A Randomized Controlled Trial Comparing the Effectiveness of Individual vs. Household Treatment for Scabies in Lambaréné, Gabon
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinical Cure
研究概览
简要总结
It is unclear whether individual treatment of scabies is similarly effective compared to household treatment. This study therefore compares these two treatment strategies with topical benzyl benzoate for treating scabies in Lambaréné and surroundings in Gabon.
Subjects presenting with uncomplicated scabies are randomized into either the Individual Treatment group, where only the affected subjects receive treatment, or the Household Treatment group, where all family members are treated in parallel to the affected subjects regardless of signs and symptoms. The primary endpoint is clinical cure after 28 days; the secondary endpoint is the proportion of affected household members per household after 28 days.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with active, uncomplicated scabies
- •no known hypersensitivity or allergy against benzyl benzoate
排除标准
- •hypersensitivity or allergy against benzyl benzoate
- •severe superinfection of scabies lesions
研究组 & 干预措施
Household Treatment
干预措施: Benzyl Benzoate 25% Topical Application Lotion (Drug)
Individual Treatment
干预措施: Benzyl Benzoate 25% Topical Application Lotion (Drug)
结局指标
主要结局
Number of Participants With Clinical Cure
时间窗: after 28 days from baseline
clinical improvement in skin lesions with no new lesions occurring since treatment application as assessed by skin examination
次要结局
- Proportion of Affected Household Members Per Household(after 28 days from baseline)
研究者
Julian Matthewman
Principal Investigator
Centre de Recherche Médicale de Lambaréné