TREATgermany: German National Clinical Registry: Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
Department of Dermatology, UniversityAllergyCenter, Medical Faculty Carl Gustav Carus, TU Dresden
RECRUITING
Dresden
Clinics for Dermatology, Allergy and Venerology, Hannover Medical School
RECRUITING
Hanover
Head Centre for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel
RECRUITING
Kiel
Contact Information
Primary
Jochen Schmitt, Prof.Dr.
jochen.schmitt@uniklinikum-dresden.de
+493514586493
Backup
Eva Haufe, Dr.
eva.haufe@uniklinikum-dresden.de
+493514586491
Time Frame
Start Date: 2016-02-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 2800
Related Therapeutic Areas
Sponsors
Leads: Technische Universität Dresden

This content was sourced from clinicaltrials.gov

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