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

Primary Purpose

Allergic Contact Dermatitis

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Anakinra
Sodium Chloride 9mg/ml Injection
Sponsored by
Herlev and Gentofte Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Contact Dermatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Anakinra

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 8, 2022
    Last Updated
    August 9, 2022
    Sponsor
    Herlev and Gentofte Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05498467
    Brief Title
    The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    April 1, 2023 (Anticipated)
    Study Completion Date
    August 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Herlev and Gentofte Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Contact Dermatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Anakinra
    Arm Type
    Active Comparator
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Anakinra
    Intervention Description
    100 mg Anakinra injections s.c.
    Intervention Type
    Drug
    Intervention Name(s)
    Sodium Chloride 9mg/ml Injection
    Intervention Description
    9 mg Sodium Chloride injections s.c.
    Primary Outcome Measure Information:
    Title
    Clinical reaction
    Description
    Number of participants with a lower clinical icdrg scoring in the active treatment group compared to placebo
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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