Alopecia Areata, Atopic Dermatitis, Cutaneous Lupus, Hidradenitis Suppurativa, Lichen Planus, Prurigo Nodularis, Psoriasis, Rosacea
Conditions
Keywords
Inflammatory Skin Diseases, Atopic Dermatitis, Psoriasis, Lupus erythematosus, Hidradenitis suppurativa, Vitiligo, Lichen planus, Prurigo nodularis
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), psoriasis (Pso), Hidradenitis suppurativa (HS), cutaneous Lupus erythematosus (LE), Lichen planus (Lp) and Vitiligo (V) are very heterogeneous diseases. Onset, clinical features, disease severity, individual trigger factors and response to therapy vary widely between patients and over time, presenting a clinical challenge for diagnosis, counseling, and individualization of management. With the growing interest in inflammatory skin diseases, the need has been recognized to better investigate their natural course and trajectories, associations with environmental and lifestyle factors, and clinical and molecular features underlying their heterogeneity. Initial 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 stable. 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.
Interventions
Observational study, treatment decisions are made independently as part of routine clinical care. Recruitment and follow-up will be independent on the type of treatment
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physician-assessed global disease activity | Baseline, week 2, week 4, every 3 months up to 2 years | Change in Investigator Global Assessment (IGA, 0-5) |
| Patient-reported global disease activity | Baseline, week 2, week 4, every 3 months up to 2 years | Change in Patient Global Assessment (IGA, 0-5) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Molecular features | Baseline, week 2, week 4, every 3 months up to 2 years | Molecular and histopathological profiles in lesional skin and blood compared across diseases, over time and in response to therapy |
Countries
Germany
Contacts
University Hospital Schleswig-Holstein