Study of the Safety and Effectiveness of JUVÉDERM VOLUX™ XC Injectable Gel for Restoring Jawline Definition

Study Identifier
V25L-002
CT.gov Identifier
NCT03712137
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Scientific Result Summary
Available Language(s): English
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Plain Language Summary
Available Language(s): English
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Study Details

Medical Condition
  • Facial Aesthetics - Fillers
    • Study Drug
    N/A
    Phase
    Phase 3
    Sex
    Female & Male
    Age
    22+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Has "Moderate" or "Severe" loss of jawline definition as determined by the EI using the ALJDs (Grade 2 or 3 on the ALJDS) on both sides. The grade does not have to be the same on both sides, but must be Grade 2 or 3 * Treating Investigator (TI) considers the subject's jaw amenable to an improvement of at least 1 grade on the scale for the jawline definition * Written Informed Consent (IC) has been obtained
    Exclusion Criteria:
    * Has ever received permanent facial implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face or neck, or is planning to be implanted with any of these products during the study * Has ever undergone fat injections in the malar, chin or jawline area or is planning to undergo this procedure during the study * Has undergone semipermanent dermal filler treatment (eg, calcium hydroxyapatite, poly-L-lactic acid) below the subnasale within 36 months before enrollment or is planning to undergo such treatment during the study * Has received deoxycholic acid treatment in the submental region in the last 6 months * Has active autoimmune disease * Females who are pregnant, nursing, or planning a pregnancy during the course of the study

    Protocol Summary

    This study will evaluate the safety and effectiveness of JUVÉDERM VOLUX™ XC injectable gel for restoring jawline definition

    Study Locations

    Location
    Status
    Location
    Total Skin and Beauty Dermatology Center, PC
    Birmingham, Alabama, United States, 35205
    Status
    Not applicable
    Location
    Westside Aesthetics
    Los Angeles, California, United States, 90025
    Status
    Not applicable
    Location
    Artemedica
    Santa Rosa, California, United States, 95401
    Status
    Not applicable
    Location
    Center for Dermatology and Dermatologic Surgery
    Washington D.C., District of Columbia, United States, 20037
    Status
    Not applicable
    Location
    Susan H Weinkle, MD
    Bradenton, Florida, United States, 34209
    Status
    Not applicable
    Location
    Hevia Cosmetic Dermatology
    Coral Gables, Florida, United States, 33134
    Status
    Not applicable
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