Microbiome in Atopic Dermatitis Under Systemic Therapy (BIO-AD)

Identification of Skin-associated Microbiota in Atopic Dermatitis Patients Undergoing Systemic Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: not applicable, observational study

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Margitta Worm, Prof; Phone Number: +49 30 450 518105; Email: margitta.worm@charite.de
• Study Contact Backup: Name: Sabine Dölle-Bierke, PhD; Phone Number: +49 30 450 518367; Email: sabine.doelle@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Dpt of Dermatology and Allergology, Charité - Universitätsmedizin Berlin
    • Contact: Sabine Dölle-Bierke, PhD; Phone Number: +49 30 450 518367; Email: sabine.doelle@charite.de
    • Contact: Wojciech Francuzik, Dr. med.
    • Contact: Margitta Worm, Prof. Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with moderate to severe atopic dermatitis presenting in the clinic of Dermatology, Charité - Universitätsmedizin Berlin, Germany.

Description

Inclusion Criteria:

• Patients with moderate to severe atopic dermatitis
• Indication for systemic therapy

Exclusion Criteria:

• Patients under 18 years of age upon introducing systemic therapy
• Pregnant and lactating women

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dupilumab treated Patients (observational); Patients with atopic dermatitis with indication for dupilumab 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
Cyclosporine treated Patients (observational); Patients with atopic dermatitis with indication for cyclosporine 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
Baricitinib treated Patients (observational); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the microbial composition	Comparison of the microbial composition of the skin before, 6 and 12 months after the initiation of systemic therapy.	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).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microbial composition and skin barrier function	Comparison of the microbial composition of the skin with the skin physiology (including transepidermal water loss, sebumetry)	1 year
Correlation of main microbial representants of skin microbiome	Correlation of the S. aureus to the P. acnes ratio	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.	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.	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.	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.	2 years

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: dupilumab; cyclosporine; baricitinib; skin microbiome
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: Microbiome and AD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No