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Post-Marketing Clinical Follow Up of ESTYME® LIFT in the Correction of Nasolabial Folds
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.
Details
| Lead sponsor | Symatese |
|---|---|
| Phase | NA |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 96 |
| Start date | 2023-06-05 |
| Completion | 2026-04 |
Conditions
- Nasolabial Folds, Wrinkles
Interventions
- Injection of the Hyaluronic Acid-Based Dermal Filler ESTYME® LIFT (Now Marketed as ESTYME® FORM).
Primary outcomes
- 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.
Countries
France