Determinants of Chronic Inflammatory Skin Disease Trajectories

NCT05928169 | Recruiting

• 1 other identifier: D452/23
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Inflammatory Skin Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Molecular features

  Baseline, week 2, week 4, every 3 months up to 2 years

Interventions

Topical and systemic drugs DRUG

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

Eligibility Criteria

• Age: 0 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic inflammatory skin disease Healthy control individuals

You may qualify if:

• dermatologist-diagnosed inflammatory skin disease
• informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

Department of Dermatology and Allergy, University Hospital Schleswig-Holstein

Kiel, 24105, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Skin biopsies, skin tape strips, skin swabs, blood

MeSH Terms

Conditions

Dermatitis, Atopic; Psoriasis; Lichen Planus; Alopecia Areata; Hidradenitis Suppurativa; Rosacea

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; Lichenoid Eruptions; Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Hidradenitis; Sweat Gland Diseases

Study Officials

• Sascha Gerdes, MD

  University Hospital Schleswig-Holstein

  STUDY DIRECTOR

Central Study Contacts

Stephan Weidinger, MD

CONTACT

0049431500; sweidinger@dermatology.uni-kiel.de

Stefanie Sievers

CONTACT

0049431500; ssievers@dermatology.uni-kiel.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Stephan Weidinger

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: July 3, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): April 30, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)