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Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata

Primary Purpose

Alopecia Areata

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Latanoprost (Xalatan)
Bimatoprost (Lumigan)
Topical application of latanoprost solution to eyelid
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia Areata focused on measuring Alopecia areata, Eyelash growth, Latanoprost, Bimatoprost

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

application to eyelid of latanoprost solution

Application of bimatoprost to eyelid

Arm Description

Subject will apply latanoprost solution with applicator daily to affected eye lid(s)

Subject will apply bimatoprost solution with applicator daily to affected eye lid(s)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
June 7, 2011
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00187577
Brief Title
Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata
Official Title
Efficacy and Safety of Latanoprost (Xalatan) and Bimatoprost (Lumigan) Ophthalmic Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Alopecia areata, Eyelash growth, Latanoprost, Bimatoprost

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
application to eyelid of latanoprost solution
Arm Type
Active Comparator
Arm Description
Subject will apply latanoprost solution with applicator daily to affected eye lid(s)
Arm Title
Application of bimatoprost to eyelid
Arm Type
Active Comparator
Arm Description
Subject will apply bimatoprost solution with applicator daily to affected eye lid(s)
Intervention Type
Drug
Intervention Name(s)
Latanoprost (Xalatan)
Intervention Type
Drug
Intervention Name(s)
Bimatoprost (Lumigan)
Other Intervention Name(s)
Bimatoprost 0.03% solution (Lumigan)
Intervention Description
Bimatoprost solution will be applied to affected eyelid(s) with cotton-tipped applicator daily.
Intervention Type
Drug
Intervention Name(s)
Topical application of latanoprost solution to eyelid
Other Intervention Name(s)
Latanoprost (Xalatan)
Intervention Description
Subject will apply latanoprost to affected eyelid with cotton-tipped applicator daily.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera H. Price, M.D.
Organizational Affiliation
Professor, University of California, San Francisco Department of Dermatology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert L. Stamper, M.D.
Organizational Affiliation
Professor, University of California, San Francisco Department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11260563
Citation
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.
Results Reference
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PubMed Identifier
9323945
Citation
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.
Results Reference
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PubMed Identifier
12724722
Citation
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.
Results Reference
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Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata

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