NCT07255261

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Symatese · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2025-07-02
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2025-12-01
• Last updated: 2025-12-08

Locations

8 sites across 1 country: France