Phase 3
N=20
The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis
Allergic Contact Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT05498467 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Clinical Reaction — 0; 0; 12; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Anakinra (Drug); Sodium Chloride 9mg/ml Injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Herlev and Gentofte Hospital
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Reaction |
0; 0; 12; 8 | — |
Summary
The study will investigate if Anakinra can ameliorate allergic contact dermatitis in participants with known nickel allergy
Eligibility 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.
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.
Data sourced from ClinicalTrials.gov (NCT05498467). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.