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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
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Study procedures:
No study related intervention will be performed. Included patients will be prospectively followed for at least 24 months. A maximum duration of follow-up is not intended.
During the observation period standardized study visits are performed to prospectively document patient characteristics, clinical data, patient-reported outcomes, physician's reasons for treatment decisions, and satisfaction with treatment.
The first study visit is scheduled at patient inclusion (baseline-visit; V1). The second and third study visits are scheduled 3 and 6 months after baseline, respectively. (V2 after 3 months, V3 after 6 months). Thereafter, study visits are scheduled after 3 months (if a new systemic treatment was initiated) or after 6 months (in case no new systemic treatment was prescribed).
In a subset of patients biosamples for molecular analyses including blood, swabs and stool will be taken at baseline and at V6, as well as skin biopsies prior to and 3 months after systemic therapy initiation. This optional module requires separate patient information and informed consent.
Data assessment:
Prospective electronic documentation of disease course and severity, medical care and pharmaceutical treatment of AD.
Pseudomized data will be stored at the registry center (Center for Evidence-based Healthcare, Dresden).
Study assessments include:
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Eva Haufe, Dr.; Jochen Schmitt, Prof.Dr.
Data sourced from clinicaltrials.gov
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