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Taking people in GermanyNo phase

Registry following patients with moderate-to-severe atopic dermatitis in routine German care

Records how patients with moderate-to-severe atopic dermatitis are treated and cared for over time.

Plain-language title generated from the registry record
Registry title: TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis

Key facts

Where
Dresden, Hanover, and Kiel, GermanySee the 3 sites

Where in Germany

  • Department of Dermatology, UniversityAllergyCenter, Medical Faculty Carl Gustav Carus, TU DresdenDresden, GermanyTaking people
  • Clinics for Dermatology, Allergy and Venerology, Hannover Medical SchoolHanover, GermanyTaking people
  • Head Centre for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus KielKiel, GermanyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Technische Universität Dresden
Trial code
NCT03057860
Record updated
9 May 2022
Original description
About 60% of all patients with AD are adults. However, the prevalence and incidence is significantly higher in childhood and adolescence.Read full original descriptionShow less

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

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

Inclusion: 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: -.

ClinicalTrials.gov NCT03057860