What side effects are associated with this type of intervention?

Common side effects of crosslinked hyaluronic acid gel implants for treating neck lines include temporary redness, swelling, pain, bruising, and tenderness at the injection site. Less common side effects may include lumps or bumps under the skin, infection, and allergic reactions. Rare but serious side effects can include vascular occlusion, which can lead to tissue necrosis if not treated promptly.

What prior FDA approvals exist?

The FDA has approved several hyaluronic acid-based fillers for cosmetic use, primarily for facial rejuvenation and the treatment of fine lines and wrinkles. Products like Juvéderm and Restylane, which are also crosslinked hyaluronic acid gels, have been widely used for these purposes. These fillers work by providing structural support and hydration to the skin, similar to the investigational product VOLITE XC being studied for neck lines. While specific FDA approvals for neck lines are less common, the use of these fillers in other facial areas suggests a potential for similar applications.

What other types of research exist?

Promising alternatives to VOLITE XC for neck lines include: 1) VYC-25L, a hyaluronic acid filler with lidocaine, designed for facial volume restoration, which could be adapted for neck lines. 2) Poly-L-lactic acid (PLLA) fillers, known for their long-lasting effects and ability to stimulate collagen production, which have been effective in treating facial lipoatrophy and nasolabial folds. 3) Calcium hydroxylapatite (Radiesse), which provides immediate volume and stimulates collagen production, used for facial wrinkles and lipoatrophy. These alternatives offer structural support and hydration, making them suitable for neck line treatment.

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Injectable Gel

VOLITE XC Injectable Gel for Neck Lines

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has moderate or severe transverse neck lines (ATNLS Grade 2 or 3) on EI live assessment

Be older than 18 years old

Must not have

Significant skin pigmentation disorders or discoloration in the neck area that would interfere with the visual assessment of the neck area

Neck deformity or significant skin laxity with severe redundant folds

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from VOLITE XC may include reactions at the injection site such as redness, swelling, pain, bruising, lumps/bumps; itching and discoloration. There might also be a risk of infection and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have moderate to severe horizontal neck lines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have a noticeable neck deformity or very loose skin with deep folds.

Select...

I haven't had HA fillers or fat injections in my neck in the last year.

Select...

I have had surgery or procedures on my neck.

Select...

I do not have any skin infections, wounds, or cancerous lesions on my neck.

Select...

I have had thyroid or skin cancer in the neck, radiation there, or a new cancer in that area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with Adverse Events

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)

Secondary study objectives

Change from baseline to Month 1 in the Rasch-transformed scores on FACE-Q Appraisal of the Neck questionnaire

Percentage of Participants Achieving "Responder" Status for EI's Assessment of global aesthetic improvement on the neck using the Global Aesthetic Improvement Scale (GAIS)

Percentage of Participants Achieving "Responder" Status for Participant's Assessment of global aesthetic improvement on the Neck using GAIS

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: VOLITE XCExperimental Treatment1 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 GroupExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VOLITE XC

2022

Completed Phase 3

~160

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Crosslinked hyaluronic acid (HA) gel implants, such as VOLITE XC, are commonly used to treat neck lines by providing structural support and hydration to the skin. HA is a naturally occurring substance in the body that attracts and retains water, which helps to maintain skin elasticity and volume. When injected into the skin, crosslinked HA gel forms a supportive matrix that fills in fine lines and wrinkles, while also promoting hydration and improving skin texture. This dual action is particularly beneficial for neck lines, which are often exacerbated by skin laxity and dehydration. By restoring volume and moisture, HA gel implants can significantly enhance the appearance of the neck, making the skin look smoother and more youthful.

Evaluating hyaluronic acid dermal fillers: A critique of current characterization methods.Safe and Effective Chin Augmentation With the Hyaluronic Acid Injectable Filler, VYC-20L.Long-Term Follow-Up of Longevity and Diffusion Pattern of Hyaluronic Acid in Nasolabial Fold Correction through High-Frequency Ultrasound.