Clinical trial NCT05928169: Determinants of Chronic Inflammatory Skin Disease Trajectories
Official title: Determinants of Chronic Inflammatory Skin Disease Trajectories
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Psoriasis
Eczema
Lichen
Alopecia Areata
Keywords: Inflammatory Skin Diseases
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic inflammatory skin disease

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physician-assessed global disease activity
timeFrame: Baseline, week 2, week 4, every 3 months up to 2 years
measure: Patient-reported global disease activity
timeFrame: Baseline, week 2, week 4, every 3 months up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Department of Dermatology and Allergy, University Hospital Schleswig-Holstein
Study officials:
affiliation: University Hospital Schleswig-Holstein
name: Sascha Gerdes, MD
role: STUDY_DIRECTOR
References: