NCT07385053

Real-Life Evaluation of the HA Dermal Filler ESTYME® LIFT

Post-Marketing Clinical Follow Up of ESTYME® LIFT in the Correction of Nasolabial Folds

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Symatese · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nasolabial Folds, Wrinkles

Interventions

Type	Name	Description
DEVICE	Injection 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.

Timeline

• Start date: 2023-06-05
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2026-02-03
• Last updated: 2026-02-03

Locations

3 sites across 1 country: France