The Immunological Profile of Nickel Dermatitis

National Allergy Research Center, Denmark26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Nickel; Eczema Nickel Sensitivity Allergy Inflammatory Response

Interventions

Nickel sulfate hexahydrateOTHER

Patch test

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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,

Locations (1)

National Allergy Research Center

Hellerup, Danmark, Denmark

Outcomes

Primary Outcomes

mRNA Nanostring screening

Screening of 600 immune-related genes

Time frame: 1 month

Secondary Outcomes

Protein verification

verification of differentially regulated mRNA at a protein level.

Time frame: 2 month

Data from ClinicalTrials.gov

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