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NCT03057860Recruiting

TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis

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

Source: ClinicalTrials.gov · Last updated 9 May 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
2800 (estimated)
First submitted
7 Feb 2017
Start date
1 Feb 2016
Primary completion date
31 Dec 2026
Lead sponsor
Technische Universität Dresden
NCT number
NCT03057860

What you commit to

  • Study type: Observational
  • Planned participants: 2800
  • From 1 Feb 2016 to the primary completion date, 31 Dec 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • \-

Who the study is looking for

  • 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

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of Dermatology, UniversityAllergyCenter, Medical Faculty Carl Gustav Carus, TU Dresden
Coordinator of this site? Confirm its status
DresdenGermanyRecruiting
Clinics for Dermatology, Allergy and Venerology, Hannover Medical School
Coordinator of this site? Confirm its status
HanoverGermanyRecruiting
Head Centre for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel
Coordinator of this site? Confirm its status
KielGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.