The Immunological Profile of Nickel Dermatitis

Study Overview
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Brief Summary
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A dose-response study on the immune phenotype of allergic nickel dermatitis on a previously exposed skin area.

Detailed Description
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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.

Official Title
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The Immunological Profile of Nickel Dermatitis

Conditions
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Nickel; Eczema, Nickel Sensitivity, Allergy, Inflammatory Response

Intervention / Treatment
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* Other: Nickel sulfate hexahydrate


Participation Criteria
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Eligibility Criteria
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inclusion criteria Must be able to understand the written and oral participant information in Danish. Previously proven nick allergy by patch testing within the last 5 years, for the nickel allergic test participants. exclusion criteria Pregnancy and / or breastfeeding. Systemic immunomodulatory treatments within the last 14 days. Local treatments of selected skin areas, such as applying hormone cream within the last two weeks or applying cream / lotion within 24 hours up to sample collection. Allergy to local anesthesia. Exposed to solar or sunlight on the back within 21 days. History of inflammatory skin diseases, asthma, Diabetes Mellitus, hives or arthritis (exclusion criteria only for participation in the healthy control group). Participation in another scientific experiment within the last 4 weeks. risks,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nickel allergic individuals<br>Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate | Other: Nickel sulfate hexahydrate<br>* Patch test<br>|
| Active Comparator: non-nickel allergic individuals<br>Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate | Other: Nickel sulfate hexahydrate<br>* Patch test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mRNA Nanostring screening | Screening of 600 immune-related genes | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein verification | verification of differentially regulated mRNA at a protein level. | 2 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patch test, metal allergy