Post-Marketing Clinical Follow Up of ESTYME® LIFT in the Correction of Nasolabial Folds
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 96
- 试验地点
- 3
- 主要终点
- 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).
研究概览
简要总结
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.
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 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.
排除标准
- •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.
研究组 & 干预措施
Aesthetic Treatment for the Correction of Nasolabial Folds.
干预措施: Injection of the Hyaluronic Acid-Based Dermal Filler ESTYME® LIFT (Now Marketed as ESTYME® FORM). (Device)
结局指标
主要结局
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).
时间窗: At each follow-up visit, including the 9-24-month visit and the 24-month visit.
次要结局
- Investigator-assessed severity of nasolabial folds using the 6-point scale (0 = no wrinkle, 6 = very deep wrinkle)(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.)
- Number of adverse device effects (ADEs) and serious adverse device effects (SADEs) assessed by the investigator.(From the initial injection (day 0) to the end of the follow-up period (24 months).)
- Injection site reactions (ISR) assessed by the investigator.(Day 0 (after the first injection), Month 1 (after the optional touch-up), and between Month 9 and Month 24 (after the optional retreatment))
- 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.(At each follow-up visit, including the 9-24-month visit and the 24-month visit.)