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Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

RecruitingNAAges 18 Years - anyAllSymatese
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In plain words

What the trial is, and whether it could suit you

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 th

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Facial injection of hyaluronic acid-based dermal fillers.
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Where

8 sites
Centre Médical Saint Jean
Arras, France
Cabinet médical
Lyon, France
Palais de Flore
Lyon, France
Centre Laser Palaiseau
Palaiseau, France
Aesthé - Marais.
Paris, France
Cabinet médical
Paris, France
Cabinet médical
Paris, France
Cabinet médical
Saint-Maur-des-Fossés, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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