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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
Summary
This trial is being conducted to assess the safety and effectiveness of VOLITE XC, an injectable gel, for the improvement of horizontal neck lines.
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.Check my eligibility
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.See study design
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Change from baseline to Month 1 on FACE-Q Appraisal of Neck Lines 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
Side effects data
From undefined Phase 3 trial • 332 Patients • NCT012403821%
Eye irritation
1%
Gastrointestinal bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.1% HA
3% DE-089
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.
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.
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.
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
983 Previous Clinical Trials
509,202 Total Patients Enrolled
1 Trials studying Neck Lines
159 Patients Enrolled for Neck Lines
ABBVIE INC.Study DirectorAbbVie
414 Previous Clinical Trials
151,733 Total Patients Enrolled
1 Trials studying Neck Lines
159 Patients Enrolled for Neck Lines
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have skin color changes on my neck that could affect skin checks.I haven't had cosmetic procedures on my neck in the last year.I have a noticeable neck deformity or very loose skin with deep folds.I haven't had HA fillers or fat injections in my neck in the last year.I want to improve the horizontal lines on my neck.I haven't had fat reduction treatments under my chin in the last 6 months.I have had surgery or procedures on my neck.I do not have any skin infections, wounds, or cancerous lesions on my neck.I have not had soft tissue fillers in my neck in the last 2 years.I have moderate to severe horizontal neck lines.I haven't had botulinum toxin in my neck in the last 6 months.I have had thyroid or skin cancer in the neck, radiation there, or a new cancer in that area.
Research Study Groups:
This trial has the following groups:- Group 1: VOLITE XC
- Group 2: Control Group
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Neck Lines Patient Testimony for trial: Trial Name: NCT05316233 — Phase 3
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