Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Facial injection of hyaluronic acid-based dermal fillers..
- Who it may be relevant to
- Registry conditions: Lips Enhancement, Perioral Wrinkles, Nasolabial Fold Wrinkles, Cheek Augmentation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post-Marketing Clinical Follow Up On Hyaluronic Acid-Based Dermal Fillers Using COLD-X™ Technology By Symatese
Overview
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
- Device 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
- 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. [Time frame: At each follow-up visit (6 months, 12 months, 18 months and 24 months)]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 8 centers
- Centre Médical Saint Jean — Arras
- Cabinet médical — Lyon
- Palais de Flore — Lyon
- Centre Laser Palaiseau — Palaiseau
- Aesthé - Marais. — Paris
- Cabinet médical — Paris
- Cabinet médical — Paris
- Cabinet médical — Saint-Maur-des-Fossés
Identifiers
NCT: NCT07255261 · CLIN2108_CIP