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

Allergan71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Eyelash Hypotrichosis Alopecia Areata

Interventions

bimatoprost ophthalmic solution 0.03%DRUG

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 SolutionDRUG

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.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Newport Beach, California, United States

Unnamed facility

São Paulo, Brazil

Outcomes

Primary Outcomes

Percentage of Participants With Adverse Events

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.

Time frame: 5 Months

Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score

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.

Time frame: Baseline, Month 4

Secondary Outcomes

Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA)

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).

Time frame: Baseline, Month 4

Change From Baseline in Upper Eyelash Thickness as Measured by DIA

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).

Time frame: Baseline, Month 4

Change From Baseline in Upper Eyelash Darkness as Measured by DIA

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).

Time frame: Baseline, Month 4

Data from ClinicalTrials.gov

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