Allergic Contact Dermatitis
Conditions
Brief summary
The study will investigate if Anakinra can ameliorate allergic contact dermatitis in participants with known nickel allergy
Interventions
DRUGAnakinra
100 mg Anakinra injections s.c.
9 mg Sodium Chloride injections s.c.
Sponsors
Herlev and Gentofte Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Reaction | 2 months | Number of participants with a lower clinical ICDRGscoring in the active treatment group compared to placebo |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anakinra Anakinra: 100 mg Anakinra injections s.c. | 12 |
| Placebo Sodium Chloride 9mg/ml Injection: 9 mg Sodium Chloride injections s.c. | 8 |
| Total | 20 |
Baseline characteristics
| Characteristic | Placebo | Total | Anakinra |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 20 Participants | 12 Participants |
| Age, Continuous | 36.6 years STANDARD_DEVIATION 13.4 | 38.6 years STANDARD_DEVIATION 11.6 | 39.8 years STANDARD_DEVIATION 11.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 19 Participants | 11 Participants |
| Region of Enrollment Denmark | 8 participants | 20 participants | 12 participants |
| Sex: Female, Male Female | 8 Participants | 19 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 8 |
| other Total, other adverse events | 0 / 12 | 0 / 8 |
| serious Total, serious adverse events | 0 / 12 | 0 / 8 |
Outcome results
Primary
Clinical Reaction
Number of participants with a lower clinical ICDRGscoring in the active treatment group compared to placebo
Time frame: 2 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Anakinra | Clinical Reaction | No clinical treatment effect | 12 Participants |
| Anakinra | Clinical Reaction | Clinical treatment effect | 0 Participants |
| Placebo | Clinical Reaction | Clinical treatment effect | 0 Participants |
| Placebo | Clinical Reaction | No clinical treatment effect | 8 Participants |