NCT03289169已完成4 期
A Single-Arm Trial, Open-label, Repeated, Long-term, Multi-center, A Phase IV Clinical Trial to Evaluate the Long-term Efficacy and Safety of Repeat Treatment With MEDITOXIN® in Treatment of Glabella Line
Medy-Tox1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年12月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment
研究概览
简要总结
This study evaluates the long-term safety of repeated administrations of Meditoxin® in the treatment of moderate to severe 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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged between 20 and 65
- •Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
- •Patients who can comply with the study procedures and visit schedule
- •Patients who voluntarily sign the informed consent
排除标准
- •Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
- •Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
- •Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
- •Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
- •Patients who were injected with botulinum toxin within the past 3 months
- •Patients with allergy or hypersensitivity to the investigational drugs or their components
- •Patients who have bleeding tendency or taking anti-coagulant
- •Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or 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 with skin disorders or infection at the injection site
- •Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
- •Patients who are unable to communicate or follow the instructions
- •Patients who are not eligible for this study based on the judgment of an investigator
研究组 & 干预措施
MEDITOXIN
Experimental
Meditoxin(Botulinum toxin type A)
干预措施: MEDITOXIN® (Drug)
结局指标
主要结局
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment
时间窗: 4 weeks after final injection
improvement are defined as subjects with glabellar line severity of none (0) or mild (1).
次要结局
- Glabellar line improvement rate at maximum frown and rest confirmed with investigator's live assessment(4 weeks after each injection)
- Glabellar line improvement rate at maximum frown and rest confirmed with investigator's photo assessment(4 weeks after each injection)
研究者
研究点 (1)
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