A mechanistic study to determine the relevance of Benralizumab targets (eosinophil-numbers and IL5-receptor) in patients with skin disorders.

• Conditions: L50.8; L20.9; C84.0; L28.1; L12.0; L92.0; L13.0; Other urticaria; Prurigo nodularis; Atopic dermatitis, unspecified

• Registration Number: DRKS00012455
• Lead Sponsor: Charite-Universitätsmedizin Berlin, Klinik für Dermatologie und Allergologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-26
• Study Completion: 2018-05-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Diagnosis: Patients with any of the following skin diseases will be included in the study, either prospectively or retrospectively:
• Chronic spontaneous urticaria
• Atopic dermatitis
• Prurigo
• Bullous pemphigoid
• Mycosis fungoides
• Granuloma anulare
• Dermatitis herpetiformis
• Healthy controls

Key inclusion criteria:
• 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
• 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

•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
•Prior or concurrent treatment with oral or systemic Corticosteroids within last 4 weeks,
•Prior or concurrent treatment with topical Corticosteroids within last 2 weeks at the sites of skin biopsy.
•Concurrent/ongoing treatment with Omomalizumab within 3 months prior to study entry
•Prior or concurrent treatment with Mepolizumab or Resilizumab.
•Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
•Lactating females or pregnant females
•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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of IL-5R and eosinophil’s levels of expression in the skin samples of the various diseases (comparison lesional and non-lesional skin) and in comparison with skin samples of healthy controls.<br>

Secondary Outcome Measures

Name	Time	Method
Correlation of the cutaneous IL-5R and eosinophil's levels of expression with disease activity, duration, other demographic and clinical parameters, presence and intensity of itching and blood levels of IL-5, IL-5R, eosinophils and eosinophilic cationic protein.