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TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis
Sponsor: Technische Universität Dresden
Summary
About 60% of all patients with AD are adults. However, the prevalence and incidence is significantly higher in childhood and adolescence. Some children, adolescents and adults with moderate-to-severe AD cannot be sufficiently controlled with topical treatments alone and require intermittent or continuous treatment with systemic immunomodulating agents or UV-therapy. Systematic reviews indicate that although several different interventions for moderate-to-severe AD have been studied in clinical trials, strong recommendations are only possible for Dupilumab in adults and the short-term use of cyclosporin A (CSA). Pharmaceutical treatment of patients suffering from AE is diverse and frequently not in line with the current guidelines (for example S2-guideline in Germany). Large head-to-head trials are missing so that long-term effectiveness of systemic interventions for moderate-to-severe AD is speculative. In this situation, clinical registries can provide valuable information for evidence-based clinical decision making. Extension of TREATgermany to children and adolescents is necessary as * moderate-to-severe AD is frequent in this age group, but the effectiveness of existing topical and systemic agents in the routine care setting on clinical severity, patient-reported outcomes, and the course of AD and associated atopic and non-atopic comorbidities over time is still poorly understood * it is unclear how many children and adolescents cannot be effectively controlled with the avoidance of trigger factors, patient education, and topical anti-inflammatory treatment alone * innovative agents will become available for these age groups within the next years and reference data will be necessary to evaluate their effectiveness and indication criteria * adequate evidence regarding patient needs in children and adolescents with moderate-to-severe AD is urgently needed to provide value-based healthcare for this vulnerable patient group * Best-practice models of transition from adolescent to adult care of patients with moderate-to-severe AD do not exist yet, but constitute a prerequisite for the establishment of efficient patient care
Official title: TREATgermany: German National Clinical Registry: Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
2800
Start Date
2016-02-01
Completion Date
2026-12-31
Last Updated
2022-05-09
Healthy Volunteers
No
Conditions
Interventions
No study intervention
Locations (3)
Clinics for Dermatology, Allergy and Venerology, Hannover Medical School
Hanover, Lower Saxony, Germany
Department of Dermatology, UniversityAllergyCenter, Medical Faculty Carl Gustav Carus, TU Dresden
Dresden, Saxony, Germany
Head Centre for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, Germany