Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency

Study Identifier
VOL-AP01
CT.gov Identifier
NCT01029535
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
  • Facial Aesthetics - Fillers
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    30 - 60 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Subjects with mild to severe mid-face and cheek volume deficit due to age-related changes, who are likely to improve by at least 2 grades following treatment with the study compound, based on a study-specific scale, as assessed by the study physician
    Exclusion Criteria:
    * Subjects who have a pre-existing medical condition or who have received any treatments or procedures which may impact on the assessment of the effects of the study compound. * Subjects with a history of allergies or other side effects to dermal fillers, lidocaine, hyaluronic acid or other component of the study compound. * Subjects were are pregnant or breast-feeding or who are of child-bearing potential and who are not prepared to practice an adequate form of contraception during the course of the study * Subjects with a history of alcoholism or drug abuse or dependence

    Protocol Summary

    This is a prospective, open-label experience study to be conducted at 6 clinical sites in Australia, with the objective to collect efficacy and safety information for Juvederm® VOLUMA™ when used for volumising the mid-face and cheek area.

    Study Locations

    Location
    Status
    Location
    Sydney, Australia
    Status
    Not applicable