TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry: Dutch National Registry for Patients With Moderate-to-severe Atopic Eczema on Photo- or Systemic Therapies
Recruiting · NCT03621137 · Observational (researchers observe without assigning treatment) · Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The TREAT NL (TREatment of ATopic eczema, the Netherlands) registry is a national registry for children and adults with moderate-to-severe atopic eczema aiming to gather data on their prescribed photo- and systemic immunomodulating therapies. Atopic eczema is a common, chronic, itchy, inflammatory skin disease that can have a major impact on the quality of life of patients and their immediate surroundings. Serious atopic eczema patients are treated by means of photo- or systemic immunomodulating therapy. Of these mostly off-label applied therapies, there is insufficient evidence on the short and long term for their effectiveness, safety and cost-effectiveness. Moreover, good comparative research and real-life data are lacking. With the arrival of new expensive treatments it is crucial to get insight into these treatments in order to improve quality of care. By means of a prospective registry these data can be collected and help to obtain information for clinical practice, for answering research questions, for reducing costs and implementing the results by guidelines and decision aids.
Who can take part
Inclusion criteria
- Patient has a diagnosis of atopic eczema, based on the U.K. working party's diagnostic criteria;
- Starts with any type of phototherapy (e.g. UVB) or systemic immunomodulating therapy (e.g. cyclosporin, systemic glucocorticosteroids, azathioprine, methotrexate, mycophenolic acid, dupilumab);
- Has voluntarily signed and dated an informed consent prior to any study related procedure or has a legal representative to do so and is willing to comply with the requirements of this study protocol.
Exclusion criteria
- Patient uses only (systemic) antibiotics or antihistamines;
- Patient starts with systemic immunomodulating therapy for another indication than atopic eczema;
- Insufficient understanding of the study by the patient or parent/legal representative.
Where it is running
1 location listed.
- Department of Dermatology, Amsterdam University Medical Centres, University of Amsterdam, Research Institute Amsterdam Public Health and Amsterdam Infection and Immunity Institute, Amsterdam, The Netherlands - Amsterdam, North Holland, Netherlands