Comparison of Topical Permethrin 1 Day Verses 2 Day Application Versus Oral Ivermectin for Treatment of Scabies in Children Greater Than 6 Yrs of Age
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Cure of scabies.
研究概览
简要总结
Scabies is highly contagious,pruritic infestation of skin.Various treatment modalities have been used but search for ideal scabicide is ongoing.we wnt to coduct this study to compare the outcome of permethrin verses ivermectin in children for treatment of scabies .This randomized clinical trial will be done in children hospital lahore for 12 months.Sample size of 90 cases;30 in each group will be included through non probability consecutive sampling.Then patient will be randomly divided into 3 groups.In group A patient will be given 5% permethrin topical application to whole body single application. In Group B ,patients will be given topical permethrin for twice application 24 hrs appart ,In group C patients will be given Tablet Ivermectin single dose 200microgram/kg.Then patients will be examined after 2 weeks and 4 weeks for no of lesions and pruritis and cure will be labeled.All this information will be recorded on performa .Data will be entered and analysed by using SPSS version 26.Three groups will be compared for cure by using chi-square test.P value less than and equal to 0.05 will be considered as significant.
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
- None
入排标准
- 年龄范围
- 6 Years 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders
- •Diagnosed with scabies (as per operational definition)
排除标准
- •Children with recurrent scabies on medical record
- •Known allergy to ivermectin or permethrin.
- •Widespread eczema or impetigo.
- •Liver dysfunction or renal failure
研究组 & 干预措施
Group A
Group A will be given Permethrin
干预措施: Permethrin Cream, 5% (Drug)
Group B
Group B will be given Permethrin 5% cream twice application
干预措施: Permethrin Cream, 5% (Drug)
Group C
Group C will be given Tab Ivermectin
干预措施: Ivermectin 200 µg/kg (Drug)
结局指标
主要结局
Cure of scabies.
时间窗: 12 months
Cure will be labeled if greater han 50% reduction in no of lesions and pruritis observed after 4 weeks of treatment.
次要结局
未报告次要终点
研究者
Sadaf Wazir
DR SADAF WAZIR
Children Hospital and Institute of Child Health, Lahore
