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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aesthetic treatment with hyaluronic acid (HA) of one or more regions of the face. | Experimental | Based on their preferences and with the agreement of the healthcare professional, subjects may receive aesthetic treatments of the lips, perioral lines, nasolabial folds, cheeks, and/or infraorbital hollows. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facial injection of hyaluronic acid-based dermal fillers. | Device | Facial injection of hyaluronic acid-based dermal fillers USING COLD-X™ TECHNOLOGY by Symatese. |
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| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Injection site reactions (ISR) assessed by the investigators. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valentin BONVALET | Contact | +33 (0)4 78 56 72 80 | v.bonvalet@symatese.com | |
| Sébastien GUYON | Contact | +33 (0)4 78 56 72 80 | s.guyon@symatese.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Médical Saint Jean | Recruiting | Arras | 62000 | France |
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| 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) |
| 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) |
| 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 |
| Cabinet médical | Recruiting | Lyon | 69005 | France |
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| Palais de Flore | Recruiting | Lyon | 69006 | France |
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| Centre Laser Palaiseau | Recruiting | Palaiseau | 91120 | France |
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| Aesthé - Marais. | Recruiting | Paris | 75004 | France |
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| Cabinet médical | Recruiting | Paris | 75008 | France |
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| Cabinet médical | Recruiting | Paris | 75116 | France |
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| Cabinet médical | Recruiting | Saint-Maur-des-Fossés | 94100 | France |
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