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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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A dose-response study on the immune phenotype of allergic nickel dermatitis on a previously exposed skin area.
Clinically controlled study comprising 15 people with known nickel allergy and 15 healthy persons as control group. At the Department of Allergy and Dermatology, Gentofte Hospital, test participants will be exposed to nickel sulfate in a patch test on their back, which will create an eczema reaction in people with nickel allergy and induce skin resident T-cells. The resident T-cells will enhance further exposure. The eczema is healed over 3-4 weeks, after which the same areas are again exposed to nickel sulfate at different concentrations in a patch test. Skin biopsies of the exposed areas are taken and the immune phenotype is analyzed trough Nanostring RNA technologies of around 600 immunerelated genes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nickel allergic individuals | Experimental | Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate |
|
| non-nickel allergic individuals | Active Comparator | Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nickel sulfate hexahydrate | Other | Patch test |
|
| Measure | Description | Time Frame |
|---|---|---|
| mRNA Nanostring screening | Screening of 600 immune-related genes | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Protein verification | verification of differentially regulated mRNA at a protein level. | 2 month |
| Measure | Description | Time Frame |
|---|---|---|
| Allergic response | Clinical evaluation of allergic response to a dose-range | 1 day |
inclusion criteria
exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jeanne D Johansen, Proff. | National Allergy Research Center, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Allergy Research Center | Hellerup | Danmark | 2900 | Denmark |
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| ID | Term |
|---|---|
| D004485 | Eczema |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| ID | Term |
|---|---|
| C029938 | nickel sulfate |
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| D007154 |
| Immune System Diseases |