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

NCT ID: NCT01023841

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-01
• Study Completion Date: 2012-11-30

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.

Conditions

Eyelash Hypotrichosis; Alopecia Areata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

bimatoprost ophthalmic solution 0.03%

Intervention Type: 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 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.

Group Type: PLACEBO_COMPARATOR

Vehicle Sterile Solution

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

LATISSE®

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

Newport Beach, California, United States

São Paulo, , Brazil

Countries

United States; Brazil

References

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.

Reference Type: BACKGROUND

PMID: 27022239 (View on PubMed)

Other Identifiers

192024-040

Identifier Type: -

Identifier Source: org_study_id