National registry for patients with moderate-to-severe atopic eczema
TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry
This study is collecting information from children and adults with moderate-to-severe eczema who are getting certain treatments to see how well they work and how safe they are in real life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | dupilumab, methotrexate |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT03621137 on ClinicalTrials.gov |
What this trial studies
The TREAT NL registry collects data on children and adults with moderate-to-severe atopic eczema who are receiving photo- or systemic immunomodulating therapies. This observational study aims to gather real-life data on the effectiveness, safety, and cost-effectiveness of these treatments, many of which are used off-label. By establishing a comprehensive registry, the study seeks to improve the quality of care for patients suffering from this chronic skin condition. The insights gained will help inform clinical practice and guide future treatment decisions.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with moderate-to-severe atopic eczema who are starting phototherapy or systemic immunomodulating therapy.
Not a fit: Patients who are only using antibiotics or antihistamines for their condition may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of treatment outcomes and improve care for patients with atopic eczema.
How similar studies have performed: Other registries and observational studies have shown success in improving treatment understanding and patient outcomes in similar conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Amsterdam, 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 (Recruiting)
Study contacts
- Principal investigator: Phyllis I. Spuls, prof.dr. — Department of Dermatology, Amsterdam University Medical Centres, University of Amsterdam, Research Institute Amsterdam Public Health and Amsterdam Infection and Immunity Institute, Amsterdam, The Netherlands
- Study coordinator: Angela L. Bosma
- Email: a.l.bosma@amsterdamumc.nl
- Phone: +31205662757
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.