Determinants of Chronic Inflammatory Skin Disease Trajectories

Study Overview
=================
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.

Official Title
-----------------
Determinants of Chronic Inflammatory Skin Disease Trajectories

Conditions
-----------------
Lichen, Eczema, Atopic Dermatitis, Psoriasis, Alopecia Areata

Intervention / Treatment
-----------------
* Drug: Topical and systemic drugs


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Topical and systemic drugs|Recruitment and follow-up will be independent on the type of treatment|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammatory Skin Diseases