Post-Marketing Study of Hyaluronic Acid Dermal Fillers Using COLD-X173 Technology for Facial Aesthetic Treatments

What this Trial Is About

Researchers are evaluating the safety and performance of hyaluronic acid-based dermal fillers designed to enhance facial features such as the lips, perioral lines, nasolabial folds, cheeks, and infraorbital hollows. This post-market interventional study aims to understand how long the effects of these products last under real-life conditions in adults aged 18 years or older. Participants may receive aesthetic treatments based on their preferences and the healthcare professionals agreement. The facial injections use hyaluronic acid-based dermal fillers with COLD-X17 technology by Symatese. Follow-up visits occur every 6 months after the initial injection, lasting up to 24 months. Retreatment is optional and may be performed at the 12-month or 18-month visits if the treated areas have returned to their pre-injection state. During each visit, investigators assess safety and performance through clinical examinations, while participants evaluate their aesthetic improvement compared to before treatment. The level of pain experienced during the initial injection is recorded. Researchers measure outcomes such as the number of patients returning to baseline appearance, injection site reactions, adverse device effects, and aesthetic improvements using validated scales. The study monitors participants over two years to gather comprehensive safety and effectiveness data.

Evaluation of Facial HA Dermal Fillers in Real-Life Conditions