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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with patch test reactions | Experimental | Patient with at least one positive/doubtful patch test reaction for nickel, limonene hydroperoxide and/or linalool hydroperoxide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Procedure | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-François Oudet | Contact | 0683346567 | jf.oudet@ecten.eu | |
| Marie Hélène Barba | Contact | mh.barba@ecten.eu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique universitaire Saint Luc | Recruiting | Brussels | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19447733 | Result | Nosbaum A, Vocanson M, Rozieres A, Hennino A, Nicolas JF. Allergic and irritant contact dermatitis. Eur J Dermatol. 2009 Jul-Aug;19(4):325-32. doi: 10.1684/ejd.2009.0686. | |
| 20477656 | Result | Vocanson M, Hennino A, Chavagnac C, Saint-Mezard P, Dubois B, Kaiserlian D, Nicolas JF. Contribution of CD4(+ )and CD8(+) T-cells in contact hypersensitivity and allergic contact dermatitis. Expert Rev Clin Immunol. 2005 May;1(1):75-86. doi: 10.1586/1744666X.1.1.75. |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Skin biopsies | Procedure | 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. |
|
| ROAT test | Procedure | 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. |
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| CHU de Grenoble | Recruiting | La Tronche | 38700 | France |
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| CHU Lyon Sud | Recruiting | Pierre-Bénite | 69495 | France |
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| Hopital Privé de la Loire | Recruiting | Saint-Etienne | 42100 | France |
|
| CHU de Saint Etienne | Recruiting | Saint-Priest-en-Jarez | 42270 | France |
|
| 19839974 | Result | Vocanson M, Hennino A, Rozieres A, Poyet G, Nicolas JF. Effector and regulatory mechanisms in allergic contact dermatitis. Allergy. 2009 Dec;64(12):1699-714. doi: 10.1111/j.1398-9995.2009.02082.x. Epub 2009 Oct 12. |
| 34174113 | Result | Lefevre MA, Nosbaum A, Rozieres A, Lenief V, Mosnier A, Cortial A, Prieux M, De Bernard S, Nourikyan J, Jouve PE, Buffat L, Hacard F, Ferrier-Lebouedec MC, Pralong P, Dzviga C, Herman A, Baeck M, Nicolas JF, Vocanson M. Unique molecular signatures typify skin inflammation induced by chemical allergens and irritants. Allergy. 2021 Dec;76(12):3697-3712. doi: 10.1111/all.14989. Epub 2021 Jul 14. |
| 35184302 | Result | Ljungberg Silic L, Lefevre MA, Bergendorff O, De Bernard S, Nourikyan J, Buffat L, Nosbaum A, Bruze M, Nicolas JF, Svedman C, Vocanson M. Gene profiling reveals a contact allergy signature in most positive Amerchol L-101 patch test reactions. Contact Dermatitis. 2022 Jul;87(1):40-52. doi: 10.1111/cod.14077. Epub 2022 Mar 25. |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |