Post-Marketing Clinical Follow Up On Hyaluronic Acid-Based Dermal Fillers Using COLD-X™ Technology By Symatese
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Symatese
- 入组人数
- 460
- 试验地点
- 13
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: At each follow-up visit (6 months, 12 months, 18 months and 24 months)
次要结局
- Investigator-assessed wrinkle severity or volume using 5- or 6-point area-specific scales for each treated area.(At each visit (Day 0 before and after injection, at 30 Days (if any visit), 6 months, 12 months, 18 months, and 24 months))
- Injection site reactions (ISR) assessed by the investigators.(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.(From the injection (day 0) to the end of the follow-up period (24 months).)
- Injection site reactions (ISR) assessed by the investigators.(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.(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.(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.(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.(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).(During the initial injection procedure at day 0)