Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicenter, assessor-blinded, cluster-randomised clinical trial

OBJECTIVE
With regards to the existing controversial data (Cochrane reviews, network meta-analysis) in classic scabies, to investigate whether oral ivermectin or topical 5% permethrin clinically cure scabies in index cases and his/her households.
DESIGN
Multicenter, assessor-blinded, cluster-randomised non-inferiority trial with a possible switch to superiority.
SETTING
28 French hospitals between January 2016 and December 2021.
PARTICIPANTS
Adults and children >15 kg, with dermoscopy-confirmed scabies—index cases—
INTERVENTIONS
Index cases were randomly assigned to either the ivermectin group or permethrin group (1:1 ratio). Each cluster member, defined as each index-case’s household, received the same treatment as the index case (except for children <15 kg, all prescribed 5% permethrin). All participants received on day (D)0 and D10, either oral 200-µg/kg ivermectin or 5% permethrin cream, applied head-to-toe.
MAIN OUTCOME MEASURES
Primary outcome was D28 clinical cure of the cl..., , # Oral ivermectin versus 5% permethrin cream to treat children and adults with classic scabies: multicenter, assessor-blinded, cluster-randomised clinical trial

Dataset DOI: [10.5061/dryad.sn02v6xjd](https://doi.org/10.5061/dryad.sn02v6xjd)

## Description of the data and file structure

Paper: Oral Ivermectin versus 5% Permethrin Cream to Treat Children and Adults with Classic Scabies: multicenter, assessor-blinded, cluster-randomised clinical trial

 

Authors: Franck Boralevi (deceased) et al

Corresponding author: Olivier Chosidow

Contact: Bruno Giraudeau [[e-mail]](mailto:[e-mail])

 

Description: This README file describes the data package accompanying the above publication.

The SCRATCH study was a French randomized trial. Data were collected using a case report form (CRF).

Files:

Data bases: there are 7 data files. The first 3 data bases correspond do data collected via the CRF while the trial was ongoing. Some comments have to be m..., We confirm that we received informed consent from all participants. There is no identifiable information in the data sets which is a requirement to conduct clinical research in France. We changed identification numbers and drop all the days from the data bases.

研究目的
针对经典疥疮领域现有存在争议的Cochrane系统评价（Cochrane reviews）、网络meta分析数据，旨在探讨口服伊维菌素（ivermectin）与外用5%扑灭司林（permethrin）乳膏，能否在索引病例及其家庭中实现疥疮的临床治愈。

研究设计
多中心、评估者设盲（assessor-blinded）、整群随机非劣效性试验，可后续转换为优效性检验。

研究场景
2016年1月至2021年12月期间的28家法国医院。

研究对象
经皮肤镜（dermoscopy）确诊疥疮的成人及体重＞15kg的儿童，即索引病例。

干预措施
将索引病例按1:1比例随机分配至伊维菌素组或扑灭司林组。以每个索引病例的家庭作为整群单位，整群内所有成员均接受与该索引病例一致的治疗方案（体重＜15kg的儿童除外，此类受试者均被处方外用5%扑灭司林乳膏）。所有受试者在第0天（D0）与第10天（D10）接受治疗：口服200μg/kg剂量的伊维菌素，或全身涂抹5%扑灭司林乳膏。

主要结局指标
主要结局为第28天（D28）的临床治愈[原文此处内容截断]。

# 口服伊维菌素对比5%扑灭司林乳膏治疗成人与儿童经典疥疮：多中心、评估者设盲、整群随机临床试验
数据集DOI：[10.5061/dryad.sn02v6xjd](https://doi.org/10.5061/dryad.sn02v6xjd)

## 数据与文件结构说明
论文：《口服伊维菌素对比5%扑灭司林乳膏治疗成人与儿童经典疥疮：多中心、评估者设盲、整群随机临床试验》

作者：弗朗克·博拉莱维（已故）等
通讯作者：奥利维耶·乔西杜
联系方式：布鲁诺·吉罗多 <[e-mail]>

说明：本自述文件用于介绍随本出版物一同发布的数据包。
本SCRATCH研究为一项法国随机对照试验，数据通过病例报告表（CRF, Case Report Form）收集。

文件：共包含7个数据库文件。前3个数据库对应试验开展期间通过CRF收集的数据。部分注释需[原文此处内容截断]。我们确认已获取所有受试者的知情同意。本数据集未包含可识别个人身份的信息，符合法国临床研究的相关要求。我们已修改受试者识别编号，并移除了数据库中的所有日期信息。