A Prospective, Randomized, Double-Blind, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 in Comparison to Placebo and to Compare Two Different Application Schemes of NT 201 in the Treatment of Lateral Periorbital Wrinkles
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 111
- 主要终点
- Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline.
研究概览
简要总结
To investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in comparison to placebo in the treatment of moderate to severe lateral periorbital wrinkles at maximum smile and to compare two different application schemes of Xeomin. Each subject will be treated on the right and left eye area, using the same dose but different application schemes (i.e. 3 or 4 injection sites).
详细描述
Conducted in Europe
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate (grade 2) to severe (grade 3) symmetrical lateral periorbital wrinkles assessed by the investigator according to the 4-point scale at maximum smile
排除标准
- •Significant facial asymmetry
研究组 & 干预措施
IncobutolinumtoxinA (Xeomin), 4-injection scheme
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150kD), free of complexing proteins' (active ingredient:
Clostridium Botulinum neurotoxin Type A free of complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl); total volume 0.24 mL per side, i.e. 4 x 0.06 mL (4 x 3 units = 12 units); mode of administration: intramuscular injection.
干预措施: IncobotulinumtoxinA (Xeomin) (Drug)
Placebo 4-injection scheme
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; total volume 0.24 mL per side, i.e. 4 x 0.06 mL placebo solution; mode of administration: intramuscular injection.
干预措施: Placebo (Drug)
IncobotulinumtoxinA (Xeomin), 3-injection scheme
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150kD), free of complexing proteins' (active ingredient:
Clostridium Botulinum neurotoxin Type A free of complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl); total volume 0.24 mL per side, i.e. 3 x 0.08 mL (3 x 4 units = 12 units); Mode of administration: intramuscular injection.
干预措施: IncobotulinumtoxinA (Xeomin) (Drug)
Placebo 3-injection Scheme
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; total volume 0.24 mL per side, i.e. 3 x 0.08 mL placebo solution; mode of administration: intramuscular injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline.
时间窗: Week 4
Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.
次要结局
- Response assessed by the investigator at maximum smile for either eye area compared to baseline.(Weeks 2, 4, 12, and 20)
- Response assessed by the subject's global assessment at maximum smile for either eye area compared to baseline.(Weeks 2, 4, 12, and 20)