Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSymatese

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Facial injection of hyaluronic acid-based dermal fillers.

Treatment groups

460 Participants
are divided into 1 treatment group

Sponsors and collaborators