Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children

Phase 4

Completed

• Conditions: Eyelash Hypotrichosis; Alopecia Areata
• Interventions: Drug: bimatoprost ophthalmic solution 0.03%; Drug: Vehicle Sterile Solution

• Registration Number: NCT01023841
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily application to the upper eyelid margins compared with vehicle in treating eyelash loss or hypotrichosis (inadequate or not enough eyelashes) in children.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-11-30
• Study First Posted: 2009-12-02
• Study Start: 2010-06-01
• Primary Completion: 2012-11-02
• Study Completion: 2012-11-30
• Results First Submitted: 2013-07-09
• Results First Submitted QC: 2013-07-09
• Results First Posted: 2013-09-13
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Children who have inadequate eyelashes or have lost their eyelashes as a result of chemotherapy treatment, who completed their chemotherapy (intensive treatment) at least 4 weeks before starting the study, are considered to be at low risk for relapse of their cancer, and are well enough to complete the study
• Children who have minimal to moderate inadequate eyelashes due to alopecia areata
• Adolescents between the ages of 15-17 years who have minimal to marked inadequate eyelashes

Exclusion Criteria

• Any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants.
• Semi-permanent eyelash tint, dye or eyelash extension application within 3 months
• Use of over the counter eyelash growth products within 6 months.
• Use of prescription eyelash growth products (eg, Latisse®)
• Any eye condition that would prevent required ophthalmology exams

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bimatoprost ophthalmic solution 0.03%	bimatoprost ophthalmic solution 0.03%	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Vehicle Sterile Solution	Vehicle Sterile Solution	One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events	5 Months	An adverse event was any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score	Baseline, Month 4	The physician evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA)	Baseline, Month 4	Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement).
Change From Baseline in Upper Eyelash Thickness as Measured by DIA	Baseline, Month 4	Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm\^2). A positive change from Baseline indicated fuller eyelashes (improvement).
Change From Baseline in Upper Eyelash Darkness as Measured by DIA	Baseline, Month 4	Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).