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

NCT07385053 | Active Not Recruiting

• 1 other identifier: CLIN1905
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 3

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.

Conditions

Nasolabial Folds, Wrinkles

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

Study Arms (1)

Aesthetic Treatment for the Correction of Nasolabial Folds.

EXPERIMENTAL

Device: Injection of the Hyaluronic Acid-Based Dermal Filler ESTYME® LIFT (Now Marketed as ESTYME® FORM).

Interventions

Injection of the Hyaluronic Acid-Based Dermal Filler ESTYME® LIFT (Now Marketed as ESTYME® FORM). DEVICE

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.

Aesthetic Treatment for the Correction of Nasolabial Folds.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Symatese: lead

Study Sites (3)

Centre Médical Saint Jean

Arras, 62000, France

Location

Cabinet médical

Lyon, 69005, France

Location

Palais de Flore

Lyon, 69006, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 3, 2026
• Study Start: June 5, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)