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NCT Number: NCT07385053

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Nasolabial Folds, Wrinkles

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Médical Saint Jean, Arras, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

    Time frame: At each follow-up visit, including the 9-24-month visit and the 24-month visit.

Secondary outcomes

  1. Number of adverse device effects (ADEs) and serious adverse device effects (SADEs) assessed by the investigator.

    Time frame: From the initial injection (day 0) to the end of the follow-up period (24 months).

  2. Injection site reactions (ISR) assessed by the investigator.

    Time frame: Day 0 (after the first injection), Month 1 (after the optional touch-up), and between Month 9 and Month 24 (after the optional retreatment)

  3. Investigator-assessed severity of nasolabial folds using the 6-point scale (0 = no wrinkle, 6 = very deep wrinkle)

    Time frame: 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.

  4. 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.

    Time frame: At each follow-up visit, including the 9-24-month visit and the 24-month visit.

Sponsors and collaborators

Lead sponsor

Symatese

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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