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

Primary Purpose

Scabies

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Global management of scabies
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scabies focused on measuring Contagious disease, Scabies infection, Poor condition, Hygiene

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Saint Antoine - Polyclinique Beaudelaire

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Healing
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

Compliance
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.
Validity of the proposed clinical criteria
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

Full Information

First Posted
February 28, 2022
Last Updated
February 28, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05271968
Brief Title
Place of Hygiene in Scabies's Treatment in Populations in Precarious Situations
Acronym
GALEHYGIE
Official Title
Place of Hygiene in Scabies's Treatment in Populations in Precarious Situations
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scabies
Keywords
Contagious disease, Scabies infection, Poor condition, Hygiene

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Global management of scabies
Intervention Description
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 Measure Information:
Title
Healing
Description
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.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Compliance
Description
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.
Time Frame
28 days
Title
Validity of the proposed clinical criteria
Description
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
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bacha Kaoutar
Phone
(0)676089262
Ext
+33
Email
bacha.kaoutar@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bacha Kaoutar
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Saint Antoine - Polyclinique Beaudelaire
City
Paris
State/Province
Ap-hp
ZIP/Postal Code
75012
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bacha Kaoutar
Phone
(0)676089262
Ext
+33
Email
bacha.kaoutar@aphp.fr

12. IPD Sharing Statement

Learn more about this trial

Place of Hygiene in Scabies's Treatment in Populations in Precarious Situations

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