Oral Ivermectin Versus Topical Permethrin to Treat Scabies in Children and Adults: a Cluster Multicenter Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,092
- 试验地点
- 29
- 主要终点
- Assessment of skin lesions and healing at day 28
研究概览
简要总结
Scabies remains a frequent condition that affects adults and children. The aim of this study is to compare the efficacy and safety of two drug treatments against scabies in children and their close contacts. One group will apply topical permethrin 5% and the other group will receive oral ivermectin.
Both groups will be treated twice, once at inclusion and the second time 10 days later. Both treatment regimens have been used widely and are safe to use.
详细描述
Scabies is a common condition, even in European countries, and the annual incidence seems to have increased over the past several years.
Children and infants represent one-third of patients with scabies. Diagnostic features comprise pruritus, skin burrows and the delta jet wing dermoscopic sign.
In many countries, topical permethrin is the first line therapy. Moreover, oral treatment with ivermectin represents an interesting alternative therapy, usually used as one dose of 200μg/kg, and more and more frequently recommended as two doses (one on day 1 and one between day 8 and day 15) without strong evidence. Management of scabies requires giving a treatment not only to the patient but also to the patient's close contacts.
The objective of our study is to compare efficacy and safety of topical permethrin applied twice at day 1 and day 10 versus oral ivermectin given twice at day 1 and day 10 to treat scabies in children and their close contacts. Children (2 to15 years) with scabies and their close contacts - or first circle- will be randomized 1:1 to receive permethrin or ivermectin.
A clinical follow-up will be performed 28 days (V2) and 56 days (V3) after the inclusion, including a dermatological examination and to collect safety data.
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
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children or adult
- •For children, weight more than 15 kg
- •Documented diagnosis of scabies, defined by positive dermoscopic examination.
排除标准
- •Previous scabies therapy during the past 4 weeks
- •Known allergy to ivermectin or permethrin
- •Widespread eczematization or impetiginization
- •Liver or renal failure
研究组 & 干预措施
Ivermectin
干预措施: Ivermectin (Drug)
Permethrin
干预措施: Permethrin (Drug)
结局指标
主要结局
Assessment of skin lesions and healing at day 28
时间窗: Day 28
Healing of skin lesions and disappearance of pruritus at day 28 of the treatment in the cluster composed by the child and its close contacts
次要结局
- Incidence of serious adverse events(Day 56)
- Number of unaffected members in clusters treated by permethrin versus ivermectin at D0, D28 and D56.(day 0, day 28 and d56)
- Assessment of skin lesions and healing at day 56(day 56)
- Evaluation of delta wing jet sign(s) and mite egs(Day 56)
- Assessment of skin lesions and healing at day 28 and 56 in children(Day 28 and Day 56)
- adherence of patients(Day 56)