Prospective Longitudinal Observational Research in Atopic Dermatitis (ProRaD)

Prospective Longitudinal Observational Research Study to Investigate the Remission of Atopic Dermatitis and Associated Allergic Diseases

Atopic dermatitis (AD) is a frequent chronic relapsing inflammatory skin disorder, characterized by intensely itchy eczema. AD usually starts within the first 2 years of life. In 30 - 60% of children, inflammation spreads onto other body surfaces such as the gastrointestinal tract, the respiratory tract, and the conjunctives within a few years. This sequence is called atopic march.

Atopic dermatitis and associated atopic diseases are more frequent in families, suggesting a genetic predisposition. However, the underlying factors such as genetic phenotype, environmental factors, or life style which cause or worsen an existing allergic disease are not understood yet. Affected people suffer from recurrent flares that result in significantly impaired quality.

This study will collect clinical and laboratory data to elucidate immunotolerance and preventiv stategies with the aim to develop new and individual treatment options of atopic diseases.

Study Overview

• Status: Recruiting
• Conditions: Asthma; Atopic Dermatitis; Atopic Dermatitis and Related Conditions

Detailed Description

Primary Objetive:

In the planned project, the main objective is to identify endogenous (e.g. immunological and molecular factors) and exogenous factors (e.g. environmental, socioeconomic and microbial factors) that influence the course and remission of AD. More specifically to identify factors that are significantly different between patients that have or do not have remission from AD.

Secondary Objective:

(i) To identify endogenous and exogenous factors such as immunological, molecular and microbial factors to separate subgroups of patients (endotypes) with distinct local and systemic inflammatory responses.

(ii) To identify potential biomarkers predicting the individual clinical course of AD and other atopic diseases including asthma, food allergy and allergic rhinitis.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • Recruiting
    • Allergy Unit, Dept. of Dermatology, Unviersity Hosptial of Zurich
    • Contact: Peter Schmid-Grendelmeier, Prof, MD; Phone Number: +41442553079; Email: peter.schmid@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with atopic dermatits, any other allergic diseases and /or healthy controls

Description

Inclusion Criteria:

• Age 0 - 85 years
• Diagnosis of AD and/or another disease of the atopic group (i.e. allergic rhinitis, allergic asthma, food allergy)
• The inclusion of patients in this study is independent from the current therapy. During the study all patients will be kept on a therapy that is medically indicated

The inclusion criteria for healthy controls in this study are as follows:

• Age 0 - 85 years
• No diagnosis or history of allergic disease
• The inclusion of patients in this study is independent from the current therapy. During the study all patients will be kept on a therapy that is medically indicated

Written consent will be obtained after detailed information of the study was given to the participant.

Exclusion Criteria

- Unable to give consent or refusal to participate in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission of atopic dermatitis and associated allergic diseases	Prospective observational study	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endogenous and exgogenouse factors that influence and predict the course of AD.	Prospective observational study	5 years
Identification of potential biomarkers predicting the course of AD	Prospective observational study	5 years

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: University of Bonn

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Eczema; Dermatitis; Atopy
• 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: BASEC 2016-00301

Drug and device information, study documents

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