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

Primary Purpose

Eyelash Hypotrichosis, Alopecia Areata

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
bimatoprost ophthalmic solution 0.03%
Vehicle Sterile Solution
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eyelash Hypotrichosis

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

bimatoprost ophthalmic solution 0.03%

Vehicle Sterile Solution

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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).
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).

Full Information

First Posted
November 30, 2009
Last Updated
April 3, 2019
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01023841
Brief Title
Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2010 (Actual)
Primary Completion Date
November 2, 2012 (Actual)
Study Completion Date
November 30, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelash Hypotrichosis, Alopecia Areata

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bimatoprost ophthalmic solution 0.03%
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Vehicle Sterile Solution
Arm Type
Placebo Comparator
Arm Description
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
Intervention Name(s)
bimatoprost ophthalmic solution 0.03%
Other Intervention Name(s)
LATISSE®
Intervention Description
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
Intervention Name(s)
Vehicle Sterile Solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events
Description
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
Title
Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Global Eyebrow Assessment (GEA) Score
Description
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 Outcome Measure Information:
Title
Change From Baseline Upper Eyelash Length as Measured by Digital Image Analysis (DIA)
Description
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
Title
Change From Baseline in Upper Eyelash Thickness as Measured by DIA
Description
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
Title
Change From Baseline in Upper Eyelash Darkness as Measured by DIA
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Newport Beach
State/Province
California
Country
United States
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
27022239
Citation
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.
Results Reference
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Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children

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