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

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.

Study Overview

• Status: Recruiting
• Conditions: Nasolabial Fold Wrinkles; Cheek Augmentation; Infraorbital Hollows; Lips Enhancement; Perioral Wrinkles
• Intervention / Treatment: Device: Facial injection of hyaluronic acid-based dermal fillers.

• Study Type: Interventional
• Enrollment (Estimated): 460
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valentin BONVALET; Phone Number: +33 (0)4 78 56 72 80; Email: v.bonvalet@symatese.com
• Study Contact Backup: Name: Sébastien GUYON; Phone Number: +33 (0)4 78 56 72 80; Email: s.guyon@symatese.com

Study Locations

• France
  • Arras, France, 62000
    • Recruiting
    • Centre Médical Saint Jean
    • Contact: Cyril Maire; Phone Number: +33 3 21 71 34 34; Email: maire.dermatologie@hotmail.fr
  • Lyon, France, 69005
    • Recruiting
    • Cabinet Medical
    • Contact: Amandine CATELAIN-LAMY; Phone Number: +33 4 78 36 85 85; Email: amandinelamy28@icloud.com
  • Lyon, France, 69006
    • Recruiting
    • Palais de Flore
    • Contact: Sophie Converset; Phone Number: +33 4 78 41 88 85; Email: drconverset@gmail.com
  • Palaiseau, France, 91120
    • Recruiting
    • Centre Laser Palaiseau
    • Contact: Diala Haykal; Phone Number: +33 1 60 10 64 55; Email: docteur.haykal@gmail.com
  • Paris, France, 75008
    • Recruiting
    • Cabinet Medical
    • Contact: Jean-Jacques DEUTSCH; Phone Number: +33 1 47 20 05 03; Email: deutschjj@gmail.com
  • Paris, France, 75004
    • Recruiting
    • Aesthé - Marais.
    • Contact: Arnaud Lambert; Phone Number: +33 1 40 61 91 58; Email: aldermoaesthetic@gmail.com
  • Paris, France, 75116
    • Recruiting
    • Cabinet Medical
    • Contact: Sylvie Poignonec; Phone Number: +33 1 45 63 13 20; Email: sylvie@poignonec.com
  • Saint-Maur-des-Fossés, France, 94100
    • Recruiting
    • Cabinet Medical
    • Contact: Elisabeth DOMERGUE THAN TRONG; Phone Number: +33 1 42 83 38 18; Email: elisabeth.domergue.than.trong@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aesthetic treatment with hyaluronic acid (HA) of one or more regions of the face.; 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.; Facial injection of hyaluronic acid-based dermal fillers USING COLD-X™ TECHNOLOGY by Symatese.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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).
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)
Subject-reported pain per treated area, rated on an 11-point scale (0 = no pain, 10 = worst pain).	During the initial injection procedure at day 0
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)

Collaborators and Investigators

• Sponsor: Symatese

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Estimated): December 1, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CLIN2108_CIP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No