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Identification and characterization of pruritus pathways in chronic skin inflammation: microbes as exogenous drivers of itch

Identification and characterization of pruritus pathways in chronic skin inflammation: microbes as exogenous drivers of itch

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025171
Enrollment
60
Registered
2023-07-13
Start date
2023-07-24
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

L20

Interventions

Group 1: arm 1: patients with chronic-inflammatory skin diseases with chronic pruritus. The main goal of the proposed project is to thoroughly characterize known (IL-31/IL-31RA) and identify novel it
B, anti-IL-4RA/duppilumab
C, JAK1/2 inhibition/baricitinib). AD patients (n=15/intervention) will be clinically characterized, undergo optimized electrical stimulation protocols, and have skin surface biopsies (cyanoacrylate a
the day after the start of the intervention (d1), one week (d7), and one month (d30). A matched cohort of healthy volunteers

Sponsors

Universitätsklinik für Dermatologie und Allergologie, Klinikum Oldenburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with chronic pruritus (due to lichen planus, psoriasis and atopic dermatitis); minimum age 18 years

Exclusion criteria

Exclusion criteria: Patients who cannot complete the questionnaires due to physical or psychiatric diseases or an insufficient understanding of the German language. Patients taking antipruritic drugs. Patients with an infection at the potential biopsy area. Patients who received anti-inflammatory therapy within the last two weeks and pregnant or breast-feeding women are excluded from the study.

Design outcomes

Primary

MeasureTime frame
Microbiome characterization of skin at each time point of intervention (d0, 1, 7, 30); expression profiles of pruritic mediators (immunohistochemical and immunofluorescence staining, ELISA, Western blots, Luminex). Gene expression profiles (qPCR, RNA sequencing), Patient questionnaires (d0, 1, 7, 30): NeuroDerm questionnaire, 5PLQ, SF12, Beck Depression Inventory (BDI), STAI-T (State-Trait Anxiety Inventory), SCQ (Self-Administered Comorbidity Questionnaire), BPI (Brief Pain Inventory), Pain Catastrophizing Scale, NPSI (Neuropathich pain symptom inventory).

Secondary

MeasureTime frame
Findings of this study will increase our understanding of molecular and cellular pathways inducing pruritus with an emphasis on understanding the role of IL-31RA signaling, will define and validate biomarkers for chronic pruritus and potentially identify disease-specific biomarkers, will characterize known therapeutic targets for the treatment of chronic pruritus and identify future therapeutic perspectives and will unravel the role of microbes as exogenous triggers of itch.

Countries

Germany

Contacts

Public ContactMaren Limberg

Universitätsklinik für Dermatologie und Allergologie, Klinikum Oldenburg

maren.limberg@uni-oldenburg.de+ 49 441/403-2851

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026