跳至主要内容
临床试验/NCT00604084
NCT00604084已完成不适用

Veron Scabies Education and Eradication Program

Edward Via Virginia College of Osteopathic Medicine1 个研究点 分布在 1 个国家目标入组 1,057 人开始时间: 2007年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1,057
试验地点
1
主要终点
Scabies incidence

研究概览

简要总结

The purpose of this project is to develop a community scabies eradication and education program for the highly endemic areas surrounding the Veron community on the eastern tip of the Dominican Republic. It proposes the use of oral Ivermectin as a replacement for topical Lindane--a readily available medical formulation, pesticide, and environmental toxin that is reported to be banned in the Dominican Republic as well as over 80 other countries throughout the world.

详细描述

Introduction

The Secretaría de Estado de Salud Pública y Asistencia Social public health clinic in Veron, Dominican Republic continually reports a subjectively high prevalence and incidence of scabies infections among its general patient population without any means of direct measurement, proper intervention, or control, raising concerns that long-term infestation may lead to multiple other secondary medical and environmental problems.

The purpose of this project is to develop a community scabies eradication and education program for the highly endemic areas surrounding the Veron community. It proposes the use of oral Ivermectin as a replacement for topical Lindane, a readily available and prescribed pesticide and environmental toxin that is reportedly banned for all uses in the Dominican Republic as well as over 80 other countries throughout the world (Boffa, Brough, & Ead, 1995; Davies, Dedhia, Mergade, Banquet, & Maibach, 1983).

Ivermectin, on the other hand, is a remarkably safe, effective, cost-comparative oral medication with a substantially broader scope of coverage, duration of effectiveness, and ease of delivery and compliance when compared to Lindane, as well as over 20 years of use in global mass eradication campaigns for other parasites on the order of more than 50 million doses to date (Alexander, Bockarie, Kastens, Kazra, & Alpers, 1998; del Guidice, Chosidow, & Caumes, 2003; Madan, Jaskiran, Gupta, & Gupta, 2001).

Specific program goals include: the quantification of community disease prevalence, a statistically significant reduction in both scabies incidence as well as secondary disease sequelae, improved community scabies awareness and prevention abilities, and decreased environmental impact on the Veron area by eliminating the use of Lindane for scabies treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • IVERMECTIN ARM:
  • able to swallow pills
  • no known allergy to Ivermectin
  • not pregnant
  • not breastfeeding
  • 5 years or older
  • taller than 90cm
  • willingness to participate in study and give written consent
  • PERMETHRIN ARM:
  • no known allergy to Permethrin 5% lotion
  • able to apply lotion to self or to other person if a child
  • breastfeeding
  • younger than 5 years
  • shorter than 90cm
  • willingness to participate in study and give written consent

排除标准

  • IVERMECTIN ARM:
  • unable to swallow pills
  • allergy to Ivermectin
  • breastfeeding
  • younger than 5 years
  • shorter than 90cm
  • unwilling to participate in study or give written consent
  • PERMETHRIN ARM:
  • unable to apply lotion to self
  • allergy to Permethrin 5% lotion
  • not pregnant
  • not breastfeeding
  • 5 years or older
  • taller than 90cm
  • unwilling to participate in study or give written consent

研究组 & 干预措施

Ivermectin

Experimental

Non-pregnant, non-breastfeeding, taller than 90cm and 5 years or older

干预措施: Ivermectin (Drug)

Permethrin

Experimental

Pregnant, breastfeeding, children under 90cm or under 5 years old

干预措施: Permethrin 5% lotion (Drug)

结局指标

主要结局

Scabies incidence

时间窗: monthly

次要结局

  • Scabies-induced skin abscess incidence(monthly)
  • Incidence of Lindane prescription and use(monthly)
  • Incidence of Ivermectin prescription and use(monthly)
  • Scabies disease, treatment, and prevention awareness(monthly)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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