Body's LousesERPOUPERNCT01287663
Effectiveness of Permethrin Impregnated Underwear in Preventing Louse Proliferation in Infected Homeless
A study testing Permethrin impregnated and no Permethrin impregnated in people with Body's Louses, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body's Louses
- What is being tested?
- Permethrin impregnated and no Permethrin impregnated
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Body's Louses
- Being tested
- Permethrin impregnated, no Permethrin impregnated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permethrin impregnatedDrug
no Permethrin impregnatedDrug
| Study group | Role | What they receive |
|---|---|---|
| no permethrin | Placebo comparator | Not described Receives: Drug: no Permethrin impregnated |
| permethrin | Experimental | Not described Receives: Drug: Permethrin impregnated |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 YEARS
Secondary outcomes (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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body's LousesStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01287663
- Sponsor's protocol ID
- 2010-A01406-33
- Other IDs
- 2010 30
- Acronym
- ERPOUPER
- Status last verified
- Aug 2014
- First submitted
- 31 Jan 2011
- Last updated
- 29 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24305799
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Permethrin Impregnated Underwear in Preventing Louse Proliferation in Infected Homeless
- ClinicalTrials.gov ID
- NCT01287663
- Acronym / sponsor ID
- ERPOUPER / 2010-A01406-33
- Conditions
- Body's Louses
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 1 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no permethrin | Placebo comparator | Drug: no Permethrin impregnated |
| permethrin | Experimental | Drug: Permethrin impregnated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permethrin impregnated | Drug | permethrin |
| no Permethrin impregnated | Drug | no permethrin |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
- Derived from this study: PubMed 24305799Benkouiten 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BERNARD BELAIGUES study director
Assistance Publique hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Permethrin impregnated and no Permethrin impregnated in people with Body's Louses, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01287663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2014.