NCT05292638已完成1 期
A Randomized, Double-blind, Active-controlled, Single-center Phase I Trial to Investigate the Safety and Efficacy of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
A single-center, randomized, double-blind, single-injection, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501A in 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)
盲法说明
Double-blind
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
- •Subjects with at least moderate glabellar frown lines at maximum frown using the severity score of at least 2(moderate) on the Facial Wrinkle Scale (4-point FWS)
排除标准
- •Any medical condition (e.g., myasthenia gravis, Lambert-Easton syndrome, amyotrophic lateral sclerosis, etc.) that can affect the neuromuscular function
- •History of facial nerve paralysis or ptosis
- •Significant facial asymmetry
- •Subjects with skin abnormalities such as infection, dermatologic disorders, scars, etc. at potential injection sites
- •Previous treatment with any serotype of botulinum toxin products within 24 weeks (6 months) prior to Screening or planning to receive treatment with botulinum toxin during the study period
- •Previous treatment with retinoids (isotretinoin, alitretinoin, etc.)
研究组 & 干预措施
CKDB-501A
Experimental
干预措施: CKDB-501A (Drug)
Botox®
Active Comparator
干预措施: Botox® (Drug)
结局指标
主要结局
Incidence of Adverse Events
时间窗: up to week 12
severity and frequency of reported adverse events
次要结局
- Changes in the investigator-assessed glabellar line severity score from baseline at each follow-up visit(Week 4, 8, 12)
- Proportion of subjects with improvement in subject's assessment of glabellar line severity at each follow-up visit(Week 4, 8, 12)
- Proportion of subjects with improvement in investigator-assessed glabellar line severity at maximum frown at each follow-up visit(Week 4, 8, 12)
- Proportion of subjects with improvement in investigator-assessed glabellar line severity at rest at each follow-up visit(Week 4, 8, 12)
- Subject-assessed satisfaction scale at each follow-up visit(Week 4, 8, 12)
研究者
研究点 (1)
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