NCT03621137 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
| NCT ID | NCT03621137 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Moderate-to-severe Atopic Eczema |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2017-11-01 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2017-11-01 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Phyllis I. Spuls, prof.dr.
PRINCIPAL INVESTIGATOR
Department of Dermatology, Amsterdam University Medical Centres, University of Amsterdam, Research Institute Amsterdam Public Health and Amsterdam Infection and Immunity Institute, Amsterdam, The Netherlands
Frequently Asked Questions
Who can join the NCT03621137 clinical trial?
This trial is open to participants of all sexes, studying Moderate-to-severe Atopic Eczema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03621137 currently recruiting?
Yes, NCT03621137 is actively recruiting participants. Contact the research team at a.l.bosma@amsterdamumc.nl for enrollment information.
Where is the NCT03621137 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT03621137 clinical trial?
NCT03621137 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Phyllis I. Spuls, prof.dr. at Department of Dermatology, Amsterdam University Medical Centres, University of Amsterdam, Research Institute Amsterdam Public Health and Amsterdam Infection and Immunity Institute, Amsterdam, The Netherlands. The trial plans to enroll 500 participants.
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