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Determination of the minimal clinical important difference (MCID) and its correlation with objective criteria of neuroanatomy in patients with chronic pruritus and dry skin under topical dermatotherapy - Subproject: Identification of relevant genes for neuroanatomy in the skin

Determination of the minimal clinical important difference (MCID) and its correlation with objective criteria of neuroanatomy in patients with chronic pruritus and dry skin under topical dermatotherapy - Subproject: Identification of relevant genes for neuroanatomy in the skin

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00022426
Enrollment
120
Registered
2020-07-10
Start date
2020-07-22
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

L29.9 L28.1

Interventions

Group 1: The minimal clinical important difference (MCID) in patients with chronic pruritus and dry skin under a topical dermatotherapy, i.e. with emoillents is not known. Detection of the MCID requi
Another third is prepared for later RNA analysis of relevant genes (such as nerve growth factor, Semaphorin3A, Artemin) with importance for neuroanatomy using qPCR
primary keratinocytes and fibroblasts are to be isolated from the remaining half. The isolated cells are used to generate two-dimensional co-cultures as well as three-dimensional skin models for in-vi

Sponsors

Klinik für Hautkrankheiten und Kompentenzzentrum Chronischer Pruritus
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with -Age =18 - clinically visible dry skin on the arm, among other things, chronic pruritus (> 6 weeks duration) on the arm, among other things - a pruritus intensity NRS bad tester 24h =3 - one of the three diagnoses mentioned: 1) Pruritus patients with chronic scratch lesions (prurigo nodularis) (L28.1) 2) Patients with pruritus on inflammatory skin (e.g. atopic dermatitis) (L 20.9) 3) Patients with pruritus on unchanged skin (L 29.9)

Exclusion criteria

Exclusion criteria: Acute exacerbation of dermatosis, cutaneous infections -Pregnancy or breastfeeding - History of drug use, alcohol addiction, drug abuse Allergy to local anesthetics, -tendency to keloids

Design outcomes

Primary

MeasureTime frame
Determination of the “Minimal Clinically Important Change (MCID)” using the anchor questionnaire and the intensity scales

Secondary

MeasureTime frame
Correlation of MCID with alloknesis and pruritus threshold and skin nerve anatomy Development of two- and three-dimensional cell cultures to investigate the causal meaning of selected candidate genes for neuroanatomy.

Countries

Germany

Contacts

Public ContactClaudia Zeidler

Universitätsklinikm MünsterKompetenzzentrum Chronischer Pruritus und Klinik für Hautkrankheiten

claudia.zeidler@ukmuenster.de0251-8351004

Outcome results

None listed

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