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

Body's Louses Clinical Trial

— ERPOUPER  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01287663
• Other study ID #: 2010-A01406-33
• Secondary ID: 2010 30
• Status: Terminated
• Phase: N/A
• First received: January 31, 2011
• Last updated: August 28, 2014
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body's Louses

Intervention

Drug:
• Permethrin impregnated

• no Permethrin impregnated

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes