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

NCT05271968 | Unknown

• 1 other identifier: APHP210864
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Scabies

Keywords

Contagious disease; Scabies infection; Poor condition; Hygiene

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days

Secondary Outcomes (2)

• Compliance

  28 days

• Validity of the proposed clinical criteria

  28 days

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

Global management of scabies PROCEDURE

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Saint Antoine - Polyclinique Beaudelaire

Paris, Ap-hp, 75012, France

Location

MeSH Terms

Conditions

Scabies; Communicable Diseases

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bacha Kaoutar

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bacha Kaoutar

CONTACT

(0)676089262; bacha.kaoutar@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-02

Locations

FR (1)