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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2027-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Moderate-to-severe Atopic Eczema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with moderate-to-severe atopic eczema

Adult and pediatric patients that start treatment with phototherapy or systemic immunomodulating therapy for their atopic eczema

No study-specific intervention

Intervention Type OTHER

Treatment of atopic eczema with phototherapy or systemic immunomodulating therapy according to usual clinical practice

Interventions

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No study-specific intervention

Treatment of atopic eczema with phototherapy or systemic immunomodulating therapy according to usual clinical practice

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Angela Bosma

Co-investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Phyllis I. Spuls, prof.dr.

Role: 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