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

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

Conditions
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Alopecia, Alopecia, Androgenetic, Baldness

Intervention / Treatment
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* Drug: Bimatoprost Solution 1
* Drug: Bimatoprost Solution 2
* Drug: Bimatoprost Vehicle


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 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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stage 1: Bimatoprost Solution 1 Twice Daily<br>Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days. | Drug: Bimatoprost Solution 1<br>* Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.<br>|
| Experimental: Stage 1: Bimatoprost Solution 1 Once Daily<br>Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days. | Drug: Bimatoprost Solution 1<br>* Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.<br>Drug: Bimatoprost Vehicle<br>* Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.<br>|
| Experimental: Stage 1: Bimatoprost Solution 2 Twice Daily<br>Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days. | Drug: Bimatoprost Solution 2<br>* Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.<br>|
| Experimental: Stage 1: Bimatoprost Solution 2 Once Daily<br>Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days. | Drug: Bimatoprost Solution 2<br>* Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.<br>Drug: Bimatoprost Vehicle<br>* Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.<br>|
| Experimental: Stage 2: Bimatoprost Solution 1 Twice Daily<br>Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months. | Drug: Bimatoprost Solution 1<br>* Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.<br>|
| Experimental: Stage 2: Bimatoprost Solution 2 Twice Daily<br>Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months. | Drug: Bimatoprost Solution 2<br>* Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.<br>|
| Placebo Comparator: Stage 2: Bimatoprost Vehicle Twice Daily<br>Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months. | Drug: Bimatoprost Vehicle<br>* Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Target Area Hair Count (TAHC) | TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs). | Baseline, Month 6 | 
| Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: Since the start of the study, the amount of my hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented. | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: Since the start of the study, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented. | Month 6 | 
| Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: Compared with the baseline image, the amount of the subject's hair has?: Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented. | Month 6 | 
| Change From Baseline in Target Area Hair Width (TAHW) | Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs). | Baseline, Month 6 | 
| Change From Baseline in Target Area Hair Darkness (TAHD) | Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs). | Baseline, Month 6 |