Neuramis® Volume Lidocaine Treatment in Patients With Loss of Mid-face Volume (NCT02721368) | Clinical Trial Compass
CompletedNot Applicable
Neuramis® Volume Lidocaine Treatment in Patients With Loss of Mid-face Volume
South Korea88 participantsStarted 2016-11-03
Plain-language summary
The purpose of this study is to compare the safety and efficacy of Neuramis® Volume Lidocaine, which is a biomaterial prosthesis and graft, with Juvederm® Voluma® with Lidocaine, for the patients who need correction due to a moderate-to-severe volume loss in the mid-facial region by inducing temporary volume restoration in mid-facial region. After the pivotal study, extension study will be conducted to confirm long-term safety and efficacy.
Who can participate
Age range
35 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject aged between 35 and 65.
. Mid-facial region symmetrical, severity greater than MFVDS moderate-to-severe level
Exclusion criteria
. Those who have anticoagulant therapy, antiplatelet therapy, and non-steroidal anti-inflammatory drugs
. Those who have history of receiving the procedures which are considered to affect on the assessment of this clinical trial.
. Those who has thin skin in the mid-facial area
. Those with hypersensitivity to sodium hyaluronate or lidocaine or amide type local anesthetics
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)
Timeframe: 24 weeks
2
Ratio of subjects defined as improved by independent photograph evaluator according to the overall Mid-Face Volume Deficit Scale(MFVDS)
. Participated in the pivotal study and completed the end of study visit
. Agreed not to receive any procedure or treatment that may have an effect on the restoration of the mid-face volume while participating in the extension study
. Those who have following procedual history between completion of the pivotal study and entry of extension study
. Subjects with asymmetric MVD(Mid-face volume deficit) or facial scar interfering with accurate assessment