Nasolabial Folds, Wrinkles
Conditions
Brief summary
The objective of this post-market interventional study is to confirm, under real-life conditions, the safety and performance of a hyaluronic acid-based dermal filler intended for the aesthetic correction of nasolabial folds. The primary question addressed by the study is: How long does the effect of the product last? Following the initial injection session, which includes an optional touch-up planned one month after the first injection, participants will attend a follow-up visit scheduled between 9 and 24 months after the initial treatment. During this visit, patients may receive a retreatment if they wish. The flexibility of the follow-up window between 9 and 24 months was defined to allow patients to return on their own initiative for retreatment, thereby indicating the end of the effect of the initial injection session. A final follow-up visit is also scheduled at 24 months. At each visit, the investigator will assess both performance and safety through a clinical examination. In addition, at each follow-up visit, participants will evaluate the aesthetic improvement compared with their pre-injection appearance.
Interventions
DEVICEInjection of the Hyaluronic Acid-Based Dermal Filler ESTYME® LIFT (Now Marketed as ESTYME® FORM).
The device will be used under real-life conditions. Following the initial injection session, an optional touch-up may be performed one month after the first injection. A retreatment session may be offered to the patient between 9 and 24 months after the initial injection.
Sponsors
Symatese
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject seeking an aesthetic procedure defined by the correction of nasolabial folds with Estyme® LIFT (now marketed as ESTYME® FORM). * 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
* Patients with a known allergy to hyaluronic acid, lidocaine or amide local anesthetics. * Patients with porphyria. * Patients with an autoimmune disorder, or using an immunosuppressant medication. * Pregnant or breastfeeding women. * Patients with cutaneous disorders, inflammation or infection (herpes, acne, etc.) at the treatment siteor nearby. * Patients with bleeding disorders or in patients receiving thrombolytic or anticoagulant treatment. * Patients with an active or history of streptococcal diseases. * Children.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients who returned to their baseline (pre-injection) state, as assessed by the investigator using the 6-point nasolabial fold scale (0 = no wrinkle; 6 = very deep wrinkle). | At each follow-up visit, including the 9-24-month visit and the 24-month visit. |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse device effects (ADEs) and serious adverse device effects (SADEs) assessed by the investigator. | From the initial injection (day 0) to the end of the follow-up period (24 months). |
| Injection site reactions (ISR) assessed by the investigator. | Day 0 (after the first injection), Month 1 (after the optional touch-up), and between Month 9 and Month 24 (after the optional retreatment) |
| Investigator-assessed severity of nasolabial folds using the 6-point scale (0 = no wrinkle, 6 = very deep wrinkle) | Assessments were performed before and after each injection (D0: initial injection; M1: optional touch-up; between M9 and M24: optional retreatment), as well as at each follow-up visit, including the 9-24-month and 24-month visits. |
| Aesthetic change, as assessed by the subject compared with baseline, using the 5-point Global Aesthetic Improvement Scale (GAIS) from 'worse' to 'very much improved. | At each follow-up visit, including the 9-24-month visit and the 24-month visit. |
Countries
France
Outcome results
None listed