Importance of mechanisms and pathophysiology of cutaneous inflammasome activation in contact dermatitis

Not Applicable

• Conditions: contact dermatitisL23 allergic contact dermatitis,healthy volunteers; L24; Irritant contact dermatitis

• Registration Number: DRKS00013748
• Lead Sponsor: Charité - Universitätsmedizin BerlinKlinik für Dermatologie, Venerologie und Allergologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-23
• Study Completion: 2020-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 25

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint:<br>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<br>

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints:<br>- assessment of the erythema in SDS-induced contact dermatitis by mexameter <br>- assessment of clinical symptoms in SDS-induced contact dermatitis by EASI (Eczema Area and Severity Index) and mTLSS (modified Total Lesion Symptom Score) <br>