Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata - Full Text View

Sponsor:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00187577

Purpose

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	Intervention
Alopecia Areata	Drug: Latanoprost (Xalatan) Drug: Bimatoprost (Lumigan) Drug: Topical application of latanoprost solution to eyelid

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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

Resource links provided by NLM:

Genetics Home Reference related topics: androgenetic alopecia

Drug Information available for: Latanoprost Bimatoprost

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

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. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment:	14
Study Start Date:	June 2005
Study Completion Date:	March 2006
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: application to eyelid of latanoprost solution Subject will apply latanoprost solution with applicator daily to affected eye lid(s)	Drug: Latanoprost (Xalatan) Other Name: Latanoprost (Xalatan) Drug: Topical application of latanoprost solution to eyelid Subject will apply latanoprost to affected eyelid with cotton-tipped applicator daily. Other Name: 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 Name: Bimatoprost 0.03% solution (Lumigan)

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187577

Locations

United States, California
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

More Information

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. 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.

Mehta JS, Raman J, Gupta N, Thoung D. Cutaneous latanoprost in the treatment of alopecia areata. Eye. 2003 Apr;17(3):444-6. No abstract available.

Responsible Party:	Robert Stamper, MD, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00187577 History of Changes
Other Study ID Numbers:	H7285-26596-01
Study First Received:	September 13, 2005
Last Updated:	June 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:

Alopecia areata
Eyelash growth
Latanoprost
Bimatoprost

Additional relevant MeSH terms:

Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Latanoprost
Bimatoprost
Cloprostenol

Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012