Clinical trial NCT03361215: Disease Trajectories and Anti-cytokine Response Signatures in Atopic Dermatitis and Psoriasis
Official title: Disease Trajectories in Atopic Dermatitis and Psoriasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Psoriasis
Healthy
Keywords: Disease progression
Disease course
Immunological characterization
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who are beeing treated in the routine care with chronic inflammatory skin diseases will be asked to participate in this project.

Brief summary: The clinical study investigates the long-term course of disease in patients with chronic inflammatory skin diseases (atopic eczema and psoriasis) and the impact of tarheted therapies on the clinical and molecular level. For this purpose, patients are asked to take part in regular examinations and data collections, and to donate biomaterials (blood, skin biopsies, skin swabs, tape strips, stool samples). Blood samples are used to analyze inflammation messengers. Punch biopsies from lesional and non-lesional skin areas are used to analyze gene expression. Tape strips are pieces of transparent adhesive tapes to strip off most of the horny layer that will be used to examine mRNA and protein expression. 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

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 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, 12 and 52.

Eligibility 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

Primary outcomes:
measure: Disease progression
timeFrame: 10 years
measure: Molecular signature changes
timeFrame: 10 years
Secondary outcomes:
measure: Development of comorbidities
timeFrame: 10 years
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel
Study officials:
affiliation: Dept. of Dermatology University Hospital Kiel
name: Stephan Weidinger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: