Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata
June 7, 2011 updated by: University of California, San Francisco
Efficacy and Safety of Latanoprost (Xalatan) and Bimatoprost (Lumigan) Ophthalmic Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata
This is a single center, randomized, investigator-masked study to determine the efficacy and safety of latanoprost and bimatoprost ophthalmic solutions in promoting eyelash growth in patients who have lost their eyelashes due to alopecia areata.
These medications are FDA-approved as eyedrops for patients with glaucoma who have been noted to grow longer, darker, and thicker eyelashes with their use.
In this study, patients will be asked to apply these solutions to the affected eyelid margins of one eye with a sterile cotton-tipped applicator once a day.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a pilot, single-center, randomized, investigator-masked study to evaluate the efficacy and safety of latanoprost (Xalatan) ophthalmic solution compared to bimatoprost (Lumigan) ophthalmic solution in patients with eyelash loss due to alopecia areata.
This is a collaborative study between the Departments of Dermatology and Ophthalmology at UCSF.
Patients will be randomized to receive either latanoprost or bimatoprost.
Patients will be instructed to apply latanoprost or bimatoprost to the affected eyelid margins of one eye using a sterile cotton-tipped applicator once a day (similar to the application of eyeliner).
The untreated eye will serve as a control.
When substantial eyelash growth is noted in the treated eye, patients will be instructed to decrease application to once a week.
Patients will be seen every four weeks in the Department of Dermatology.
In addition, eyelash growth will be assessed in the Beckman Vision Center where eyelash length will be measured, and photographs will be taken at baseline, 2 months, and 4 months.
Intraocular pressure will be documented at baseline and at each visit to the Beckman Vision Center.
The study will be conducted over four months.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
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
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California
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San Francisco, California, United States, 94117
- University of California, San Francisco
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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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females in good general health, ages 18-70.
- Patients with alopecia areata who have had 50% or more eyelash loss for 6 months or longer.
Exclusion Criteria:
- Any pre-existing eye disorder that would preclude use of a topical agent around the eyes (e.g. infection, inflammation, recent surgery.)
- Subjects with limited close vision who cannot see their eyelid margin clearly.
- Immunosuppressed state.
- Women who are pregnant or who are trying to become pregnant, or are breast-feeding.
- Patients with known allergy to latanoprost or bimatoprost, other prostaglandin F-2a or related drugs, or to benzalkonium.
- Unable to read or follow instructions.
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: application to eyelid of latanoprost solution
Subject will apply latanoprost solution with applicator daily to affected eye lid(s)
|
Subject will apply latanoprost to affected eyelid with cotton-tipped applicator daily.
Other Names:
|
|
Active Comparator: Application of bimatoprost to eyelid
Subject will apply bimatoprost solution with applicator daily to affected eye lid(s)
|
Bimatoprost solution will be applied to affected eyelid(s) with cotton-tipped applicator daily.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Eyelash growth in response to topical application of latanoprost or bimatoprost to the eyelid margins of patients with alopecia areata; eyelid photographs and eyelash length will be documented at 8 week intervals.
Time Frame: 16 weeks
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16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Vera H. Price, M.D., Professor, University of California, San Francisco Department of Dermatology
- Principal Investigator: Robert L. Stamper, M.D., Professor, University of California, San Francisco Department of Ophthalmology
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
- Demitsu T, Manabe M, Harima N, Sugiyama T, Yoneda K, Yamada N. Hypertrichosis induced by latanoprost. J Am Acad Dermatol. 2001 Apr;44(4):721-3. doi: 10.1067/mjd.2001.111625. No abstract available.
- Johnstone MA. Hypertrichosis and increased pigmentation of eyelashes and adjacent hair in the region of the ipsilateral eyelids of patients treated with unilateral topical latanoprost. Am J Ophthalmol. 1997 Oct;124(4):544-7. doi: 10.1016/s0002-9394(14)70870-0.
- Mehta JS, Raman J, Gupta N, Thoung D. Cutaneous latanoprost in the treatment of alopecia areata. Eye (Lond). 2003 Apr;17(3):444-6. doi: 10.1038/sj.eye.6700354. No abstract available.
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
June 1, 2005
Primary Completion (Actual)
February 1, 2006
Study Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
June 9, 2011
Last Update Submitted That Met QC Criteria
June 7, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H7285-26596-01
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