Actively Recruiting

Age: 18Years +
All Genders
ID05099315

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

Led by Charite University, Berlin, Germany · Updated on 2025-02-13

600

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are exploring the role of the skin microbiome in moderate to severe atopic dermatitis and how systemic therapies like biologics or Janus kinase inhibitors might change the skin's microbial balance. The goal is to better understand whether changes in skin bacteria cause or result from skin inflammation and to develop new ways to measure disease severity. This observational study is led by Charite University in Berlin, Germany. Participants include patients starting systemic treatment with drugs such as dupilumab, cyclosporine, or baricitinib. Patients will be followed for two years with routine quarterly visits, including a special follow-up six weeks after therapy begins. The study involves collecting blood samples to analyze inflammatory markers and genetic factors, along with skin swabs to examine the microbiome. During the study, researchers will compare skin microbial composition with blood biomarkers and disease severity scores over one and two years. Non-invasive skin and blood tests will be done regularly, and all samples will be anonymized and stored securely for five years after the study. Participants will attend scheduled visits for assessments but will experience no changes to their usual care beyond study procedures.

CONDITIONS

Brief Title

Microbiome in Atopic Dermatitis Under Systemic Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with moderate to severe atopic dermatitis
  • Indication for systemic therapy
  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - 2 years

Participants who undergo routine systemic therapy for atopic dermatitis are observed with regular examinations and sample collections.

Quarterly visits plus a follow-up visit 6 weeks after therapy initiation, and visits at 6, 12, and 24 months after starting therapy

Trial Site Locations

Total: 1 location

1

Dpt of Dermatology and Allergology, Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, Germany, 10117

Actively Recruiting

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Research Team

M

Margitta Worm, Prof

S

Sabine Dölle-Bierke, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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