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NCT Number: 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

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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Key information

Conditions

Moderate-to-severe Atopic Eczema Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Location status: Recruiting

Location contact

Angela Bosma

CONTACT

Angela Bosma

SUB_INVESTIGATOR

Ariënna Hyseni

CONTACT

Ariënna Hyseni

SUB_INVESTIGATOR

Louise Gerbens, dr.

SUB_INVESTIGATOR

Phyllis Spuls, prof.dr.

PRINCIPAL_INVESTIGATOR

Pina Middelkamp Hup, dr.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No study-specific intervention

Other

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

Primary outcomes

  1. Mean change in EASI (Eczema Area and Severity Index) score

    Time frame: 5 years

    Investigator-assessed outcome measure for disease severity at physical examination

  2. Mean change in IGA (Investigator's Global Assessment) score

    Time frame: 5 years

    Investigator-assessed outcome measure for global disease severity

  3. Mean change in POEM (Patient-Oriented Eczema Measure) score

    Time frame: 5 years

    Patient-reported outcome measure for symptoms of atopic eczema

  4. Mean change in PGA (Patient's Global Assessment) score

    Time frame: 5 years

    Patient-reported outcome measure for global disease severity

  5. Mean change in DLQI (Dermatology Life Quality Index) score

    Time frame: 5 years

    Patient-reported outcome measure for skin-related quality of life

  6. Mean time to reach a change in EASI (Eczema Area and Severity Index) score of 50%

    Time frame: 5 years

    Investigator-assessed outcome measure for disease severity at physical examination

  7. The occurrence of severe adverse events

    Time frame: 5 years

    Any undesirable experience of severe nature occurring to a subject is reported

  8. Drug survival of the therapies

    Time frame: 5 years

    Assessment of the duration until discontinuation of a drug together with the reason thereof

Study contacts

Contact information is provided by the study sponsor or research team.

Angela L. Bosma

CONTACT

[email protected]

+31205662757

Ariënna M. Hyseni

CONTACT

[email protected]

+31205662481

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry

Acronym: TREAT NL

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Aug 8, 2018
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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