Emervel for the Correction of Lower Face Wrinkles & Folds (NCT02718040) | Clinical Trial Compass
CompletedPhase 4
Emervel for the Correction of Lower Face Wrinkles & Folds
30 participantsStarted 2016-04
Plain-language summary
This study is designed to
1. evaluate the naturalness of facial expressions in motion (2D video images), by treating investigator assessment
2. evaluate naturalness of facial expressions (photographs), by treating investigator assessment
3. evaluate perceived attractiveness and age of subject (2D videos), by treating investigator assessment
4. evaluate aesthetic improvement, by subject and treating investigator assessments
5. evaluate subject satisfaction
6. evaluate nasolabial fold (NLF) severity, by treating investigator assessment
7. evaluate marionette lines (MLs) severity, by treating investigator assessment
8. evaluate dynamic facial strain in animation using 3D digital photogrammetric analysis
9. evaluate all adverse events reported during the study.
Who can participate
Age range
40 Years – 65 Years
Sex
FEMALE
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
. Seeking correction of bilateral NLFs: severe (i.e., bilateral WSRS = 3-4) or moderate (i.e., bilateral WSRS = 2-3) AND bilateral MLs: severe (i.e., WAS = 3-4) or moderate (i.e., WAS = 2-3).
. Subjects of childbearing potential who agree to use medically accepted methods of contraception during the study and for 30 days following study completion.
. Intent to undergo optimal correction of bilateral NLFs and MLs. Optimal correction is defined as the best possible aesthetic outcome as agreed to by the treating investigator and subject.
Exclusion criteria
. Subject who presents with a severity of wrinkles or folds that require other treatments, e.g. laser treatment, chemical peeling, to achieve optimal correction.
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
Number of Subjects With Naturalness of Expression in Motion (2D Video)
. Previous facial surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area.
. Previous tissue augmenting therapy or contouring with permanent or non-permanent filler or fat-injection in the facial area.
. Previous tissue revitalization treatment with neurotoxin in the facial area within 6 months before treatment.
. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel.
. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
. Known/previous allergy or hypersensitivity to gram-positive bacterial proteins.
. Any medical condition that, in the opinion of the treating investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).