Ignite Creation Date:
2024-05-06 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05271968
Status:
UNKNOWN
Last Update Posted:
2022-03-09
First Post:
2022-02-28
Brief Title:
Place of Hygiene in Scabiess Treatment in Populations in Precarious Situations
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Place of Hygiene in Scabiess Treatment in Populations in Precarious Situations
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GALEHYGIE
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 andor 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 redbrown 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 dAccès 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 treatments scabies in this population including the hygiene treatment
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 andor 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 redbrown 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 dAccès 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 treatments 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None