Study of Bimatoprost Gel on Eyelash Growth

Phase 3

Completed

• Conditions: Hypotrichosis; Madarosis
• Interventions: Drug: Bimatoprost eyelash gel

• Registration Number: NCT01200251
• Lead Sponsor: Duke University

Brief Summary

A internally controlled, single-blinded, randomized controlled trial to investigate the use of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and IRB approval have been obtained.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2007-09
• Study Completion: 2008-12
• Status Verified: 2010-09
• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-09-10
• Study First Posted: 2010-09-13
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• 18-80 YO females
• madarosis or hypotrichosis (loss of eyelashes) due to chemotherapy used to treat breast cancer
• only breast cancer patients

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Exclusion Criteria

• inability to follow up, apply gel
• active eye/eyelid infection or inflammatory process
• cancer not related to breast cancer, healthy patients
• males

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bimatoprost treated eyelid	Bimatoprost eyelash gel	one eyelid of the patient was randomized to the treatment arm and given the gel to use

Primary Outcome Measures

Name	Time	Method
eyelash length	6 months	eyelash ruler used to measure eyelash length

Secondary Outcome Measures

Name	Time	Method
eyelash pigment	6 mos	blinded grader used digital photos to grade degree of pigment on scale of 1-5
eyelash thickness	6 mos	blinded grader used digital photos to grade degree of thickness on scale of 1-5
eyelash amount	6 mos	blinded grader used digital photos to grade degree of amount by counting lashes
eyelash side effects	6 mos	any side effects (irritation, allergy, iop change, visual acuity, macular edema, uveitis, iris color change, etc... were assessed

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States