Bimatoprost for the Treatment of Eyebrow Hypotrichosis

Allergan357 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

357

Conditions

Eyebrow Hypotrichosis

Interventions

bimatoprost solutionDRUG

Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.

Vehicle to bimatoprost solutionDRUG

Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Houston, Texas, United States

Unnamed facility

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Month 7

Secondary Outcomes

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).

Time frame: 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).

Time frame: 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.

Time frame: Month 7

Data from ClinicalTrials.gov

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