The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Derm… (NCT05498467) | Clinical Trial Compass
CompletedPhase 3
The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis
Denmark20 participantsStarted 2022-10-11
Plain-language summary
The study will investigate if Anakinra can ameliorate allergic contact dermatitis in participants with known nickel allergy
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.
* 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.
* Allergy to any of the ingredients in the drug.