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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Centre Médical Saint Jean
Arras, France
Cabinet médical
Lyon, France
Palais de Flore
Lyon, France
Centre Laser Palaiseau
Palaiseau, France
Aesthé - Marais.
Paris, France
Cabinet médical
Paris, France
Cabinet médical
Paris, France
Cabinet médical
Saint-Maur-des-Fossés, France
Start Date
July 2, 2025
Primary Completion Date
July 1, 2028
Completion Date
July 1, 2028
Last Updated
December 8, 2025
460
ESTIMATED participants
Facial injection of hyaluronic acid-based dermal fillers.
DEVICE
Lead Sponsor
Symatese
NCT06854796
NCT07367204
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05162326