Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

NCT ID: NCT07255261

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-02

Study Completion Date

2028-07-31

Brief Summary

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The goal of this post-market interventional study is to confirm, under real-life conditions, the safety and performance of hyaluronic acid-based dermal fillers intended to modify skin anatomy and facial appearance. Subjects aged 18 years or older seeking aesthetic treatment of the lips, perioral lines, nasolabial folds, cheeks, and/or infraorbital hollows may be included. The main question the study aims to answer is: How long does the effect of the products last?

Participants will attend follow-up visits every 6 months after the initial injection, until the end of follow-up at 24 months. During each visit, the investigator will assess performance and safety through a simple clinical examination. At each follow-up visit, subjects will also evaluate the aesthetic improvement compared with their pre-injection appearance. Subjects will be asked about the level of pain experienced during the initial injection.

If the subject wishes, a retreatment may be performed at the 12-month or 18-month follow-up visit, provided that the treated area(s) have returned to the pre-injection state.

Detailed Description

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Conditions

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Lips Enhancement Perioral Wrinkles Nasolabial Fold Wrinkles Cheek Augmentation Infraorbital Hollows

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aesthetic treatment with hyaluronic acid (HA) of one or more regions of the face.

Based on their preferences and with the agreement of the healthcare professional, subjects may receive aesthetic treatments of the lips, perioral lines, nasolabial folds, cheeks, and/or infraorbital hollows.

Group Type EXPERIMENTAL

Facial injection of hyaluronic acid-based dermal fillers.

Intervention Type DEVICE

Facial injection of hyaluronic acid-based dermal fillers USING COLD-X™ TECHNOLOGY by Symatese.

Interventions

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Facial injection of hyaluronic acid-based dermal fillers.

Facial injection of hyaluronic acid-based dermal fillers USING COLD-X™ TECHNOLOGY by Symatese.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject seeking an aesthetic correction of the infraorbital hollows with FASY P and/ or an aesthetic correction of the lips with ESTYME® LIPS, and/ or an aesthetic correction of the perioral lines with ESTYME® SMOOTH, and/ or an aesthetic correction of nasolabial folds with ESTYME® SMOOTH, and/ or an aesthetic correction of cheeks with ESTYME® SCULPT.
* 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

* Minors
* Subjects with a known allergy to hyaluronic acid, lidocaine or amide local anesthetics.
* Subjects with porphyria.
* Subjects with an autoimmune disorder, or using an immunosuppressant medication.
* Pregnant or breastfeeding women.
* Subjects with inflammation, infection or cutaneous disorders, at the treatment site or nearby.
* Subjects with bleeding disorders or in subjects receiving thrombolytic or anticoagulant treatment.
* Areas other than those recommended by the IFU.
* Subject deprived of liberty by judicial or administrative decision.
* Adults under a legal protection measure (guardianship/curatorship).
* Subject under legal protection order.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Symatese

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Médical Saint Jean

Arras, , France

Site Status RECRUITING

Cabinet médical

Lyon, , France

Site Status RECRUITING

Palais de Flore

Lyon, , France

Site Status RECRUITING

Centre Laser Palaiseau

Palaiseau, , France

Site Status RECRUITING

Aesthé - Marais.

Paris, , France

Site Status RECRUITING

Cabinet médical

Paris, , France

Site Status RECRUITING

Cabinet médical

Paris, , France

Site Status RECRUITING

Cabinet médical

Saint-Maur-des-Fossés, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Valentin BONVALET

Role: CONTACT

+33 (0)4 78 56 72 80

Sébastien GUYON

Role: CONTACT

+33 (0)4 78 56 72 80

Facility Contacts

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Cyril Maire

Role: primary

+33 3 21 71 34 34

Amandine CATELAIN-LAMY

Role: primary

+33 4 78 36 85 85

Sophie Converset

Role: primary

+33 4 78 41 88 85

Diala Haykal

Role: primary

+33 1 60 10 64 55

Arnaud Lambert

Role: primary

+33 1 40 61 91 58

Jean-Jacques DEUTSCH

Role: primary

+33 1 47 20 05 03

Sylvie Poignonec

Role: primary

+33 1 45 63 13 20

Elisabeth DOMERGUE THAN TRONG

Role: primary

+33 1 42 83 38 18

Other Identifiers

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CLIN2108_CIP

Identifier Type: -

Identifier Source: org_study_id

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