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NCT03621137 | RECRUITING | Moderate-to-severe Atopic Eczema

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
Sponsor:

Academic Medical Center - University of Amsterdam (AMC-UvA)

Information provided by (Responsible Party):

Angela Posma

Brief Summary:

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.

Condition or disease

Moderate-to-severe Atopic Eczema

Intervention/treatment

No study-specific intervention

Study Type : OBSERVATIONAL
Estimated Enrollment : 500 participants
Official Title : TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry
Actual Study Start Date : 2017-11-01
Estimated Primary Completion Date : 2027-10-31
Estimated Study Completion Date : 2027-10-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
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

Location Details

NCT03621137

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Netherlands, North Holland

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,