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

Completed · Phase 3

Conditions studied: Neck Lines

In brief

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.

Key facts

Study ID

NCT05316233

Run by

AbbVie

People needed

159

Starts

2022-05-02

Expected to finish

2024-09-12

Last updated by the study team

2025-04-29

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Steve Yoelin MD Medical Associate Inc /ID# 239072 — Newport Beach, California, United States
• Laser & Skin surgery Medical group, Inc /ID# 241999 — Sacramento, California, United States
• Cosmetic Laser Dermatology /ID# 239121 — San Diego, California, United States
• Art of Skin MD /ID# 239071 — Solana Beach, California, United States
• Center for Dermatology and Dermatologic Surgery /ID# 239137 — Washington D.C., District of Columbia, United States
• Hevia Cosmetic Dermatology /ID# 239118 — Coral Gables, Florida, United States
• Skin Research Institute LLC /ID# 239109 — Coral Gables, Florida, United States
• Research Institute of the Southeast, LLC /ID# 239070 — West Palm Beach, Florida, United States
• Delricht Research /ID# 242001 — New Orleans, Louisiana, United States
• Rkmd, Llc /Id# 239075 — North Bethesda, Maryland, United States
• image Dermatology, P.C. /ID# 239136 — Montclair, New Jersey, United States
• Skin And Aesthetics Surgery Of Manhattan /ID# 243607 — New York, New York, United States
• Mariwalla Dermatology /ID# 239102 — West Islip, New York, United States
• Aesthetic Solutions /ID# 239074 — Chapel Hill, North Carolina, United States
• Bellaire Dermatology Associates /ID# 239133 — Bellaire, Texas, United States

Full record on ClinicalTrials.gov

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