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

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00187577
First received: September 13, 2005
Last updated: June 7, 2011
Last verified: June 2011

September 13, 2005
June 7, 2011
June 2005
February 2006   (final data collection date for primary outcome 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. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00187577 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata
Efficacy and Safety of Latanoprost (Xalatan) and Bimatoprost (Lumigan) Ophthalmic Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Alopecia Areata
  • Drug: Latanoprost (Xalatan)
    Other Name: Latanoprost (Xalatan)
  • Drug: Bimatoprost (Lumigan)
    Bimatoprost solution will be applied to affected eyelid(s) with cotton-tipped applicator daily.
    Other Name: Bimatoprost 0.03% solution (Lumigan)
  • 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 to eyelid of latanoprost solution
    Subject will apply latanoprost solution with applicator daily to affected eye lid(s)
    Interventions:
    • Drug: Latanoprost (Xalatan)
    • Drug: Topical application of latanoprost solution to eyelid
  • Active Comparator: Application of bimatoprost to eyelid
    Subject will apply bimatoprost solution with applicator daily to affected eye lid(s)
    Intervention: Drug: Bimatoprost (Lumigan)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
March 2006
February 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00187577
H7285-26596-01
No
Robert Stamper, MD, University of California, San Francisco
University of California, San Francisco
Not Provided
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
University of California, San Francisco
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP