Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05928169

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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical and systemic drugs

Drug

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

Primary outcomes

  1. Physician-assessed global disease activity

    Time frame: Baseline, week 2, week 4, every 3 months up to 2 years

    Change in Investigator Global Assessment (IGA, 0-5)

  2. Patient-reported global disease activity

    Time frame: Baseline, week 2, week 4, every 3 months up to 2 years

    Change in Patient Global Assessment (IGA, 0-5)

Secondary outcomes

  1. Molecular features

    Time frame: Baseline, week 2, week 4, every 3 months up to 2 years

    Molecular and histopathological profiles in lesional skin and blood compared across diseases, over time and in response to therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Stefanie Sievers

CONTACT

[email protected]

0049431500 ext. 21102

Stephan Weidinger, MD

CONTACT

[email protected]

0049431500 ext. 21101

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Important dates

Study start
2023
Primary completion
2032
Study completion
2032
First posted
Jul 3, 2023
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.