NCT00694148已完成3 期
NT 201 is a Botulinum Toxin Type A Preparation Free of Complexing Proteins. Injected Into the Muscle, NT 201 Causes a Reversible Local Relaxation of the Injected Muscle. Botulinum Toxin Type A is Widely Used for Aesthetic Treatment of Mimic Wrinkles. This Study Will Investigate the Safety and Efficacy of NT 201 in the Treatment of Glabellar Frown Lines.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Investigator's assessment
研究概览
简要总结
NT 201 is a Botulinum toxin type A preparation free of complexing proteins. Injected into the muscle, NT 201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is widely used for aesthetic treatment of mimic wrinkles. This study will investigate the safety and efficacy of NT 201 in the treatment of glabellar frown lines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •moderate to severe glabellar frown lines at maximum frown ((severity score of 2 or 3 on Facial Wrinkle Scale(FWS)as assessed by the investigator's rating: 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe'
- •Stable medical condition
- •Age: between 18 and 65 years (inclusively)
排除标准
- •Previous treatment with Botulinum toxin of any serotype in the upper third part of the face within the last 6 month
- •Previous treatment with biodegradable fillers in the glabellar area within the last 12 month
- •Previous insertion of permanent material in the glabellar area, including fat graft (regardless of the time between previous treatment and this study)
- •Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area
- •Any other planned cosmetic procedure in the upper third part of the face during the trial period
- •Inability to substantially lessen glabellar frown lines even by physically spreading them apart
- •Marked facial asymmetry or ptosis of eyelid and/or eyebrow
- •History of facial nerve palsy
- •Any infection in the area of the injection sites
结局指标
主要结局
Investigator's assessment
时间窗: 4 weeks after initial injection session
次要结局
未报告次要终点
研究者
研究点 (2)
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