Evaluation of Facial HA Dermal Fillers in Real-Life Conditions (NCT07255261) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
France460 participantsStarted 2025-07-02
Plain-language summary
The goal of this post-market interventional study is to confirm, under real-life conditions, the safety and performance of hyaluronic acid-based dermal fillers intended to modify skin anatomy and facial appearance. Subjects aged 18 years or older seeking aesthetic treatment of the lips, perioral lines, nasolabial folds, cheeks, and/or infraorbital hollows may be included. The main question the study aims to answer is: How long does the effect of the products last?
Participants will attend follow-up visits every 6 months after the initial injection, until the end of follow-up at 24 months. During each visit, the investigator will assess performance and safety through a simple clinical examination. At each follow-up visit, subjects will also evaluate the aesthetic improvement compared with their pre-injection appearance. Subjects will be asked about the level of pain experienced during the initial injection.
If the subject wishes, a retreatment may be performed at the 12-month or 18-month follow-up visit, provided that the treated area(s) have returned to the pre-injection state.
Who can participate
Age range
18 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 seeking an aesthetic correction of the infraorbital hollows with FASY P and/ or an aesthetic correction of the lips with ESTYME® LIPS, and/ or an aesthetic correction of the perioral lines with ESTYME® SMOOTH, and/ or an aesthetic correction of nasolabial folds with ESTYME® SMOOTH, and/ or an aesthetic correction of cheeks with ESTYME® SCULPT.
* Subject who agreed to participate and have signed an informed consent.
* Age: over 18 years old.
* Subject being affiliated to a health social security system.
Exclusion Criteria:
* Minors
* Subjects with a known allergy to hyaluronic acid, lidocaine or amide local anesthetics.
* Subjects with porphyria.
* Subjects with an autoimmune disorder, or using an immunosuppressant medication.
* Pregnant or breastfeeding women.
* Subjects with inflammation, infection or cutaneous disorders, at the treatment site or nearby.
* Subjects with bleeding disorders or in subjects receiving thrombolytic or anticoagulant treatment.
* Areas other than those recommended by the IFU.
* Subject deprived of liberty by judicial or administrative decision.
* Adults under a legal protection measure (guardianship/curatorship).
* Subject under legal protection order.
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 patients returning to their baseline (pre-injection) state for each treated area, based on the investigator's assessment using 5- or 6-point area-specific scales.
Timeframe: At each follow-up visit (6 months, 12 months, 18 months and 24 months)