Long Term Safety and Efficacy Assessment of Hyaluronic Acid Dermal Filler With for the Treatment of Nasolabial Folds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number and description of adverse events that are related to treatment
研究概览
简要总结
This study evaluates the injection of a hyaluronic acid dermal filler with lidocaine 0.3% in the treatment of nasolabial folds (NLF). Each patient will receive 1 concentration in a NLF (20 mg/mL) and an other concentration in the other NLF (24 mg/mL).
详细描述
Interventional, monocentric, double blind, randomised study Evaluation of safety the 1st month (primary criteria) and until 12 month Evaluation of performance at baseline, month 3, month 6, month 9 and month 12 : WSRS (wrinkle scale), profilometry (image measuring wrinkle depth and area), GAIS : satisfaction scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least 19 years of age.
- •Has Fitzpatrick Skin Type IV, V, or VI.
- •Has a WSRS score > or = to 3 for both NLF
- •Understands and accepts the obligation not to receive any other procedures or treatments in the nasolabial fold for 6 months
排除标准
- •Has keloid formation, or hypertrophic scarring or dyschromic scaring. Has hypersensitivity to hyaluronic acid, Chlorhexidine lidocaine or local anaesthetic drugs
- •Has a known bleeding disorder or is receiving drug therapy that could increase the risk of bleeding.
- •Has nasolabial folds that are too severe to be corrected in one treatment session.
- •Has received any dermal filler or other injections, grafting or surgery in either nasolabial fold during the last year.
- •Is pregnant, lactating, or not using acceptable contraception.
研究组 & 干预措施
HA 20 mg/mL
干预措施: Hyaluronic acid dermal filler with lidocaine 0.3% (Device)
HA 24 mg/mL
干预措施: Hyaluronic acid dermal filler with lidocaine 0.3% (Device)
结局指标
主要结局
Number and description of adverse events that are related to treatment
时间窗: 1 month
次要结局
- Number and description of adverse events that are related to treatment(72h/3 months/6 Months/9 months/12 months)
- Treatment efficacy assessed by WSRS(1/3/6/9/12 months)