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

Herlev and Gentofte Hospital

Status and phase: Completed; Phase 3

Conditions: Allergic Contact Dermatitis

Treatments: Drug: Sodium Chloride 9mg/ml Injection; Drug: Anakinra

Study type: Interventional

Funder types: Other

Identifiers

NCT05498467

LEOSIC

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Anakinra

Active Comparator group

Treatment:

Drug: Anakinra

Placebo

Placebo Comparator group

Treatment:

Drug: Sodium Chloride 9mg/ml Injection