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
- Conditions
- Moderate-to-severe Atopic Eczema
- Interventions
- Other: No study-specific intervention
- Registration Number
- NCT03621137
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with moderate-to-severe atopic eczema No study-specific intervention Adult and pediatric patients that start treatment with phototherapy or systemic immunomodulating therapy for their atopic eczema
- Primary Outcome Measures
Name Time Method Mean change in POEM (Patient-Oriented Eczema Measure) score 5 years Patient-reported outcome measure for symptoms of atopic eczema
Mean change in PGA (Patient's Global Assessment) score 5 years Patient-reported outcome measure for global disease severity
Mean change in DLQI (Dermatology Life Quality Index) score 5 years Patient-reported outcome measure for skin-related quality of life
Drug survival of the therapies 5 years Assessment of the duration until discontinuation of a drug together with the reason thereof
Mean change in EASI (Eczema Area and Severity Index) score 5 years Investigator-assessed outcome measure for disease severity at physical examination
Mean change in IGA (Investigator's Global Assessment) score 5 years Investigator-assessed outcome measure for global disease severity
Mean time to reach a change in EASI (Eczema Area and Severity Index) score of 50% 5 years Investigator-assessed outcome measure for disease severity at physical examination
The occurrence of severe adverse events 5 years Any undesirable experience of severe nature occurring to a subject is reported
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
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