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

NCT03361215 | Recruiting

• 1 other identifier: A100/12a1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Atopic Dermatitis; Psoriasis; Healthy

Keywords

Disease progression; Disease course; Immunological characterization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Development of comorbidities

  10 years

Study Arms (2)

Atopic dermatitis

Patients with dermatologist-diagnosed atopic dermatitis, psoriasis or autoimmune skin disease.

Other: Biosampling for molecular analysis

Controls

Healthy volunteers with no history of atopic, autoimmune or chronic inflammatory disease.

Other: Biosampling for molecular analysis

Interventions

Biosampling for molecular analysis OTHER

Observational study with no therapeutic intervention. Biosampling for molecular analysis

Atopic dermatitis; Controls

Eligibility Criteria

• Age: 0 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel

Kiel, 24105, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, including EDTA, PBMC and serum samples for genetic and gene expression analysis Lesional and nonlesional biopsies (4 mm punch biopsies) for gene expression analysis Skin swabs for microbiome assessments Tape strips for protein analyis Stool samples for microbiome analyses

MeSH Terms

Conditions

Dermatitis, Atopic; Psoriasis; Disease Progression

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephan Weidinger, Prof. Dr.

  Dept. of Dermatology University Hospital Kiel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephan Weidinger, Prof. Dr.

CONTACT

+49431500; sweidinger@dermatology.uni-kiel.de

Sascha Gerdes, PD Dr.

CONTACT

+49431500; sgerdes@dermatology.uni-kiel.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 4, 2017
• Study Start: March 16, 2015
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

DE (1)