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

Sponsor
Herlev and Gentofte Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05498467
Collaborator
(none)
20
2
11

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Anakinra

Drug: Anakinra
100 mg Anakinra injections s.c.

Placebo Comparator: Placebo

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

Outcome Measures

Primary Outcome Measures

  1. Clinical reaction [2 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Herlev and Gentofte Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kelvin Yeung, MD, Principal Investigator, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier:
NCT05498467
Other Study ID Numbers:
  • LEOSIC
First Posted:
Aug 12, 2022
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2022