Disease Trajectories and Anti-cytokine Response Signatures in Atopic Dermatitis and Psoriasis

Healthy Clinical Trial

— DiTrAP  

Official title:

Disease Trajectories in Atopic Dermatitis and Psoriasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03361215
• Other study ID #: A100/12a1
• Status: Recruiting
• Start date: March 16, 2015
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2023
• Source: University Hospital Schleswig-Holstein
• Contact: Stephan Weidinger, Prof. Dr.
• Phone: +49431500
• Email: sweidinger[@]dermatology.uni-kiel.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2030
• Est. primary completion date: March 15, 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema
• Healthy
• Psoriasis

Intervention

Other:
• Biosampling for molecular analysis
Observational study with no therapeutic intervention. Biosampling for molecular analysis

Locations

Country	Name	City	State
Germany	Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease progression	Epidemiological and phenotypical data of patients	10 years
Primary	Molecular signature changes	Molecular signatures will be measured using OMICS and sequencing technologies	10 years
Secondary	Development of comorbidities	Assessment of newly developed comorbid diseases over time	10 years