Status:
RECRUITING
Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
Lead Sponsor:
Symatese
Conditions:
Lips Enhancement
Perioral Wrinkles
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 faci...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT07255261
Start Date
July 2 2025
End Date
July 1 2028
Last Update
December 8 2025
Active Locations (8)
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1
Centre Médical Saint Jean
Arras, France, 62000
2
Cabinet médical
Lyon, France, 69005
3
Palais de Flore
Lyon, France, 69006
4
Centre Laser Palaiseau
Palaiseau, France, 91120