Determinants of Chronic Inflammatory Skin Disease Trajectories

NCT ID: NCT05928169

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2032-12-31

Brief Summary

Although it is well known that the clinical expression and course of chronic inflammatory skin diseases are highly variable, there are insufficient epidemiological data on this, and the factors that determine the manifestation, clinical features and course are also largely unknown. There are currently no reliable markers that could predict or delineate patient subgroups to support patient management. The aim of this project is to identify clinical and molecular factors that correlate with disease, disease subtypes and progression through in-depth long-term clinical characterization of patients with chronic inflammatory skin diseases and examination of individual biomaterials.

Detailed Description

Chronic inflammatory skin diseases such as atopic dermatitis (AD), psoriasis (Pso) and Hidradenitis suppurativa (HS) are very heterogeneous diseases. Onset, clinical features, disease severity, individual trigger factors and response to therapy vary widely between patients and over time, presenting a clinical challenge for diagnosis, counseling, and individualization of management. With the growing interest in inflammatory skin diseases, the need has been recognized to better investigate their natural course and trajectories, associations with environmental and lifestyle factors, and clinical and molecular features underlying their heterogeneity. Initial pilot studies suggested disease subtypes that differ molecularly and/or clinically; however, molecular profiles in particular are subject to variation over time and not necessarily stable. To confirm and extend such preliminary observations, a larger cohort of patients will be studied with careful longitudinal clinical characterization as well as repeatedly obtained specimens, in order to gain deeper insights into disease dynamics. In particular, we will search for clinical and molecular factors that correlate with disease progression and subtypes, and investigate variability in the regulation of molecular mechanisms over time and at resolution and flare-ups.

Conditions

Atopic Dermatitis; Psoriasis; Lichen Planus; Alopecia Areata; Hidradenitis Suppurativa; Prurigo Nodularis; Cutaneous Lupus; Rosacea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Topical and systemic drugs

Recruitment and follow-up will be independent on the type of treatment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• dermatologist-diagnosed inflammatory skin disease
• informed consent

Exclusion Criteria

• subject and/or the legal guardians are not able to give written informed consent
• pregnant and breastfeeding women
• concurrent participation in a clinical trial
• use of systemic immunosuppressive therapy or phototherapy during the last 4 weeks or receipt of biologics therapy (e.g. dupilumab, tralokinumab) within the last 3 months
• treatment of the target skin areas with topical corticosteroids, calcineurin inhibitors or emollients 24 hours before sample collection

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Stephan Weidinger

Prof. Dr. Stephan Weidinger

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sascha Gerdes, MD

Role: STUDY_DIRECTOR

University Hospital Schleswig-Holstein

Locations

Department of Dermatology and Allergy, University Hospital Schleswig-Holstein

Kiel, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Stephan Weidinger, MD

Role: CONTACT

sweidinger@dermatology.uni-kiel.de

0049431500 ext. 21101

Stefanie Sievers

Role: CONTACT

ssievers@dermatology.uni-kiel.de

0049431500 ext. 21102

Facility Contacts

Stefanie Sievers

Role: primary

ssievers@dermatology.uni-kiel.de

0049431500 ext. 21102

Jacline Wendler

Role: backup

jwendler@dermatology.uni-kiel.de

0049431500 ext. 21101

Other Identifiers

D452/23

Identifier Type: -

Identifier Source: org_study_id