Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

Официальное название

Post-Marketing Clinical Follow Up On Hyaluronic Acid-Based Dermal Fillers Using COLD-X™ Technology By Symatese

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Number of patients returning to their baseline (pre-injection) state for each treated area, based on the investigator's assessment using 5- or 6-point area-specific scales. [Срок оценки: At each follow-up visit (6 months, 12 months, 18 months and 24 months)]

Вторичные конечные точки (6)

• Injection site reactions (ISR) assessed by the investigators. [Срок оценки: D0 (post-first injection), M1 (post optional touch-up), M12/M18 (post optional retreatment)]
• Number of adverse device effects (ADEs) and serious adverse device effects (SADEs) assessed by the investigators. [Срок оценки: From the injection (day 0) to the end of the follow-up period (24 months).]
• Subject-assessed aesthetic improvement of each treated area, measured using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale ranging from "worse" to "very much improved. [Срок оценки: At each visit (Day 0 after injection, day 30 (if any visit), 6 months, 12 months, 18 months and 24 months)]
• Investigator-assessed aesthetic improvement of each treated area, measured using the Global Aesthetic Improvement Scale (GAIS), a 5-point scale ranging from "worse" to "very much improved. [Срок оценки: At each visit (Day 0 after injection, day 30 (if any visit), 6 months, 12 months, 18 months and 24 months)]
• Investigator-assessed wrinkle severity or volume using 5- or 6-point area-specific scales for each treated area. [Срок оценки: At each visit (Day 0 before and after injection, at 30 Days (if any visit), 6 months, 12 months, 18 months, and 24 months)]
• Subject-reported pain per treated area, rated on an 11-point scale (0 = no pain, 10 = worst pain). [Срок оценки: During the initial injection procedure at day 0]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 8 центров

• Centre Médical Saint Jean — Arras
• Cabinet médical — Lyon
• Palais de Flore — Lyon
• Centre Laser Palaiseau — Palaiseau
• Aesthé - Marais. — Paris
• Cabinet médical — Paris
• Cabinet médical — Paris
• Cabinet médical — Saint-Maur-des-Fossés

Идентификаторы

NCT: NCT07255261 · CLIN2108_CIP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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