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

Symatese

Status: Active, not recruiting

Conditions: Nasolabial Folds, Wrinkles

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07385053

CLIN1905

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

Aesthetic Treatment for the Correction of Nasolabial Folds.

Experimental group

Treatment:

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