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

NCT01023841 | Completed Phase 4 Results

• 1 other identifier: 192024-040
• Study Type: interventional
• Target: 71
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

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

  Baseline, Month 4

• Change From Baseline in Upper Eyelash Thickness as Measured by DIA

  Baseline, Month 4

• Change From Baseline in Upper Eyelash Darkness as Measured by DIA

  Baseline, Month 4

Study Arms (2)

bimatoprost ophthalmic solution 0.03%

ACTIVE COMPARATOR

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%

Vehicle Sterile Solution

PLACEBO COMPARATOR

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

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.

Also known as: LATISSE®

bimatoprost ophthalmic solution 0.03%

Vehicle Sterile Solution 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

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Newport Beach, California, United States

Location

Unknown Facility

São Paulo, Brazil

Location

Related 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.

  PMID: 27022239 BACKGROUND

MeSH Terms

Conditions

Alopecia Areata

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2009
• First Posted: December 2, 2009
• Study Start: June 1, 2010
• Primary Completion: November 2, 2012
• Study Completion: November 30, 2012
• Last Updated: April 17, 2019
• Results First Posted: September 13, 2013

Record last verified: 2019-04

Locations

US (1); BR (1)