Bimatoprost for the Treatment of Eyebrow Hypotrichosis

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of bimatoprost solution compared with vehicle in the treatment of eyebrow hypotrichosis (inadequate eyebrows).

Conditions
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Eyebrow Hypotrichosis

Intervention / Treatment
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* Drug: bimatoprost solution
* Drug: Vehicle to bimatoprost solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth). Exclusion Criteria: Patients with disease, infection, or abnormality of the eyebrow area Patients with permanent eyebrow loss due to over-grooming

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimatoprost Solution BID<br>Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months. | Drug: bimatoprost solution<br>* Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.<br>|
| Experimental: Bimatoprost Solution QD<br>Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months. | Drug: bimatoprost solution<br>* Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.<br>Drug: Vehicle to bimatoprost solution<br>* Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.<br>|
| Placebo Comparator: Vehicle to Bimatoprost Solution BID<br>Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months. | Drug: Vehicle to bimatoprost solution<br>* Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale | The physician evaluated eyebrow fullness using the 4-point GEBA Scale where: 1=very sparse, 2=sparse, 3=full and 4=very full. The percentage of participants with at least a 1-grade increase from Baseline is reported. | Baseline, Month 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA) | Photographs were taken of the eyebrows. Eyebrow fullness was measured by DMSIA for both eyes and averaged. Eyebrow fullness was reported in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyebrows (improvement). | Baseline, Month 7 | 
| Change From Baseline in Eyebrow Darkness as Measured Using DMSIA | Photographs were taken of the eyebrows. Eyebrow darkness (intensity) was measured by DMSIA for both eyes and averaged. Eyebrow darkness was reported in intensity units. A negative change from Baseline indicated darker eyebrows (improvement). | Baseline, Month 7 | 
| Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6 | ESS Item #6 measured the participant's satisfaction with eyebrow treatment: Overall, how satisfied are you with the way the eyebrow treatment makes your eyebrows look right now? using a 5-point scale where: 1=very satisfied, 2=mostly satisfied, 3=neither dissatisfied nor satisfied, 4=mostly dissatisfied and 5=very dissatisfied. The percentage of participants 'very satisfied' or 'mostly satisfied' is reported. | Month 7 |