Determinants of Chronic Inflammatory Skin Disease Trajectories

Sponsor

University Hospital Schleswig-Holstein (Other)

Overall Status

Recruiting

CT.gov ID

NCT05928169

Collaborator

(none)

1,000

Enrollment

Location

116

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis Psoriasis Eczema Lichen Alopecia Areata	Drug: Topical and systemic drugs

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Determinants of Chronic Inflammatory Skin Disease Trajectories

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2032

Anticipated Study Completion Date :

Dec 31, 2032

Outcome Measures

Primary Outcome Measures

Physician-assessed global disease activity [Baseline, week 2, week 4, every 3 months up to 2 years]
Change in Investigator Global Assessment (IGA, 0-4)
Patient-reported global disease activity [Baseline, week 2, week 4, every 3 months up to 2 years]
Change in Patient Global Assessment (IGA, 0-4)

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 99 Years

Sexes Eligible for Study:

All

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