Allergy, Inflammatory Response, Nickel; Eczema, Nickel Sensitivity
Conditions
Keywords
Patch test, metal allergy
Brief summary
A dose-response study on the immune phenotype of allergic nickel dermatitis on a previously exposed skin area.
Detailed description
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.
Interventions
OTHERNickel sulfate hexahydrate
Patch test
Sponsors
University of Copenhagen
National Allergy Research Center, Denmark
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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 (
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mRNA Nanostring screening | 1 month | Screening of 600 immune-related genes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Protein verification | 2 month | verification of differentially regulated mRNA at a protein level. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Allergic response | 1 day | Clinical evaluation of allergic response to a dose-range |
Countries
Denmark
Outcome results
None listed