Prospective Longitudinal Observational Research in Atopic Dermatitis

Asthma Clinical Trial

— ProRaD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04240522
• Other study ID #: BASEC 2016-00301
• Status: Recruiting
• Start date: April 4, 2017
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2022
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Gender: All
• Age group: 1 Year to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Atopic Dermatitis
• Atopic Dermatitis and Related Conditions
• Dermatitis
• Dermatitis, Atopic
• Eczema

Locations

Country	Name	City	State
Switzerland	Allergy Unit, Dept. of Dermatology, Unviersity Hosptial of Zurich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	University of Bonn

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission of atopic dermatitis and associated allergic diseases	Prospective observational study	5 years
Secondary	Endogenous and exgogenouse factors that influence and predict the course of AD.	Prospective observational study	5 years
Secondary	Identification of potential biomarkers predicting the course of AD	Prospective observational study	5 years