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Determinants of Chronic Inflammatory Skin Disease Trajectories

Determinants of Chronic Inflammatory Skin Disease Trajectories

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05928169
Enrollment
1000
Registered
2023-07-03
Start date
2023-05-01
Completion date
2032-12-31
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia Areata, Atopic Dermatitis, Cutaneous Lupus, Hidradenitis Suppurativa, Lichen Planus, Prurigo Nodularis, Psoriasis, Rosacea

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

DRUGTopical and systemic drugs

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

University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 80 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Physician-assessed global disease activityBaseline, week 2, week 4, every 3 months up to 2 yearsChange in Investigator Global Assessment (IGA, 0-5)
Patient-reported global disease activityBaseline, week 2, week 4, every 3 months up to 2 yearsChange in Patient Global Assessment (IGA, 0-5)

Secondary

MeasureTime frameDescription
Molecular featuresBaseline, week 2, week 4, every 3 months up to 2 yearsMolecular and histopathological profiles in lesional skin and blood compared across diseases, over time and in response to therapy

Countries

Germany

Contacts

CONTACTStephan Weidinger, MD
sweidinger@dermatology.uni-kiel.de0049431500
CONTACTStefanie Sievers
ssievers@dermatology.uni-kiel.de0049431500
STUDY_DIRECTORSascha Gerdes, MD

University Hospital Schleswig-Holstein

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026