Treatment with anakinra versus placebo to patients with nickle allergy

Phase 1

• Conditions: Allergic contact dermatitis. Patients with nickel allergy to be specific; MedDRA version: 21.1Level: LLTClassification code 10056265Term: Allergic contact dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2021-004750-39-DK
• Lead Sponsor: Herlev Gentofte Hospital - Department of Dermatology and Allergy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-12
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 22

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

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified