Investigating the skin microbiome in patients with atopic dermatitis receiving systemic therapy
Identification of Skin-associated Microbiota in Atopic Dermatitis Patients Undergoing Systemic Therapy
Charite University, Berlin, Germany · NCT05099315
This study looks at how the skin bacteria of people with moderate to severe atopic dermatitis change while they are on systemic treatments to see if it can help improve their care and understanding of the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany (other) |
| Locations | 1 site (Berlin, State of Berlin) |
| Trial ID | NCT05099315 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how the skin microbiome changes in patients with moderate to severe atopic dermatitis undergoing systemic therapy, such as biologics or Janus kinase inhibitors. Patients will be monitored over two years with routine examinations every quarter, including blood and skin microbiome sampling. The study seeks to generate new hypotheses regarding the pathogenesis of atopic dermatitis and develop objective scales for assessing disease severity. By understanding these changes, the research could lead to improved therapeutic strategies and disease management.
Who should consider this trial
Good fit: Ideal candidates are adults with moderate to severe atopic dermatitis who are indicated for systemic therapy.
Not a fit: Patients under 18 years of age or those who are pregnant or lactating will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding and management of atopic dermatitis, leading to better treatment options for patients.
How similar studies have performed: While the specific approach of this study is exploratory, similar studies have shown promise in understanding the role of the microbiome in skin conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Berlin, State of Berlin
- Dpt of Dermatology and Allergology, Charité - Universitätsmedizin Berlin — Berlin, State of Berlin, Germany (RECRUITING)
Study contacts
- Study coordinator: Margitta Worm, Prof
- Email: margitta.worm@charite.de
- Phone: +49 30 450 518105
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atopic Dermatitis, dupilumab, cyclosporine, skin microbiome, baricitinib