The Immunological Profile of Nickel Dermatitis

NCT ID: NCT04438330

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-06-01

Brief Summary

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

Detailed Description

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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

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Nickel; Eczema Nickel Sensitivity Allergy Inflammatory Response

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nickel allergic individuals

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

Group Type EXPERIMENTAL

Nickel sulfate hexahydrate

Intervention Type OTHER

Patch test

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

Group Type ACTIVE_COMPARATOR

Nickel sulfate hexahydrate

Intervention Type OTHER

Patch test

Interventions

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Nickel sulfate hexahydrate

Patch test

Intervention Type OTHER

Eligibility Criteria

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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.
* Participation in another scientific experiment within the last 4 weeks. risks,
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

National Allergy Research Center, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeanne D Johansen, Proff.

Role: STUDY_DIRECTOR

National Allergy Research Center, Denmark

Locations

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National Allergy Research Center

Hellerup, Danmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-19080328

Identifier Type: -

Identifier Source: org_study_id

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