Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Patients with moderate to severe atopic dermatitis
- Indication for systemic therapy
- Adults aged 18 years or older
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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