A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Determine the Optimal Dose of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS)
研究概览
简要总结
NT 201 is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, NT 201 causes local weakening to full paralysis depending on the administered dose. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study will determine the optimal dose of NT 201 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
- Triple (Participant, Investigator, 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
- •Moderate to severe glabellar frown lines
排除标准
- •Previous insertion of permanent material in the glabellar area
- •Neuromuscular function disease
研究组 & 干预措施
20 U NT 201
干预措施: Botulinum neurotoxin type A, free of complexing proteins (Drug)
Placebo
干预措施: Placebo (Drug)
10 U NT 201
干预措施: Botulinum neurotoxin type A, free of complexing proteins (Drug)
30 U NT 201
干预措施: Botulinum neurotoxin type A, free of complexing proteins (Drug)
结局指标
主要结局
Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS)
时间窗: Baseline (Day 0) to Day 30
Responders on the FWS are defined as subjects with glabellar line severity of none (0) or mild (1). The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints.
Percentage of responders at maximum frown at Day 30 as assessed by patient's assessment according to 4-point scale
时间窗: Baseline (Day 0) to Day 30
Responders will be subjects with at least a 1-point improvement compared to Day 0. The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints.
次要结局
- Percentage of responders at maximum frown at Day 90 as assessed by the investigator according to FWS(Baseline (Day 0) to Day 90)
- Percentage of responders at maximum frown at Day 90 as assessed by patient's assessment(Baseline (Day 0) to Day 90)