Back to resultsThe 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
About this trial
This is an interventional treatment trial for Allergic Contact Dermatitis
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.
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
NCT ID
NCT05498467
First Posted
August 8, 2022
Last Updated
August 9, 2022
Sponsor
Herlev and Gentofte Hospital
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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