Study of Bimatoprost Gel on Eyelash Growth

July 14, 2014 updated by: Duke University

The Role of Bimatoprost Eyelash Gel in Chemotherapy-induced Madarosis: an Analysis of Efficacy and Safety

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Bimatoprost treated eyelid
one eyelid of the patient was randomized to the treatment arm and given the gel to use
Drug: Bimatoprost eyelash gel
Bimatoprost 0.03% solution was compounded into a gel - patients used on eyelash margin once daily placing gel with a fingertip or Q-tip for 6 months
Other Names:
  • lumigan
NO_INTERVENTION: control arm - no gel
the other fellow eyelid of the patient did not receive any treatment until month 4 and the patient crossed over to treating both eyelids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eyelash length
Time Frame: 6 months
eyelash ruler used to measure eyelash length
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

September 1, 2007

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

September 10, 2010

First Submitted That Met QC Criteria

September 10, 2010

First Posted (ESTIMATE)

September 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 16, 2014

Last Update Submitted That Met QC Criteria

July 14, 2014

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9459 (Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium)
  • 71320 (REGISTRY: IND)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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