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

AbbVie

Status and phase: Active, not recruiting; Phase 3

Conditions: Neck Lines

Treatments: Device: VOLITE XC

Study type: Interventional

Funder types: Industry

Identifiers

NCT05316233

2029-701-008

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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159 participants in 2 patient groups

VOLITE XC

Experimental group

Description:

Participants will receive VOLITE XC for initial treatment 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.

Treatment:

Device: VOLITE XC

Device: VOLITE XC

Control Group

Other group

Description:

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.

Treatment:

Device: VOLITE XC

Device: VOLITE XC