National registry for patients with moderate-to-severe atopic dermatitis in Germany
TREATgermany: German National Clinical Registry: Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis
This study is creating a national registry to track the experiences and treatments of people in Germany with moderate-to-severe atopic dermatitis over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2800 (estimated) |
| Sex | All |
| Sponsor | Technische Universität Dresden Academic / other |
| Drugs / interventions | Dupilumab |
| Locations | 3 sites (Hanover, Lower Saxony and 2 other locations) |
| Trial ID | NCT03057860 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a national clinical registry for patients suffering from moderate-to-severe atopic dermatitis (AD) in Germany. Patients will be followed for at least 24 months, during which their clinical data, treatment decisions, and patient-reported outcomes will be systematically documented. The study includes standardized visits at baseline, 3 months, and 6 months, with additional visits based on treatment changes. Optional biosamples will be collected for molecular analyses to enhance understanding of the disease.
Who should consider this trial
Good fit: Ideal candidates include adults and children diagnosed with moderate-to-severe atopic dermatitis who meet specific clinical criteria.
Not a fit: Patients with mild atopic dermatitis or those not meeting the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could improve treatment strategies and outcomes for patients with moderate-to-severe atopic dermatitis.
How similar studies have performed: While there have been various studies on atopic dermatitis treatments, this registry approach is relatively novel and aims to fill gaps in long-term effectiveness data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * AD according to the United Kingdom (UK) working party diagnostic criteria * Moderate to severe AD * Objective SCORAD \> 20 or Currently anti-inflammatory systemic treatment for AD or Previous anti-inflammatory systemic treatment for AD within past 24 months Exclusion Criteria: \-
Where this trial is running
Hanover, Lower Saxony and 2 other locations
- Clinics for Dermatology, Allergy and Venerology, Hannover Medical School — Hanover, Lower Saxony, Germany (Recruiting)
- Department of Dermatology, UniversityAllergyCenter, Medical Faculty Carl Gustav Carus, TU Dresden — Dresden, Saxony, Germany (Recruiting)
- Head Centre for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel — Kiel, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Principal investigator: Jochen Schmitt, Prof.Dr. — Center for Evidence-based Healthcare, Technical University Dresden
- Study coordinator: Jochen Schmitt, Prof.Dr.
- Email: jochen.schmitt@uniklinikum-dresden.de
- Phone: +493514586493
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.