Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455891
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-07
Brief Title:
MYCobiome Analysis in Atopic Dermatitis With Head and Neck Involvement
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
MYCobiome Analysis in Atopic Dermatitis With Head and Neck Involvement
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
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:
MYCAH
Brief Summary:
It is an open study explorative proof of concept study concerning mycobiota dysbiosis implication in AD patients with head and neck involvement
Detailed Description:
The aim of this study is to carry out an analysis of the mycobiome in the head and neck regions of 30 adults with Atopic dermatitis compared with 15 healthy controls
patients and participants will be recruited from 2 centers Hôpital Tenon AP-HP Pr A Soria and CHU Lille Pr D Staumont-Sallé over a 12-month period
Patient will be classified in 2 subgroups according to topography and body surface area involved by AD
Group 1 Generalized AD defined by AD skin lesion involved more or equal 50 of total body surface area with head and neck involvement 15 patients
Group 2 Head and neck AD HNAD defined by AD involving at least 80 of the head and neck area with or without AD involvement outside the head and neck area but 20 of total body surface area 15 patients Group 3 Healthy control without chronic skin disease Healthy control will be recruited from non-atopic patients explored in ours departments for drug allergy after resolution of acute events 15 healthy controls In the framework of consultation medical examination with clinical assessment non-invasive skin microbiota samples 3x2 skin ESwab will be performed and a supplemental blood sample was collected 35 mL for study of innate and adaptive immune response see Diagram of the study summarising the chronology of the study For each patient the end of participation in the study is achieved after the completion of swab and blood samples No follow up is planned Patients participation is 1 day at maximum
Skin samples will be used for study of Mycobiome by culture and MALDI-TOF and NGS analysis and Blood sample will be used for study of the immune innate and adaptative response
patients and participants will be recruited from 2 centers Hôpital Tenon AP-HP Pr A Soria and CHU Lille Pr D Staumont-Sallé over a 12-month period
Patient will be classified in 2 subgroups according to topography and body surface area involved by AD
Group 1 Generalized AD defined by AD skin lesion involved more or equal 50 of total body surface area with head and neck involvement 15 patients
Group 2 Head and neck AD HNAD defined by AD involving at least 80 of the head and neck area with or without AD involvement outside the head and neck area but 20 of total body surface area 15 patients Group 3 Healthy control without chronic skin disease Healthy control will be recruited from non-atopic patients explored in ours departments for drug allergy after resolution of acute events 15 healthy controls In the framework of consultation medical examination with clinical assessment non-invasive skin microbiota samples 3x2 skin ESwab will be performed and a supplemental blood sample was collected 35 mL for study of innate and adaptive immune response see Diagram of the study summarising the chronology of the study For each patient the end of participation in the study is achieved after the completion of swab and blood samples No follow up is planned Patients participation is 1 day at maximum
Skin samples will be used for study of Mycobiome by culture and MALDI-TOF and NGS analysis and Blood sample will be used for study of the immune innate and adaptative response
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-A00281-46 | OTHER | IDRCB ANSM | None |