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

Multicenter, Evaluator-blinded, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLITE™ for Correction of Neck Lines in Chinese Adults

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.

Study Overview

• Status: Completed
• Conditions: Neck Lines
• Intervention / Treatment: Other: Control; Device: JUVÉDERM® VOLITE™

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • China-Japan Friendship Hospital /ID# 243984
    • Beijing, Beijing Municipality, China, 100730
      • Beijing Hospital /ID# 243982
    • Xicheng District, Beijing Municipality, China, 100034
      • Peking University First Hospital /ID# 243980
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • The Third Affiliated Hospital, Sun Yat-Sen University /ID# 243987
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 243981
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Zhongda Hospital Southeast University /ID# 243986
    • Wuxi, Jiangsu, China, 214023
      • Wuxi People's Hospital /ID# 245875
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital, Fudan University /ID# 244044
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Medical University General Hospital /ID# 244107

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JUVÉDERM® VOLITE™; 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™; Injection, subdermal and/or intradermal; Other Names: AGN-8015
Other: Control - No Treatment; 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.	Other: Control; No-treatment control; Device: JUVÉDERM® VOLITE™; Injection, subdermal and/or intradermal; Other Names: AGN-8015

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving "Responder" Status for EI's Assessment of global aesthetic improvement on the neck using the Global Aesthetic Improvement Scale (GAIS)	A "responder" is a participant who shows improvement in the overall aesthetic assessment on the neck using GAIS. GAIS is a 5-point ordinal scale (2=Much Improved, -2=Much Worse).	Month 2
Percentage of Participants Achieving "Responder" Status for Participant's Assessment of global aesthetic improvement on the Neck using GAIS	A "responder" is a participant who shows improvement in the overall aesthetic assessment in the neck using GAIS. GAIS is a 5-point ordinal scale (2=Much Improved, -2=Much Worse)	Month 2
Change from baseline to Month 2 on FACE-Q Appraisal of Neck questionnaire overall score	FACE-Q is a 10-item questionnaire assessing various aspects of the neck appearance. In the FACE-Q Appraisal of Neck Lines questionnaire, the responses will be summed and converted to a Rasch-transformed score that ranges from 0 to 100.	Baseline to Month 2

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2023
• Primary Completion (Actual): December 9, 2024
• Study Completion (Actual): December 9, 2024

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Skin Wrinkling; Neck Lines; Juvederm VOLITE; VOLITE
• Other Study ID Numbers: M21-870

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No