The Safety and Efficacy Study of PROTOXIN in Subjects With Moderate to Severe Glabellar Lines
2021年8月8日 更新者:Protox Inc.
A Randomized, Double-blinded, Active Comparator, Single-dose, Phase I/II Trial to Evaluate the Safety and Efficacy of Treatment With PROTOXIN as Compared to BOTOX® in Adult Subjects Who Need Improvement of Moderate or Severe Glabellar Lines
This study will be conducted in Phase I/II clinical trials.
In Phase I, subjects with moderate to severe glabellar lines are enrolled and those who are judged to be eligible for this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL
each) in five sites of the glabellar lines.
Safety is assessed after 12 weeks.
In Phase II, subjects with moderate to severe glabellar lines are enrolled and will be injected the "PROTOXIN" or the "BOTOX®" at a total of 20U(4U/0.1mL
each)in five sites of the glabellar lines.
Thereafter, efficacy and safety are assessed by comparing with BOTOX®.
研究概览
研究类型
介入性
注册 (实际的)
60
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Seoul、大韩民国
- Chung-Ang University Hospital
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Seoul、大韩民国
- Nowon Eulji Medical Center
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Men and women aged between 19 to 65 years old
- Subjects attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum frown
- Fertile women who have properly agreed to contraception during the clinical trial period
- Subjects who voluntarily sign the informed consent
Exclusion Criteria:
- Subjects who answered 'Yes' any of the C-SSRS questions (only Phase I)
- Subjects with the general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome)
- Subjects who suffer from muscle weakness or paralysis in the forehead area
- Subjects with infection, skin disorders, or scars at the glabellar region.
- Subjects with noticeable facial asymmetry
- Subjects with allergy or hypersensitivity to the botulinum toxin or their components
- Subjects who have taken Anti-Coagulant, Anti-Platelet agent, Aspirin and NSAIDs within 7 days prior to administration of the investigational drug
- Subjects who were injected facial with botulinum toxin within the past 6 months or whose dose exceeds 200 U for the whole body
- Subjects with previous treatment of Face Lifting, Permanent Implant, and/or Filler in the glabellar region
- Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks of the screening date.
- A history of drug or alcohol abuse
- Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception
- Subjects who are not eligible for this study based on the judgment of an investigator
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:PROTOXIN (Phase I/II)
PROTOXIN will be injected to 5 glabellar lines (Each 4U/0.1mL,
Total 20U/0.5mL).
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A型肉毒毒素
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有源比较器:Botox® (Phase II)
Botox® will be injected to 5 glabellar lines (Each 4U/0.1mL,
Total 20U/0.5mL).
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A型肉毒毒素
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)
大体时间:12 weeks after the injection
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12 weeks after the injection
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Glabellar line improvement rate confirmed with investigator's assessment (Phase II)
大体时间:4 weeks after the injection
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4 weeks after the injection
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次要结果测量
结果测量 |
大体时间 |
---|---|
Glabellar line improvement rate confirmed with investigator's assessment (Phase II)
大体时间:4, 8, 12 weeks after the injection
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4, 8, 12 weeks after the injection
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Glabellar line improvement rate confirmed by subject' satisfaction assessment (Phase II)
大体时间:4, 8, 12 weeks after the injection
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4, 8, 12 weeks after the injection
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Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II)
大体时间:12 weeks after the injection
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12 weeks after the injection
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年12月10日
初级完成 (实际的)
2021年4月2日
研究完成 (实际的)
2021年5月26日
研究注册日期
首次提交
2021年8月2日
首先提交符合 QC 标准的
2021年8月2日
首次发布 (实际的)
2021年8月9日
研究记录更新
最后更新发布 (实际的)
2021年8月10日
上次提交的符合 QC 标准的更新
2021年8月8日
最后验证
2021年8月1日
更多信息
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