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

Recruiting

• Conditions: Atopic Dermatitis

• Registration Number: NCT05819463
• Lead Sponsor: Swiss Society of Dermatology and Venereology

Brief Summary

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.

Detailed Description

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:

1. to evaluate the psychosocial impact of AD;

2. to provide up-to-date epidemiologic data that allow investigating risk factors for favorable or unfavorable disease courses and comorbidities; and

3. 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.

Study Timeline

• Study Start: 2022-06-02
• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30
• Primary Completion: 2032-05
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the type of systemic therapy used in patients with moderate-to-severe atopic dermatitis	24 months	assess medical substances given systemically to treat AD

Secondary Outcome Measures

Name	Time	Method
assessment of past treatment and current treatment	24 months	assess specific medical substances (name, dosage, duration of therapy, clinical effects, adverse effects)
assessment of past and current comorbidities	24 months	describe diseases
change in RECAP (Recap of atopic eczema)	24 months	Patient-reported outcome measure to capture eczema control
assessment of patients demographic data	24 months	assess sex (male, female), age (years)
assessment of concomitant topical therapy for AD and concomitant treatment	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
change in EASI (Eczema Area and Severity Index)	24 months	Investigator-assessed outcome measure for disease severity
change in POEM (Patient Oriented Eczema Measure)	24 months	Patient-reported outcome measure for atopic eczema severity
change in subjective and objective SCORAD (SCORing Atopic Dermatitis)	24 months	outcome measure for disease severity
change in DLQI (Dermatology Life Quality Index)	24 months	Patient-reported outcome measure for skin-related quality of life

Trial Locations

Locations (9)

Institut für Dermatologie und Venerologie Stadtspital Zürich Europaallee; 🇨🇭 Zürich, Switzerland

Universitätsspital Basel, Allergologie; 🇨🇭 Basel, Switzerland

Inselspital, Department of Dermatology; 🇨🇭 Bern, Switzerland

Dermatology & Skin Care Clinic; 🇨🇭 Buochs, Switzerland

HFR Hôpital Cantonal de Fribourg; 🇨🇭 Fribourg, Switzerland

Dermatologie CHUV; 🇨🇭 Lausanne, Switzerland

Luzerner Kantonsspital, Zentrum für Dermatologie und Allergologie; 🇨🇭 Luzern, Switzerland

Kantonsspital St. Gallen - Klinik für Dermatologie, Venerologie und Allergologie; 🇨🇭 St. Gallen, Switzerland

PLAZA Kliniken; 🇨🇭 Uster, Switzerland