The Evaluation of Efficacy and Safety of Stylage® XL Lidocaïne for the Restoration and/or Augment… (NCT04166292) | Clinical Trial Compass
CompletedNot Applicable
The Evaluation of Efficacy and Safety of Stylage® XL Lidocaïne for the Restoration and/or Augmentation of Facial Volume
France40 participantsStarted 2019-11-21
Plain-language summary
Stylage® XL Lidocaïne is a CE-marketed hyaluronic acid gel indicated for the restoration or augmentation of facial volume by injection into the deep dermis or subcutaneously. Lidocaine hydrochloride is intended to reduce the pain associated with the injection.
In this study 40 healthy subjects between the age of 30 and 65 years, presenting a volume deficit on the face as evaluated by the investigator at inclusion in the study, who have given his/her informed consent and met all the eligibility criteria, will be enrolled.
Subjects will come to a total of 6 visits over a period of 18 months and a screening visit prior to baseline injection. The facial volume variation after baseline injection will be assessed. Treatment responders rate, Global Aesthetic Improvement, volume on the cheekbones, volume on the chin and chin angle (for applicable subjects), subject's satisfaction and safety will be also assessed.
Who can participate
Age range
30 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:
* Healthy Subject;
* Sex: male or female;
* Age: between 30 and 65 years;
* Subject having given freely and expressly his informed consent;
* Subject requiring injection on the cheekbones (upper part of the cheek);
* Subject with grade from 3 to 5 on the Facial Volume Loss Scale (FVLS);
* Subject, psychologically able to understand the study related information and to give a written informed consent;
* Subject affiliated to a health social security system;
* Female of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study and during all the study;
* Subject agreeing to keep their usual cleansing / care products during the whole study period;
* Subject agreeing to apply a Sun Protection Factor (SPF) 50 cream during non-intensive exposure to sunlight.
Exclusion Criteria:
In terms of population
* Pregnant or nursing woman or planning a pregnancy during the study;
* Subject with a scar, moles or anything on the face which might interfere with the evaluation;
* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship;
* Subject in a social or sanitary establishment;
* Subject participating to another research on human beings or who is in an exclusion period of one;
* Subject having received 4500 euros indemnities for participation in researches involving human beings in the 12 previous months, including participation in the …
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.