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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
460
Facial injection of hyaluronic acid-based dermal fillers USING COLD-X™ TECHNOLOGY by Symatese.
Centre Médical Saint Jean
Arras, France
RECRUITINGCabinet médical
Lyon, France
RECRUITINGPalais de Flore
Lyon, France
RECRUITINGCentre Laser Palaiseau
Palaiseau, France
RECRUITINGAesthé - Marais.
Paris, France
RECRUITINGCabinet médical
Paris, France
RECRUITINGCabinet médical
Paris, France
RECRUITINGCabinet médical
Saint-Maur-des-Fossés, France
RECRUITINGNumber 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.
Time frame: At each follow-up visit (6 months, 12 months, 18 months and 24 months)
Injection site reactions (ISR) assessed by the investigators.
Time frame: D0 (post-first injection), M1 (post optional touch-up), M12/M18 (post optional retreatment)
Number of adverse device effects (ADEs) and serious adverse device effects (SADEs) assessed by the investigators.
Time frame: 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.
Time frame: At each visit (Day 0 after injection, day 30 (if any visit), 6 months, 12 months, 18 months and 24 months)
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.
Time frame: At each visit (Day 0 after injection, day 30 (if any visit), 6 months, 12 months, 18 months and 24 months)
Investigator-assessed wrinkle severity or volume using 5- or 6-point area-specific scales for each treated area.
Time frame: 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).
Time frame: During the initial injection procedure at day 0
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