Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

Symatese

Status: Enrolling

Conditions: Cheek Augmentation; Infraorbital Hollows; Perioral Wrinkles; Nasolabial Fold Wrinkles; Lips Enhancement

Treatments: Device: Facial injection of hyaluronic acid-based dermal fillers.

Study type: Interventional

Funder types: Industry

Identifiers

NCT07255261

CLIN2108_CIP

Details and patient eligibility

About

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.

Enrollment: 460 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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460 participants in 1 patient group

Aesthetic treatment with hyaluronic acid (HA) of one or more regions of the face.

Experimental group

Description:

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.

Treatment:

Device: Facial injection of hyaluronic acid-based dermal fillers.