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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.