Phase 3 N=357 Randomized Double-blind Treatment

Bimatoprost for the Treatment of Eyebrow Hypotrichosis

Eyebrow Hypotrichosis

Bottom Line

View on ClinicalTrials.gov: NCT01765764 ↗

Enrolled (actual)

357

Serious AEs

2.0%

Results posted

Jan 2015

Primary outcome: Primary: Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale — 83.9; 77.1; 43.0 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: bimatoprost solution (Drug); Vehicle to bimatoprost solution (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With at Least a 1-Grade Increase (Improvement) in the 4-Point Global Eyebrow Assessment (GEBA) Scale	83.9; 77.1; 43.0	—
SECONDARY Change From Baseline in Eyebrow Fullness as Measured Using Digital Monitoring System Image Analysis (DMSIA)	101.08; 97.80; 98.17; 34.51; 30.96; 6.42	—
SECONDARY Change From Baseline in Eyebrow Darkness as Measured Using DMSIA	53.90; 53.59; 52.87; -4.53; -3.76; 0.11	—
SECONDARY Percentage of Participants With 'Very Satisfied' or 'Mostly Satisfied' in Eyebrow Satisfaction Scale (ESS) Item #6	70.3; 52.5; 36.4	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01765764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.