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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05819463
• Other study ID #: 2022-00205
• Status: Recruiting
• Start date: May 9, 2022
• Est. completion date: December 31, 2032

Study information

• Verified date: April 2023
• Source: Swiss Society of Dermatology and Venereology
• Contact: Dagmar Simon, Prof. Dr. med.
• Phone: +41 31 63 2 22 78
• Email: dagmar.simon[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 31, 2032
• Est. primary completion date: May 31, 2032
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
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	Luzerner Kantonsspital, Zentrum für Dermatologie und Allergologie	Luzern
Switzerland	Kantonsspital St. Gallen - Klinik für Dermatologie, Venerologie und Allergologie	St. Gallen
Switzerland	PLAZA Kliniken	Uster

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Society of Dermatology and Venereology

Country where clinical trial is conducted

Switzerland, 

Outcome

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