Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia

Study Identifier
192024-057
CT.gov Identifier
NCT01325337
EudraCT Identifier
2011-000379-15
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Hair Loss - Other
    • Study Drug
  • bimatoprost Formulation A
  • bimatoprost Formulation B
  • bimatoprost Formulation C
  • bimatoprost vehicle solution
  • minoxidil 5% solution
    • Phase
    Phase 2
    Sex
    Male
    Age
    18 - 49 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year * Willingness to have micro-dot-tattoo applied to scalp * Willingness to maintain same hair style, length and hair color during study
    Exclusion Criteria:
    * Drug or alcohol abuse within 12 months * HIV positive * Received hair transplants or had scalp reductions * Use of hair weaves, hair extensions or wigs within 3 months * Oral or topical minoxidil treatment within 6 months * Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks

    Protocol Summary

    This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.

    Study Locations

    Location
    Status
    Location
    Portland, Oregon, United States
    Status
    Not applicable
    Location
    Berlin, Germany
    Status
    Not applicable