Clinical trial NCT00187577: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alopecia Areata
Keywords: Alopecia areata
Eyelash growth
Latanoprost
Bimatoprost
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: Professor, University of California, San Francisco Department of Dermatology
name: Vera H. Price, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor, University of California, San Francisco Department of Ophthalmology
name: Robert L. Stamper, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.