A Study to Assess Adverse Events and Effectiveness of Intradermally Injected JUVÉDERM® VOLITE™ Gel Filler in Adult Participants For the Improvement of Skin Quality

Study Identifier
M24-486
CT.gov Identifier
NCT06547125
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
    Phase 2/Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Fitzpatrick skin types II-IV * Participants' FACE-Q Satisfaction with Skin Scale scores must meet the following criteria: * Participants must have FACE-Q Satisfaction with Skin Scale sum of raw scores of 39 or less * Participants must score "Very Dissatisfied" or "Somewhat Dissatisfied" on the following two questions: * How hydrated your facial skin looks? * How radiant your facial skin looks?
    Exclusion Criteria:
    * Any skin condition in the face area that might not be suitable for injection * Uncontrolled systemic disease * History of anaphylactic shock, or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid (HA) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study * Active autoimmune disease * Tendency to develop hypertrophic scarring * Currently undergoing chemotherapy/radiotherapy * Is undergoing orthodontia before enrollment or is planning to undergo it during the study

    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 the treatment of fine lines and improving skin quality.

    VOLITE is an investigational device being developed for improving skin quality. 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 skin quality, especially hydration and radiance, in the treatment area will be enrolled. Around 135 participants will be enrolled in the study at approximately 6 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 regular 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# 260959
    Beijing, Beijing Municipality, China, 100029
    Status
    Not applicable
    Location
    Peking University First Hospital /ID# 260957
    Xicheng District, Beijing Municipality, China, 100034
    Status
    Not applicable
    Location
    Nanjing Drum Tower Hospital /ID# 260950
    Nanjing, Jiangsu, China, 210008
    Status
    Not applicable
    Location
    Zhongda Hospital Southeast University /ID# 260951
    Nanjing, Jiangsu, China, 210009
    Status
    Not applicable
    Location
    Huashan Hospital, Fudan University /ID# 261582
    Shanghai, Shanghai Municipality, China, 200040
    Status
    Not applicable
    Location
    Hangzhou First People's Hospital /ID# 260952
    Hangzhou, Zhejiang, China, 310003
    Status
    Not applicable