NCT01791920已完成3 期
Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of "Botulax®" Compared to Botox Inj. in Patients With Moderate to Severe Glabellar Lines
Hugel6 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2011年8月最近更新:
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
- 262
- 试验地点
- 6
- 主要终点
- Responder rate of improvement in glabellar lines with Physician's rating of line severity
研究概览
简要总结
To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 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 18 and 65
- •Patients attaining grade 2 or 3 in the investigator's rating of glabellar lines severity at maximum frown
- •Patients who voluntarily sign the informed consent
- •Patients who can comply with the study procedures and visit schedule
排除标准
- •Subjects who had facial plastic surgery (tissue augmentation, brow lift, and dermal resurfacing)treatment within 6 months. Those who had peeling or laser therapy
- •Subjects with skin disorders, scar or infection around glabellar region
- •Subjects who are taking Aspirin, NSAIDS or anti-coagulant
- •Subjects with facial palsy or eyelid ptosis
- •Subjects who diagnosed as neuromuscular junction disorder (e.g., myasthenia gravis, Lambert-Eaton Syndrome)
- •Subjects with history of drug intoxication, alcohol abuse and/or depressive disorder
- •Subjects with severe internal diseases (cardiovascular, respiratory, renal disease, liver disorder)
- •Subjects who have previously been treated with botulinum toxin within 3 months (Botulinum toxin type A: 3months, type B: 4 months)
- •Subject who have administered following drugs within the previous 4 months: Spectinomycin Hydrochloride, Aminoglycoside antibiotics, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics, muscle relaxants, anti-cholinergic agents, benzodiazepine and similar drugs, benzamide drugs, Tubocurarine-type muscle relaxants
- •Subjects who have possibility to take the drugs listed above
- •Subjects who have a plan to receive facial cosmetic procedures including dermal filler, chemical peeling and dermabrasion during study period
- •Subjects who have glabellar lines that are unable to be improved with any physical method
- •Subjects who have history of hypersensitivity to Botulinum toxin and other agents
- •Subjects who are pregnant or breast-feeding
- •Subjects who have a plan to be pregnant in 3months, or who are not doing contraceptive
- •Subjects who participated in other studies within 30 days or were not passed over 5 times of half life for investigational product
- •Subjects who are having trouble with acute disease
- •Subjects who have taken any treatment that can affect to glabellar lines and/or any lines around forehead within the previous 6 months
- •Subjects who are unable to communicate or follow the instructions
- •Subjects who are not eligible for this study based on investigator's judgement
研究组 & 干预措施
Botulinum toxin type A(Botox®)
Active Comparator
Botulinum toxin type A
干预措施: Botulinum toxin type A(Botulax®) (Drug)
Botulinum toxin type A (Botulax®)
Experimental
Botulinum toxin type A
干预措施: Botulinum toxin type A(Botox®) (Drug)
结局指标
主要结局
Responder rate of improvement in glabellar lines with Physician's rating of line severity
时间窗: at 4 weeks post-injection
Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 4weeks post injection.
次要结局
- Safety evaluation in experimental drug treatment group(4, 8, 12, 16 weeks post-injection)
- Responder rate of improvement in glabellar lines at rest with investigator's live assessment of severity(4, 8, 12, 16 weeks post-injection)
- Responder rate of improvement in glabellar lines with Subject's improvement assessment(4, 8, 12, 16 weeks post-injections)
- Responder rate of improvement in glabellar lines with Physician's rating of line severity(8, 12, 16 weeks post-injection)
- Responder rate of improvement in glabellar lines at rest with investigator's photo assessment(4, 8, 12, 16 weeks post inejection)
- Subject's satisfaction rate(4, 8, 12, 16 weeks post-injection)
- Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment(4, 8, 12, 16 weeks post-injection)
研究者
研究点 (6)
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