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

NCT ID: NCT05819463

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-02

Study Completion Date

2032-12-31

Brief Summary

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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

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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.

Conditions

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Atopic Dermatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Society of Dermatology and Venereology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dagmar Simon, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Inselspital

Locations

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Universitätsspital Basel, Allergologie

Basel, , Switzerland

Site Status RECRUITING

Inselspital, Department of Dermatology

Bern, , Switzerland

Site Status RECRUITING

Dermatology & Skin Care Clinic

Buochs, , Switzerland

Site Status RECRUITING

HFR Hôpital Cantonal de Fribourg

Fribourg, , Switzerland

Site Status RECRUITING

Dermatologie CHUV

Lausanne, , Switzerland

Site Status RECRUITING

Luzerner Kantonsspital, Zentrum für Dermatologie und Allergologie

Lucerne, , Switzerland

Site Status NOT_YET_RECRUITING

Kantonsspital St. Gallen - Klinik für Dermatologie, Venerologie und Allergologie

Sankt Gallen, , Switzerland

Site Status RECRUITING

PLAZA Kliniken

Uster, , Switzerland

Site Status RECRUITING

Institut für Dermatologie und Venerologie Stadtspital Zürich Europaallee

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Dagmar Simon, Prof. Dr. med.

Role: CONTACT

+41 31 632 22 78

Facility Contacts

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Karin Hartmann, Prof. Dr. med.

Role: primary

+41 61 265 40 98

Dagmar Simon, Prof. Dr. med.

Role: primary

+41 31 63 2 22 78

Ahmad Jalili, PD Dr. Dr. med.

Role: primary

+41 41 620 00 60

Basile Page, Dr. med.

Role: primary

+41 26 306 22 10

Teofila Caplanusi, Dr. med.

Role: primary

+41 79 556 47 27

Christoph Brand, Prof. Dr. med.

Role: primary

+41 41 205 52 25

Ieva Saulite, Dr. med.

Role: primary

+41 71 494 19 29

Tobias Plaza, Dr. med.

Role: primary

+41 44 940 49 49

Siegfried Borelli, Dr. med.

Role: primary

+41 44 416 32 00

Other Identifiers

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2022-00205

Identifier Type: -

Identifier Source: org_study_id

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