Determinants of Chronic Inflammatory Skin Disease Trajectories

Last updated: December 3, 2024
Sponsor: University Hospital Schleswig-Holstein
Overall Status: Active - Recruiting

Phase

N/A

Condition

Warts

Hives (Urticaria)

Rash

Treatment

Topical and systemic drugs

Clinical Study ID

NCT05928169
D452/23
  • Ages < 99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • dermatologist-diagnosed inflammatory skin disease

  • informed consent

Exclusion

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 orreceipt of biologics therapy (e.g. dupilumab, tralokinumab) within the last 3 months

  • treatment of the target skin areas with topical corticosteroids, calcineurininhibitors or emollients 24 hours before sample collection

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Topical and systemic drugs
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
December 31, 2032

Study Description

Chronic inflammatory skin diseases such as atopic dermatitis (AD) and psoriasis (Pso) are exceptionally heterogeneous diseases. Clinical manifestations, disease severity, and individual trigger factors vary widely between patients and over time, presenting a clinical challenge for diagnosis, counseling, and individualization of treatment strategies. With the growing interest in inflammatory skin diseases, the need has been recognized to better investigate their natural history and associations with environmental and lifestyle factors, and to conduct research to identify the clinical and, where appropriate, molecular features underlying heterogeneity. Initial small 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. 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.

Connect with a study center

  • Department of Dermatology and Allergy, University Hospital Schleswig-Holstein

    Kiel, 24105
    Germany

    Active - Recruiting

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