Clinical trial NCT03358693: Molecular Signatures in Inflammatory Skin Disease
Official title: Systematic Profiling of Anti-cytokine Signatures in the Treatment of Chronic Inflammatory Skin Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Psoriasis
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate to severe psoriasis or atopic dermatitis who receive specified biologics from their treating dermatologist during routine care

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.

Detailed description: This is an exploratory study with the aim to identify molecular profiles and signatures in skin and blood that correlate with inflammatory skin disease, disease activity and disease progression, and that are associated with possible disease subtypes/endotypes. Primary target variables are differentially expressed genes (alone or in combination), secondary target variables are genetic, immunological and microbiological signatures. Influencing variables of interest include age of manifestation, disease duration, disease activity/severity, disease progression, comorbidities and therapy/treatment. Obtained biomaterial will be used for molecular profiling including DNA/RNA sequencing, ELISA, mass spectrometry, flow cytometry to identify markers and/or signatures that can correlate with individual disease courses.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with the protocol
* Diagnosis of chronic psoriasis or atopic dermatitis
* PASI score ≥ 10 or EASI score ≥ 16
* Investigator Global Assessment (IGA) ≥ 3
* 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.

Primary outcomes:
measure: Changes of molecular profiles over time
timeFrame: Baseline and week 1, week 2, week 12, week 52
measure: Changes of molecular profiles associated with disease severity/remission
timeFrame: Baseline and week 1, week 2, week 12, week 52
measure: Changes of molecular profiles associated with treatment
timeFrame: Baseline and day 1, day 7, day 14, day 84, day 364
measure: Changes of molecular profiles associated with treatment response
timeFrame: Baseline and week 1, week 2, week 12, week 52
Secondary outcomes:
measure: Change in Eczema Area and Severity Index (EASI) score
timeFrame: Baseline and week 1, week 2, week 12, week 52
measure: Change in Score of Atopic Dermatitis (SCORAD)
timeFrame: Baseline and week 1, week 2, week 12, week 52
measure: Change in Psoriasis Area Severity Index (PASI) score
timeFrame: Baseline and week 1, week 2, week 12, week 52
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Department of Dermatology, University Hospital Schleswig Holstein, Campus Kiel
Study officials:
affiliation: Department of Dermatology, university Hospital Schleswig-Holstein, Campus Kiel
name: Stephan Weidinger, MD
role: PRINCIPAL_INVESTIGATOR
References: