A Parallel, Active Drug Controlled, Double Blind, Randomized, Multi-center, Phase III Clinical Trial to Compare the Efficacy and Safety of MT10107 Versus BOTOX® in Treatment of Glabella Line
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 主要终点
- Investigator's live assessment of glabella line improvement rate
研究概览
简要总结
This study design is a parallel, active drug controlled, double blind, randomized, multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus BOTOX® in treatment of glabella line.
详细描述
This study design is a parallel, active drug controlled, double blind, randomized, multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus BOTOX® in treatment of glabella line. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the comparator at a total of 20U (4U/0.1ml each) in five sites of the glabella line. Thereafter, follow-up visits will be made at 4 weeks, 10 weeks, 16 weeks and the efficacy and safety assessments will be conducted for a total of 16 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients attaining ≥grade 2(moderate) in the investigator's rating of the severity of glabella line at maximum frown
- •Men and women aged between 20 and 65
- •Patients who him/herself or him/her legal representatives voluntarily signed the informed consent
- •Patients who can comply with the study procedures and visit schedule
排除标准
- •Patients with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis)
- •Patients who have bleeding tendency or taking anti-coagulant
- •Patients suffering from acute diseases
- •Patients who have been injected with botulinum toxin within past 3 months before the injection
- •Patients with allergy or hypersensitivity to the investigational products or their components
- •Patients who are pregnant or lactating or found to be pregnant through the urine or serum test or disagreed to avoid pregnancy during 16 weeks study period
- •Patients who have been given any of the following drugs within previous 4 weeks at screening: Muscle relaxants, benzodiazepine, aminoglycoside antibiotics, other antibiotics, and anticholinergic drugs.
- •Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
- •Patients with skin damage or infection at the injection site.
- •Patients who scheduled a double eyelid operation during the clinical trial.
- •Patients who have received or have a plan to receive other procedures, which may affect glabella and forehead lines within 6 months
- •Patients whose glabella lines cannot be spread apart even with physical methods like using hands.
- •Patients who are participating in other clinical trials or have participated in other clinical trials within 30 days of the screening date.
- •Patients who are unable to communicate or follow the instructions
- •Patients who are not eligible for this study at the discretion of the investigator
研究组 & 干预措施
Botox (Botulinum toxin type A)
20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.
干预措施: Botox (Botulinum toxin type A) (Drug)
Botox (Botulinum toxin type A)
20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.
干预措施: MT10107 (Botulinum toxin type A) (Drug)
MT10107 (Botulinum toxin type A)
20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.
干预措施: Botox (Botulinum toxin type A) (Drug)
MT10107 (Botulinum toxin type A)
20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.
干预措施: MT10107 (Botulinum toxin type A) (Drug)
结局指标
主要结局
Investigator's live assessment of glabella line improvement rate
时间窗: 4 weeks after the injection
Glabella line improvement rate determined by investigator's live assessment of glabella line severity at maximum frown at 4 weeks after the injection.
次要结局
- Investigator's live assessment of glabella line improvement rate(4, 10, 16 weeks after the injection)
- Investigator's photographic assessment of glabella line improvement rate at maximum frown(4 weeks after the injection)
- Subject's satisfaction questionnaire to assess treatment efficacy(4, 10, 16 weeks after the injection)
- Investigator's photographic assessment of glabella line improvement rate at rest(4 weeks after the injection)
- The number of participants with adverse events determined by MedDra ver 17.0 for assessment of safety in IP(Through study completion, approximately 8 months)
- Glabella line improvement rate of subject's assessment(4, 10, 16 weeks after the injection)