A Study to Assess Adverse Events and Effectiveness of Injected JUVÉDERM® VOLITE™ Gel Filler for Change in Neck Lines in Adult Chinese Participants

NCT05741034 | Completed Phase 3

• 1 other identifier: M21-870
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 9

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 participants complaining about its crepey texture and deep lines. JUVÉDERM® VOLITE™ is a crosslinked Hyaluronic Acid (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 in Chinese adults seeking correction of transverse neck lines. VOLITE is an investigational product being developed for correction of transverse 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 159 adult participants with transverse neck lines will be enrolled in the study at approximately 8 sites in China. Participants in the treatment group will receive the initial injection of VOLITE at Visit 1 and followed for up to 13 months. Participants may have the opportunity to receive optional touch-up treatment of VOLITE during the follow-up duration period. Participants in the control group will receive no treatment but will have the opportunity to receive VOLITE treatment after 2 months. Participants in the control group will be followed for up to 10 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

Keywords

Neck Lines; Skin Wrinkling; Juvederm VOLITE; VOLITE

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 2

• 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 13 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 2

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

  Month 2

• Change from baseline to Month 2 on FACE-Q Appraisal of Neck questionnaire overall score

  Baseline to Month 2

Study Arms (2)

JUVÉDERM® VOLITE™

EXPERIMENTAL

Participants will receive VOLITE for initial treatment and exit the study at month 12 after last treatment. Participants may have the opportunity to receive optional touch-up treatment of VOLITE during the follow-up duration period.

Device: JUVÉDERM® VOLITE™

Control - No Treatment

OTHER

Participants in the control group will receive no treatment. At Month 2, these participants will have the option to receive VOLITE treatment and exit the study at month 9 after last treatment.

Device: JUVÉDERM® VOLITE™; Other: Control

Interventions

JUVÉDERM® VOLITE™ DEVICE

Injection, subdermal and/or intradermal

Also known as: AGN-8015

Control - No Treatment; JUVÉDERM® VOLITE™

Control OTHER

No-treatment control

Control - No Treatment

Eligibility Criteria

• Age: 18 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 (TI) judgment, including no known active pandemic infection.
• Participants seeking improvement of transverse neck lines and hydration in neck area.
• Has moderate or severe transverse neck lines (ATNLS Grade 2 or 3) on EI live assessment.
• The participant is able to achieve at least a 1-point improvement in Allergan Transverse Neck Lines Scale (ATNLS) score with the allowed injection volume in the judgment of TI.

You may not qualify if:

• Neck deformity or significant skin laxity with severe redundant folds.
• History of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), HA (hyaluronic acid) products, or Streptococcal protein, or is planning to undergo desensitization therapy during the study.
• Have a history of or currently suffer from autoimmune disease (e.g., rheumatoid arthritis, Crohn's disease).
• Current cutaneous inflammatory or infectious processes (e.g., acne, herpes, dermatitis), abscess, an unhealed wound, or a cancerous or precancerous lesion on skin of the neck.
• History of thyroid cancer, thyroid-related diseases, skin cancer of the neck, radiation of the treatment area, or de novo cancer in the treatment area.
• Tendency to develop hypertrophic scarring.
• Has ever received permanent soft tissue fillers (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene), calcium hydroxyapatite filler, or autologous fat in the neck area.
• Has undergone neck surgery.
• Semi-permanent soft tissue fillers (e.g., poly-L-lactic acid, polycaprolactone) in the neck area within 2 years before enrollment.
• Botulinum toxin in the neck area within 6 months before enrollment.
• Neck tattoos, piercings, pigmentation, hair, or past trauma that would interfere with the visualization of the neck area for the effectiveness assessments.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (9)

China-Japan Friendship Hospital /ID# 243984

Beijing, Beijing Municipality, 100029, China

Location

Beijing Hospital /ID# 243982

Beijing, Beijing Municipality, 100730, China

Location

Peking University First Hospital /ID# 243980

Xicheng District, Beijing Municipality, 100034, China

Location

The Third Affiliated Hospital, Sun Yat-Sen University /ID# 243987

Guangzhou, Guangdong, 510630, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 243981

Wuhan, Hubei, 430022, China

Location

Zhongda Hospital Southeast University /ID# 243986

Nanjing, Jiangsu, 210009, China

Location

Wuxi People's Hospital /ID# 245875

Wuxi, Jiangsu, 214023, China

Location

Huashan Hospital, Fudan University /ID# 244044

Shanghai, Shanghai Municipality, 200040, China

Location

Tianjin Medical University General Hospital /ID# 244107

Tianjin, Tianjin Municipality, 300052, China

Location

Related Links

• clinical study report synopsis

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: February 14, 2023
• First Posted: February 23, 2023
• Study Start: April 7, 2023
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: December 8, 2025

Record last verified: 2025-12

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

CN (9)