Swiss Itch Registry (SWITCHR)

December 12, 2024 updated by: University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4055
        • Recruiting
        • Department of Dermatology, University Hospital Basel
        • Contact:
        • Principal Investigator:
          • Simon Mueller, PD Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients will be recruited by consecutive ongoing recruitment in the investigators' clinical practice during 10 years.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Dermatology Life Quality Index (DLQI)
Time Frame: up to 60 months
The Dermatology Life Quality Index (DLQI) consists of 10 questions concerning patient's perception of the impact of skin diseases on different aspects of their health-related QoL over the last week. The DLQI evaluates the impact of the patient's skin disease on daily activities, leisure, work and personal relationships. DLQI score 0-1 = no effect at all on patient's life DLQI score of 2-5 = small effect on patient's life, DLQI score of 6-10 = moderate effect on patient's life, DLQI score of 11-20 = very large effect on patient's life, DLQI score of 21-30 = extremely large effect on patient's life.
up to 60 months
Change in ItchyQoL questionnaire
Time Frame: up to 60 months
The ItchyQoL is a questionnaire to measure the quality of life in CP patients. It is composed of 22 items regarding symptoms, functions, emotions and self-perception. Each of the questions is scored 1-5 (1:never; 2: rarely; 3: sometimes; 4: often; 5: all of the time) withthe sum forming the raw ItchyQol score with a range of 22-110.
up to 60 months
Change in NeuroDerm questionnaire
Time Frame: up to 60 months
This questionnaire comprises questions and descriptions deemed to be clinically relevant for chronic pruritus: It consists of a general part and special modules such as beginning and course, topographical distribution, influencing factors, intensity, quality of CP.
up to 60 months
Change in Itch Controlled Days (ICD) Questionnaire
Time Frame: up to 60 months
This questionnaire consists of eight items addressing itch intensity, scratching behaviour, itch-related sleep disturbance and temporal aspects of feeling itchy.
up to 60 months
Change in Dynamic Pruritus Score (DPS)
Time Frame: up to 60 months
This score compares the reduction in the current level of pruritus with a defined point earlier in time. It is comprised of a horizontal line measuring itch improvement via 11 marks on a scale, each labelled with both a numerical and verbal description.
up to 60 months
Change in Regensburg Insomnia Scale (RIS)
Time Frame: up to 60 months
This 10-item rating scale is designed for the assessment of psychophysiological insomnia and is composed of 10 different sections addressing latency, duration, continuity, depth of sleep, experience of sleepless nights, sleep-related thoughts or fear, and use of sleep medication. Total scores range from 0 to 40 points with higher scores indicative of more cognitive, behavioural, and emotional difficulties consistent with psychophysiological insomnia. Scores from 0-12 are considered normal and scores above the cutoff (13+) are indicative of symptoms consistant with psychophysiological insomnia that warrant further investigation.
up to 60 months
Change in Itch-related patient's drawing
Time Frame: up to 60 months
Patients (on a voluntary basis) draw their itch-related perception, emotions, concerns, wishes and desires in a 10- minutes sketch. Drawings of CP patients usually contain additional diagnostic information not captured in usual history taking and might also be helpful to discuss treatment strategies in an "imaged-based" manner.
up to 60 months
Change in the Eight-item Patient Health Questionnaire (PHQ-8)
Time Frame: up to 60 months
The Eight-item Patient Health Questionnaire (PHQ-8) is a tool for the screening of depression (presence and severity). PHQ-8 questions refer to the last two weeks, addressing the level of interest in doing things, feeling down or depressed, difficulty with sleeping, energy levels, eating habits, self-perception, ability to concentrate, speed of functioning and thoughts of suicide. The score range is 0 to 27 (0-4 = none- minimal, 5-9 = mild, 10-14 = moderate, 15-19 = moderate severe, 20-27 = severe)
up to 60 months
Change in the Somatic Symptom Scale-8 (SSS-8)
Time Frame: up to 60 months
The Somatic Symptom Scale-8 (SSS-8) is a brief version of the Patient Health Questionnaire-15 (PHQ-15) used to assess somatic symptom burden during the last two weeks. It measures the perceived burden of common somatic symptoms. (Score 0-3 = Severity: No to minimal. Score: 16 - 32 = Severity: Very high)
up to 60 months
Change in the Somatic Symptom Disorder - B Criteria Scale (SSD-12)
Time Frame: up to 60 months
The Somatic Symptom Disorder - B Criteria Scale (SSD-12) is a brief self-report questionnaire used to assess the patient's perception of symptom-related thoughts, feelings, and behaviors during the last 30 days. The SSD-12 consists of 12 questions and measures three psychological sub-criteria (cognitive, affective, and behavioral) with scores between 0 and 4 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = very often)
up to 60 months
Change in the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time Frame: up to 60 months
The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) consists of 12 questions, covers 6 domains of functioning (cognition, mobility, self-care, getting along, life activities, participation) and asks about difficulties during the last 30 days due to diseases or other health problems. The scores assigned to each of the items-"none" (1), "mild" (2), "moderate" (3), "severe" (4), and "extreme" (5)-are summed.
up to 60 months
Change in the Generalized Anxiety Disorder 7 (GAD-7)
Time Frame: up to 60 months
The Generalized Anxiety Disorder 7 (GAD-7) is a self- reported questionnaire for screening and assessment of the severity of generalized anxiety disorder (GAD). It consists of 7 questions including nervousness, inability to stop worrying, excessive worry, restlessness, difficulty in relaxing, easy irritation and fear of something awful happening. Each item is rated from 0-15+ ((0-4 = No to Low risk, 5-9 = mild, 10-14 = moderate, 15+ = severe)
up to 60 months
Change in the SCORing Atopic Dermatitis (SCORAD)
Time Frame: up to 60 months
SCORing Atopic Dermatitis (SCORAD) is a clinical tool for assessing the extent (A: according to the rule of nines; 20% of the score), the intensity composed of six items (B: erythema, oedema/papules, effect of scratching, oozing/crust formation, lichenification and dryness; 60% of the score; each item has four grades: 0, 1, 2, 3) and subjective symptoms (C: itch, sleeplessness; 20% of the score) which are rated on a 0-10 VAS.
up to 60 months
Change in the Eczema Area and Severity Index (EASI)
Time Frame: up to 60 months
The Eczema Area and Severity Index (EASI) is a tool used to measure the extent (area) and severity of atopic eczema. Inflamed areas of four body regions (head and neck, trunk, upper limbs and lower limbs) are assessed. The area score ranging from 0-6 is the percentage of skin affected by eczema for each body region (0 = no active eczema in this region, 1= 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, 6 = 90-100%: the entire region is affected by eczema).
up to 60 months
Change in the Psoriasis Area and Severity Index (PASI)
Time Frame: up to 60 months
The Psoriasis Area and Severity Index (PASI) is a composite variable used to assess the severity of Psoriasis. The PASI evaluates the area of psoriatic involvement in 4 main areas (head, trunk, upper and lower extremities) and the severity of the psoriatic lesions with respect to three target symptoms: erythema, infiltration and desquamation, each to be rated on a scale from 0-4.
up to 60 months
Change in the Physician Global Assessment (PGA)
Time Frame: up to 60 months
The Physician Global Assessment (PGA) relies on clinical assessment of the patient's skin presentation. The investigator (or qualified site personnel) scores the erythema, pustules, and scaling of all lesions on a scale from 0 to 4. Each component is graded separately, the average is calculated, and the final PGA is determined based on this composite score. A lower score indicates a lower severity, with 0 being clear and 1 being almost clear.
up to 60 months
Change in the Investigator's Global Assessment of Chronic Prurigo (IGA-CPG)
Time Frame: up to 60 months
The Investigator's Global Assessment of Chronic Prurigo is designed to categorize the stage and activity of chronic prurigo and prurigo nodularis on scores from 0-4 each.
up to 60 months
Change in Quantitative Sensory Testing (QST)
Time Frame: up to 60 months
QST measures the detection threshold of accurately calibrated sensory stimuli (i.e. touch, vibration, thermosensation, pain). It quantifies individual sensory perceptions using direct patient feedback. Subject values are compared to normal data to determine whether the subject has a deficit in any modality.
up to 60 months
Change in skin surface by 3DSkin imaging (Vectra®)
Time Frame: up to 60 months
The Vectra whole-body scanner is a high-definition 3D-visual documentation creating a 3D avatar, capturing nearly the entire skin surface. It monitors itch-related primary and secondary skin lesions, scratching patterns and treatment responses.
up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Simon Mueller, PD Dr. med., Department of Dermatology, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 18, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2033

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-00310; th21Mueller

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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