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

Allergic Contact Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05498467
• Other study ID #: LEOSIC
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2022
• Source: Herlev and Gentofte Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Contact Dermatitis
• Dermatitis
• Dermatitis, Allergic Contact
• Dermatitis, Contact

Intervention

Drug:
• Anakinra
100 mg Anakinra injections s.c.
• Sodium Chloride 9mg/ml Injection
9 mg Sodium Chloride injections s.c.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical reaction	Number of participants with a lower clinical icdrg scoring in the active treatment group compared to placebo	2 months