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

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 Overview

• Status: Completed
• Conditions: Alopecia Areata; Eyelash Hypotrichosis
• Intervention / Treatment: Drug: bimatoprost ophthalmic solution 0.03%; Drug: Vehicle Sterile Solution

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
• United States
  • California
    • Newport Beach, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.; Other Names: LATISSE®
Placebo Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline, Month 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	Baseline, Month 4

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

General Publications

• Borchert M, Bruce S, Wirta D, Yoelin SG, Lee S, Mao C, VanDenburgh A. An evaluation of the safety and efficacy of bimatoprost for eyelash growth in pediatric subjects. Clin Ophthalmol. 2016 Mar 10;10:419-29. doi: 10.2147/OPTH.S89561. eCollection 2016.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2010
• Primary Completion (Actual): November 2, 2012
• Study Completion (Actual): November 30, 2012

Study Registration Dates

• First Submitted: November 30, 2009
• First Submitted That Met QC Criteria: November 30, 2009
• First Posted (Estimate): December 2, 2009

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hair Diseases; Alopecia; Alopecia Areata; Hypotrichosis; Antihypertensive Agents; Ophthalmic Solutions; Pharmaceutical Solutions; Bimatoprost
• Other Study ID Numbers: 192024-040