Study of Bimatoprost Gel on Eyelash Growth

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01200251
First received: September 10, 2010
Last updated: July 14, 2014
Last verified: September 2010
  Purpose

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 Intervention Phase
Madarosis
Hypotrichosis
Drug: Bimatoprost eyelash gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Bimatoprost Eyelash Gel in Chemotherapy-induced Madarosis: an Analysis of Efficacy and Safety

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • eyelash length [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    eyelash ruler used to measure eyelash length


Secondary Outcome Measures:
  • eyelash pigment [ Time Frame: 6 mos ] [ Designated as safety issue: No ]
    blinded grader used digital photos to grade degree of pigment on scale of 1-5

  • eyelash thickness [ Time Frame: 6 mos ] [ Designated as safety issue: No ]
    blinded grader used digital photos to grade degree of thickness on scale of 1-5

  • eyelash amount [ Time Frame: 6 mos ] [ Designated as safety issue: No ]
    blinded grader used digital photos to grade degree of amount by counting lashes

  • eyelash side effects [ Time Frame: 6 mos ] [ Designated as safety issue: Yes ]
    any side effects (irritation, allergy, iop change, visual acuity, macular edema, uveitis, iris color change, etc... were assessed


Enrollment: 20
Study Start Date: February 2007
Study Completion Date: December 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01200251

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

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01200251     History of Changes
Other Study ID Numbers: 9459, 71320
Study First Received: September 10, 2010
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypotrichosis
Hair Diseases
Skin Diseases
Bimatoprost
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014