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Disease Trajectories in Atopic Dermatitis and Psoriasis (DiTrAP)

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ClinicalTrials.gov Identifier: NCT03361215
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Stephan Weidinger, University of Schleswig-Holstein

Brief Summary:
The clinical study investigates the course of disease in patients with chronic inflammatory skin diseases (atopic eczema and psoriasis). For this purpose, patients are asked once a year to take part in a data collection, questionnaires on the severity and quality of life are filled in and patients are also asked to give blood samples and skin swabs. The skin smears are superficial smears of three areas of skin with cotton swabs, which are used to examine bacteria on the skin. The blood samples are used to analyze inflammation messengers during the course of the disease. Optionally, patients are asked to submit second skin biopsies once a year to analyze inflammatory cell-level changes in the skin. Overall, the study will help to monitor the pathogenesis of the participating patients for at least ten years and to collect information about the inflammatory mechanisms of the diseases. The study has no effect on the therapies of the disease, it serves only the accompanying data collection

Condition or disease
Atopic Dermatitis Psoriasis

Detailed Description:
Atopic dermatitis and psoriasis are the most common chronic inflammatory skin diseases in dermatology. Due to genetic predispositions, inflammatory changes of the skin occur. The specific immunological inflammatory mechanisms are partly understood for both diseases and targeted therapies are established in psoriasis therapy and are currently available for the first time in the treatment of atopic eczema. In order to better understand the course of the disease and to characterize the changes in the inflammatory mechanisms during the course of the disease, longitudinal prospective studies are needed to evaluate biological samples. This study investigates long-term clinical epidemiological data from affected patients, as well as biological samples, including blood samples, non-invasive skin swabs for microbiome detection, and optional skin biopsies for histological, immunohistological and molecular characterization of the disease. Patients are screened once a year and followed up for at least ten years.

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Disease Trajectories in Atopic Dermatitis and Psoriasis
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : January 1, 2027
Estimated Study Completion Date : January 1, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Psoriasis




Primary Outcome Measures :
  1. Disease progression [ Time Frame: 10 years ]
    Epidemiological and phenotypical data of patients

  2. Molecular signature changes [ Time Frame: 10 years ]
    molecular signatures will be measured using OMICS technologies


Secondary Outcome Measures :
  1. Development of comorbidities [ Time Frame: 10 years ]
    Assessment of newly developed comorbit diseases over time


Biospecimen Retention:   Samples With DNA
Blood samples, including EDTA and serum samples Skin swabs for microbiome assessments Skin biopsies Stool samples for microbiome analyses


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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient who are beeing treated in the Routine care with either atopic Dermatitis or Psoriasis will be asked to participate in this observational study. There are no limmitations besides having atopic eczema or Psoriasis to participate in this study.
Criteria

Inclusion Criteria:

  • Patients with a clinical diagnosis of atopic eczema or psoriasis

Exclusion Criteria:

  • patients who decline participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361215


Contacts
Contact: Stephan Weidinger, Prof. Dr. +49431500 ext 21110 sweidinger@dermatology.uni-kiel.de
Contact: Sascha Gerdes, PD Dr. +49431500 ext 21151 sgerdes@dermatology.uni-kiel.de

Locations
Germany
Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel Recruiting
Kiel, Germany, 24105
Contact: Stephan Weidinger, MD         
Contact: Sascha Gerdes, MD         
Sponsors and Collaborators
University of Schleswig-Holstein
Investigators
Principal Investigator: Stephan Weidinger, Prof. Dr. Dept. of Dermatology University Hospital Kiel

Responsible Party: Prof. Dr. Stephan Weidinger, Prof. Dr. med., University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03361215     History of Changes
Other Study ID Numbers: A100/17
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Stephan Weidinger, University of Schleswig-Holstein:
Disease progression
Disease course
Immunological characterization

Additional relevant MeSH terms:
Eczema
Psoriasis
Dermatitis
Dermatitis, Atopic
Skin Diseases, Papulosquamous
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases