Clinical trial NCT05819463: Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis - TREATswitzerland
Official title: Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis - Swiss National Clinical Registry TREATswitzerland
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Lead sponsor: Swiss Society of Dermatology and Venereology
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 700
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study aims at including 700 patients with moderate to severe atopic dermatitis in the registry.

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.

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

Primary outcomes:
measure: Evaluation of the type of systemic therapy used in patients with moderate-to-severe atopic dermatitis
timeFrame: 24 months
Secondary outcomes:
measure: assessment of patients demographic data
timeFrame: 24 months
measure: assessment of past treatment and current treatment
timeFrame: 24 months
measure: assessment of concomitant topical therapy for AD and concomitant treatment
timeFrame: 24 months
measure: assessment of past and current comorbidities
timeFrame: 24 months
measure: change in subjective and objective SCORAD (SCORing Atopic Dermatitis)
timeFrame: 24 months
measure: change in EASI (Eczema Area and Severity Index)
timeFrame: 24 months
measure: change in DLQI (Dermatology Life Quality Index)
timeFrame: 24 months
measure: change in POEM (Patient Oriented Eczema Measure)
timeFrame: 24 months
measure: change in RECAP (Recap of atopic eczema)
timeFrame: 24 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel, Allergologie
city: Bern
country: Switzerland
facility: Inselspital, Department of Dermatology
city: Buochs
country: Switzerland
facility: Dermatology & Skin Care Clinic
city: Fribourg
country: Switzerland
facility: HFR Hôpital Cantonal de Fribourg
city: Lausanne
country: Switzerland
facility: Dermatologie CHUV
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital, Zentrum für Dermatologie und Allergologie
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen - Klinik für Dermatologie, Venerologie und Allergologie
city: Uster
country: Switzerland
facility: PLAZA Kliniken
city: Zürich
country: Switzerland
facility: Institut für Dermatologie und Venerologie Stadtspital Zürich Europaallee
Study officials:
affiliation: Department of Dermatology, Inselspital
name: Dagmar Simon, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: