NCT07622004已完成3 期
A Multi-center, Double-blind, Randomized, Parallel, Active-controlled Phase III Trial to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection INI101 Compared to BOTOX® in Subjects With Moderate to Severe Glabellar Lines.
INIBIO Co., Ltd.1 个研究点 分布在 1 个国家目标入组 292 人开始时间: 2021年5月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 292
- 试验地点
- 1
研究概览
简要总结
To evaluate the efficacy and safety of botulinum toxin type A for injection INI101 compared to BOTOX® in subjects 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
- •Adult male or female participants aged between 19 and 65 years old.
- •Participants whose glabellar line score was 2 (moderate) or higher of glabellar line score at maximum frown based on the investigator's judgment at screening and randomization.
- •Participants who voluntarily gave a consent in writing to participate in the clinical study with full knowledge of details of the study after listening to them.
- •Participants who can understand and comply with the procedures and visit schedules of the study.
排除标准
- •Systemic neuromuscular junction disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, hereditary motor neuropathy, etc.)
- •History of blepharoplegia or ptosis
- •Prominent facial asymmetry
- •Glabellar lines that are physically difficult to be improved, such as the case where the lines are not removed by hands
- •Participants who have received any drugs that can act as a systemic muscle relaxant within 4 weeks prior to screening
- •Participants who have received anticoagulants, anti-platelet agents, or systemic NSAIDs within 7 days prior to administration of investigational products (however, low-dose aspirin [325 mg/day or less] administered for antithrombotic purposes is acceptable)
- •Participants who have participated in other clinical trials of a drug/medical device within 30 days from participating in this clinical study and have been administered/treated with the investigational product/medical device
- •Participants deemed ineligible for this study for other reasons based on the investigator's judgment
研究者
研究点 (1)
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