Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2019-10-01
2025-12-31
Brief Summary
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The influence of new systemic therapies for the treatment of moderate to severe atopic dermatitis (such as biologics or Janus kinase inhibitors) on the skin microbiome is largely unknown.
The main aim of this scientific exploratory study is to investigate whether and how the skin microbiome changes in patients with moderate to severe atopic dermatitis during systemic therapy. This not only allows new hypotheses to be generated on the pathogenesis of atopic dermatitis, but also new objective scales for the severity of atopic dermatitis can be developed.
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Detailed Description
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The routine examinations are carried out every quarter with routine visits over two years. The dates before, 6, 12, and 24 months after the initiation of systemic therapy are relevant for this study. Deviations from normal practice are not intended.
Patients in whom a new initiation of systemic therapy is planned will be invited for a follow-up 6 weeks after initiation and quarterly follow-up visits.
Blood samples must be obtained for the examination. The blood is taken to determine the systemic level of inflammatory mediators (serological biomarkers, PBMCs) and for genetic examinations (e.g. filaggrin gene mutation - FLG) as well as mRNA / lncRNA profile. The skin physiological examinations are not invasive or pain-related procedures. Microbiome sampling will be conducted by a skin swab of the inter-scapular region.
The blood / skin samples taken as part of this scientific study are pseudonymized in the research laboratories. The samples are stored in the laboratories for a period of 5 years after the end of the study and then destroyed.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Dupilumab treated Patients (observational)
Patients with atopic dermatitis with indication for dupilumab treatment will be observed.
not applicable, observational study
Patients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study
Cyclosporine treated Patients (observational)
Patients with atopic dermatitis with indication for cyclosporine treatment will be observed.
not applicable, observational study
Patients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study
Baricitinib treated Patients (observational)
Patients with atopic dermatitis with indication for baricitinib treatment will be observed.
not applicable, observational study
Patients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study
Interventions
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not applicable, observational study
Patients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study
Eligibility Criteria
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Inclusion Criteria
* Indication for systemic therapy
Exclusion Criteria
* Pregnant and lactating women
18 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Margitta Worm
Prof. Dr. med. Margitta Worm
Locations
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Dpt of Dermatology and Allergology, Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Microbiome and AD
Identifier Type: -
Identifier Source: org_study_id
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