Neck LinesPhase 3NCT05316233

JUVÉDERM® VOLITE™ XC Injectable Gel for Improvement in Neck Appearance

A Phase 3 study testing VOLITE XC in people with Neck Lines, run by AbbVie at 15 sites in United States.

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

Who is it for?: Ages 22 years and older
Conditions the study is for: Neck Lines
What is being tested?: VOLITE XC
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 159 participants
Where: 15 sitesUnited States
Study dates: 2 May 2022to 12 Sep 2024
Phase: Phase 3

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 22 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 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) based on EI live assessment.

Who cannot join

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.

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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 locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Bellaire Dermatology Associates /ID# 239133
Bellaire, Texas, 77401
Aesthetic Solutions /ID# 239074
Chapel Hill, North Carolina, 27517-9901
Hevia Cosmetic Dermatology /ID# 239118
Coral Gables, Florida, 33134
Skin Research Institute LLC /ID# 239109
Coral Gables, Florida, 33146-1837
image Dermatology, P.C. /ID# 239136
Montclair, New Jersey, 07042
Delricht Research /ID# 242001
New Orleans, Louisiana, 70115
Skin And Aesthetics Surgery Of Manhattan /ID# 243607
New York, New York, 10022-3607
Steve Yoelin MD Medical Associate Inc /ID# 239072
Newport Beach, California, 92663
Rkmd, Llc /Id# 239075
North Bethesda, Maryland, 20852-3093
Laser & Skin surgery Medical group, Inc /ID# 241999
Sacramento, California, 95816-5520
Cosmetic Laser Dermatology /ID# 239121
San Diego, California, 92121-2119
Art of Skin MD /ID# 239071
Solana Beach, California, 92075-2228
Center for Dermatology and Dermatologic Surgery /ID# 239137
Washington D.C., District of Columbia, 20037-1445
Mariwalla Dermatology /ID# 239102
West Islip, New York, 11795-4916
Research Institute of the Southeast, LLC /ID# 239070
West Palm Beach, Florida, 33401-2712

Other trials in United States

About this study

Official title: Multicenter, Evaluator-blinded, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLITE™ XC Injectable Gel for Improvement in Neck Appearance

The cumulative effects of aging, weight change, ergonomics (i.e., "tech neck"), and environmental exposures (i.e., 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 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 smoothness. The purpose of this study is to assess safety and effectiveness of VOLITE XC in adults seeking improvement in neck appearance.

VOLITE XC is an investigational product intended to reduce horizontal neck lines for improvement of neck appearance. Participants are placed in 1 of 2 groups, called treatment arms. Participation will be randomized in a 2:1 ratio in treatment and control arms. Up to 212 adult participants with moderate or severe transverse neck lines will be enrolled in the study at up to 20 sites.

Participants in the treatment group will receive VOLITE XC at Day 1 and be 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 be 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
Being tested: VOLITE XC

What participants receive

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

VOLITE XCDevice
Also called JUVÉDERM® VOLITE™ XC, SKINVIVE by JUVÉDERM®, JUVÉDERM® VOLITE™
Intradermal Injection
VOLITE XCDevice
Also called JUVÉDERM® VOLITE™ XC, SKINVIVE by JUVÉDERM®, JUVÉDERM® VOLITE™
Subdermal Injection

Study groups in NCT05316233
Study group	Role	What they receive
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. Receives: 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. Receives: Device: VOLITE XC

What is being measured

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

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)
ATNLS is a 5-point photonumeric scale to grade the severity of transverse neck lines (0=None, 4=Extreme). A "responder" is a participant with at least 1-grade improvement on the ATNLS.
Measured: Month 1
Number of Participants With Treatment-Emergent 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: Baseline to end of study (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)
GAIS is a 5-point ordinal scale (2=Much Improved, -2=Much Worse). A "responder" is a participant who shows improvement in the overall aesthetic assessment on the neck using GAIS.
Measured: Month 1
Change From Baseline to Month 1 in the Rasch-transformed Scores on FACE-Q Appraisal of the Neck Questionnaire
FACE-Q is a 10-item questionnaire assessing various aspects of the neck appearance. In the FACE-Q Appraisal of the Neck questionnaire, the responses will be summed and converted to a Rasch-transformed score that ranges from 0 to 100. A higher score indicates greater satisfaction with facial appearance.
Measured: Baseline to Month 1
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 1

Timeline

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

2 May 202212 Sep 2024

First posted7 Apr 2022
Study start2 May 2022
Primary completion12 Sep 2024
Study completion12 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Neck LinesStudies of the same condition, open and under way.
More trials run by AbbVieThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: NCT05316233
Sponsor's protocol ID: 2029-701-008
Status last verified: Aug 2026
First submitted: 31 Mar 2022
Last updated: 3 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
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.