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Neck LinesPhase 3NCT05741034

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

A Phase 3 study testing JUVÉDERM® VOLITE™ in people with Neck Lines, run by AbbVie at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neck Lines
What is being tested?
JUVÉDERM® VOLITE™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
9 sitesChina
Study dates
7 Apr 2023to 9 Dec 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • China-Japan Friendship Hospital /ID# 243984

    Beijing, Beijing Municipality, 100029

  • Beijing Hospital /ID# 243982

    Beijing, Beijing Municipality, 100730

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

    Guangzhou, Guangdong, 510630

  • Zhongda Hospital Southeast University /ID# 243986

    Nanjing, Jiangsu, 210009

  • Huashan Hospital, Fudan University /ID# 244044

    Shanghai, Shanghai Municipality, 200040

  • Tianjin Medical University General Hospital /ID# 244107

    Tianjin, Tianjin Municipality, 300052

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

    Wuhan, Hubei, 430022

  • Wuxi People's Hospital /ID# 245875

    Wuxi, Jiangsu, 214023

  • Peking University First Hospital /ID# 243980

    Xicheng District, Beijing Municipality, 100034

Other trials in China

About this study

Official title: 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.

Read more

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
Being tested
JUVÉDERM® VOLITE™, Control
Keywords
Neck Lines, Skin Wrinkling, Juvederm VOLITE, VOLITE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JUVÉDERM® VOLITE™Device

    Also called AGN-8015

    Injection, subdermal and/or intradermal

  • ControlOther

    No-treatment control

Study groups in NCT05741034
Study groupRoleWhat they receive
JUVÉDERM® VOLITE™ExperimentalParticipants 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.
Receives: Device: JUVÉDERM® VOLITE™
Control - No TreatmentOtherParticipants 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.
Receives: Device: JUVÉDERM® VOLITE™; Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Month 2

  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.

    Measured: Up to 13 Months

Secondary outcomes (3)

  1. 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).

    Measured: Month 2

  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)

    Measured: Month 2

  3. 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.

    Measured: Baseline to Month 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2023
  2. Study start7 Apr 2023
  3. Primary completion9 Dec 2024
  4. Study completion9 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05741034
Sponsor's protocol ID
M21-870
Status last verified
Dec 2025
First submitted
14 Feb 2023
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JUVÉDERM® VOLITE™ in people with Neck Lines, run by AbbVie at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Month 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05741034.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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