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

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT00187577

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alopecia Areata	Drug: Latanoprost (Xalatan) Drug: Bimatoprost (Lumigan) Drug: Topical application of latanoprost solution to eyelid	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Latanoprost (Xalatan) and Bimatoprost (Lumigan) Ophthalmic Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Feb 1, 2006

Actual Study Completion Date :

Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: application to eyelid of latanoprost solution Subject will apply latanoprost solution with applicator daily to affected eye lid(s)	Drug: Latanoprost (Xalatan) Drug: Topical application of latanoprost solution to eyelid Subject will apply latanoprost to affected eyelid with cotton-tipped applicator daily. Other Names: Latanoprost (Xalatan)
Active Comparator: Application of bimatoprost to eyelid Subject will apply bimatoprost solution with applicator daily to affected eye lid(s)	Drug: Bimatoprost (Lumigan) Bimatoprost solution will be applied to affected eyelid(s) with cotton-tipped applicator daily. Other Names: Bimatoprost 0.03% solution (Lumigan)

Arm

Intervention/Treatment

Active Comparator: application to eyelid of latanoprost solution

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

Drug: Latanoprost (Xalatan)

Drug: Topical application of latanoprost solution to eyelid

Subject will apply latanoprost to affected eyelid with cotton-tipped applicator daily.

Other Names:

Latanoprost (Xalatan)

Active Comparator: Application of bimatoprost to eyelid

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

Drug: Bimatoprost (Lumigan)

Bimatoprost solution will be applied to affected eyelid(s) with cotton-tipped applicator daily.

Other Names:

Bimatoprost 0.03% solution (Lumigan)

Outcome Measures

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. [16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94117

Sponsors and Collaborators

University of California, San Francisco

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