Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia

Study Identifier
192024-053
CT.gov Identifier
NCT01189279
EudraCT Identifier
Not available
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
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 64 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Males with moderate male-pattern baldness (androgenic alopecia) * Females with moderate female pattern hair loss * Non-smoker or smoker with at least 30 days abstinence from smoking/using nicotine-containing products
    Exclusion Criteria:
    * Any dermatological condition of the scalp other than androgenic alopecia (males) or female pattern hair loss (females) * Use of bimatoprost or other prostaglandin analogs within 3 months * Prior use of scalp hair growth treatment (eg, finasteride, minoxidil) within 6 months * Any prior hair growth procedures (eg, hair transplant or laser) * Blood donation or equivalent blood loss within 90 days * History of alcohol or drug addiction

    Protocol Summary

    This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Part 2 will begin after Part 1 has completed.

    Study Locations

    Location
    Status
    Location
    Tempe, Arizona, United States
    Status
    Not applicable