Swiss Itch Registry

Pruritus Clinical Trial

— SWITCHR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120907
• Other study ID #: 2023-00310; th21Mueller
• Status: Recruiting
• Start date: October 18, 2023
• Est. completion date: October 2033

Study information

• Verified date: November 2023
• Source: University Hospital, Basel, Switzerland
• Contact: Simon Mueller, PD Dr. med.
• Phone: +41 61 328 69 64
• Email: simon.mueller[@]usb.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 2033
• Est. primary completion date: October 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pruritus

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of Dermatology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Dermatology Life Quality Index (DLQI)	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
Primary	Change in ItchyQoL questionnaire	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
Primary	Change in NeuroDerm questionnaire	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
Primary	Change in Itch Controlled Days (ICD) Questionnaire	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
Primary	Change in Dynamic Pruritus Score (DPS)	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
Primary	Change in Regensburg Insomnia Scale (RIS)	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
Primary	Change in Itch-related patient's drawing	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
Primary	Change in the Eight-item Patient Health Questionnaire (PHQ-8)	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
Primary	Change in the Somatic Symptom Scale-8 (SSS-8)	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
Primary	Change in the Somatic Symptom Disorder - B Criteria Scale (SSD-12)	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
Primary	Change in the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)	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
Primary	Change in the Generalized Anxiety Disorder 7 (GAD-7)	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
Primary	Change in the SCORing Atopic Dermatitis (SCORAD)	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
Primary	Change in the Eczema Area and Severity Index (EASI)	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
Primary	Change in the Psoriasis Area and Severity Index (PASI)	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
Primary	Change in the Physician Global Assessment (PGA)	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
Primary	Change in the Investigator's Global Assessment of Chronic Prurigo (IGA-CPG)	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
Primary	Change in Quantitative Sensory Testing (QST)	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
Primary	Change in skin surface by 3DSkin imaging (Vectra®)	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