Evaluate the Efficacy and Safety of INI101 Compared to BOTOX® in Subjects With Moderate to Severe Glabellar Lines.
2026年6月1日 更新者:INIBIO Co., Ltd.
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.
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.
研究概览
研究类型
介入性
注册 (实际的)
292
阶段
- 第三阶段
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、韩国
- INIBIO Co., Ltd.
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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
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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 |
|---|---|
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实验性的:Botulinum toxin type A (INI101)
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Single administration, Day 0, 20 units
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有源比较器:Botulinum toxin type A (BOTOX®)
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单次给药,第 0 天,20 个单位
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment
大体时间:Baseline to week 4
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Investigator assessed the subject's glabellar lines 'At maximum frown' on a 4-point facial wrinkle scale (FWS) after 4 weeks of the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
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Baseline to week 4
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment
大体时间:Baseline to week 8, 12, 16
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Investigator assessed the subject's glabellar lines 'At maximum frown' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
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Baseline to week 8, 12, 16
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Improvement rate of glabellar lines at rest according to the investigator's on-site assessment
大体时间:Baseline to week 4, 8, 12, 16
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Investigator performed on-site assessment of the subject's glabellar lines 'At rest' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
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Baseline to week 4, 8, 12, 16
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Improvement rate of glabellar lines at maximum frown according to the independent assessor's photo assessment
大体时间:Baseline to week 4, 8, 12, 16
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Independent assessor assessed the subject's glabellar lines 'At maximum frown' ' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
An independent assessor separately conducted the FWS assessment subsequently based on the photographs taken.
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Baseline to week 4, 8, 12, 16
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Improvement rate of glabellar lines at rest according to the independent assessor's photo assessment
大体时间:Baseline to week 4, 8, 12, 16
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Independent assessor assessed the subject's glabellar lines 'At rest' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
An independent assessor separately conducted the FWS assessment subsequently based on the photographs taken.
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Baseline to week 4, 8, 12, 16
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Improvement rate of glabellar lines as assessed by the subject
大体时间:Baseline to week 4, 8, 12, 16
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Subjects assessed their glabellar lines at each time point after the administration of the investigational product compared to baseline.
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Baseline to week 4, 8, 12, 16
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Subject's satisfaction
大体时间:Baseline to week 4, 8, 12, 16
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Subject's satisfaction score for the improvement of glabellar lines was investigated at each time point after the administration of the investigational product compared to before administration.
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Baseline to week 4, 8, 12, 16
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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。
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)
2021年5月27日
初级完成 (实际的)
2022年1月30日
研究完成 (实际的)
2022年3月5日
研究注册日期
首次提交
2026年5月26日
首先提交符合 QC 标准的
2026年5月27日
首次发布 (实际的)
2026年6月2日
研究记录更新
最后更新发布 (实际的)
2026年6月3日
上次提交的符合 QC 标准的更新
2026年6月1日
最后验证
2026年6月1日
更多信息
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