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临床试验/NCT01287663
NCT01287663终止不适用

Effectiveness of Permethrin Impregnated Underwear in Preventing Louse Proliferation in Infected Homeless

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2011年1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
终止
入组人数
125
试验地点
1
主要终点
Show that underwear soaked with permethrine in 8 % allow to reduce in a long-lasting way (J90 and J365) of 50 % the index of infestation and prevalency of the louses in the group treated with regard to the group placebo.

研究概览

简要总结

Homelessness, also name the fourth world, is a growing public health problem worldwide. Previous studies showed that up to 30% of the homeless people reported pruritus that often results in itchy lesions, which expose them to bacterial skin infections.

The investigators therefore conducted a randomized, double-blind, placebo-controlled trial to test the hypothesis that a single oral dose of ivermectin was effective in significantly reducing the prevalence of pruritus in a sheltered homeless population.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient HOMELESS PERSON " individual who has no regular access to a conventional residence ", appearing during the period of study at reception centers (Forbin or Madrague Ville) and being in the habit of wearing there (at least 4 times a week),
  • Male genital organ and feminine,
  • Of more than 18 years old,
  • Presenting of the prurit, hurts of scratching or the louses
  • Wishing to change his underwear,
  • Having given his lit(enlightened) consent

排除标准

  • Woman presenting a sexually transmitted infection (infection with gonococcus, with Chlamydia trachomatis, with Trichomonas vaginalis) revealing on the takings realized during the consultation of inclusion but the bacteriological results of which will be known only secondarily.
  • Pregnant Woman presenting to the consultation of inclusion of métrorragies either a break of the pocket of waters or an infectious complication of the pregnancy.
  • Woman removing her consent during the study.
  • Lost sight Woman.
  • Woman deprived of freedom, judicial or administrative;
  • Woman hospitalized for quite other reason that looks for her(it);
  • Woman hospitalized in a sanitary establishment or social in the other purposes that the research;
  • Major Woman except state to express its consent

研究组 & 干预措施

no permethrin

Placebo Comparator

干预措施: no Permethrin impregnated (Drug)

permethrin

Experimental

干预措施: Permethrin impregnated (Drug)

结局指标

主要结局

Show that underwear soaked with permethrine in 8 % allow to reduce in a long-lasting way (J90 and J365) of 50 % the index of infestation and prevalency of the louses in the group treated with regard to the group placebo.

时间窗: 2 YEARS

次要结局

  • Show that underwear soaked with permethrine in 8 % allow to reduce in a long-lasting way (J90 and J365) of 50 % the index of infestation and prevalency of the louses in the group treated with regard to the group placebo.(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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