L50.8 L28.1 L20.9
Conditions
Interventions
Group 1: Patients with chronic urticaria, Prurigo nodularis or atopic eczema are surveyed regarding their anamnesis, disease status and quality of life, examined and blood and skin samples extracted f
Sponsors
Charite-Universitätsmedizin Berlin, Klinik für Dermatologie und Allergologie
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Healthy subject group or patients who suffer from one of the following diseases: - chronic spontanous urticaria - atopic dermatitis - prurigo nodularis. Furthermore: - adults (18 years or older) - existing health insurance - disease diagnosis for > 3 months - in females of childbearing potential: Negative pregnancy test - Patients may have additional concomitant disease, but only one dominant skin disease - no participation in other clinical trials 4 weeks before in this study
Exclusion criteria
Exclusion criteria: - Concurrent/ongoing treatment with immunosuppressives (e.g. cyclosporine, methotrexate, dapsone or others) within 4 weeks or 5 half lives prior to study entry whichever is longer - Concurrent/ongoing treatment with omalizumab, dupilumab or another "biologic" within 3 months prior to study entry - Lactating females or pregnant females - Blood donation within the last weeks - anemia - Enrollment in another investigational treatment or device study or use of an investigational agent, or less than 4 weeks or 5 half-lives, whichever is longer, since end of another investigational device or drug trial - 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 - Subjects who are detained officially or legally to an official institute - Intake of leukotriene antagonists within 7 days prior to study entry - History of hypersensitivity/allergy to local anesthetics - History of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) that could limit the subject’s ability to comply with study procedures - Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the expression of the common beta chain (ßc, CD131), IL-3, IL-5, and GM-CSF and eosinophils, basophils, neutrophils, and mast cells numbers in the skin (via histological examination of skin biopsies in patients with inflammatory skin disorders). To assess the expression of the common beta chain (ßc, CD131), IL-3, IL-5, and GM-CSF on blood cells in patients with inflammatory skin disorders | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess blood levels of IL-3, IL-5, and GM-CSF and other cytokines in the same patients. RNA-Analysis of skin and blood samples. Assess disease activity and duration, as well as itch intensity and quality of life impairment in the same patients. | — |
Countries
Germany
Contacts
Public ContactSabine Altrichter
Charite-Universitätsmedizin Berlin, Klinik für Dermatologie und Allergologie
Outcome results
None listed