Clinical trial NCT06120907: Swiss Itch Registry
Official title: Swiss Itch Registry (SWITCHR) - A Prospective Registry to Collect Data of Patients With Chronic Pruritus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pruritus
Keywords: Itch
Chronic pruritus (CP)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited by consecutive ongoing recruitment in the investigators' clinical practice during 10 years.

Brief summary: 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.

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)

Primary outcomes:
measure: Change in Dermatology Life Quality Index (DLQI)
timeFrame: up to 60 months
measure: Change in ItchyQoL questionnaire
timeFrame: up to 60 months
measure: Change in NeuroDerm questionnaire
timeFrame: up to 60 months
measure: Change in Itch Controlled Days (ICD) Questionnaire
timeFrame: up to 60 months
measure: Change in Dynamic Pruritus Score (DPS)
timeFrame: up to 60 months
measure: Change in Regensburg Insomnia Scale (RIS)
timeFrame: up to 60 months
measure: Change in Itch-related patient's drawing
timeFrame: up to 60 months
measure: Change in the Eight-item Patient Health Questionnaire (PHQ-8)
timeFrame: up to 60 months
measure: Change in the Somatic Symptom Scale-8 (SSS-8)
timeFrame: up to 60 months
measure: Change in the Somatic Symptom Disorder - B Criteria Scale (SSD-12)
timeFrame: up to 60 months
measure: Change in the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: up to 60 months
measure: Change in the Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: up to 60 months
measure: Change in the SCORing Atopic Dermatitis (SCORAD)
timeFrame: up to 60 months
measure: Change in the Eczema Area and Severity Index (EASI)
timeFrame: up to 60 months
measure: Change in the Psoriasis Area and Severity Index (PASI)
timeFrame: up to 60 months
measure: Change in the Physician Global Assessment (PGA)
timeFrame: up to 60 months
measure: Change in the Investigator's Global Assessment of Chronic Prurigo (IGA-CPG)
timeFrame: up to 60 months
measure: Change in Quantitative Sensory Testing (QST)
timeFrame: up to 60 months
measure: Change in skin surface by 3DSkin imaging (Vectra®)
timeFrame: up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Dermatology, University Hospital Basel
Study officials:
affiliation: Department of Dermatology, University Hospital Basel
name: Simon Mueller, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: