VOLITE XC Injectable Gel for Neck Lines

No longer recruiting at 19 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Neck deformity, Skin pigmentation disorders, Cancer history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests VOLITE XC, a gel treatment designed to improve the appearance of horizontal neck lines. The trial aims to evaluate the treatment's effectiveness and identify any side effects. Participants will either receive the treatment or join a control group without treatment, with an opportunity to receive the treatment later. Adults in good health with noticeable neck lines (but not severe skin issues) may qualify for this trial. Participants will attend regular check-ups to monitor results and any side effects. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, certain cosmetic procedures and treatments in the neck area are not allowed within specific timeframes before enrollment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that JUVÉDERM® VOLITE™ XC is generally safe. Past studies on the face and neck have demonstrated a good safety record. Side effects, if any, are usually mild and temporary, such as swelling, redness, or tenderness at the injection site.

The product is approved in Europe for facial use, meeting certain safety standards. While this trial examines its use for neck lines, similar products have been safely used for facial wrinkles in the U.S.

Every treatment can have side effects, but evidence so far indicates that VOLITE XC is generally safe. Discuss any concerns with the trial team or your healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

JUVÉDERM® VOLITE™ XC Injectable Gel is unique because it targets neck lines with a formulation specifically designed for skin hydration and elasticity. Unlike traditional treatments like topical creams or more invasive procedures, VOLITE XC offers a minimally invasive option that delivers hyaluronic acid directly into the skin, promoting a smoother appearance and long-lasting results. Researchers are excited about this treatment because it combines effectiveness with convenience, potentially offering noticeable improvements with fewer sessions and less downtime.

What evidence suggests that this trial's treatment could be effective for neck lines?

Studies have shown that JUVÉDERM VOLITE XC can improve skin quality and reduce fine lines. In this trial, participants will receive VOLITE XC for initial treatment and be monitored for up to 14 months. A control group will initially receive no treatment but can opt for VOLITE XC after 6 months. In a study with 235 patients, a similar product, Juvéderm Voluma XC, significantly improved facial appearance, with 92.8% of patients noticing a positive change. Research suggests that Juvéderm Volite helps make skin look smoother and healthier. This treatment uses a special gel to hydrate the skin and fill in lines, making it look more youthful. While specific results for neck lines are still under study, the outcomes for facial use are promising. ^{1 2 3 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults with moderate to severe horizontal neck lines who are in good health and have not had certain treatments or conditions that could affect their neck appearance. People can't join if they've had recent cosmetic procedures, skin pigmentation issues, scars, tattoos, or infections in the neck area; are pregnant; or have a history of certain cancers.

Inclusion Criteria

I want to improve the horizontal lines on my neck.

Participants in general good health as determined by Treating Investigator's judgment, including no known active pandemic infection

I have moderate to severe horizontal neck lines.

Exclusion Criteria

Permanent soft tissue fillers in the neck area

Pregnant, nursing or planning a pregnancy

I have skin color changes on my neck that could affect skin checks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the treatment group receive VOLITE XC at Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with optional touch-up and repeat treatments

14 months

Regular visits (in-person)

Control Follow-up

Control group participants are followed for up to 6 months after randomization

6 months

Regular visits (in-person)

Optional Extension

Control group participants can opt to receive VOLITE XC and are followed for an additional 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• JUVÉDERM® VOLITE™ XC Injectable Gel

Trial Overview The study tests VOLITE XC injectable gel's safety and effectiveness on improving the appearance of neck lines. Participants will be randomly assigned to either receive VOLITE XC treatment or no treatment (control group). The treated group gets injections at Day 1 with follow-ups for up to 14 months including optional touch-ups.

How Is the Trial Designed?

Group I: VOLITE XC Experimental Treatment 1 Intervention

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.

Group II: Control Group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

In a study of 235 patients, Juvéderm Voluma XC significantly improved midface volume and overall facial appearance, with 92.8% of patients reporting improvement at 6 months and 79.0% at 2 years after treatment.

The treatment was well-tolerated, with most side effects like tenderness and swelling being mild to moderate and lasting less than 2 weeks, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multicenter, Single-Blind Randomized, Controlled Study of a Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Patient-Reported Outcomes at 2 Years. Few, J., Cox, SE., Paradkar-Mitragotri, D., et al.[2022]

The hyaluronic acid filler VYC-20L was found to be safe and effective for chin augmentation, with a high responder rate of 91.8% when assessed live at 6 months after treatment.

Live assessments of treatment response yielded significantly higher rates of improvement compared to photographic assessments (91.8% vs. 56.3%), suggesting that live evaluations may better reflect real-world outcomes in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Higher Responder Rates Observed With Live Participant Assessment Versus Photo Assessment After VYC-20L Hyaluronic Acid Treatment for Chin Augmentation. Dayan, S., Green, JB., Schlesinger, T., et al.[2023]

In a study of 167 subjects with age-related midface volume deficit, repeat treatment with Juvéderm Voluma XC (VYC-20L) demonstrated high effectiveness, with 82.8% and 91.1% of subjects showing improvement at 6 and 12 months, respectively.

The safety profile improved with repeat treatments, as the incidence and severity of common treatment-site responses were lower compared to initial treatments, indicating that VYC-20L is well tolerated over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Results After Repeat Treatment. Baumann, L., Narins, RS., Beer, K., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05316233

NCT05316233 | A Study to Assess Adverse Events and ... 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 ...

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=2029-701-008

A Study to Assess Adverse Events and Change in Disease ... The purpose of this study is to assess adverse events and effectiveness of VOLITE XC in adults seeking improvement in neck appearance.

3. withpower.com withpower.com/trial/phase-ae989

VOLITE XC Injectable Gel for Neck Lines In a study of 235 patients, Juvéderm Voluma XC significantly improved midface volume and overall facial appearance, with 92.8% of patients reporting improvement ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf11/P110033S059B.pdf

Summary of Safety and Effectiveness Data (SSED) The current supplement was submitted for SKINVIVE™ by JUVÉDERM® for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8493242/

Clinical experience with a new injectable hyaluronic acid ... This study has shown, based on clinical observation, that Juvéderm Volite is a useful tool to improve skin quality, requiring fewer and less frequent ...

6. media.allergan.com media.allergan.com/actavis/actavis/media/general/73402ED13_Volite%20_DFU_ANZ_approved.pdf

V O L I T E™ The efficacy and safety of Juvéderm® VOLITE™ has been clinically studied only in the face and neck. • Health care professionals must take into account the fact ...

7. drtyrone.com drtyrone.com/content/uploads/pdfs/juvederm.pdf

JUVÉDERM® XC Indication and Important Safety Information JUVÉDERM® XC injectable gel is for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds ...