Effectiveness of Permethrin Impregnated Underwear in Preventing Louse Proliferation in Infected Homeless (ERPOUPER)

• ClinicalTrials.gov Identifier: NCT01287663
• Recruitment Status: Terminated
• First Posted: February 1, 2011
• Last Update Posted: August 29, 2014
• Sponsor: Assistance Publique Hopitaux De Marseille
• Information provided by (Responsible Party): Assistance Publique Hopitaux De Marseille

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Body's Louses	Drug: Permethrin impregnated; Drug: no Permethrin impregnated	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 125 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Permethrin Impregnated Underwear in Preventing Louse Proliferation in Infected Homeless
• Study Start Date: January 2011
• Actual Primary Completion Date: May 2012
• Actual Study Completion Date: May 2012

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: no permethrin	Drug: no Permethrin impregnated
Experimental: permethrin	Drug: Permethrin impregnated

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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):

Benkouiten S, Drali R, Badiaga S, Veracx A, Giorgi R, Raoult D, Brouqui P. Effect of permethrin-impregnated underwear on body lice in sheltered homeless persons: a randomized controlled trial. JAMA Dermatol. 2014 Mar;150(3):273-9. doi: 10.1001/jamadermatol.2013.6398.

• 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 )
• First Posted: February 1, 2011
• Last Update Posted: August 29, 2014
• Last Verified: August 2014

Additional relevant MeSH terms:

Permethrin; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action