NCT03894748已完成2 期
A Parallel, Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Efficacy and Safety of MT10109L Versus BOTOX® in Treatment of Glabella Line(Including a Preliminary Study to Evaluate Safety of MT10109L)
Medy-Tox3 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 3
- 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 multi-center, randomized, double-blind, parallel group, active controlled, phase 3 clinical trial(Including randomized, double-blind, parallel group, active controlled, preliminary study). 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 4 weeks, 10weeks, 16weeks and efficacy and safety assessments will be conducted for total 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main inclusion criteria
- •Patients attaining ≥grade 2(moderate) in the investigator's rating of the severity of glabella line at maximum frown
- •Other inclusion criteria
- •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 pregnancy through the urine or serum test or disagreed to avoid pregnancy during 16 weeks study period
- •* All childbearing female subjects, excepting who had amenorrhea over 12 months or sterilization operation(bilateral tubal ligation, bilateral oophorrectomy or hysterectomy), shouldn't be enrolled the study until they tested negative on pregnancy test(urine or serum). The contraceptions which are medically allowable are spermicides, oral contraceptives, barrier method, intrauterine contrace, complete sexual abstinence
- •Patients who have been given any of the following drugs within previous 4 weeks at screening
- •① Muscle relaxants: Tubocurarine Chloride, Dantrolene Sodium, baclofen etc.
- •② Spectinomycin HCl
- •③ Aminoglycoside antibiotics: gentamicin sulfate, neomycin sulfate etc.
- •④ Polypeptide antibiotics: Polymyxin B Sulfate etc.
- •⑤ Tetracycline antibiotics
- •⑥ Lincomycin (lincosamides)
- •⑦ Anticholinergic drugs: butylbromide bromide, Trihexyphenidyl HCl etc.
- •⑧ Benzodiazepines and similar drugs: Diazepam, Etizolam etc.
- •⑨ Benzamide drugs: Tiapride HCl, Sulpiride etc.
- •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 have received or have a plan to receive other procedures which may affect glabella and forehead lines within 6 months
- •* These treatments include soft tissue augmentation in the range of glabella (e.g. hyaluronic acid or collagen-type implants), medium depth peels, facial lifting, dermal photorejuvenation et cetera.
- •Patients whose glabella lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands
- •Patients who are participating in other clinical trials or have participated in other clinical trials within 30days 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
MT10109L(Botulinum toxin type A)
Experimental
干预措施: Botulinum Toxin Type A (Drug)
BOTOX® 50U(Botulinum toxin type A)
Active Comparator
干预措施: 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
次要结局
- Investigator's live assessment of glabella line improvement rate(4, 16 weeks after the injection)
- Investigator's photographic assessment of glabella line improvement rate(4 weeks after the injection)
- Subject's assessment of glabella line improvement rate(4, 10, 16 weeks after the injection)
- Subject's satisfaction questionnaire(4, 10, 16 weeks after the injection)
- Number of adverse events in subjects(Up to 16 weeks)
研究者
研究点 (3)
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