NCT03358693 Molecular Signatures in Inflammatory Skin Disease
| NCT ID | NCT03358693 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Prof. Dr. Stephan Weidinger |
| Condition | Atopic Dermatitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2017-01-20 |
| Primary Completion | 2028-12-31 |
Trial Parameters
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Brief Summary
This pilot project intends to examine the utility of a systems medicine approach to identify regulatory networks and their perturbation in psoriasis and atopic dermatitis, and to obtain a comprehensive perspective on disease and disease control by integrating and modelling data across multiple cellular levels and time following specific blockade of single pathophysiological factors through use of licensed biologics during routine care as systems biology challenge. To this end, ultra-deep phenotyping and prospective molecular characterization in short time-intervals and different disease equilibrium states will be carried out in targeted small sets of patients. The different layers and types of clinical and molecular information will then be integrated (integrative personal omics profiling iPOP) for generating insights into disease pathways and for extraction of molecular signatures that correspond to clinical severity scores. It will provide a good starting point for planning future trials aimed at identifying biological patterns useful for guiding targeted treatment.
Eligibility Criteria
Inclusion Criteria: * Ability to provide written informed consent and comply with the protocol * Dermatologist-diagnosed chronic inflammatory skin disease * Subject receives systemic therapy within routine care (in-label use of biologics) Exclusion Criteria: * Subject is unable to provide written informed consent or comply with the protocol. * Having used immunosuppressive/immunomodulating therapy or phototherapy within 4 weeks before the baseline visit. * Treatment of selected skin areas to be examined with topical corticosteroid or topical calcineurin inhibitor within 1 week before the baseline visit.
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