A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM® VOLITE™ Gel Filler in Adult Participants in China With Fine Lines Around the Mouth

Study Identifier
M21-528
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Results Available

Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Facial Aesthetics - Fillers
  • Study Drug
    N/A
    Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    Facial fine lines and wrinkles are caused by skin thinning, loss of moisture, and loss of elasticity due to factors such as age, ultraviolet (UV) radiation, and environmental exposures. Today, many injectable fillers are used to treat facial aging and correct skin defects. In this study, adverse effects and effectiveness of JUVÉDERM® VOLITE™ will be assessed in correcting perioral lines (around the mouth).

    VOLITE is an investigational device being developed for the correction of perioral lines. In this study, participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to the no-treatment control group. Adult participants seeking improvement of lines, hydration, and skin smoothness in perioral area will be enrolled. Around 198 participants will be enrolled in the study at approximately 12 sites in China.

    Participants in the treatment group will receive the initial injection of VOLITE; the control group will receive no treatment, but will have the opportunity to receive VOLITE after 2 months. Participants will be followed up for 12 months.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects, and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    China-Japan Friendship Hospital /ID# 252139
    Beijing, Beijing Municipality, China, 100029
    Status
    Not applicable
    Location
    Plastic Surgery Hospital(Institute), Cams, Pumc /ID# 231394
    Beijing, Beijing Municipality, China, 100144
    Status
    Not applicable
    Location
    Beijing Hospital /ID# 231393
    Beijing, Beijing Municipality, China, 100730
    Status
    Not applicable
    Location
    Peking University First Hospital /ID# 231392
    Xicheng District, Beijing Municipality, China, 100034
    Status
    Not applicable
    Location
    The Third Affiliated Hospital, Sun Yat-Sen University /ID# 231398
    Guangzhou, Guangdong, China, 510630
    Status
    Not applicable
    Location
    Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 231396
    Wuhan, Hubei, China, 430022
    Status
    Not applicable
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