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

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

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis

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 Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Dagmar Simon, Prof. Dr. med.; Phone Number: +41 31 63 2 22 78; Email: dagmar.simon@insel.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Universitätsspital Basel, Allergologie
    • Contact: Karin Hartmann, Prof. Dr. med.; Phone Number: +41 61 265 40 98; Email: allergologie@usb.ch
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital, Department of Dermatology
    • Contact: Dagmar Simon, Prof. Dr. med.; Phone Number: +41 31 63 2 22 78; Email: dagmar.simon@insel.ch
  • Buochs, Switzerland, 6374
    • Recruiting
    • Dermatology & Skin Care Clinic
    • Contact: Ahmad Jalili, PD Dr. Dr. med.; Phone Number: +41 41 620 00 60; Email: ahmad.jalili@dsc-clinic.ch
  • Fribourg, Switzerland, 1752
    • Not yet recruiting
    • HFR Hôpital Cantonal de Fribourg
    • Contact: Basile Page, Dr. med.; Phone Number: +41 26 306 22 10; Email: basile.page@h-fr.ch
  • Luzern, Switzerland, 6000
    • Not yet recruiting
    • Luzerner Kantonsspital, Zentrum für Dermatologie und Allergologie
    • Contact: Christoph Brand, Prof. Dr. med.; Phone Number: +41 41 205 52 25; Email: christoph.brand@luks.ch
  • St. Gallen, Switzerland, 9007
    • Recruiting
    • Kantonsspital St. Gallen - Klinik für Dermatologie, Venerologie und Allergologie
    • Contact: Ieva Saulite, Dr. med.; Phone Number: +41 71 494 19 29; Email: studien.dermatologie@kssg.ch
  • Uster, Switzerland, 8610
    • Recruiting
    • PLAZA Kliniken
    • Contact: Tobias Plaza, Dr. med.; Phone Number: +41 44 940 49 49; Email: t.plaza@hin.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study aims at including 700 patients with moderate to severe atopic dermatitis in the registry.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Swiss Society of Dermatology and Venereology
• Investigators: Principal Investigator: Dagmar Simon, Prof. Dr. med., Department of Dermatology, Inselspital

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Estimated): May 31, 2032
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 2022-00205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No