Back to resultsStudy of Bimatoprost Gel on Eyelash Growth
Primary Purpose
Madarosis, Hypotrichosis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bimatoprost eyelash gel
Sponsored by
About this trial
This is an interventional treatment trial for Madarosis
Eligibility 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
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bimatoprost treated eyelid
control arm - no gel
Arm Description
one eyelid of the patient was randomized to the treatment arm and given the gel to use
the other fellow eyelid of the patient did not receive any treatment until month 4 and the patient crossed over to treating both eyelids
Outcomes
Primary Outcome Measures
eyelash length
eyelash ruler used to measure eyelash length
Secondary Outcome Measures
eyelash pigment
blinded grader used digital photos to grade degree of pigment on scale of 1-5
eyelash thickness
blinded grader used digital photos to grade degree of thickness on scale of 1-5
eyelash amount
blinded grader used digital photos to grade degree of amount by counting lashes
eyelash side effects
any side effects (irritation, allergy, iop change, visual acuity, macular edema, uveitis, iris color change, etc... were assessed
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01200251
Brief Title
Study of Bimatoprost Gel on Eyelash Growth
Official Title
The Role of Bimatoprost Eyelash Gel in Chemotherapy-induced Madarosis: an Analysis of Efficacy and Safety
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Madarosis, Hypotrichosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bimatoprost treated eyelid
Arm Type
Experimental
Arm Description
one eyelid of the patient was randomized to the treatment arm and given the gel to use
Arm Title
control arm - no gel
Arm Type
No Intervention
Arm Description
the other fellow eyelid of the patient did not receive any treatment until month 4 and the patient crossed over to treating both eyelids
Intervention Type
Drug
Intervention Name(s)
Bimatoprost eyelash gel
Other Intervention Name(s)
lumigan
Intervention Description
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
Primary Outcome Measure Information:
Title
eyelash length
Description
eyelash ruler used to measure eyelash length
Time Frame
6 months
Secondary Outcome Measure Information:
Title
eyelash pigment
Description
blinded grader used digital photos to grade degree of pigment on scale of 1-5
Time Frame
6 mos
Title
eyelash thickness
Description
blinded grader used digital photos to grade degree of thickness on scale of 1-5
Time Frame
6 mos
Title
eyelash amount
Description
blinded grader used digital photos to grade degree of amount by counting lashes
Time Frame
6 mos
Title
eyelash side effects
Description
any side effects (irritation, allergy, iop change, visual acuity, macular edema, uveitis, iris color change, etc... were assessed
Time Frame
6 mos
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15577756
Citation
Tosti A, Pazzaglia M, Voudouris S, Tosti G. Hypertrichosis of the eyelashes caused by bimatoprost. J Am Acad Dermatol. 2004 Nov;51(5 Suppl):S149-50. doi: 10.1016/j.jaad.2004.05.002. Erratum In: J Am Acad Dermatol. 2004 Dec;51(6):1040.
Results Reference
result
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Study of Bimatoprost Gel on Eyelash Growth
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