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The Immunological Profile of Nickel Dermatitis

Primary Purpose

Nickel; Eczema, Nickel Sensitivity, Allergy

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Nickel sulfate hexahydrate
Sponsored by
National Allergy Research Center, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nickel; Eczema focused on measuring Patch test, metal allergy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

  • National Allergy Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nickel allergic individuals

non-nickel allergic individuals

Arm Description

Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate

Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate

Outcomes

Primary Outcome Measures

mRNA Nanostring screening
Screening of 600 immune-related genes

Secondary Outcome Measures

Protein verification
verification of differentially regulated mRNA at a protein level.

Full Information

First Posted
June 16, 2020
Last Updated
January 3, 2023
Sponsor
National Allergy Research Center, Denmark
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT04438330
Brief Title
The Immunological Profile of Nickel Dermatitis
Official Title
The Immunological Profile of Nickel Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Allergy Research Center, Denmark
Collaborators
University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nickel; Eczema, Nickel Sensitivity, Allergy, Inflammatory Response
Keywords
Patch test, metal allergy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nickel allergic individuals
Arm Type
Experimental
Arm Description
Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate
Arm Title
non-nickel allergic individuals
Arm Type
Active Comparator
Arm Description
Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate
Intervention Type
Other
Intervention Name(s)
Nickel sulfate hexahydrate
Intervention Description
Patch test
Primary Outcome Measure Information:
Title
mRNA Nanostring screening
Description
Screening of 600 immune-related genes
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Protein verification
Description
verification of differentially regulated mRNA at a protein level.
Time Frame
2 month
Other Pre-specified Outcome Measures:
Title
Allergic response
Description
Clinical evaluation of allergic response to a dose-range
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanne D Johansen, Proff.
Organizational Affiliation
National Allergy Research Center, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
National Allergy Research Center
City
Hellerup
State/Province
Danmark
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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The Immunological Profile of Nickel Dermatitis

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