A Prospective, Randomized, Double-blind, Multicenter Study to Investigate the Safety and Duration of Effect of Different NT 201 Dose Groups Following the Treatment of Glabellar Frown Lines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 9
- 主要终点
- Number of Participants With at Least One Treatment-emergent Serious Adverse Event (TESAE)
研究概览
简要总结
The purpose of the study is to investigate the safety and duration of effect following different doses of Botulinum Toxin A (NT 201) in the treatment of glabellar frown lines (GFL).
详细描述
This prospective, randomized, double-blind, multi-Center clinical study consists of a two stage experimental main period comparing different dose groups, followed by an optional open-label extension period (20 Units follow-up treatment).
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, Investigator)
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
- •Male or female participant 18 years or over.
- •Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by investigator on the 4-point facial wrinkle scale (FWS).
- •Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by participant on the 4-point FWS.
排除标准
- •Previous treatment with Botulinum neurotoxin (BoNT) of any serotype in the facial area within the last 12 months before injection.
- •Previous treatment with any facial cosmetic procedure (example, chemical peeling, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, tattooing of eyebrows) in the glabellar area within the last 12 months before injection.
- •Previous treatment with any biodegradable filler in the glabellar area within the last 12 months before injection.
- •Inability to substantially reduce GFL by physically spreading them apart as assessed by the investigator.
- •Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of the face.
- •Any surgery or scars in the glabellar area.
- •Marked facial asymmetry.
- •Eyelid ptosis.
- •Marked brow ptosis and/or dermatochalasis.
- •Ongoing severe or unstable medical conditions, example, systemic infection, or pulmonary disease, at the discretion of the investigator.
研究组 & 干预措施
NT 201 Dose group 1
Stage 1 and 2. Intramuscular injection into the glabellar area.
干预措施: NT 201 (Drug)
NT 201 Dose group 2
Stage 1. Intramuscular injection into the glabellar area.
干预措施: NT 201 (Drug)
NT 201 Dose group 3
Stage 1. Intramuscular injection into the glabellar area.
干预措施: NT 201 (Drug)
NT 201 Dose group 4
Stage 2. Intramuscular injection into the glabellar area.
干预措施: NT 201 (Drug)
NT 201 Dose group 5
Open Label Extension Period. Intramuscular injection into the glabellar area.
干预措施: NT 201 (Drug)
结局指标
主要结局
Number of Participants With at Least One Treatment-emergent Serious Adverse Event (TESAE)
时间窗: From the time of first treatment up to Day 390
Number of Participants With at Least One Treatment Related TEAE
时间窗: From the time of first treatment up to Day 390
Number of Participants With at Least One Treatment-emergent Adverse Event of Special Interest (TEAESI)
时间窗: From the time of first treatment up to Day 390
Number of Participants With at Least One Treatment Related TESAE
时间窗: From the time of first treatment up to Day 390
Duration of Effect Defined as Time Between Treatment and Relapse to Baseline Status Assessed by the Investigator on the FWS
时间窗: From the time of first treatment up to Day 360
Duration of effect: time between treatment and first occurrence of relapse to baseline status. If no effect was observed, duration of effect was set to 0. Effect: any improvement (at least 1 point) at maximum frown as assessed by investigator on FWS. Investigator's FWS assessed status of GFL according to 4-point severity grades at maximum frown as: 0 (none), 1 (mild), 2 (moderate), 3 (severe). Descriptors of each severity grade for investigator's FWS assessment at maximum frown were as: 0 (no muscle action at all), 1 (some even slight muscle action possible \[that is, visible furrows\]), 2 (moderately strong muscle action possible \[that is, visible muscle bulges\]), 3 (strong muscle action possible which may cause local pallor). Duration of effect was analyzed using Kaplan-meier analysis, and 95 percent (%) confidence interval (CI) were calculated using log-log transformation.
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
时间窗: From the time of first treatment up to Day 390
次要结局
- Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Participant's Rating on FWS(At Day 180)
- Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Investigator's Rating on FWS(At Day 180)
- Duration of Effect Whereby Effect Was Defined as Score of None (0) or Mild (1) at Maximum Frown as Assessed by the Investigator According to FWS(From the time of first treatment up to Day 360)
- Duration of Effect Whereby Effect Was Defined by 2-point Improvement From Baseline at Maximum Frown as Assessed by the Investigator According to FWS(From the time of first treatment up to Day 360)
- Percentage of Participants Rated as None (0) or Mild (1) at Maximum Frown by Investigator's Rating on FWS(At Day 180)
- Percentage of Participants Rated as at Least 1-point Improvement Compared to Baseline at Maximum Frown by Participant's Rating on FWS(At Day 180)