The Immunological Profile of Nickel Dermatitis

January 3, 2023 updated by: National Allergy Research Center, Denmark
A dose-response study on the immune phenotype of allergic nickel dermatitis on a previously exposed skin area.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Danmark
      • Hellerup, Danmark, Denmark, 2900
        • National Allergy Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nickel allergic individuals
Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate
Other: Nickel sulfate hexahydrate
Patch test
Active Comparator: non-nickel allergic individuals
Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate
Other: Nickel sulfate hexahydrate
Patch test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mRNA Nanostring screening
Time Frame: 1 month
Screening of 600 immune-related genes
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Protein verification
Time Frame: 2 month
verification of differentially regulated mRNA at a protein level.
2 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Allergic response
Time Frame: 1 day
Clinical evaluation of allergic response to a dose-range
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Allergy Research Center, Denmark

Collaborators

University of Copenhagen

Investigators

  • Study Director: Jeanne D Johansen, Proff., National Allergy Research Center, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19080328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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