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Phase 3 N=20 Randomized Double-blind Treatment

The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis

Allergic Contact Dermatitis

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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