The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis
Study Details
Study Description
Brief Summary
The study will investigate if Anakinra can ameliorate allergic contact dermatitis in participants with known nickel allergy
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Anakinra
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Drug: Anakinra
100 mg Anakinra injections s.c.
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Placebo Comparator: Placebo
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Drug: Sodium Chloride 9mg/ml Injection
9 mg Sodium Chloride injections s.c.
|
Outcome Measures
Primary Outcome Measures
- Clinical reaction [2 months]
Number of participants with a lower clinical icdrg scoring in the active treatment group compared to placebo
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged at least eighteen years old.
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Able to provide written informed consent.
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Have a medical diagnosis of nickel allergy with at least a +2 reaction on the
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ICDRG scoring system when challenged with nickel.
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Fitzpatrick skin type 1-4.
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Able to speak and understand Danish.
Exclusion Criteria:
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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.
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Received systemic immunomodulating or immunosuppressive treatment four weeks prior to day 0.
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Any skin lesions at the area of interest such as nevi, scar tissue or pigment changes.
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Dermatitis and/or infection.
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Recent (3 months or less) administration of a live virus vaccine.
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Women of childbearing potential who are not taking adequate contraception or who are pregnant, plan to become pregnant during the study duration or lactating.
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Taking part in any other intervention study.
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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).
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Presence of any condition or use of any medication which precludes the use of the study drug.
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Allergy to any of the ingredients in the drug.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Herlev and Gentofte Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LEOSIC