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Place of Hygiene in Scabies's Treatment in Populations in Precarious Situations (GALEHYGIE)

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ClinicalTrials.gov Identifier: NCT05271968
Recruitment Status : Not yet recruiting
First Posted : March 9, 2022
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Scabies is a parasitic pathology contracted mainly through human contamination. It is caused by a parasite (Sarcoptes Scabiei var. hominis) which lodges into the top layer of the epidermis creating a burrow, which can measure 5 mm to 15 mm, where the female lays her eggs.

After 4-6 weeks the patient develops an allergic reaction to the presence of mite proteins and feces in the scabies burrow, causing intense itch and rash. The usual adult form, called common scabies, is characterized by this nocturnal pruritus, and typical and/or atypical lesions. The typical lesions are the vesicle (translucent vesicle on an erythematous base), the scabious burrow (due to the tunnel dug by the female in the stratum), and the papulo- nodule -nodular scabious (red/brown infiltrated on palpation, predominantly on the male genital areas). They predominate in certain regions: the interdigital region of the hands, the anterior face of the wrists, the external face of the elbows, the axillary region, the areolas, the nipples, the umbilical region, the male external genitalia, the buttock region, the face inner thighs.

Scabies occurs worldwide. However, studies have shown a greater prevalence among populations that do not have access to common hygiene measures: poor, young children and elderly in resource -poor communities, migrant, homeless populations, etc. The "Baudelaire outpatient clinic" (BOPC) at St Antoine hospital in Paris offers general medicine consultations. It has the particularity of offering a so called "Permanent d'Accès Aux Soins" service that allowed any person without health assurance to have access to a general practitioner and treatment, free of charge and help to recover its social rights. Consequently, more than 60% of the patients encountered at the consultation of the BOPC are in a precarious situation.

Usually, poor patients with scabies may be offered a shower and clean clothes at the BOPC Therefore it seemed to us the ideal place to evaluate a treatment's scabies in this population including the hygiene treatment.


Condition or disease Intervention/treatment Phase
Scabies Procedure: Global management of scabies Not Applicable

Detailed Description:

The objective of our study is to evaluate the superiority of a global management of scabies compared to a conventional treatment.

The classic treatment recommended is the prescription of an oral drug, Ivermectin to be taken two times at one or 2 weeks interval. And recommendations on the need to change the clothes and the linen of the bedding the following day after taking the drug, washing them at more than 50° as well as all the clothes three days before are explained. The first course of oral treatment is swallowed at the BOPC, while the second course is given to be swallowed one week later.

For the interventional arm, the first course of the oral treatment has also to be swallowed at the BOPC but the patient will have to come back the following day to take a shower at the BOPC and will receive new clothes. The second course will be given, but the patient will have to come back the following day of the second course to take a shower at the BOPC and to receive again new clothes.

We will compare the number of patients cured in the interventional arm versus the control arm at D28.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Place of Hygiene in Scabies's Treatment in Populations in Precarious Situations
Estimated Study Start Date : April 2022
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scabies

Arm Intervention/treatment
No Intervention: Control
Standard Care : The classic treatment recommended is the prescription of an oral drug, Ivermectin to be taken two times at one or 2 weeks interval. And recommendations on the need to change the clothes and the linen of the bedding the following day after taking the drug, washing them at more than 50° as well as all the clothes three days before are explained. The first course of oral treatment is swallowed at the BOPC, while the second course is given to be swallowed one week later.
Experimental: Intervention
Patients in this interventional arm will come back to BOPC the following day after intake the treatment (D1 and D8) to take a shower and to receive again new clothes
Procedure: Global management of scabies

For the interventional arm, the first course of the oral treatment has also to be swallowed at the BOPC service, but the patient will have to come back the following day to take a shower at the BOPC service and will receive new clothes.

The second course will be given, but the patient will have to come back the following day of the second course to take a shower at the BOPC service and to receive again new clothes





Primary Outcome Measures :
  1. Healing [ Time Frame: 28 days ]

    To assess the impact on the scabies healing rate by providing to patient in precarious situation a shower and clean clothes, twice at one-week intervals, versus the standard hygiene recommendations given to patients.

    Number of patients cured in the interventional arm (P=Policlinic) versus the control arm (D=home) at D28.



Secondary Outcome Measures :
  1. Compliance [ Time Frame: 28 days ]
    Compliance with treatment and effectiveness of the proposed device: determination of the number of patients seen again on D2 and D8 for the shower, and on D28 for the two groups.

  2. Validity of the proposed clinical criteria [ Time Frame: 28 days ]
    Validity of the proposed clinical criteria: the cure rate in each group will be analyzed according to the three clinical grades, confirmed, probable and possible



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient seen in consultation at the outpatient clinic, diagnosed with non-hyperkeratotic scabies.
  • Living on the streets or without access to body care.
  • Having received information on the protocol and having signed consent

Exclusion Criteria :

  • Patient alcoholic on the day of the consultation
  • Medical history fo psychiatric disease , severe somatic comorbidity, allergy to Ivermectin, pregnant woman
  • Patient not understanding the on-site management (shower, change of clothes, taking the first dose of the drug on site)
  • Non-communicating patient
  • Hyperkeratotic or impetiginized scabies
  • Patients not reachable by phone
  • Patient having been treated for scabies less than 45 days before
  • Patients under guardianship / curator ship or adults and subject to another protective measure.
  • Pregnant and breastfeeding women
  • Persons deprived of liberty by judicial and administrative decision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05271968


Contacts
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Contact: Bacha Kaoutar (0)676089262 ext +33 bacha.kaoutar@aphp.fr

Locations
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France
Hopital Saint Antoine - Polyclinique Beaudelaire
Paris, Ap-hp, France, 75012
Contact: Bacha Kaoutar    (0)676089262 ext +33    bacha.kaoutar@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Bacha Kaoutar Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT05271968    
Other Study ID Numbers: APHP210864
First Posted: March 9, 2022    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Contagious disease
Scabies infection
Poor condition
Hygiene
Additional relevant MeSH terms:
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Scabies
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Infections
Skin Diseases, Infectious
Skin Diseases