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

Phase 3

Completed

• Conditions: Allergic Contact Dermatitis
• Interventions: Drug: Sodium Chloride 9mg/ml Injection; Drug: Anakinra

• Registration Number: NCT05498467
• Lead Sponsor: Herlev and Gentofte Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-12
• Study Start: 2022-10-11
• Primary Completion: 2023-12-01
• Study Completion: 2024-08-01
• Results First Submitted: 2025-03-10
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-18
• Results First Posted: 2025-05-20
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Sodium Chloride 9mg/ml Injection	-
Anakinra	Anakinra	-

Primary Outcome Measures

Name	Time	Method
Clinical Reaction	2 months	Number of participants with a lower clinical ICDRGscoring in the active treatment group compared to placebo

Trial Locations

Locations (1)

Gentofte Hospital; 🇩🇰 Hellerup, Denmark