A Pivotal USA Randomized, Evaluator-blinded, Active-controlled, Multi-center, Split-face Comparison Study of Emervel Classic Lidocaine Versus Juvederm® Ultra in the Treatment of Moderate to Severe Facial Wrinkle Folds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 171
- 试验地点
- 23
- 主要终点
- Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection
研究概览
简要总结
The purpose of this study is to compare the effectiveness and safety of Emervel Classic Lidocaine versus Juvederm® Ultra in the treatment of moderate to severe facial wrinkles and 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is a male or female 18 years of age or older
- •The subject has bilateral nasolabial folds that, in the opinion of both the Blinded Evaluating Investigator and the Unblinded Injecting Investigator, can be corrected with an injectable dermal implant
- •The subject has the same Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe) for each nasolabial fold
排除标准
- •The subject has active skin disease or inflammation on or near a nasolabial fold that, in the Principal Investigator's opinion, would interfere with the study device injections and/or study assessments.
- •The subject has a history of sensitivity to hyaluronic acid
- •The subject has a history of sensitivity to lidocaine or other amide type anesthetics
- •The subject is, in the Principal Investigator's opinion, at undue risk based on the precautions, warnings and contraindications for local lidocaine anesthetics.
结局指标
主要结局
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection
时间窗: Baseline, Week 24 after final initial injection
WSRS is a validated 5-point reference scale with photographs that classifies facial wrinkles (nasolabial folds). WSRS represents clinically meaningful change in NLF severity from the adjacent grades where 1= absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 millimeter (mm) visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.
次要结局
- Participant Pain Assessment After the Initial Injection(At 0 ,15, 30, 45, 60 minutes and 24 hours after the initial injection)
- Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 12 After Final Initial Injection(Baseline, Week 12 after final initial injection)
- Mean Change From Baseline in Wrinkle Severity Scale (WSRS) at Week 36 After Final Initial Injection(Baseline, Week 36 after final initial injection)
- Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 3 After the Final Initial Injection(Baseline, Week 3 after final initial injection)
- Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 48 After Final Initial Injection(Baseline, Week 48 after final initial injection)
- Mean Change From Baseline in Participant Self-Assessment of Wrinkle Severity at Week 24 After Final Initial Injection(Baseline, Week 24 after final initial injection)
- Number of Participants With Adverse Events (AEs)(From start of study drug administration up to 56 weeks)
- Participant Pain Assessment After the Initial Touch-up Injection(At 0, 15, 30, 45, 60 minutes and 24 hours after the Initial Touch-up Injection)