Identification of a cell receptor structure (common-beta-chain) in inflammatory skin conditions

• Conditions: L50.8; L28.1; L20.9; Other urticaria; Prurigo nodularis; Atopic dermatitis, unspecified

• Registration Number: DRKS00017608
• Lead Sponsor: Charite-Universitätsmedizin Berlin, Klinik für Dermatologie und Allergologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-05
• Study Completion: 2020-10-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 51

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

- 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br><br>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 Outcome Measures

Name	Time	Method
Assess blood levels of IL-3, IL-5, and GM-CSF and other cytokines in the same patients.<br><br>RNA-Analysis of skin and blood samples.<br><br>Assess disease activity and duration, as well as itch intensity and quality of life impairment in the same patients.