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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nasolabial Folds, Wrinkles
• Intervention / Treatment: Device: Injection of the Hyaluronic Acid-Based Dermal Filler ESTYME® LIFT (Now Marketed as ESTYME® FORM).

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Arras, France, 62000
    • Centre Médical Saint Jean
  • Lyon, France, 69006
    • Palais de Flore
  • Lyon, France, 69005
    • Cabinet Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aesthetic Treatment for the Correction of Nasolabial Folds.	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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: Symatese

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CLIN1905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No