Determinants of Chronic Inflammatory Skin Disease Trajectories

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-80
SponsorUniversity Hospital Schleswig-Holstein

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

dermatologist-diagnosed inflammatory skin disease

informed consent

Disqualifiers

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

Trial population

Patients with chronic inflammatory skin disease Healthy control individuals

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Topical and systemic drugs

    Drug

    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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Physician-assessed global disease activity

Change in Investigator Global Assessment (IGA, 0-5)

Time frame
Baseline, week 2, week 4, every 3 months up to 2 years
2

Patient-reported global disease activity

Change in Patient Global Assessment (IGA, 0-5)

Time frame
Baseline, week 2, week 4, every 3 months up to 2 years

Secondary outcomes

1

Molecular features

Molecular and histopathological profiles in lesional skin and blood compared across diseases, over time and in response to therapy

Time frame
Baseline, week 2, week 4, every 3 months up to 2 years

Other outcomes

Sponsors and contacts

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