Molecular Diagnosis of Allergic Contact Dermatitis (SMECA).

Study Overview
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Brief Summary
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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, i.e. 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).

Official Title
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The Value of Molecular Signatures in the Diagnosis of Allergic Contact Dermatitis.

Conditions
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Eczema, Allergic Contact Eczema Nos

Intervention / Treatment
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* Procedure: Blood sample
* Procedure: Skin biopsies
* Procedure: ROAT test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient, male or female, over 18 years of age. Patient with at least one positive/doubtful patch test reaction for nickel, limonene hydroperoxide and/or linalool hydroperoxide Patient agreeing to undergo skin biopsies and blood sampling Patient agreeing to non-identifying pictures being taken of lesions Patient available to carry out skin tests and their interpretation Patient affiliated to or benefiting from a social security regime Patient having been informed and having signed a written, free and informed consent. Exclusion Criteria: Patient with active dermatitis lesions on the forearm Patient with a history of allergic reaction to a local anesthetic product Patient with wound healing disorders (hypertrophic or keloids scars) Patient with hematological disorders Patient having topical treatments with corticosteroids or immunomodulators on the forearms during the 21 days prior to the start of the study Patient having had excessive exposure to ultraviolet during the 21 days prior to the start of the study. Patient on systemic corticosteroid therapy, immunosuppressants or biological therapy. Patient whose follow-up is impossible for reasons psychological or geographical. Patient taking part in another clinical study Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision Pregnant, breast-feeding or parturient woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with patch test reactions<br>Patient with at least one positive/doubtful patch test reaction for nickel, limonene hydroperoxide and/or linalool hydroperoxide | Procedure: Blood sample<br>* A blood sample (48 ml) will be collected from each patient before performing the ROAT tests. This sample will be used to perform in vitro lymphocyte proliferation test, and cytokine measurements.<br>Procedure: Skin biopsies<br>* 2 skin biopsies will be performed at the inclusion: one from positive/doubtful patch test reaction and one from control patch test. In case of positive ROAT test, 2 additional biopsies will be collected: one from positive ROAT test reaction and one from control area. Molecular analysis will be performed.<br>Procedure: ROAT test<br>* ROAT test (repeated open application test) is a use test used to establish the clinical relevance of patch tests. Patients will be exposed to 3 solutions of increasing concentration containing the culprit allergen (nickel, limonene hydroperoxide or linalool hydroperoxide), as well as a solution containing the vehicle alone (control solution), 2 times a day for up to 21 days, in the absence of a reaction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression levels of allergy biomarkers | Expressed as fold change (ratio between gene expression levels in lesional skin of patch test reaction and their expression levels in healthy skin = control patch test, of the same patient) in patients with positive or negative ROAT test (Gold standard) | 1 month |