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NCT Number: NCT05819463

Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis - TREATswitzerland

As structured and detailed data on the management of AD, a common chronic inflammatory skin disease which has a high impact on patients' quality of life and socioeconomic burden, are not available in Switzerland, the planned registry will overcome this gap. It will provide data on the medical care of patients with AD for health care research and allow to study the efficacy and safety of approved and available therapies for AD in daily life.

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Key information

Conditions

Atopic Dermatitis 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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsspital Basel, Allergologie, Basel, Switzerland

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About this study

A prospective, non-interventional, national multicenter study in patients with moderate-to-severe AD. According to the availability of approved systemic drugs for the treatment of AD, the study will include children ≥12 years, adolescents and adult patients.

The general goal of the AD registry TREATswitzerland is to provide the scientific community with a disease-oriented prospective cohort of patients suffering from moderate-to-severe AD.

The primary objective of the AD registry is the documentation of medical care given to patients with moderate-to-severe AD in order to assess the appropriateness of care.

Further objectives of the AD registry are:

  • to evaluate the psychosocial impact of AD;
  • to provide up-to-date epidemiologic data that allow investigating risk factors for favorable or unfavorable disease courses and comorbidities; and
  • to establish a research network and foster clinical research projects.

The study procedures include:

  • No study related intervention will be performed
  • Patients have to fulfill all inclusion criteria to be enrolled in the study.
  • Included patients are prospectively followed for at least 24 months. A maximum duration of follow-up is not intended.
  • During the observation period, standardized study visits are performed to prospectively document patient characteristics, clinical data, patient-reported outcomes, reasons for treatment decisions, and satisfaction with treatment.

Who can participate

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

Inclusion criteria

  • Age ≥ 12 years
  • AD according to the UK Working Party's Diagnostic Criteria (28)
  • Moderate to severe AD as defined by
  • objective SCORAD > 20 or IGA ≥ 3 (moderate) or
  • currently on systemic antiinflammatory therapy for AD or
  • previous systemic antiinflammatory therapy for AD within past 24 months

Exclusion criteria

  • refusal to sign the informed consent form

Treatment and study plan

Primary outcomes

  1. Evaluation of the type of systemic therapy used in patients with moderate-to-severe atopic dermatitis

    Time frame: 24 months

    assess medical substances given systemically to treat AD

Secondary outcomes

  1. assessment of patients demographic data

    Time frame: 24 months

    assess sex (male, female), age (years)

  2. assessment of past treatment and current treatment

    Time frame: 24 months

    assess specific medical substances (name, dosage, duration of therapy, clinical effects, adverse effects)

  3. assessment of concomitant topical therapy for AD and concomitant treatment

    Time frame: 24 months

    describe medical substances given for AD skin therapy (e.g. topical corticosteroids) and topical calcineurin inhibitors), and medical substances given for concomitant diseases

  4. assessment of past and current comorbidities

    Time frame: 24 months

    describe diseases

  5. change in subjective and objective SCORAD (SCORing Atopic Dermatitis)

    Time frame: 24 months

    outcome measure for disease severity

  6. change in EASI (Eczema Area and Severity Index)

    Time frame: 24 months

    Investigator-assessed outcome measure for disease severity

  7. change in DLQI (Dermatology Life Quality Index)

    Time frame: 24 months

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

  8. change in POEM (Patient Oriented Eczema Measure)

    Time frame: 24 months

    Patient-reported outcome measure for atopic eczema severity

  9. change in RECAP (Recap of atopic eczema)

    Time frame: 24 months

    Patient-reported outcome measure to capture eczema control

Study contacts

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

Dagmar Simon, Prof. Dr. med.

CONTACT

[email protected]

+41 31 632 22 78

Sponsors and collaborators

Lead sponsor

Swiss Society of Dermatology and Venereology

Other

Registry information

Official study title

Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis - Swiss National Clinical Registry TREATswitzerland

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Apr 19, 2023
Registry last updated
Apr 30, 2025

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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