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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 months
Awards & highlights
Study 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.
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.
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
962 Previous Clinical Trials
502,954 Total Patients Enrolled
1 Trials studying Neck Lines
159 Patients Enrolled for Neck Lines
ABBVIE INC.Study DirectorAbbVie
400 Previous Clinical Trials
147,528 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To how many patients does this trial have access?
"This trial is based in Mariwalla Dermatology in West Islip, New york; Research Institute of the Southeast, LLC in West Palm Beach, Florida; Skin And Aesthetics Surgery Of Manhattan in New York, District of Columbia; and 15 other locations."
Answered by AI
How many participants are being taken in for this clinical trial?
"A total of 212 participants are required for this clinical trial, all of which must meet the certain eligibility requirements. Patients can enroll at different research sites, such as Mariwalla Dermatology in West Islip, New york and Research Institute of the Southeast, LLC in West Palm Beach, Florida."
Answered by AI
Are people with the necessary medical conditions able to sign up for this study?
"According to the latest information available on clinicaltrials.gov, this study is actively looking for participants. The original posting date was May 1st, 2022 and the listing was most recently updated on July 5th, 2022."
Answered by AI
Who else is applying?
What state do they live in?
Louisiana
California
New York
Other
How old are they?
18 - 65
What site did they apply to?
Delricht Research /ID# 242001
Skin And Aesthetics Surgery Of Manhattan /ID# 243607
Mariwalla Dermatology /ID# 239102
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0
What questions have other patients asked about this trial?
How long will the screening take?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I would love to be rid of these neck lines as they age me significantly. For years I’ve not liked the lines on my neck at least the last 50 years. It would be nice not to have them any longer.
PatientReceived 2+ prior treatments
I want to look my best as much as possible. I want to age gracefully and enjoy a long productive life. Looking better makes me feel better.
PatientReceived no prior treatments
I am only 46, but feel as though my neck lines have aged me more. I feel as though many of my new wrinkles have snuck up on me all at once, and I am looking for the best way to minimize their appearance.
PatientReceived no prior treatments
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