Bimatoprost for the Treatment of Eyebrow Hypotrichosis

Phase 3

Completed

• Conditions: Eyebrow Hypotrichosis
• Interventions: Drug: bimatoprost solution; Drug: Vehicle to bimatoprost solution

• Registration Number: NCT01765764
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-10
• Study Start: 2013-03-13
• Primary Completion: 2014-01-31
• Study Completion: 2014-02-11
• Results First Submitted: 2015-01-16
• Results First Submitted QC: 2015-01-16
• Results First Posted: 2015-01-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 357

Inclusion Criteria

-Adult participants with eyebrow hypotrichosis (inadequate eyebrow growth).

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Exclusion Criteria

• Patients with disease, infection, or abnormality of the eyebrow area
• Patients with permanent eyebrow loss due to over-grooming

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bimatoprost Solution QD	bimatoprost solution	Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
Bimatoprost Solution BID	bimatoprost solution	Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
Vehicle to Bimatoprost Solution BID	Vehicle to bimatoprost solution	Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
Bimatoprost Solution QD	Vehicle to bimatoprost solution	Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale	Baseline, Month 7	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)	Baseline, Month 7	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).
Change From Baseline in Eyebrow Darkness as Measured Using DMSIA	Baseline, Month 7	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).
Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6	Month 7	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.