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

• ClinicalTrials.gov Identifier: NCT00187577
• Recruitment Status: Completed
• First Posted: September 16, 2005
• Last Update Posted: June 9, 2011
• Sponsor: University of California, San Francisco
• Information provided by: University of California, San Francisco

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	Not Applicable

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 (Clinical Trial)
• 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: June 2005
• Actual Primary Completion Date: February 2006
• Actual Study Completion Date: March 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 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)

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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. 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.

• Responsible Party: Robert Stamper, MD, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT00187577
• Other Study ID Numbers: H7285-26596-01
• First Posted: September 16, 2005
• Last Update Posted: June 9, 2011
• Last Verified: June 2011

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; Bimatoprost; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions; Antihypertensive Agents