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

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

Tracking Information
First Submitted Date  ICMJE January 31, 2011
First Posted Date  ICMJE February 1, 2011
Last Update Posted Date August 29, 2014
Study Start Date  ICMJE January 2011
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01287663 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2011)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Permethrin Impregnated Underwear in Preventing Louse Proliferation in Infected Homeless
Official Title  ICMJE Effectiveness of Permethrin Impregnated Underwear in Preventing Louse Proliferation in Infected Homeless
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Body's Louses
Intervention  ICMJE
  • Drug: Permethrin impregnated
  • Drug: no Permethrin impregnated
Study Arms  ICMJE
  • Placebo Comparator: no permethrin
    Intervention: Drug: no Permethrin impregnated
  • Experimental: permethrin
    Intervention: Drug: Permethrin impregnated
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 28, 2014)
125
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2011)
334
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01287663
Other Study ID Numbers  ICMJE 2010-A01406-33
2010 30 ( Other Identifier: AP HM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique Hopitaux De Marseille
Study Sponsor  ICMJE Assistance Publique Hopitaux De Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
PRS Account Assistance Publique Hopitaux De Marseille
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP