NCT04996810已完成1 期
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
Protox Inc.2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年12月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Glabellar line improvement rate confirmed with investigator's assessment (Phase II)
研究概览
简要总结
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Glabellar line improvement rate confirmed with investigator's assessment (Phase II)
时间窗: 4 weeks after the injection
Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)
时间窗: 12 weeks after the injection
次要结局
- Glabellar line improvement rate confirmed with investigator's assessment (Phase II)(4, 8, 12 weeks after the injection)
- Glabellar line improvement rate confirmed by subject' satisfaction assessment (Phase II)(4, 8, 12 weeks after the injection)
- Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II)(12 weeks after the injection)
研究者
研究点 (2)
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