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

NCT ID: NCT00187577

Last Updated: 2011-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2006-03-31

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.

Conditions

Alopecia Areata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

application to eyelid of latanoprost solution

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

Group Type: ACTIVE_COMPARATOR

Latanoprost (Xalatan)

Intervention Type: DRUG

Topical application of latanoprost solution to eyelid

Intervention Type: DRUG

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

Application of bimatoprost to eyelid

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

Group Type: ACTIVE_COMPARATOR

Bimatoprost (Lumigan)

Intervention Type: DRUG

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

Interventions

Latanoprost (Xalatan)

Intervention Type: DRUG

Bimatoprost (Lumigan)

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

Intervention Type: DRUG

Topical application of latanoprost solution to eyelid

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

Intervention Type: DRUG

Other Intervention Names

Bimatoprost 0.03% solution (Lumigan); Latanoprost (Xalatan)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

University of California, San Francisco

Principal Investigators

Vera H. Price, M.D.

Role: PRINCIPAL_INVESTIGATOR

Professor, University of California, San Francisco Department of Dermatology

Robert L. Stamper, M.D.

Role: PRINCIPAL_INVESTIGATOR

Professor, University of California, San Francisco Department of Ophthalmology

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 11260563 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9323945 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12724722 (View on PubMed)

Other Identifiers

H7285-26596-01

Identifier Type: -

Identifier Source: org_study_id