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

NCT03057860 | Recruiting

• 1 other identifier: EK-118032016
• Study Type: observational
• Target: 2,800
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Moderate-to-severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Score of Atopic Dermatitis (oSCORAD)

  Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis: Dermatology 1993;186:23-31

  Change from Baseline oSCORAD at 2 years

Secondary Outcomes (5)

• Patient Oriented Eczema Measure (POEM)

  Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years

• Severity of Pruritus and Sleeping Problems (VAS)

  Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years

• Flares (totally/well controlled weeks)

  Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years

• Health-related Quality of Life (DLQI)

  Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years

• Eczema Area and Severity Index (EASI)

  Baseline (month 0) - 3 months - 6 months - 12 months - 18 months - 2 years

Interventions

No study intervention OTHER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate-to-severe atopic dermatitis

You may qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (3)

Clinics for Dermatology, Allergy and Venerology, Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Department of Dermatology, UniversityAllergyCenter, Medical Faculty Carl Gustav Carus, TU Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Head Centre for Inflammatory Skin Diseases, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Related Links

• All Information about the Register-Project

Study Officials

• Jochen Schmitt, Prof.Dr.

  Center for Evidence-based Healthcare, Technical University Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jochen Schmitt, Prof.Dr.

CONTACT

+493514586493; jochen.schmitt@uniklinikum-dresden.de

Eva Haufe, Dr.

CONTACT

+493514586491; eva.haufe@uniklinikum-dresden.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2017
• First Posted: February 20, 2017
• Study Start: February 1, 2016
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)