VOLITE XC Injectable Gel for Neck Lines

Recruiting at 18 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

159 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug JUVÉDERM® VOLITE™ XC Injectable Gel for neck lines?

Research shows that Juvéderm Volite, which is similar to JUVÉDERM® VOLITE™ XC, is effective in improving skin smoothness and hydration when used on the face. This suggests it might also help with neck lines by enhancing skin quality. ^{1 2 3 4 5}

Is JUVÉDERM® VOLITE™ XC Injectable Gel safe for use in humans?

Research shows that JUVÉDERM® VOLITE™ XC, a hyaluronic acid gel, is generally safe for improving skin quality, such as smoothness and hydration, when injected into the skin. ^{1 2 3 6 7}

How is the drug JUVÉDERM® VOLITE™ XC unique for treating neck lines?

JUVÉDERM® VOLITE™ XC is unique because it is an injectable gel made from hyaluronic acid (a substance that helps keep skin hydrated and plump) designed for intradermal injection, which means it's injected just under the skin to improve skin quality and smoothness. It offers longer-lasting effects with a lower concentration of hyaluronic acid compared to other treatments. ^{1 2 3 8 9}

What is the purpose of this trial?

This trial is testing VOLITE XC, a gel injected into the neck to reduce fine lines and improve skin quality. It targets adults with noticeable neck lines. The gel works by filling in lines and improving skin texture, with a small amount of anesthetic to reduce pain. Participants will be monitored for side effects and effectiveness over time. Juvéderm Volite has been shown to improve skin quality in previous studies.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical experience with a new injectable hyaluronic acid designed to improve skin quality in a private clinic in Brazil: A retrospective cohort study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Volumizing Hyaluronic Acid Filler for Midface Volume Deficit: Results After Repeat Treatment. [2015]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of the Hyaluronic Acid Dermal Filler VYC-17.5L for Nasolabial Folds: Results of a Randomized, Controlled Study. [2022]

6. England 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Duration of effect by injection volume and facial subregion for a volumizing hyaluronic acid filler in treating midface volume deficit. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of Repeat Treatment With VYC-15L for Lip and Perioral Enhancement: Results From a Prospective Multicenter Study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of VYC-15L, a Hyaluronic Acid Filler for Lip and Perioral Enhancement: One-Year Results From a Randomized, Controlled Study. [2017]