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

NCT05316233 | Completed Phase 3 FDA Device

• 1 other identifier: 2029-701-008
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Neck Lines

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving "Responder" status based on Evaluating Investigator's (EI) live assessment of transverse neck lines using the Allergan Transverse Neck Lines Scale (ATNLS)

  A "responder" is a participant with at least 1-grade improvement on the ATNLS. ATNLS is a 5-point photonumeric scale to grade the severity of transverse neck lines (0=None, 4=Extreme)

  Month 1

• Number of Participants with Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.

  Up to 14 Months

Secondary Outcomes (3)

• Percentage of Participants Achieving "Responder" Status for EI's Assessment of global aesthetic improvement on the neck using the Global Aesthetic Improvement Scale (GAIS)

  Month 1

• Percentage of Participants Achieving "Responder" Status for Participant's Assessment of global aesthetic improvement on the Neck using GAIS

  Month 1

• Change from baseline to Month 1 in the Rasch-transformed scores on FACE-Q Appraisal of the Neck questionnaire

  Baseline to Month 1

Study Arms (2)

VOLITE XC

EXPERIMENTAL

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.

Device: VOLITE XC

Control Group

OTHER

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.

Device: VOLITE XC

Interventions

VOLITE XC DEVICE

Intradermal Injection

Also known as: JUVÉDERM® VOLITE™ XC

Control Group; VOLITE XC

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (15)

Steve Yoelin MD Medical Associate Inc /ID# 239072

Newport Beach, California, 92663, United States

Location

Laser & Skin surgery Medical group, Inc /ID# 241999

Sacramento, California, 95816-5520, United States

Location

Cosmetic Laser Dermatology /ID# 239121

San Diego, California, 92121-2119, United States

Location

Art of Skin MD /ID# 239071

Solana Beach, California, 92075-2228, United States

Location

Center for Dermatology and Dermatologic Surgery /ID# 239137

Washington D.C., District of Columbia, 20037-1445, United States

Location

Hevia Cosmetic Dermatology /ID# 239118

Coral Gables, Florida, 33134, United States

Location

Skin Research Institute LLC /ID# 239109

Coral Gables, Florida, 33146-1837, United States

Location

Research Institute of the Southeast, LLC /ID# 239070

West Palm Beach, Florida, 33401-2712, United States

Location

Delricht Research /ID# 242001

New Orleans, Louisiana, 70115, United States

Location

Rkmd, Llc /Id# 239075

North Bethesda, Maryland, 20852-3093, United States

Location

image Dermatology, P.C. /ID# 239136

Montclair, New Jersey, 07042, United States

Location

Skin And Aesthetics Surgery Of Manhattan /ID# 243607

New York, New York, 10022-3607, United States

Location

Mariwalla Dermatology /ID# 239102

West Islip, New York, 11795-4916, United States

Location

Aesthetic Solutions /ID# 239074

Chapel Hill, North Carolina, 27517-9901, United States

Location

Bellaire Dermatology Associates /ID# 239133

Bellaire, Texas, 77401, United States

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 7, 2022
• Study Start: May 2, 2022
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (15)