Trial record 1 of 3 for:
Open Studies | "Lice Infestations"
Effectiveness of Permethrin Impregnated Underwear in Preventing Louse Proliferation in Infected Homeless (ERPOUPER)
This study is currently recruiting participants.
Verified February 2011 by Assistance Publique Hopitaux De Marseille
Sponsor:
Assistance Publique Hopitaux De Marseille
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01287663
First received: January 31, 2011
Last updated: February 9, 2011
Last verified: February 2011
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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 |
|---|---|
|
Lice |
Drug: Permethrin impregnated Drug: no Permethrin impregnated |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 334 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | January 2013 (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 |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287663
Contacts
| Contact: philippe BROUQUI | philippe.brouqui@ap-hm.fr |
Locations
| France | |
| Assistance Publique Hopitaux de Marseille | Recruiting |
| Marseille, France, 13354 | |
| Contact: philippe BROUQUI | |
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
| Study Director: | BERNARD BELAIGUES | Assistance Publique hôpitaux de Marseille |
More Information
No publications provided
| Responsible Party: | direction de la recherche, ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE |
| ClinicalTrials.gov Identifier: | NCT01287663 History of Changes |
| Other Study ID Numbers: | 2010-A01406-33, 2010 30 |
| Study First Received: | January 31, 2011 |
| Last Updated: | February 9, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Lice Infestations Ectoparasitic Infestations Skin Diseases, Parasitic Parasitic Diseases Skin Diseases, Infectious |
Skin Diseases Permethrin Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013