A Study to Assess Adverse Events and Change in Disease Activity of JUVÉDERM® VOLITE™ XC Injectable Gel for Change in Neck Appearance in Adult Participants

Study Identifier
2029-701-008
CT.gov Identifier
NCT05316233
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 3
    Sex
    Female & Male
    Age
    22+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants in general good health as determined by Treating Investigator's judgment, including no known active pandemic infection. * Participants seeking improvement of transverse neck lines. * Has moderate or severe transverse neck lines (ATNLS Grade 2 or 3) on EI live assessment.
    Exclusion Criteria:
    * Neck deformity or significant skin laxity with severe redundant folds. * Significant skin pigmentation disorders or discoloration in the neck area that would interfere with the visual assessment of the neck area. * Current cutaneous inflammatory or infectious processes (eg. acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the neck. * Tendency to develop hypertrophic scarring. * History of thyroid cancer, skin cancer of the neck, radiation of the treatment area, or de novo cancer in the treatment area. * Permanent soft tissue fillers in the neck area. * Semi-permanent soft tissue fillers in the neck area within 2 years before enrollment. * HA fillers or autologous fat in the neck area within 12 months before enrollment. * Mesotherapy, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, microneedling, laser, or other cosmetic procedures in the neck area within 12 months before enrollment. * Botulinum toxin in the neck area within 6 months before enrollment. * Deoxycholic acid injections or cryolipolysis in the submentum area within 6 months before enrollment. * Neck surgeries and procedures. * Neck tattoos, piercings, pigmentation, hair, or past trauma that would interfere with the visualization of the neck area for the effectiveness assessments. * Pregnant, nursing or planning a pregnancy.

    Protocol Summary

    The cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The neck is a frequently mentioned area by patients complaining about its crepey texture and deep lines. VOLITE XC is a crosslinked HA gel implant formulated with lidocaine that was developed to provide a safe, minimally invasive method of treating fine lines and improving skin quality. The purpose of this study is to assess adverse events and effectiveness of VOLITE XC in adults seeking improvement in neck appearance.

    VOLITE XC is an investigational product being developed for the improvement of horizontal neck lines. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in 3 chance that participants will be assigned to the control group. Around 212 adult participants with transverse neck lines will be enrolled in the study at approximately 20 sites.

    Participants in the treatment group will receive VOLITE XC at Day 1 and followed for up to 14 Months. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of VOLITE XC during the follow-up duration period. The control group received no treatment and will be followed for up to 6 months after randomization. Participants can then opt to receive VOLITE XC and followed for 6 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
    Steve Yoelin MD Medical Associate Inc /ID# 239072
    Newport Beach, California, United States, 92663
    Status
    Not applicable
    Location
    Laser & Skin surgery Medical group, Inc /ID# 241999
    Sacramento, California, United States, 95816-5520
    Status
    Not applicable
    Location
    Cosmetic Laser Dermatology /ID# 239121
    San Diego, California, United States, 92121-2119
    Status
    Not applicable
    Location
    Art of Skin MD /ID# 239071
    Solana Beach, California, United States, 92075-2228
    Status
    Not applicable
    Location
    Center for Dermatology and Dermatologic Surgery /ID# 239137
    Washington D.C., District of Columbia, United States, 20037-1445
    Status
    Not applicable
    Location
    Hevia Cosmetic Dermatology /ID# 239118
    Coral Gables, Florida, United States, 33134
    Status
    Not applicable
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