contact dermatitis L23 allergic contact dermatitis, healthy volunteers L24
Conditions
Interventions
Group 1: Placebo/ negative control base cream DAC for 24 h on healthy skin (approx. 1.5 cm diameter lesion)
Group 2: Disulfiram 5% in base cream DAC for 24 h on healthy skin (approx. 1.5 cm diameter l
Sponsors
Charité - Universitätsmedizin BerlinKlinik für Dermatologie, Venerologie und Allergologie
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: The subjects have to be adults (18 years or older) and able to read, understand and willing to sign the informed consent form and abide with study procedures.
Exclusion criteria
Exclusion criteria: Exclusion criteria: - skin diseases of hands/arms such as psoriasis, viral, bacterial or fungal infections - treatment with: concurrent/ongoing treatment with a stable dose of systemic corticosteroids not greater than 10mg/d for 14 days prior to screening ciclosporin, methotrexate, dapsone, azathioprine or other immunosuppressives during 4 weeks prior to screening topical glucocorticoids, vitamin D, calcineurin-inhibitors during 2 weeks prior to screening UV-treatment during 4 weeks prior to screening - Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial - subjects with known hypersensitivity to the applied sbustances (Disulfiram, mometasone, SDS) - Lactating females or pregnant females - participation in other clinical trials 4 weeks before participation in this study - Subjects for whom there is concern about compliance with the protocol procedures - Any medical condition which, in the opinion of the Investigator, would interfere with participation in the study or place the subject at risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Analysis of the inflammasome activation (quantitative IL-1ß und IL-18 response in keratinocytes by using microdialysis of skin lesions) in healthy controls after induction of a localized contact dermatitis by SDS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - assessment of the erythema in SDS-induced contact dermatitis by mexameter - assessment of clinical symptoms in SDS-induced contact dermatitis by EASI (Eczema Area and Severity Index) and mTLSS (modified Total Lesion Symptom Score) | — |
Countries
Germany
Contacts
Public ContactHanna Bonnekoh
Charité - Universitätsmedizin BerlinKlinik für Dermatologie, Venerologie und Allergologie
Outcome results
None listed