Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children

Study Identifier
192024-040
CT.gov Identifier
NCT01023841
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
  • Hypotrichosis
  • Alopecia Areata
    • Study Drug
  • bimatoprost ophthalmic solution 0.03%
  • Vehicle Sterile Solution
    • Phase
    Phase 4
    Sex
    Female & Male
    Age
    5 - 17 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Children who have inadequate eyelashes or have lost their eyelashes as a result of chemotherapy treatment, who completed their chemotherapy (intensive treatment) at least 4 weeks before starting the study, are considered to be at low risk for relapse of their cancer, and are well enough to complete the study * Children who have minimal to moderate inadequate eyelashes due to alopecia areata * Adolescents between the ages of 15-17 years who have minimal to marked inadequate eyelashes
    Exclusion Criteria:
    * Any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants. * Semi-permanent eyelash tint, dye or eyelash extension application within 3 months * Use of over the counter eyelash growth products within 6 months. * Use of prescription eyelash growth products (eg, Latisse®) * Any eye condition that would prevent required ophthalmology exams

    Protocol Summary

    This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily application to the upper eyelid margins compared with vehicle in treating eyelash loss or hypotrichosis (inadequate or not enough eyelashes) in children.

    Study Locations

    Location
    Status
    Location
    Newport Beach, California, United States
    Status
    Not applicable
    Location
    São Paulo, Brazil
    Status
    Not applicable