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

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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 16, 2005
Last Update Posted Date June 9, 2011
Study Start Date  ICMJE June 2005
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Latanoprost and Bimatoprost Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata
Official Title  ICMJE Efficacy and Safety of Latanoprost (Xalatan) and Bimatoprost (Lumigan) Ophthalmic Solutions in Promoting Eyelash Growth in Patients With Alopecia Areata
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
Intervention  ICMJE
  • Drug: 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)
Study Arms  ICMJE
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 7, 2011)
14
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
20
Actual Study Completion Date  ICMJE March 2006
Actual Primary Completion Date February 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00187577
Other Study ID Numbers  ICMJE H7285-26596-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Stamper, MD, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of California, San Francisco
Verification Date June 2011

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