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NCT04438330 Clinical Trial

The Immunological Profile of Nickel Dermatitis

Allergy Clinical Trial

Official title:
The Immunological Profile of Nickel Dermatitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04438330
Other study ID # H-19080328
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date June 1, 2022

Study information
Verified date April 2022
Source National Allergy Research Center, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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,

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Nickel sulfate hexahydrate
Patch test

Locations
Country Name City State
Denmark National Allergy Research Center Hellerup Danmark

Sponsors (2)
Lead Sponsor Collaborator
National Allergy Research Center, Denmark University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Other Allergic response Clinical evaluation of allergic response to a dose-range 1 day
Primary mRNA Nanostring screening Screening of 600 immune-related genes 1 month
Secondary Protein verification verification of differentially regulated mRNA at a protein level. 2 month
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