimatoprost 0.3% (Formulation B)<br>0.25 mL of bimatoprost 0.3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. | Drug: Bimatoprost<br> <br> * Other names: Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.;|
| Experimental: Cohort 2: Bimatoprost 1% (Formulation A)<br>0.25 mL of bimatoprost 1% (Formulation A) applied onto pre-specified area on the scalp once daily for 28 days. | Drug: Bimatoprost<br> <br> * Other names: Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.;|
| Experimental: Cohort 2: Bimatoprost 1% (Formulation B)<br>0.25 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. | Drug: Bimatoprost<br> <br> * Other names: Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.;|
| Experimental: Cohort 3: Bimatoprost 1% (Formulation B)<br>1 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. | Drug: Bimatoprost<br> <br> * Other names: Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.;|
| Experimental: Cohort 4: Bimatoprost 3% (Formulation B)<br>1 mL of bimatoprost 3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days. | Drug: Bimatoprost<br> <br> * Other names: Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |