2025-520499-24-00招募中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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 31
- 主要终点
- Composite 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 the MAPS-D at Visit 4 (V4; Main Period [MP] Week 2).
研究概览
简要总结
To evaluate the safety and efficacy of a single and repeat treatment of NT 201 in participants with moderate to severe platysma prominence compared with placebo
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Open label treatment period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Is male or female between ≥ 18 and ≤ 65 years old at the time of signing the informed consent.
- •Presence of four (medial and lateral, left and right) platysmal bands.
- •Has a score of Grade 3 (‘moderate’) or Grade 4 (‘severe’) on the MAPS-D at maximum contraction, as assessed by the investigator and participant (the ratings of the investigator and participant do not have to coincide).
- •Has a response of ‘agree’ or ‘strongly agree’ to Platysma PRO Item #1 (“I am bothered by the appearance of my neck”) AND attain a total score of ≥ 16 for platysma PRO.
- •For female participants only: A participant is eligible to participate if not pregnant or breastfeeding, and one of the following conditions applies: • Is of non-childbearing potential as defined in the protocol. OR • Is of childbearing potential (CBP) and using an acceptable contraceptive method as described in the protocol.
排除标准
- •Known hypersensitivity or history of allergic reaction to BoNT 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, including myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other disorders that might interfere with neuromuscular function.
- •Any serious disease or disorder that could, in the judgment of the investigator, interfere with the safe completion of treatment according to this protocol or with study outcome assessments, or compromise participant safety.
- •BoNT treatment in the face, jawline, or neck within the last seven months prior to study treatment.
- •History of lower face surgery, neck or chest surgery, aesthetic procedures, and orthodontic procedures in the 12 months prior to study treatment, or any other procedures which in the investigator’s judgment would interfere with study evaluations.
- •Previous use of any permanent or semi-permanent, calcium hydroxylapatite, facial tissue augmentation therapy, lifting sutures, permanent implants, or autologous fat to the lower face, neck, or chest within 12 months prior to study treatment.
- •Previous use of any hyaluronic acid-based or collagen-based biodegradable facial tissue augmentation therapy to the lower face, neck, or chest within 12 months prior to study treatment.
结局指标
主要结局
Composite 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 the MAPS-D at Visit 4 (V4; Main Period [MP] Week 2).
Composite 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 the MAPS-D at Visit 4 (V4; Main Period [MP] Week 2).
次要结局
- • Achievement of Grade 1 (‘none to minimal’) or Grade 2 (‘mild’) AND at least 2-grade improvement from baseline based on the investigator’s assessment using MAPS-D at V4.
- • 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 V4.
- • Achievement of at least a +1 (‘somewhat satisfied’) score using the participant’s satisfaction questionnaire at V4.
研究者
Public Disclosure Manager, Merz Aesthetics
Scientific
Merz Aesthetics GmbH
研究点 (31)
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