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NCT Number: NCT07255261

Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

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.

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Key information

Conditions

Lips Enhancement Cheek Augmentation Infraorbital Hollows Nasolabial Fold Wrinkles Perioral Wrinkles

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Médical Saint Jean, Arras, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Facial injection of hyaluronic acid-based dermal fillers.

Device

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

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.

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

Secondary outcomes

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

    Time frame: D0 (post-first injection), M1 (post optional touch-up), M12/M18 (post optional retreatment)

  2. Number of adverse device effects (ADEs) and serious adverse device effects (SADEs) assessed by the investigators.

    Time frame: From the injection (day 0) to the end of the follow-up period (24 months).

  3. 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.

    Time frame: At each visit (Day 0 after injection, day 30 (if any visit), 6 months, 12 months, 18 months and 24 months)

  4. 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.

    Time frame: At each visit (Day 0 after injection, day 30 (if any visit), 6 months, 12 months, 18 months and 24 months)

  5. Investigator-assessed wrinkle severity or volume using 5- or 6-point area-specific scales for each treated area.

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

  6. Subject-reported pain per treated area, rated on an 11-point scale (0 = no pain, 10 = worst pain).

    Time frame: During the initial injection procedure at day 0

Study contacts

Contact information is provided by the study sponsor or research team.

Sébastien GUYON

CONTACT

[email protected]

+33 (0)4 78 56 72 80

Valentin BONVALET

CONTACT

[email protected]

+33 (0)4 78 56 72 80

Sponsors and collaborators

Lead sponsor

Symatese

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Dec 1, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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