A Randomized Controlled Double-blind Trial Assessing the Efficacy of a 400µg/kg Ivermectin /5% Permethrin / Emollient Cream Regimen in Patients With Crusted Scabies as Compared to a 200µg/kg Ivermectin /5% Permethrin /Emollient Cream Regimen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Rate of a successful treatment defined by : -Two negative parasitologic and/or two dermoscopic exams
研究概览
简要总结
Severe forms of scabies (crusted scabies and profuse scabies) require a specific treatment. Ivermectin is a recommended treatment in common forms of scabies and represents a promising treatment in crusted scabies in case reports. However, response to ivermectin remains variable among studies, and there is no consensus on the schemes to adopt (dosages and administrations). Ivermectin at 400 µg/kg has already been used, without showing toxicity (in head lice treatment in particular). Investigators propose to demonstrate that 400µg/kg ivermectin dosage will show better efficacy than a 200µg/kg in patients with severe forms of scabies (crusted and profuse).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients ≥ 18 years old, diagnosed with severe forms of scabies
- •clinical criteria : cutaneous lesions of scabies
- •crusted scabies: at least two sites of hyperkeratosis will define crusted scabies and/or
- •profuse scabies : spreading lesions with erythematous scaly eruption of the neck, face or trunk without hyperkeratosis
- •paraclinical criteria:
- •Positive parasitological test
- •and/or dermoscopic exam with signs of scabies
- •Effective contraception for women in age of pregnancy Written consent from patient or his/her legal representant, trustworthy person or family member Affiliated to a social security scheme
排除标准
- •Pregnant and/or breastfeeding women
- •Intolerance to ivermectin or topical treatment (permethrin 5% cream) or emollient cream
- •Use of anti parasitic drug (ivermectin or albendazole) within the past 7 days
- •Abnormal liver test results: ALT and/or AST >3N within the past 7 days (within 6 months if no hepatic history)
- •Participation in other biomedical drug research
- •Patient deprived of freedom
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
研究组 & 干预措施
Oral ivermectin 400 µg/kg
Oral ivermectin 400 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other)
干预措施: Ivermectin 400 µg/kg (Drug)
Oral ivermectin 200 µg/kg
Oral ivermectin 200 µg/kg + topical treatment (permethrin 5% cream) + emollient cream (Dexeryl® or other)
干预措施: Ivermectin 200 µg/kg (Drug)
结局指标
主要结局
Rate of a successful treatment defined by : -Two negative parasitologic and/or two dermoscopic exams
时间窗: Days 21+/-2 days
Parasitologic and/or dermoscopic exams will be perform at days 18 +/-2days and at days 21+/-2 days
Rate of a successful treatment defined by : - A clinical response : disappearance of clinical active lesions
时间窗: Days 28+/- 2 days
次要结局
- Rate of adverse effects(Days 18 +/-2 days, Days 21+/-2 days and Days 28+/-2 days)