The Immunological Profile of Nickel Dermatitis

National Allergy Research Center, Denmark

Status: Completed

Conditions: Nickel Sensitivity; Nickel; Eczema; Inflammatory Response; Allergy

Treatments: Other: Nickel sulfate hexahydrate

Study type: Interventional

Funder types: Other

Identifiers

NCT04438330

H-19080328

Details and patient eligibility

About

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

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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,

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

26 participants in 2 patient groups

Nickel allergic individuals

Experimental group

Description:

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

Treatment:

Other: Nickel sulfate hexahydrate

non-nickel allergic individuals

Active Comparator group

Description:

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

Treatment:

Other: Nickel sulfate hexahydrate