Determinants of Chronic Inflammatory Skin Disease Trajectories

Psoriasis Clinical Trial

Official title:

Determinants of Chronic Inflammatory Skin Disease Trajectories

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928169
• Other study ID #: D452/23
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: December 31, 2032

Study information

• Verified date: June 2023
• Source: University Hospital Schleswig-Holstein
• Contact: Stephan Weidinger, MD
• Phone: 0049431500
• Email: sweidinger[@]dermatology.uni-kiel.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2032
• Est. primary completion date: April 30, 2032
• Gender: All
• Age group: 0 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Atopic Dermatitis
• Dermatitis
• Eczema
• Lichen
• Psoriasis
• Skin Diseases

Intervention

Drug:
• Topical and systemic drugs
Recruitment and follow-up will be independent on the type of treatment

Locations

Country	Name	City	State
Germany	Department of Dermatology and Allergy, University Hospital Schleswig-Holstein	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician-assessed global disease activity	Change in Investigator Global Assessment (IGA, 0-4)	Baseline, week 2, week 4, every 3 months up to 2 years
Primary	Patient-reported global disease activity	Change in Patient Global Assessment (IGA, 0-4)	Baseline, week 2, week 4, every 3 months up to 2 years