Disease Trajectories in Atopic Dermatitis and Psoriasis

Study Purpose

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 in the context of their routine visits to take part in an examination and data collection, and are asked to donate biomaterials (blood, skin biopsies, skin swabs, tape strips, stool samples). Blood samples are used to analyze inflammation messengers. 4mm punch biopsies from lesional and non-lesional skin areas are used to analyze gene expression in the skin. Tape strips are pieces of transparent adhesive tapes to strip off most of the horny layer. The skin smears are superficial smears of three areas of skin with cotton swabs, which are used to examine bacteria on the skin. Overall, the study will help to monitor the disease course clinically and on the molecular level in participating patients for at least ten years and to collect information about the impact of various external factors including treatments. The study has no effect on the therapies of the disease, it serves only the accompanying data collection

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients with a clinical diagnosis of atopic dermatitis, psoriasis or autoimmune skin disease.
  • - Written informed consent obtained from the subject.

Exclusion Criteria:

  • - Patients who decline participation.
In patients<18 years of age no biopsies will be taken

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03361215
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital Schleswig-Holstein
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Stephan Weidinger, Prof. Dr.
Principal Investigator Affiliation Dept. of Dermatology University Hospital Kiel
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Atopic Dermatitis, Psoriasis
Additional Details

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 mechanisms are only partly understood for both diseases and targeted therapies are established in psoriasis therapy and are becoming available for atopic dermatitis. 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 and under the influence of external factors such as therapies, longitudinal prospective studies are needed to evaluate clinical data and biological samples. This study investigates long-term clinical and epidemiological data from affected patients, as well as biological samples, including blood samples, skin biopsies, non-invasive skin swabs for microbiome detection, and tape strips for the molecular characterization of the disease. Data collection and biosampling will be done during routine visits, typically at week 0, 2 and 12.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Kiel, Germany

Status

Recruiting

Address

Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel

Kiel, , 24105

Site Contact

Stephan Weidinger, MD

[email protected]

+49431500

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