The Immunological Profile of Nickel Dermatitis

Not Applicable

Completed

• Conditions: Allergy; Nickel; Eczema; Nickel Sensitivity; Inflammatory Response
• Interventions: Other: Nickel sulfate hexahydrate

• Registration Number: NCT04438330
• Lead Sponsor: National Allergy Research Center, Denmark

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.

Study Timeline

• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-18
• Study Start: 2021-03-01
• Status Verified: 2022-04
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-nickel allergic individuals	Nickel sulfate hexahydrate	Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate
Nickel allergic individuals	Nickel sulfate hexahydrate	Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate

Primary Outcome Measures

Name	Time	Method
mRNA Nanostring screening	1 month	Screening of 600 immune-related genes

Secondary Outcome Measures

Name	Time	Method
Protein verification	2 month	verification of differentially regulated mRNA at a protein level.

Trial Locations

Locations (1)

National Allergy Research Center; 🇩🇰 Hellerup, Danmark, Denmark