A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 1
- 主要终点
- Main Period: Percentage of Glabellar Frown Line (GFL) Responders at Day 30
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of NT 201 (active ingredient: Botulinum (neuro)toxin type A, free from complexing proteins) in the combined treatment of wrinkles in the upper face (Upper Facial Lines [UFL]): Horizontal Forehead Lines [HFL], Glabellar Frown Lines [GFL], and Lateral Canthal Lines [LCL]). It is a prospective, randomized, double-blind, placebo-controlled, multicenter study with a placebo-control main period (MP) followed by an open-label extension (OLEX) period.
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
- Quadruple (Participant, Care Provider, 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
- •Outpatients (male or female) 18 years of age or older.
- •Horizontal forehead lines (HFL), glabellar frown lines (GFL), and symmetrical lateral canthal lines (LCL) of moderate to severe intensity at maximum contraction as assessed by the investigator and subject according to Merz Aesthetics Scales (MAS).
排除标准
- •Previous treatment with botulinum neurotoxin (BoNT) of any serotype in the face within the last 12 months before injection.
- •Any facial cosmetic procedure within the last 12 months before baseline injection.
- •Previous treatment with any biodegradable filler in the face within the last 12 months before injection.
- •Any previous insertion of permanent material in the face (regardless of the time between previous treatment and this study).
- •Any medical condition that may put the subject at increased risk with exposure to NT201.
研究组 & 干预措施
Main Period: Placebo (Group P)
Subjects will receive placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period.
干预措施: Placebo (Drug)
Main Period: NT 201 (Group U)
Subjects will receive a total of 64 Units (U) of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period.
干预措施: NT 201 (Drug)
Main Period: NT 201 and Placebo (Group G and H)
Subjects will receive a total of 40 U of NT 201: 20 U of NT 201 injection both in the GFL and HFL area, and placebo injection in the LCL area on Day 1 of main period.
干预措施: NT 201 (Drug)
Main Period: NT 201 and Placebo (Group G and H)
Subjects will receive a total of 40 U of NT 201: 20 U of NT 201 injection both in the GFL and HFL area, and placebo injection in the LCL area on Day 1 of main period.
干预措施: Placebo (Drug)
OLEX: NT 201 (Main Period: Group P)
Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.
干预措施: NT 201 (Drug)
OLEX: NT 201 (Main Period: Group U)
Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.
干预措施: NT 201 (Drug)
OLEX: NT 201 (Main Period: Group G and H)
Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.
干预措施: NT 201 (Drug)
结局指标
主要结局
Main Period: Percentage of Glabellar Frown Line (GFL) Responders at Day 30
时间窗: Day 30
The Merz aesthetics scales (MAS) are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. GFL-response was defined as a score of 0 (no) or 1 (mild) and at least two-grade improvement from baseline to Day 30 of main period on MAS for GFL at maximum contraction as assessed by both the investigator and the subject. The MAS for GFL ranged as 0 to 4 where 0 is "No glabellar lines", 1 is "Mild glabellar lines", 2 is "Moderate glabellar lines", 3 is "Severe glabellar lines" and 4 is "Very severe glabellar lines".
Main Period: Percentage of Horizontal Forehead Lines (HFL) Responders at Day 30
时间窗: Day 30
The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. HFL-response was defined as a score of 0 (no) or 1 (mild) and at least two-grade improvement from baseline to Day 30 of main period on MAS for HFL at maximum contraction as assessed by both the investigator and the subject. The MAS for HFL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
Main Period: Percentage of Lateral Canthal Lines (LCL) Responders at Day 30
时间窗: Day 30
The MAS are 5-point scales used to identify responders in a clinical context. They are validated photograph-based outcome instruments designed specifically for assessment of each upper facial area. LCL-response was defined as a score of 0 (no) or 1 (mild) and at least two-grade improvement from baseline to Day 30 of main period on MAS for both left and right LCL at maximum contraction as assessed by both the investigator and the subject. The MAS for LCL ranged as 0 to 4 where 0 is "No lines", 1 is "Mild lines", 2 is "Moderate lines", 3 is "Severe lines" and 4 is "Very severe lines".
次要结局
- Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 on MAS for HFL at Maximum Contraction as Assessed by the Investigator(Day 30)
- Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Investigator(Day 30)
- Main Period: Global Aesthetic Improvement Scale (GAIS) at Day 30 as Assessed by the Investigator(Day 30)
- Main Period: Number of Subjects With Related Treatment-Emergent Adverse Events (TEAEs)(Up to 22 Weeks)
- OLEX Period: Number of Subjects With Related TEAEs(Up to 39 Weeks)
- Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for HFL at Maximum Contraction as Assessed by the Investigator at Day 30(Day 30)
- Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Investigator at Day 30(Day 30)
- Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for GFL at Maximum Contraction as Assessed by the Subject at Day 30(Day 30)
- Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for HFL at Maximum Contraction as Assessed by the Subject at Day 30(Day 30)
- Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for Both Left and Right LCL at Maximum Contraction as Assessed by the Subject at Day 30(Day 30)
- Main Period: Percentage of Subjects With a Score of 0 (no) or 1 (Mild) on MAS for GFL at Maximum Contraction as Assessed by the Investigator at Day 30(Day 30)
- Main Period: Global Aesthetic Improvement Scale (GAIS) at Day 30 as Assessed by the Subjects(Day 30)
- Main Period: Percentage of Subjects With at Least One-grade Improvement From Baseline to Day 30 on MAS for GFL at Maximum Contraction as Assessed by the Investigator(Day 30)