Characterization of the extent, the time course and the underlying pathomechanism of the elevated skin reactivity of chronic urticaria patients in comparison with healthy test subjects.
- Conditions
- L50.8Other urticaria
- Registration Number
- DRKS00012471
- Lead Sponsor
- Charite-Universitätsmedizin Berlin, Klinik für Dermatologie und Allergologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 95
• Adults (18 years or older)
• Able to read, understand and willing to sign the informed consent form and abide with study procedures
• Willing, committed and able to complete all study-related procedures
• Arm1: Diagnosis of urticaria for more than 6 weeks
• Patients may have additional concomitant disease, but only one dominant skin disease.
• No participation in other clinical trials 4 weeks before in this study
• Concurrent/ongoing treatment with immunosuppressives (e.g. cyclosporine, methotrexate, dapsone, systemic Corticosteroids or others) within 4 weeks or 5 half lives prior to study entry whichever is longer
• Concurrent/ongoing treatment with Omomalizumab within 3 months prior to study entry
• Prior or concurrent treatment with antihistamines within the last 5 days.
• Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
• Lactating females or pregnant females
• Any medical condition which, in the opinion of the Investigator, would interfere with participation in the study or place the subject at risk
• Intake of leukotriene antagonists within 7 days prior to study entry
• History of hypersensitivity/allergy to local anesthetics
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The size and the time course of inducible skin wheals in patients with chronic urticaria and healthy test subjects will be assessed via planimetry, volumetry and speckle-bloodflow analysis by repetetive non-invasive measurements over a time of about 2 hours.
- Secondary Outcome Measures
Name Time Method Correlation of the wheal caracteristics with parameter of the histological analysis and serum parameter.