Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177314
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2023-12-11
Brief Title:
Molecular Diagnosis of Allergic Contact Dermatitis
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Molecular Diagnosis of Allergic Contact Dermatitis
Status:
RECRUITING
Status Verified Date:
2023-12
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:
MODAL
Brief Summary:
Allergic contact dermatitis ACD is a common inflammatory skin disease affecting approximately 15-20 of the general population in industrialized countries and ranking first among occupational diseases in many European countries
ACD typically presents as a severe skin inflammation with redness edema oozing and crusting It is characterized by a delayed type IV hypersensitivity response mediated by allergen-specific T cells in sensitized individuals
Current diagnosis relies on clinical investigations by diagnostic patch testing with suspected allergenic chemicals The patch test method aims at reproducing the eczematous lesions by applying occlusive patches containing the suspected allergens to the patients healthy skin This is a time consuming and costly process It requires experienced medical staff to read the reaction and is only performed by a limited number of expert dermato-allergologists across Europe which limits the accessibility of suspected ACD patients to diagnosis Finally if the robustness of the patch-test method is undisputable it cannot be neglected that patch-test results are sometimes false positive or non-relevant which leads to non-appropriate disease management
Therefore there is today an urgent need for the availability of new ex vivoin vitro tools based on the modern understanding of the immune mechanisms of ACD to enhance the current diagnostic procedure and open new avenues for a personalized diagnosis of skin ACD
In this context the team Epidermal Immunity and Allergy CIRI Inserm U1111 recently characterized the molecular signatures of ACD using microarrays based on positive patch-test reactions to reference chemical allergens or non-allergenic irritants It was shown that there are unique molecular profiles and signaling pathways characterizing each inflammation Machine learning methods were then developed to identify and validate classification algorithms based on the expression levels of a minimum set of biomarkers n12 enabling very good discrimination between allergen-induced and irritant-induced patch-test inflammation which was confirmed by complementary quantitative RT-PCR analyses Finally some patients with weak positive patch-test reactions to allergens show nolow marks of allergy molecular signature questioning about the reliabilityrelevance of their patch-tests results
Our results therefore stress the value of molecular profiling of patch-test reactions to improvereinforce clinical ACD diagnosis and to help the dermatologist to discriminate true versus false positive patch test reactions
Importantly those results also open new avenues for the development of a future point care diagnosis Indeed it is currently is estimated that only 20 of patients being sent for allergology work-ups suffer from true skin allergy ie patients with positive patch-tests combined with relevant clinical history and confirmatory use tests Most of the patients 80 are in fact suffering from skin irritation Therefore the detection of ACD biomarkers in active eczema lesions could provide the dermatologist with major information to improve and accelerate its clinical diagnosis This could also prevent numerous patients negative for ACD biomarkers being sent for unnecessary allergology work-ups
However to date it remains to be demonstrated that i the same panel of ACD biomarkers is expressed both in acute eczema lesions and positive patch-test reactions and that ii the detection of these biomarkers allows for a sensitive and reliable diagnosis of skin allergy
The main objective of the study will be to make the proof of concept that the expression of allergy biomarkers correlates with patients suffering from true ACD ie patients with high biomarker expression in acute lesions positive patch-tests and relevant clinical history versus those developing skin irritation nolow biomarker expression in acute lesions negative patch-tests and lack of clinical history
ACD typically presents as a severe skin inflammation with redness edema oozing and crusting It is characterized by a delayed type IV hypersensitivity response mediated by allergen-specific T cells in sensitized individuals
Current diagnosis relies on clinical investigations by diagnostic patch testing with suspected allergenic chemicals The patch test method aims at reproducing the eczematous lesions by applying occlusive patches containing the suspected allergens to the patients healthy skin This is a time consuming and costly process It requires experienced medical staff to read the reaction and is only performed by a limited number of expert dermato-allergologists across Europe which limits the accessibility of suspected ACD patients to diagnosis Finally if the robustness of the patch-test method is undisputable it cannot be neglected that patch-test results are sometimes false positive or non-relevant which leads to non-appropriate disease management
Therefore there is today an urgent need for the availability of new ex vivoin vitro tools based on the modern understanding of the immune mechanisms of ACD to enhance the current diagnostic procedure and open new avenues for a personalized diagnosis of skin ACD
In this context the team Epidermal Immunity and Allergy CIRI Inserm U1111 recently characterized the molecular signatures of ACD using microarrays based on positive patch-test reactions to reference chemical allergens or non-allergenic irritants It was shown that there are unique molecular profiles and signaling pathways characterizing each inflammation Machine learning methods were then developed to identify and validate classification algorithms based on the expression levels of a minimum set of biomarkers n12 enabling very good discrimination between allergen-induced and irritant-induced patch-test inflammation which was confirmed by complementary quantitative RT-PCR analyses Finally some patients with weak positive patch-test reactions to allergens show nolow marks of allergy molecular signature questioning about the reliabilityrelevance of their patch-tests results
Our results therefore stress the value of molecular profiling of patch-test reactions to improvereinforce clinical ACD diagnosis and to help the dermatologist to discriminate true versus false positive patch test reactions
Importantly those results also open new avenues for the development of a future point care diagnosis Indeed it is currently is estimated that only 20 of patients being sent for allergology work-ups suffer from true skin allergy ie patients with positive patch-tests combined with relevant clinical history and confirmatory use tests Most of the patients 80 are in fact suffering from skin irritation Therefore the detection of ACD biomarkers in active eczema lesions could provide the dermatologist with major information to improve and accelerate its clinical diagnosis This could also prevent numerous patients negative for ACD biomarkers being sent for unnecessary allergology work-ups
However to date it remains to be demonstrated that i the same panel of ACD biomarkers is expressed both in acute eczema lesions and positive patch-test reactions and that ii the detection of these biomarkers allows for a sensitive and reliable diagnosis of skin allergy
The main objective of the study will be to make the proof of concept that the expression of allergy biomarkers correlates with patients suffering from true ACD ie patients with high biomarker expression in acute lesions positive patch-tests and relevant clinical history versus those developing skin irritation nolow biomarker expression in acute lesions negative patch-tests and lack of clinical history
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 69HCL23_1277 | OTHER | Eaysdore | None |