NCT05321979已完成3 期
Open-label, Single Group, Multi-center, Repeat-dose Long-term Extension Study to Evaluate the Long-term Safety and Efficacy of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
Medytox Korea1 个研究点 分布在 1 个国家目标入组 253 人开始时间: 2022年2月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- The result of anti-drug-andibodies (ADA) and neutralizing antibodies
研究概览
简要总结
This study is intended to evaluate long-term safety and efficacy of MBA-P01 in treatment of glabellar lines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Patients who completed the phase III trial (MT14-KR20GBL309)
- •Patients who were capable of understanding and complying with the protocol and have signed the informed consent form voluntarily
排除标准
- •Patients who have received other procedures which may affect glabellar lines within 6 months (except of MBA-P01 or BOTOX® treated in phase III trial, MT14-KR20GBL309)
- •Female patients who are pregnant or lactating. Female patients of childbearing age who have a plan to get pregnant during the study period.
- •Patient who do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
- •Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
- •Patients who are not eligible for this study based on the judgment of an investigator
研究组 & 干预措施
MBA-P01
Experimental
MBA-P01 will be injected into GL:
干预措施: MBA-P01 (Drug)
结局指标
主要结局
The result of anti-drug-andibodies (ADA) and neutralizing antibodies
时间窗: Through study completion, an average of 1 year
Incidence rate of treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs), serious adverse events (SAEs) and adverse event of special interest (AESI), when MBA-P01 is administered in repeated treatments.
时间窗: Through study completion, an average of 1 year
Incidence rate of TEAE, ADR, SAE and AESI of each cycle
时间窗: Through each cycle, an average of 3 months
The change of laboratory test and vital sign
时间窗: Through study completion, an average of 1 year
次要结局
- Investigator-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle(at week 4, week 8 and 12 of each cycle)
- Investigator-rated improvement rate of glabellar lines (GL) at maximum frown at week 4, week 8 and 12 of each cycle(at week 4, week 8 and 12 of each cycle)
- Participant-rated satisfaction rate of GL at rest at week 4, week 8 and 12 of each cycle(at week 4, week 8 and 12 of each cycle)
- Time to retreatment(Through study completion, an average of 1 year)
- Participant-rated improvement rate of GL at frown at week 4, week 8 and 12 of each cycle(at week 4, week 8 and 12 of each cycle)
- Participant-rated improvement rate of GL at rest at week 4, week 8 and 12 of each cycle(at week 4, week 8 and 12 of each cycle)
研究者
研究点 (1)
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