Cheek Augmentation, Infraorbital Hollows, Lips Enhancement, Nasolabial Fold Wrinkles, Perioral Wrinkles
Conditions
Brief 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.
Interventions
DEVICEFacial injection of hyaluronic acid-based dermal fillers.
Facial injection of hyaluronic acid-based dermal fillers USING COLD-X™ TECHNOLOGY by Symatese.
Sponsors
Symatese
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | At each follow-up visit (6 months, 12 months, 18 months and 24 months) |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse device effects (ADEs) and serious adverse device effects (SADEs) assessed by the investigators. | From the injection (day 0) to the end of the follow-up period (24 months). |
| Subject-assessed aesthetic improvement of each treated area, measured using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale ranging from worse to very much improved. | At each visit (Day 0 after injection, day 30 (if any visit), 6 months, 12 months, 18 months and 24 months) |
| Injection site reactions (ISR) assessed by the investigators. | D0 (post-first injection), M1 (post optional touch-up), M12/M18 (post optional retreatment) |
| Investigator-assessed wrinkle severity or volume using 5- or 6-point area-specific scales for each treated area. | At each visit (Day 0 before and after injection, at 30 Days (if any visit), 6 months, 12 months, 18 months, and 24 months) |
| Subject-reported pain per treated area, rated on an 11-point scale (0 = no pain, 10 = worst pain). | During the initial injection procedure at day 0 |
| Investigator-assessed aesthetic improvement of each treated area, measured using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale ranging from worse to very much improved. | At each visit (Day 0 after injection, day 30 (if any visit), 6 months, 12 months, 18 months and 24 months) |
Countries
France
Contacts
Primary ContactValentin BONVALET
Backup ContactSébastien GUYON
Outcome results
None listed