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Effectiveness of Permethrin Impregnated Underwear in Preventing Louse Proliferation in Infected Homeless (ERPOUPER)
This study has been terminated.
Sponsor:
Assistance Publique Hopitaux De Marseille
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01287663
First received: January 31, 2011
Last updated: August 28, 2014
Last verified: August 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
| Body's Louses | Drug: Permethrin impregnated Drug: no Permethrin impregnated |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | Effectiveness of Permethrin Impregnated Underwear in Preventing Louse Proliferation in Infected Homeless |
Resource links provided by NLM:
Further study details as provided by Assistance Publique Hopitaux De Marseille:
Primary Outcome Measures:
- 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. [ Time Frame: 2 YEARS ]
Secondary Outcome Measures:
- 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. [ Time Frame: 2 years ]
| Enrollment: | 125 |
| Study Start Date: | January 2011 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: no permethrin | Drug: no Permethrin impregnated |
| Experimental: permethrin | Drug: Permethrin impregnated |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01287663
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287663
Locations
| France | |
| Assistance Publique Hopitaux de Marseille | |
| Marseille, France, 13354 | |
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
| Study Director: | BERNARD BELAIGUES | Assistance Publique hôpitaux de Marseille |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Assistance Publique Hopitaux De Marseille |
| ClinicalTrials.gov Identifier: | NCT01287663 History of Changes |
| Other Study ID Numbers: |
2010-A01406-33 2010 30 ( Other Identifier: AP HM ) |
| Study First Received: | January 31, 2011 |
| Last Updated: | August 28, 2014 |
Additional relevant MeSH terms:
|
Permethrin Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 23, 2017