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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Allergan

ClinicalTrials.gov Identifier:

NCT01023841

First received: November 30, 2009

Last updated: December 11, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 30, 2009

Last Updated Date

December 11, 2012

Start Date ^ICMJE

June 2010

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of Patients Reports Adverse Events [ Time Frame: Month 5 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Overall Eyelash Prominence [ Time Frame: Month 4 ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01023841 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Upper Eyelash Length [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
Upper Eyelash Thickness [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
Upper Eyelash Darkness [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
Overall Eyelash Prominence [ Time Frame: Month 4 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Upper Eyelash Length [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
Upper Eyelash Thickness [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
Upper Eyelash Darkness [ Time Frame: Month 4 ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Eyelash Hypotrichosis
Alopecia Areata

Intervention ^ICMJE

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 Name: LATISSE®
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.

Study Arm (s)

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.

Intervention: Drug: bimatoprost ophthalmic solution 0.03%
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.

Intervention: Drug: Vehicle Sterile Solution

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2012

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

5 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Brazil

Administrative Information

NCT Number ^ICMJE

NCT01023841

Other Study ID Numbers ^ICMJE

192024-040

Has Data Monitoring Committee

Responsible Party

Allergan

Study Sponsor ^ICMJE

Allergan

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Director

Allergan

Information Provided By

Allergan

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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