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Completed

NCT Number: NCT04438330

The Immunological Profile of Nickel Dermatitis

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Allergy Research Center

Hellerup, Danmark, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Nickel sulfate hexahydrate

Other

Patch test

Primary outcomes

  1. mRNA Nanostring screening

    Time frame: 1 month

    Screening of 600 immune-related genes

Secondary outcomes

  1. Protein verification

    Time frame: 2 month

    verification of differentially regulated mRNA at a protein level.

Other outcomes

  1. Allergic response

    Time frame: 1 day

    Clinical evaluation of allergic response to a dose-range

Sponsors and collaborators

Lead sponsor

National Allergy Research Center, Denmark

Other

Collaborators

  • University of Copenhagen

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2020
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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