NCT00262418已完成2 期
A Randomised, Double Blind, Double Dummy Study to Compare the Efficacy and Safety of a Single Administration of Ivermectin to a Single Administration of Permethrin for the Treatment of Scabies
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Clinical healing of the skin injuries
研究概览
简要总结
Comparison of the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies
详细描述
Administration of ivermectin or permethrin on day0 Clinical examination and pictures on day0, day14 and day28 Blood sample on day0 VAS for pruritus, DLQI and SF-36 on day0, day14 and day28
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one of the following inclusion criteria:
- •Scabies tunnels
- •Positive microscopic examination (acarids, faeces or ova)
- •At least two of the three following inclusion criteria:
- •Non-specific injuries with a typical distribution pattern
- •Serious itching which increases during the night
- •Family or contacts with similar complaints
排除标准
- •Treatment for scabies < 4 weeks ago
- •Treatment with corticoids < 1 week ago
- •Pregnancy
- •Breast-feeding
- •Serious immunodepressive patients
- •Sensitivity or allergy to one of the components of the study medication
- •Damage of the central nerve system
结局指标
主要结局
Clinical healing of the skin injuries
时间窗: on day28
次要结局
- Decrease of itching(on day28)
- Amelioration of the life quality(on day28)
- Number and gravity of adverse events
研究者
研究点 (2)
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