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

NCT00187577 | Completed

• 1 other identifier: H7285-26596-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Keywords

Alopecia areata; Eyelash growth; Latanoprost; Bimatoprost

Outcome Measures

Primary Outcomes (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.

  16 weeks

Study Arms (2)

application to eyelid of latanoprost solution

ACTIVE COMPARATOR

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

Drug: Latanoprost (Xalatan); Drug: Topical application of latanoprost solution to eyelid

Application of bimatoprost to eyelid

ACTIVE COMPARATOR

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

Drug: Bimatoprost (Lumigan)

Interventions

Latanoprost (Xalatan) DRUG

application to eyelid of latanoprost solution

Bimatoprost (Lumigan) DRUG

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

Also known as: Bimatoprost 0.03% solution (Lumigan)

Application of bimatoprost to eyelid

Topical application of latanoprost solution to eyelid DRUG

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

Also known as: Latanoprost (Xalatan)

application to eyelid of latanoprost solution

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94117, United States

Location

Related Publications (3)

• 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.

  PMID: 11260563 BACKGROUND

• 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.

  PMID: 9323945 BACKGROUND

• 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.

  PMID: 12724722 BACKGROUND

MeSH Terms

Conditions

Alopecia Areata

Interventions

Latanoprost; Bimatoprost; Solutions

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Amides; Organic Chemicals; Cloprostenol; Pharmaceutical Preparations

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: June 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: March 1, 2006
• Last Updated: June 9, 2011

Record last verified: 2011-06

Locations

US (1)