NCT02961673已完成1 期
A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1)
研究概览
简要总结
A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in Subject with Moderate to Severe Glabellar Lines
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
- •Facial Wrinkle Scale (FWS) score > 2 when Subject knits brow extremely
排除标准
- •Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
- •From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks
- •Subject who has skin disorder including infection and scar on injection site
- •Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.
- •Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day)
- •Any condition that, in the view of the investigator, would interfere with study participation
研究组 & 干预措施
HU-014 Inj(Phase 1 and 2)
Experimental
HU-014 Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM)
干预措施: HU-014 Inj (Biological)
Botox Inj(Phase 2)
Active Comparator
Botox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM)
干预措施: Botox Inj (Biological)
结局指标
主要结局
Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1)
时间窗: Week 4
Change from Baseline of Glabellar Lines improvement rate(Frown)
时间窗: Week 4
次要结局
- Assessment of Columbia Suicide Severity Rating Scale(C-SSRS)(Week 4, Week 8, Week 12)
- change from Baseline of Glabellar Lines improvement rate (Frown)(Week 8, Week 12)
- change from Baseline of Glabellar Lines improvement rate (Not frown)(Week4, Week 8, Week 12)
- Efficacy Outcome Measure (Phase 2) by colleting Subject Satisfaction assessment(Week 4, Week 8, Week 12)
- Assessment of TEAs (Treatment-Emergent Adverse events), ADRs (Adverse Drug Reactions) and SAEs (Serious Adverse Events) after injecting Investigational Product(Week 4, Week 8, Week 12)
研究者
研究点 (2)
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