A Multi-Center, Randomized, Subject and Evaluator Blind, Split-Face Comparative Medical Device Clinical Study to Evaluate the Efficacy and Safety of Dermalax Implant Plus to Restylane® Sub-Q for Correction of Nasolabial Folds
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group
研究概览
简要总结
This study is to verify that Dermalax Implant Plus is not inferior to the reference device, Restylane® Sub-Q, in terms of efficacy and safety in the correction of nasolabial folds
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects no younger than 30 and no more than 75 years of age.
- •Subjects who scored 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) and want to improve the appearance of their nasolabial folds (the subject does not need to have the same score on both sides.*)
- •*The scores need not to be same on both sides, but the two nasolabial folds should have symmetry in the range of 3-
- •Subjects who have symmetric nasolabial folds.
排除标准
- •Subjects who received an antithrombotic agent within 2 weeks prior to screening (with the exception of low dose Aspirin less than 300 mg/day)
- •Subjects who have a history of bleeding disorder.
- •Subjects who have received calcium hydroxyapatite, CaHA injection in nasolabial area.
研究组 & 干预措施
Dermalax Implant Plus
Subject injected in the nasolabial folds of one side of the face in the initial treatment period.
干预措施: Dermalax Implant Plus (Device)
Dermalax Implant Plus
Subject injected in the nasolabial folds of one side of the face in the initial treatment period.
干预措施: Restylane Sub-Q (Device)
Restylane Sub-Q
Subject injected in the nasolabial folds of one side of the face in the initial treatment period.
干预措施: Dermalax Implant Plus (Device)
Restylane Sub-Q
Subject injected in the nasolabial folds of one side of the face in the initial treatment period.
干预措施: Restylane Sub-Q (Device)
结局指标
主要结局
Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group
时间窗: baseline, week 12
Improvement of wrinkle severity system scale(WSRS) scores at week 12 compared to baseline by independent evaluator using photos.
次要结局
- Improvement of wrinkle severity system scale(WSRS) scores of both Dermalax implant plus and Restylane® Sub-Q Group(baseline, at week 2~24)
- Proportion of subjects whose Global Aesthetic improvement Scale (GAIS) scores improved(at week 2~24)
- 100 mm visual analogue scale (VAS) scores evaluation(week 0)