NCT01818076终止3 期
Open Label Study to Assess Long-term Safety of Repeat Administration of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 311
- 试验地点
- 1
- 主要终点
- Incidences of treatment-emergent adverse events and serious treatment-emergent adverse events when the drug product is administered in repeated treatments
研究概览
简要总结
This study will evaluate the long-term safety of botulinum toxin type A for the treatment of moderate to severe crow's feet lines after repeat application.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe crow's feet lines
- •Female or male, 18 years of age and above and in good general health
- •Women of childbearing potential must agree to use an effective method of birth control during the course of the study
排除标准
- •Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A
- •Muscle weakness or paralysis, particularly in the area receiving study treatment
- •Active skin disease or irritation at the treatment area
- •Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
- •Treatment with botulinum toxin type A for crow's feet lines in the last 3 months
- •Chemical peel during the 9 months prior to treatment
- •Use of prescription retinoid products during the 3 months prior to treatment
研究组 & 干预措施
Dose A
Experimental
Dose A: Botulinum toxin type A
干预措施: Botulinum Toxin Type A (Drug)
结局指标
主要结局
Incidences of treatment-emergent adverse events and serious treatment-emergent adverse events when the drug product is administered in repeated treatments
时间窗: Up to 24 months
Incidences of treatment-emergent laboratory, skin erythema, cranial nerve, and ocular irritation abnormalities when the drug product is administered in repeated treatments
时间窗: Up to 24 months
次要结局
未报告次要终点
研究者
研究点 (1)
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