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Recruiting NCT06120907

Swiss Itch Registry

— Observational Pruritus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data collection.
Who it may be relevant to
Registry conditions: Pruritus. Basic parameters: from 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Swiss Itch Registry (SWITCHR) - A Prospective Registry to Collect Data of Patients With Chronic Pruritus

Overview

This project is to develop a national registry for CP patients. Patients admitted to this registry will be examined and documented with PROs, physician-based assessments, blood tests, 3D photodocumentation and, if indicated, by skin biopsies, neurophysiological testing and radiological imaging at defined timepoints. The data collection will allow deepened insights into patient needs, different mechanisms and courses of pruritic conditions, treatment outcomes and treatment-related safety issues. In addition, the collection of clinical, biological and image-based data may be used for retrospective analyses.

Detailed description

Pruritus (synonymous "itch") is the commonest skin-related symptom caused by numerous dermatological and non-dermatological conditions. Chronic pruritus (CP) defined by a duration of \> 6 weeks is associated with significantly impaired quality of life and high socio-economic burden. At present, a data registry to monitor and compare clinical presentation, treatment outcomes and safety issues of these patients is lacking in Switzerland. The implementation of the SWITCHR could help to i.) improve medical care of CP patients, ii.) allow standardised comparison of different pruritic conditions as well as national data with international CP populations and iii.) raise the awareness for CP in general practitioners, health care institutions, national public health authorities and pharmaceutical companies within Switzerland.

Interventions

  • Other Data collection
    The data include phenotypic data, treatments administered, response to treatment, Three-dimensional total body images, biopsies and blood plasma.

Primary outcome measures

  • Change in Dermatology Life Quality Index (DLQI) [Time frame: up to 60 months]
  • Change in ItchyQoL questionnaire [Time frame: up to 60 months]
  • Change in NeuroDerm questionnaire [Time frame: up to 60 months]
  • Change in Itch Controlled Days (ICD) Questionnaire [Time frame: up to 60 months]
  • Change in Dynamic Pruritus Score (DPS) [Time frame: up to 60 months]
  • Change in Regensburg Insomnia Scale (RIS) [Time frame: up to 60 months]
  • Change in Itch-related patient's drawing [Time frame: up to 60 months]
  • Change in the Eight-item Patient Health Questionnaire (PHQ-8) [Time frame: up to 60 months]
  • Change in the Somatic Symptom Scale-8 (SSS-8) [Time frame: up to 60 months]
  • Change in the Somatic Symptom Disorder - B Criteria Scale (SSD-12) [Time frame: up to 60 months]

Eligibility criteria

Inclusion criteria

  • Age ≥ 14 years.
  • Written informed consent of the patient.
  • Diagnosis of CP irrespective of the International Forum for the Study of Itch (IFSI) group (I-III) and/or underlying cause (according to the judgment of the investigator).
  • A Numerical Rating Scale (NRS) score of min. ≥ 4 within the last 7 days.
  • Sufficient language skills (in the languages which the patient information and the consent form is available) to provide informed consent.

Exclusion criteria

  • Any medical or psychological condition in the treating physician's opinion, which may prevent the patient in registry participation
  • Lack of informed consent for registry participation.
  • Refusal to complete Patient Reported Outcomes (PROs)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Department of Dermatology, University Hospital Basel — Basel

Identifiers

NCT: NCT06120907 · 2023-00310; th21Mueller

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗