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

Alopecia Areata Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023841
• Other study ID #: 192024-040
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2010
• Est. completion date: November 30, 2012

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 30, 2012
• Est. primary completion date: November 2, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Eyelash Hypotrichosis
• Hypotrichosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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