A Prospective, Multicenter, Randomized, Rater- and Subject-Blind, Parallel Group Trial to Investigate the Non-Inferiority of NT 201, Free of Complexing Proteins, in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 381
- 主要终点
- Responder by Independent Rater's Assessment at Maximum Frown at Week 4
研究概览
简要总结
NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is used for aesthetic treatment of mimic wrinkles and in the therapy of neurologic diseases. This study will investigate the safety and efficacy (non-inferiority) of NT 201 in comparison with OnabotulinumtoxinA (Vistabel®) in the treatment of glabellar frown lines.
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
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on a 4-point facial wrinkle scale) as assessed by the investigator's rating: 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe'.
排除标准
- •Marked facial asymmetry.
- •Ptosis of eyelid and/or eyebrow.
研究组 & 干预措施
IncobotulinumtoxinA (Xeomin®/Bocouture®)
IncobotulinumtoxinA (Xeomin®/Bocouture®), 24 units; mode of administration: intramuscular injection.
干预措施: NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®)) (Drug)
OnabotulinumtoxinA (Vistabel®)
OnabotulinumtoxinA (Vistabel®), 24 units; mode of administration: intramuscular injection.
干预措施: OnabotulinumtoxinA (Vistabel®) (Drug)
结局指标
主要结局
Responder by Independent Rater's Assessment at Maximum Frown at Week 4
时间窗: 4 weeks after injection
The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.
次要结局
- Responder by Independent Rater's Assessment at Maximum Frown at Week 12(12 weeks after injection)
- Responder by Independent Rater's Assessment at Rest at Week 4(4 weeks after injection)
- Responder by Independent Rater's Assessment at Rest at Week 12(12 weeks after injection)
- Responder by Investigator's Assessment at Maximum Frown at Week 4(4 weeks after injection)
- Responder by Investigator's Assessment at Maximum Frown at Week 12(12 weeks after injection)
- Responder by Investigator's Assessment at Rest at Week 4(4 weeks after injection)
- Responder by Investigator's Assessment at Rest at Week 12(12 weeks after injection)
- Responder by Patient's Assessment at Maximum Frown at Week 4(4 weeks after injection)
- Responder by Patient's Assessment at Maximum Frown at Week 12(12 weeks after injection)
- Responder by Patient's Assessment at Rest at Week 4(4 weeks after injection)
- Response by Patient's Assessment at Rest at Week 12(12 weeks after injection)
- Responder by Patient's Global Assessment at Week 4(4 weeks after injection)
- Responder by Patient's Global Assessment at Week 12(12 weeks after injection)