NCT04438330

The Immunological Profile of Nickel Dermatitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: National Allergy Research Center, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nickel; Eczema
• Nickel Sensitivity
• Allergy
• Inflammatory Response

Interventions

Type	Name	Description
OTHER	Nickel sulfate hexahydrate	Patch test

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2020-06-18
• Last updated: 2023-01-04

Locations

1 site across 1 country: Denmark