NCT07210463进行中（未招募）3 期
A Phase 3, Randomized, Parallel-group, Double-blind, Multicenter Study Investigating the Safety and Efficacy of NT 201 Compared With Placebo in Adult Participants With Moderate to Severe Platysma Prominence in Europe
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 26
- 主要终点
- Composite Achievement of Grade 1 or Grade 2 and at Least a 2-Grade Improvement From Baseline Based on Both the Investigator's Assessment and Participant's Self-Assessment Using the Merz Aesthetics Platysma Scale Dynamic (MAPSD) At Week 2 of MP
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of NT 201 compared with placebo in participants with moderate to severe platysma prominence. The study will be conducted in two periods: Main Period (MP) and Open label Extension Period (OLEX).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of four (medial and lateral, left and right) platysmal bands assessed at screening and baseline.
- •A score of Grade 3 ('moderate') or Grade 4 ('severe') on the MAPSD at maximum contraction by the investigator AND participant.
排除标准
- •Hypersensitivity or a history of allergic reaction to botulinum toxin of any serotype or any of their formulation ingredients.
- •Any medical condition that may put the participant at increased risk with exposure to botulinum toxin of any serotype, or any disorders that might interfere with neuromuscular function.
- •Any serious disease or disorder that could interfere with the safe completion of treatment or with study outcome assessments, or compromise participant safety.
- •Botulinum toxin treatment in the face (below the lower orbital rim), jawline, or neck within the last seven months.
- •History of lower face surgery, neck or chest surgery, and aesthetic procedures in the past 12 months and/or orthodontic procedures in the past 6 months.
- •Planned surgery or aesthetic procedures to the lower face, neck, or chest during the study period.
- •Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study products).
研究组 & 干预措施
Main Period: NT 201 Matching Placebo
Placebo Comparator
Participants will receive NT 201 matching placebo IM injection, once on Day 1 of the MP.
干预措施: NT 201 Placebo (Drug)
OLEX Period: NT 201
Experimental
Participants will receive a reinjection of NT 201 IM injection, once on Day 1 of OLEX period.
干预措施: NT 201 (Drug)
Main Period: NT 201
Experimental
Participants will receive NT 201 IM injection, once on Day 1 of the MP.
干预措施: NT 201 (Drug)
结局指标
主要结局
Composite Achievement of Grade 1 or Grade 2 and at Least a 2-Grade Improvement From Baseline Based on Both the Investigator's Assessment and Participant's Self-Assessment Using the Merz Aesthetics Platysma Scale Dynamic (MAPSD) At Week 2 of MP
时间窗: At Week 2 of MP
MAPSD is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement.
Composite Achievement of Grade 1 or Grade 2 and at Least a 2-Grade Improvement From Baseline Based on Both the Investigator's Assessment and Participant's Self-Assessment Using the Merz Aesthetics Platysma Scale - Dynamic (MAPS-D) At Week 2 of MP
时间窗: At Week 2 of MP
MAPS-D is a validated five-point scale that will be used to grade the platysma prominence. Scores range from Grade 1 (none to minimal) to Grade 5 (very severe). A lower score indicates improvement.
次要结局
- Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on the Investigator's Assessment Using MAPSD at Week 2 of MP(At Week 2 of MP)
- Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on the Participant's Self-Assessment Using MAPSD at Week 2 of MP(At Week 2 of MP)
- Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on Both the Investigator's Assessment and Participant's Self-Assessment Using MAPSD at Week 1 and Week 4 up to Week 17 of MP(At Week 1 and Week 4 up to Week 17 of MP)
- Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on the Investigator's Assessment Using MAPSD at Week 1 and Week 4 up to Week 17 of MP(At Week 1 and Week 4 up to Week 17 of MP)
- Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on Participant's Self-Assessment Using MAPSD at Week 1 and Week 4 up to Week 17 of MP(At Week 1 and Week 4 up to Week 17 of MP)
- Achievement of at Least a +1 (Improved) Score on the Global Aesthetic Improvement Scale (GAIS)-Platysmal Bands at maximum contraction Based on the Investigator's Assessment at Week 2 of MP(At Week 2 of MP)
- Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands at maximum contraction Based on the Participant's Self-Assessment at Week 2 of MP(At Week 2 of MP)
- Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on the Investigator's Assessment Using MAPS-D at Week 2 of MP(At Week 2 of MP)
- Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on the Participant's Self-Assessment Using MAPS-D at Week 2 of MP(At Week 2 of MP)
- Achievement of at Least a +1 (Somewhat Satisfied) Score Using the Participant's Satisfaction Questionnaire at Week 2 of MP(At Week 2 of MP)
- Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on Both the Investigator's Assessment and Participant's Self-Assessment Using MAPS-D at Week 1 and Week 4 up to Week 17 of MP(At Week 1 and Week 4 up to Week 17 of MP)
- Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on the Investigator's Assessment Using MAPS-D at Week 1 and Week 4 up to Week 17 of MP(At Week 1 and Week 4 up to Week 17 of MP)
- Achievement of Grade 1 (None to Minimal) or Grade 2 (Mild) and at Least a 2-Grade Improvement From Baseline Based on Participant's Self-Assessment Using MAPS-D at Week 1 and Week 4 up to Week 17 of MP(At Week 1 and Week 4 up to Week 17 of MP)
- Achievement of at Least a +1 (Improved) Score on the Global Aesthetic Improvement Scale (GAIS)-Platysmal Bands Based on the Investigator's Assessment at Week 2 of MP(At Week 2 of MP)
- Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands Based on the Participant's Self-Assessment at Week 2 of MP(At Week 2 of MP)
- Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands at Rest Based on the Investigator's Assessment at Week 2 of MP(At Week 2 of MP)
- Achievement of at Least a +1 (Improved) Score on the GAIS-Platysmal Bands at Rest Based on the Participant's Self-Assessment at Week 2 of MP(At Week 2 of MP)
- Achievement of at Least a +1 (Improved) Score Using the GAIS-Lower Face Contour According to the Investigator's Assessment at Week 2 of MP(At Week 2 of MP)
- Achievement of at Least a +1 (Improved) Score Using the GAIS-Lower Face Contour According to the Participant's Self-Assessment at Week 2 of MP(At Week 2 of MP)
研究者
研究点 (26)
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