Hyaluronic acid fillers for lips, cheeks, nasolabial folds, perioral lines, and under-eye hollows in everyday practice
Post-Marketing Clinical Follow Up On Hyaluronic Acid-Based Dermal Fillers Using COLD-X™ Technology By Symatese
This trial will try hyaluronic acid dermal fillers in adults who want cosmetic treatment of the lips, cheeks, nasolabial folds, perioral lines, or infraorbital hollows to see how long the effects last and to record safety.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 460 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Symatese Industry-sponsored |
| Locations | 8 sites (Arras and 7 other locations) |
| Trial ID | NCT07255261 on ClinicalTrials.gov |
What this trial studies
This post-market interventional protocol delivers hyaluronic acid-based dermal filler injections to adults seeking aesthetic correction of specified facial areas and follows outcomes under routine clinical conditions. Participants receive an initial injection and attend follow-up visits every six months up to 24 months, with optional retreatment at 12 or 18 months if desired. At each visit the investigator performs a brief clinical exam and participants rate their aesthetic improvement compared with pre-injection appearance and report pain from the initial injection. The primary focus is on duration of effect and ongoing monitoring for device-related adverse events in real-life use.
Who should consider this trial
Good fit: Ideal candidates are adults (18+) seeking correction of lips, perioral lines, nasolabial folds, cheeks, or infraorbital hollows who can give informed consent and are covered by a health social security system.
Not a fit: People who are pregnant or breastfeeding, have known allergy to hyaluronic acid or local anesthetics, active skin infection at the treatment site, bleeding disorders, autoimmune disease, or are taking immunosuppressant or anticoagulant medications are unlikely to be eligible or to benefit from participation.
Why it matters
Potential benefit: If successful, the results could give patients and clinicians clearer, product-specific information about how long aesthetic effects last and confirm safety in everyday practice.
How similar studies have performed: Hyaluronic acid dermal fillers have extensive prior clinical and post-market experience showing they are generally safe and can provide cosmetic benefit, although durability varies by product and treatment site.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Arras and 7 other locations
- Centre Médical Saint Jean — Arras, France (Recruiting)
- Cabinet médical — Lyon, France (Recruiting)
- Palais de Flore — Lyon, France (Recruiting)
- Centre Laser Palaiseau — Palaiseau, France (Recruiting)
- Aesthé - Marais. — Paris, France (Recruiting)
- Cabinet médical — Paris, France (Recruiting)
- Cabinet médical — Paris, France (Recruiting)
- Cabinet médical — Saint-Maur-des-Fossés, France (Recruiting)
Study contacts
- Study coordinator: Valentin BONVALET
- Email: v.bonvalet@symatese.com
- Phone: +33 (0)4 78 56 72 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.