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Study of Bimatoprost Gel on Eyelash Growth

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ClinicalTrials.gov Identifier: NCT01200251
Recruitment Status : Completed
First Posted : September 13, 2010
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Madarosis Hypotrichosis Drug: Bimatoprost eyelash gel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Bimatoprost Eyelash Gel in Chemotherapy-induced Madarosis: an Analysis of Efficacy and Safety
Study Start Date : February 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Bimatoprost
U.S. FDA Resources

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 Name: 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



Primary Outcome Measures :
  1. eyelash length [ Time Frame: 6 months ]
    eyelash ruler used to measure eyelash length


Secondary Outcome Measures :
  1. eyelash pigment [ Time Frame: 6 mos ]
    blinded grader used digital photos to grade degree of pigment on scale of 1-5

  2. eyelash thickness [ Time Frame: 6 mos ]
    blinded grader used digital photos to grade degree of thickness on scale of 1-5

  3. eyelash amount [ Time Frame: 6 mos ]
    blinded grader used digital photos to grade degree of amount by counting lashes

  4. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200251


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University

Publications of Results:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01200251     History of Changes
Other Study ID Numbers: 9459
71320 ( Registry Identifier: IND )
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: September 2010

Additional relevant MeSH terms:
Hypotrichosis
Hair Diseases
Skin Diseases
Bimatoprost
Antihypertensive Agents