Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.

Conditions
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Alopecia, Alopecia, Androgenetic, Baldness

Intervention / Treatment
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* Drug: bimatoprost Formulation A
* Drug: bimatoprost Formulation B
* Drug: bimatoprost Formulation C
* Drug: bimatoprost vehicle solution
* Drug: minoxidil 5% solution


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 have micro-dot-tattoo applied to scalp Willingness to maintain same hair style, length and hair color during study 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 Oral or topical minoxidil treatment within 6 months 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: bimatoprost Formulation A<br>Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. | Drug: bimatoprost Formulation A<br>* Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.<br>|
| Experimental: bimatoprost Formulation B<br>Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. | Drug: bimatoprost Formulation B<br>* Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.<br>|
| Experimental: bimatoprost Formulation C<br>Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. | Drug: bimatoprost Formulation C<br>* Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.<br>|
| Placebo Comparator: bimatoprost vehicle solution<br>Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months. | Drug: bimatoprost vehicle solution<br>* Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.<br>|
| Active Comparator: minoxidil 5% solution<br>Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months. | Drug: minoxidil 5% solution<br>* Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.<br>* Other names: Regaine®;|

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). | 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. | Baseline, 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. | Baseline, 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. | Baseline, 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). | 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). | Baseline, Month 6 |