A prospective observational study to evaluate biomarkers and disease mechanisms in patients with moderate to severe atopic dermatitis with systemic therapy

Recruiting

Conditions: L20.9
L20.8
Atopic dermatitis, unspecified
Other atopic dermatitis

Registration Number: DRKS00024175

Lead Sponsor: Department of Dermatology and AllergyUniversity Hospital Schleswig-Holstein (UKSH)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1) Written informed consent from the study participant prior to performing any study-related activities.
2) Age = 18 years at the time of study entry.
3) Clinically diagnosed atopic dermatitis.
4) Initiation of systemic therapy for atopic dermatitis by the treating physician as part of routine care
5) Study participant agrees and, in the judgment of study personnel, is able to comply with the study protocol for the duration of the study

Exclusion Criteria

1) Study participant is not capable of consenting to study participation or adhering to the study protocol.
2) Tendency to keloid/hypertrophic scarring and/or known wound healing disorder.
3) Tattooing and/or skin lesions due to a dermatosis in the puncture area not investigated in this study
4) Needle phobia
5) Pregnancy
6) Liver/biliary tract disease present at the time of the study and judged unstable by the study physician, manifested by ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, persistent jaundice, and/or liver cir-rhosis
7) Known allergy and/or hypersensitivity to the materials used.
8) Any reason that, in the opinion of the study physician, may prevent safe participation of the study participant.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differentially expressed genes at week 2 as compared to baseline<br>Differentially expressed genes at week 12 as compared to baseline

Secondary Outcome Measures

Name	Time	Method
Clinical response at week 12 after treatment start, defined as relative and absolute change in Eczema Area and Severityx Index (EASI) <br>Multiple physician- und patient-reported outcomes