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Recruiting NCT04240522

Prospective Longitudinal Observational Research in Atopic Dermatitis

Observational Atopic Dermatitis Asthma Atopic Dermatitis and Related Conditions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Atopic Dermatitis, Asthma, Atopic Dermatitis and Related Conditions. Basic parameters: 1 year — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Primary outcome measures

  • Remission of atopic dermatitis and associated allergic diseases [Time frame: 5 years]
Secondary outcome measures (2)
  • Endogenous and exgogenouse factors that influence and predict the course of AD. [Time frame: 5 years]
  • Identification of potential biomarkers predicting the course of AD [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Allergy Unit, Dept. of Dermatology, Unviersity Hosptial of Zurich — Zurich

Identifiers

NCT: NCT04240522 · ProRaD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗