NCT07255261 Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
| NCT ID | NCT07255261 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Symatese |
| Condition | Lips Enhancement |
| Study Type | INTERVENTIONAL |
| Enrollment | 460 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 460 participants in total. It began in 2025-07-02 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07255261 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lips Enhancement. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07255261 currently recruiting?
Yes, NCT07255261 is actively recruiting participants. Contact the research team at v.bonvalet@symatese.com for enrollment information.
Where is the NCT07255261 trial being conducted?
This trial is being conducted at Arras, France, Lyon, France, Lyon, France, Palaiseau, France and 4 additional locations.
Who is sponsoring the NCT07255261 clinical trial?
NCT07255261 is sponsored by Symatese. The trial plans to enroll 460 participants.