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Clinical Trial NCT07255261 for Lips Enhancement, Perioral Wrinkles, Nasolabial Fold Wrinkles, Cheek Augmentation, Infraorbital Hollows is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
Clinical Trial NCT07255261 is an interventional study for Lips Enhancement, Perioral Wrinkles, Nasolabial Fold Wrinkles, Cheek Augmentation, Infraorbital Hollows that is recruiting. It started on 2 July 2025 with plans to enroll 460 participants. Led by Symatese, it is expected to complete by 1 July 2028. The latest data from ClinicalTrials.gov was last updated on 1 December 2025.
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.
Official Title
Post-Marketing Clinical Follow Up On Hyaluronic Acid-Based Dermal Fillers Using COLD-X™ Technology By Symatese
Conditions
Lips EnhancementPerioral WrinklesNasolabial Fold WrinklesCheek AugmentationInfraorbital HollowsOther Study IDs
- CLIN2108_CIP
NCT ID Number
Start Date (Actual)
2025-07-02
Last Update Posted
2025-12-01
Completion Date (Estimated)
2028-07
Enrollment (Estimated)
460
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalAesthetic treatment with hyaluronic acid (HA) of one or more regions of the face. 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. | Facial Injection of Hyaluronic Acid-based Dermal Fillers. Facial injection of hyaluronic acid-based dermal fillers USING COLD-X™ TECHNOLOGY by Symatese. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | 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) |
| Outcome Measure | 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. | 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). | 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). | 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 |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Subject seeking an aesthetic correction of the infraorbital hollows with PRECISE-HA Filler EYE 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.
- 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.
SymateseStudy Central Contact
Contact: Valentin BONVALET, +33 (0)4 78 56 72 80, [email protected]
Contact: Sébastien GUYON, +33 (0)4 78 56 72 80, [email protected]
8 Study Locations in 1 Countries
Centre Médical Saint Jean, Arras, 62000, France
Cyril Maire, Contact, +33 3 21 71 34 34, [email protected]
Recruiting
Cabinet médical, Lyon, 69005, France
Amandine CATELAIN-LAMY, Contact, +33 4 78 36 85 85, [email protected]
Recruiting
Palais de Flore, Lyon, 69006, France
Sophie Converset, Contact, +33 4 78 41 88 85, [email protected]
Recruiting
Centre Laser Palaiseau, Palaiseau, 91120, France
Diala Haykal, Contact, +33 1 60 10 64 55, [email protected]
Recruiting
Aesthé - Marais., Paris, 75004, France
Arnaud Lambert, Contact, +33 1 40 61 91 58, [email protected]
Recruiting
Cabinet médical, Paris, 75008, France
Jean-Jacques DEUTSCH, Contact, +33 1 47 20 05 03, [email protected]
Recruiting
Cabinet médical, Paris, 75116, France
Sylvie Poignonec, Contact, +33 1 45 63 13 20, [email protected]
Recruiting
Cabinet médical, Saint-Maur-des-Fossés, 94100, France
Elisabeth DOMERGUE THAN TRONG, Contact, +33 1 42 83 38 18, [email protected]
Recruiting