Allergic contact dermatitis. Patients with nickel allergy to be specific MedDRA version: 21.1 Level: LLT Classification code 10056265 Term: Allergic contact dermatitis System Organ Class: 100000004858
Conditions
Sponsors
Herlev Gentofte Hospital - Department of Dermatology and Allergy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Aged at least eighteen years old. • Able to provide written informed consent. • Have a medical diagnosis of nickel allergy with at least a +2 reaction on the ICDRG scoring system when challenged with nickel. • Fitzpatrick skin type 1-4. • Able to speak and understand Danish Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: • Received any topical immunomodulating or immunosuppresive treatment on the lower back two weeks prior, or applied crème/lotion on the lower back 24 hours prior to day 0 • Received systemic immunomodulating or immunosuppressive treatment four weeks prior to day 0 • Any skin lesions at the area of interest such as nevi, scar tissue or pigment changes. • Dermatitis and/or infection on their lower back • Recent (3 months or less) administration of a live virus vaccine. • Women of childbearing potential who are not taking adequate contraception or who are pregnant, plan to become pregnant during the study duration or lactating. • Taking part in any other intervention study. • Has any other condition which would, in the Investigator’s opinion, deem the patient unsuitable for participation in the study (e.g. condition requiring long term or frequent oral steroid use). • Presence of any condition or use of any medication which precludes the use of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if there is a clinical difference in severity of ACD in participants treated with anakinra compared to placebo measured by different scoring systems for ACD.;Secondary Objective: To assess if there is a decrease in TRM function and inflammation after treatment with Anakinra compared to the control group, using following methods: flow cytometry, single cell RNA sequencing, immunohistochemistry, ELISA, digital spatial profiling, and qPCR. ;Primary end point(s): To see a reduction in clinical score by 1 point between groups;Timepoint(s) of evaluation of this end point: After the second and third patch tests | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To see a statistically significant reduction in total number of immune cells or cytokines between the two groups;Timepoint(s) of evaluation of this end point: After the analysis of biopsies taken from third patch test | — |
Countries
Denmark
Contacts
Public ContactKelvin Yeung
LEO SIC
Outcome results
None listed