Trial record 8 of 291 for:    Open Studies | "Parasitic Diseases"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Assistance Publique Hopitaux De Marseille

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 31, 2014