An observational study in Atopic Dermatitis, sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Charite University, Berlin, Germany · Observational
The skin microbiome plays a role in the pathogenesis of atopic dermatitis. However, it is unclear whether the range of microbiota on the skin is the cause or consequence of atopic skin inflammation.
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.
A better understanding of the pathology of atopic dermatitis could lead to the development of new therapeutic strategies for this disease and contribute to better and more targeted disease management - an advantage for all patients with atopic dermatitis.
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 600 is above the median of 150 across 282 observational studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients with moderate to severe atopic dermatitis presenting in the clinic of Dermatology, Charité - Universitätsmedizin Berlin, Germany.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with atopic dermatitis with indication for dupilumab treatment will be observed.
Other: not applicable, observational study
Patients with atopic dermatitis with indication for cyclosporine treatment will be observed.
Other: not applicable, observational study
Patients with atopic dermatitis with indication for baricitinib treatment will be observed.
Other: not applicable, observational study
Patients undergoing systemic therapy according to international accepted guidelines for the therapy of atopic dermatitis, observational study
This study also gives Dupilumab. No intervention listed here names it: that was found by reading the record.
Comparison of the microbial composition
Comparison of the microbial composition of the skin before, 6 and 12 months after the initiation of systemic therapy.
Time frame: 1 year
Comparison of microbial composition of the skin with serological biomarkers
Comparison of microbial composition of the skin with serological biomarkers (z.B.TARC, TSLP, CCL27).
Time frame: 1 year
Microbial composition and skin barrier function
Comparison of the microbial composition of the skin with the skin physiology (including transepidermal water loss, sebumetry)
Time frame: 1 year
Correlation of main microbial representants of skin microbiome
Correlation of the S. aureus to the P. acnes ratio
Time frame: 1 year
Correlation of microbiome and severity of atopic dermatitis EASI
Correlation of the microbiome with the Eczema Area and Severity Index (EASI). EASI ranges from 0-72, increasing severity with increasing score.
Time frame: 2 years
Correlation of microbiome and severity of atopic dermatitis SCORAD
Correlation of the microbiome with Scoring of Atopic Dermatitis (SCORAD). SCORAD ranges from 0-103, increasing severity with increasing score.
Time frame: 2 years
Association of the skin microbiome with the mRNA EASI
Correlation of the main representants of skin microbiota and the Eczema Area and Severity Index (EASI). EASI ranges from 0-72, increasing severity with increasing score.
Time frame: 2 years
Association of the skin microbiome with the mRNA SCORAD
Correlation of the main representants of skin microbiota and Scoring of Atopic Dermatitis (SCORAD). SCORAD ranges from 0-103, increasing severity with increasing score.
Time frame: 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2019 (actual). Primary completion is estimated for Dec 2026, 86 months after the start.
Of 96 non-industry observational studies under Dermatitis, Atopic, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 19. This study's planned 86 months is above that.
Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 17.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: primary completion Dec 2025 → Dec 2026 and completion Dec 2025 → Dec 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Charite University, Berlin, Germany →