RecruitingNot ApplicableNCT07255261

Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

Post-Marketing Clinical Follow Up On Hyaluronic Acid-Based Dermal Fillers Using COLD-X™ Technology By Symatese


Sponsor

Symatese

Enrollment

460 participants

Start Date

Jul 2, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria11

  • 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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Interventions

DEVICEFacial injection of hyaluronic acid-based dermal fillers.

Facial injection of hyaluronic acid-based dermal fillers USING COLD-X™ TECHNOLOGY by Symatese.


Locations(8)

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

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NCT07255261


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