Determinants of Chronic Inflammatory Skin Disease Trajectories

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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis; Rosacea; Atopic Dermatitis; Hidradenitis Suppurativa; Alopecia Areata; Lichen Planus; Prurigo Nodularis; Cutaneous Lupus
• Intervention / Treatment: Drug: Topical and systemic drugs

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.

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

Contacts and Locations

• Study Contact: Name: Stephan Weidinger, MD; Phone Number: 21101 0049431500; Email: sweidinger@dermatology.uni-kiel.de
• Study Contact Backup: Name: Stefanie Sievers; Phone Number: 21102 0049431500; Email: ssievers@dermatology.uni-kiel.de

Study Locations

• Germany
  • Kiel, Germany, 24105
    • Recruiting
    • Department of Dermatology and Allergy, University Hospital Schleswig-Holstein
    • Contact: Stefanie Sievers; Phone Number: 21102 0049431500; Email: ssievers@dermatology.uni-kiel.de
    • Contact: Jacline Wendler; Phone Number: 21101 0049431500; Email: jwendler@dermatology.uni-kiel.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with chronic inflammatory skin disease Healthy control individuals

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician-assessed global disease activity	Change in Investigator Global Assessment (IGA, 0-5)	Baseline, week 2, week 4, every 3 months up to 2 years
Patient-reported global disease activity	Change in Patient Global Assessment (IGA, 0-5)	Baseline, week 2, week 4, every 3 months up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular features	Molecular and histopathological profiles in lesional skin and blood compared across diseases, over time and in response to therapy	Baseline, week 2, week 4, every 3 months up to 2 years

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Investigators: Study Director: Sascha Gerdes, MD, University Hospital Schleswig-Holstein

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): April 30, 2032
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): July 3, 2023

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: Inflammatory Skin Diseases
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Infections; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Hypotrichosis; Hair Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Lichen Planus; Alopecia Areata; Hidradenitis Suppurativa; Hidradenitis; Alopecia; Dermatitis; Skin Diseases; Prurigo; Rosacea
• Other Study ID Numbers: D452/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD can be made available only to individual collaborating researchers in compliance with other researchers in line with national as well as international data protection laws (e.g. GDPR, DSGVO)

Drug and device information, study documents

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