Actively Recruiting
Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
Led by Symatese · Updated on 2025-12-08
460
Participants Needed
8
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Seeking aesthetic correction of infraorbital hollows with FASY P and/or lips with ESTYME�AE LIPS
- Seeking aesthetic correction of perioral lines or nasolabial folds with ESTYME�AE SMOOTH
- Seeking aesthetic correction of cheeks with ESTYME�AE SCULPT
- Age over 18 years old
- Agreed to participate and signed informed consent
- Affiliated to a health social security system
You will not qualify if you...
- Under 18 years old (minors)
- Known allergy to hyaluronic acid, lidocaine, or amide local anesthetics
- Porphyria
- Autoimmune disorders or on immunosuppressant medications
- Pregnant or breastfeeding women
- Inflammation, infection, or skin disorders at or near treatment site
- Bleeding disorders or receiving thrombolytic or anticoagulant treatment
- Treatment on areas other than those recommended by the instructions for use
- Deprived of liberty by judicial or administrative decision
- Adults under legal protection measures (guardianship/curatorship)
- Subject under legal protection order
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Centre Médical Saint Jean
Arras, France, 62000
Actively Recruiting
2
Cabinet médical
Lyon, France, 69005
Actively Recruiting
3
Palais de Flore
Lyon, France, 69006
Actively Recruiting
4
Centre Laser Palaiseau
Palaiseau, France, 91120
Actively Recruiting
5
Aesthé - Marais.
Paris, France, 75004
Actively Recruiting
6
Cabinet médical
Paris, France, 75008
Actively Recruiting
7
Cabinet médical
Paris, France, 75116
Actively Recruiting
8
Cabinet médical
Saint-Maur-des-Fossés, France, 94100
Actively Recruiting
Research Team
V
Valentin BONVALET
CONTACT
S
Sébastien GUYON
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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