Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults

Study Identifier
VOLBELLA-005
CT.gov Identifier
NCT03519204
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Statistical Analysis Plan
Available Language(s): English
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Protocol
Available Language(s): English
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Study Details

Medical Condition
  • Facial Aesthetics - Fillers
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Male or female, 18 years of age or older with an overall baseline Lip Fullness Scale (LFS) score of minimal, mild or moderate on the 5-point LFS scale. * Has the ability to follow study instructions and is likely to complete all required visits
    Exclusion Criteria:
    * Has had any facial procedures or trauma that may interfere with the study procedures and results * Is on anti-coagulation therapy or other contraindicated treatments * Has current cutaneous inflammatory or infectious processes or lesions in the mouth area

    Protocol Summary

    This study will evaluate the safety and effectiveness of VOLBELLA with Lidocaine injectable gel in Chinese adults seeking lip enhancement.

    Study Locations

    Location
    Status
    Location
    General Hospital of Southern Theatre Command
    Guangzhou, Guangdong, China, 510010
    Status
    Not applicable
    Location
    Nanfang Hospital, Southern Medical University
    Guangzhou, Guangdong, China, 510515
    Status
    Not applicable
    Location
    Union Hospital Tongji Medical College Huazhong University of Science and Technology
    Wuhan, Hubei, China, 430000
    Status
    Not applicable
    Location
    China-Japan Friendship Hospital
    Beijing, China, 100029
    Status
    Not applicable
    Location
    Peking University Third Hospital
    Beijing, China, 100083
    Status
    Not applicable