An interventional study of Global management of scabies in Scabies, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-09.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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.
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.
51 studies on the registry are indexed under Scabies; 10 are open to participants now.
This study's planned enrollment of 218 is above the median of 183 across 41 interventional studies indexed under Scabies.
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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
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
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.
Time frame: 28 days
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.
Time frame: 28 days
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
Time frame: 28 days
Start is estimated for Apr 2022; primary completion for Apr 2022, 0 months later.
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This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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