Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

NCT07255261 | Recruiting

• 1 other identifier: CLIN2108_CIP
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At each follow-up visit (6 months, 12 months, 18 months and 24 months)

Secondary Outcomes (6)

• Injection site reactions (ISR) assessed by the investigators.

  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.

  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.

  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.

  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.

  At each visit (Day 0 before and after injection, at 30 Days (if any visit), 6 months, 12 months, 18 months, and 24 months)

Study Arms (1)

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

EXPERIMENTAL

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.

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

Interventions

Facial injection of hyaluronic acid-based dermal fillers. DEVICE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Symatese: lead

Study Sites (8)

Centre Médical Saint Jean

Arras, 62000, France

RECRUITING

Cabinet médical

Lyon, 69005, France

RECRUITING

Palais de Flore

Lyon, 69006, France

RECRUITING

Centre Laser Palaiseau

Palaiseau, 91120, France

RECRUITING

Aesthé - Marais.

Paris, 75004, France

RECRUITING

Cabinet médical

Paris, 75008, France

RECRUITING

Cabinet médical

Paris, 75116, France

RECRUITING

Cabinet médical

Saint-Maur-des-Fossés, 94100, France

RECRUITING

Central Study Contacts

Valentin BONVALET

CONTACT

+33 (0)4 78 56 72 80; v.bonvalet@symatese.com

Sébastien GUYON

CONTACT

+33 (0)4 78 56 72 80; s.guyon@symatese.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 1, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)