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

Disease Trajectories in Atopic Dermatitis and Psoriasis

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

Study Overview

• Status: Recruiting
• Conditions: Healthy; Psoriasis; Atopic Dermatitis
• Intervention / Treatment: Other: Biosampling for molecular analysis

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, 4, 12 and 52.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Stephan Weidinger, Prof. Dr.; Phone Number: 21110 +49431500; Email: sweidinger@dermatology.uni-kiel.de
• Study Contact Backup: Name: Sascha Gerdes, PD Dr.; Phone Number: 21151 +49431500; Email: sgerdes@dermatology.uni-kiel.de

Study Locations

• Germany
  • Kiel, Germany, 24105
    • Recruiting
    • Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel
    • Contact: Stephan Weidinger, MD
    • Contact: Sascha Gerdes, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Atopic dermatitis; Patients with dermatologist-diagnosed atopic dermatitis, psoriasis or autoimmune skin disease.	Other: Biosampling for molecular analysis; Observational study with no therapeutic intervention. Biosampling for molecular analysis
Controls; Healthy volunteers with no history of atopic, autoimmune or chronic inflammatory disease.	Other: Biosampling for molecular analysis; Observational study with no therapeutic intervention. Biosampling for molecular analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease progression	Epidemiological and phenotypical data of patients	10 years
Molecular signature changes	Molecular signatures will be measured using OMICS and sequencing technologies	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of comorbidities	Assessment of newly developed comorbid diseases over time	10 years

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Investigators: Principal Investigator: Stephan Weidinger, Prof. Dr., Dept. of Dermatology University Hospital Kiel

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2015
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Disease progression; Disease course; Immunological characterization
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases, Papulosquamous; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Psoriasis; Dermatitis, Atopic; Dermatitis; Eczema
• Other Study ID Numbers: A100/12a1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No