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Completed

NCT Number: NCT05498467

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

The study will investigate if Anakinra can ameliorate allergic contact dermatitis in participants with known nickel allergy

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gentofte Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anakinra

Drug

100 mg Anakinra injections s.c.

Sodium Chloride 9mg/ml Injection

Drug

9 mg Sodium Chloride injections s.c.

Primary outcomes

  1. Clinical Reaction

    Time frame: 2 months

    Number of participants with a lower clinical ICDRGscoring in the active treatment group compared to placebo

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Registry information

Official study title

The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis: A Randomized Controlled Trial With Anakinra vs. Placebo

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 12, 2022
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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