Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06124781
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-10-26
Brief Title:
Molecular Diagnosis of Allergic Contact Dermatitis SMECA
Sponsor:
Ramsay Générale de Santé
Organization:
Ramsay Générale de Santé
Study Overview
Official Title:
The Value of Molecular Signatures in the Diagnosis of Allergic Contact Dermatitis
Status:
RECRUITING
Status Verified Date:
2023-11
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:
SMECA
Brief Summary:
Allergic contact dermatitis ACD is a common inflammatory skin disease which represents a major public health issue in industrialized countries ACD is induced by repeated contact of individuals with environmental chemicals and is characterized by a delayed type IV hypersensitivity response with skin inflammation mediated by allergen-specific T cells in sensitized individuals
The current diagnosis is based on clinical examination assessment of environmental exposures and patch testing Although the robustness of patch tests has long been established this method can sometimes give inconclusive results leading to problems in disease management
Preliminary results indicate that the molecular analysis of Patch-Tests PT reactions could allow a more reliable diagnosis Importantly this gene profiling approach may help to identify patients with false positive PT reactions ie patients whose PT reactions did not show any allergy signature
However it remains to be demonstrated that the presence or absence of allergy biomarkers in PT lesions are indeed predictive of ACD response in patients
The main objective is to describe the correlation between these molecular signatures and the reactivity of individuals when they are exposed to allergenic compounds under conditions of use using ROAT test
The current diagnosis is based on clinical examination assessment of environmental exposures and patch testing Although the robustness of patch tests has long been established this method can sometimes give inconclusive results leading to problems in disease management
Preliminary results indicate that the molecular analysis of Patch-Tests PT reactions could allow a more reliable diagnosis Importantly this gene profiling approach may help to identify patients with false positive PT reactions ie patients whose PT reactions did not show any allergy signature
However it remains to be demonstrated that the presence or absence of allergy biomarkers in PT lesions are indeed predictive of ACD response in patients
The main objective is to describe the correlation between these molecular signatures and the reactivity of individuals when they are exposed to allergenic compounds under conditions of use using ROAT test
Detailed Description:
None
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