A Study to Evaluate the Safety and Effectiveness of JUVÉDERM Products in Adult Participants for the Change of Their Overall Facial Appearance

Study Identifier
M25-631
CT.gov Identifier
NCT07186595
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruitment Complete
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Study Details

Medical Condition
  • Facial Aesthetics - Fillers
    • Study Drug
    N/A
    Phase
    Phase 4
    Sex
    Female & Male
    Age
    22 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Must meet at least 3 of the following criteria for treatment in the face with at least 2 JUVÉDERM products, per investigator's assessment: * Minimal, moderate, or severe on Allergan Temple Hollowing Scale (ATHS) * Moderate or severe for both eyes on Allergan Infraorbital Hollow Scale (AIHS) * Moderate or severe on Allergan Cheek Smoothness Scale (ACSS) * Moderate, significant, or severe on Mid-face Volume Deficit Scale (MFVDS) * Moderate or severe on Nasolabial Fold Severity Scale (NLFSS) * Minimal, mild, or moderate on Allergan Lip Fullness Scale 2 (ALFS2) * Moderate or severe on Allergan Chin Retrusion Scale (ACRS) * Moderate or severe on Allergan Loss of Jawline Definition Scale (ALJDS) * Must be in good health as determined by subject's medical history, physical examination, and vital sign measurements.
    Exclusion Criteria:
    * Prior treatment with non-permanent soft tissue fillers or fat-reducing injectables in the face or neck within 12 months prior to screening. * Excessively loose skin in the face and/or neck. * Tendency to develop hypertrophic scarring and/or keloid scarring.

    Protocol Summary

    The purpose of this study is to evaluate the safety and effectiveness of JUVÉDERM products in adults seeking improvement in facial volume and/or skin quality.

    Study Locations

    Location
    Status
    Location
    Kian Aesthetic Institute /ID# 277045
    Los Angeles, California, United States, 90025
    Status
    Not applicable
    Location
    West Dermatology La Jolla /ID# 277034
    San Diego, California, United States, 92121
    Status
    Not applicable
    Location
    Pacific Clinical Innovations /ID# 277026
    Vista, California, United States, 92083
    Status
    Not applicable
    Location
    Skin Research Institute LLC /ID# 277038
    Coral Gables, Florida, United States, 33146-1837
    Status
    Not applicable
    Location
    Monarch Plastic Surgery and Skin Renewal Center /ID# 278182
    Atlanta, Georgia, United States, 30328
    Status
    Not applicable
    Location
    Advanced Dermatology - Lincolnshire /ID# 277036
    Lincolnshire, Illinois, United States, 60069
    Status
    Not applicable
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