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Swiss Itch Registry

NCT ID: NCT06120907

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-18

Study Completion Date

2033-10-31

Brief Summary

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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

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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.

Conditions

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Pruritus

Keywords

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Itch Chronic pruritus (CP)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Data collection

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon Mueller, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, University Hospital Basel

Locations

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Department of Dermatology, University Hospital Basel

Basel, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Simon Mueller, PD Dr. med.

Role: CONTACT

Phone: +41 61 328 69 64

Email: [email protected]

Facility Contacts

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Simon Mueller, PD Dr. med.

Role: primary

Other Identifiers

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2023-00310; th21Mueller

Identifier Type: -

Identifier Source: org_study_id