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Prospective Longitudinal Observational Research in Atopic Dermatitis (ProRaD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04240522
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborator:
University of Bonn
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date January 20, 2020
First Posted Date January 27, 2020
Last Update Posted Date January 27, 2020
Actual Study Start Date April 4, 2017
Actual Primary Completion Date January 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 20, 2020)
  • Remission of atopic dermatitis and associated allergic diseases [ Time Frame: 5 years ]
    Prospective observational study
  • Endogenous and exgogenouse factors that influence and predict the cours of AD. [ Time Frame: 5 years ]
    SCORAD
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Longitudinal Observational Research in Atopic Dermatitis
Official Title Prospective Longitudinal Observational Research Study to Investigate the Remission of Atopic Dermatitis and Associated Allergic Diseases
Brief 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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
serum samples, Microbiom swabs Ski biopsy (selcted cases)
Sampling Method Non-Probability Sample
Study Population All patietns with atopic dermatits, any other allergic diseases and /or healthy controls
Condition
  • Https://Meshb.Nlm.Nih.Gov/Record/ui?ui=D003876
  • Atopic Dermatitis
  • Asthma
  • Atopic Dermatitis and Related Conditions
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 20, 2020)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 4, 2024
Actual Primary Completion Date January 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

-

The inclusion criteria for patients in this study are as follows:

  1. Age 0 - 85 years
  2. Diagnosis of AD and/or another disease of the atopic group (i.e. allergic rhinitis, allergic asthma, food allergy)
  3. 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:

  1. Age 0 - 85 years
  2. No diagnosis or history of allergic disease
  3. 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

-

Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT04240522
Other Study ID Numbers BASEC 2016-00301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators University of Bonn
Investigators Not Provided
PRS Account University of Zurich
Verification Date January 2020