Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis - TREATswitzerland
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis - Swiss National Clinical Registry TREATswitzerland
Overview
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.
Primary outcome measures
- Evaluation of the type of systemic therapy used in patients with moderate-to-severe atopic dermatitis [Time frame: 24 months]
Secondary outcome measures (9)
- assessment of patients demographic data [Time frame: 24 months]
- assessment of past treatment and current treatment [Time frame: 24 months]
- assessment of concomitant topical therapy for AD and concomitant treatment [Time frame: 24 months]
- assessment of past and current comorbidities [Time frame: 24 months]
- change in subjective and objective SCORAD (SCORing Atopic Dermatitis) [Time frame: 24 months]
- change in EASI (Eczema Area and Severity Index) [Time frame: 24 months]
- change in DLQI (Dermatology Life Quality Index) [Time frame: 24 months]
- change in POEM (Patient Oriented Eczema Measure) [Time frame: 24 months]
- change in RECAP (Recap of atopic eczema) [Time frame: 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Switzerland · 9 centers
- Universitätsspital Basel, Allergologie — Basel
- Inselspital, Department of Dermatology — Bern
- Dermatology & Skin Care Clinic — Buochs
- HFR Hôpital Cantonal de Fribourg — Fribourg
- Dermatologie CHUV — Lausanne
- Luzerner Kantonsspital, Zentrum für Dermatologie und Allergologie — Lucerne
- Kantonsspital St. Gallen - Klinik für Dermatologie, Venerologie und Allergologie — Sankt Gallen
- PLAZA Kliniken — Uster
- … and 1 more center
Identifiers
NCT: NCT05819463 · 2022-00205