Swiss Itch Registry
ConditionPruritus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial population
Patients will be recruited by consecutive ongoing recruitment in the investigators' clinical practice during 10 years.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Data collection
Other interventionThe data include phenotypic data, treatments administered, response to treatment, Three-dimensional total body images, biopsies and blood plasma.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
up to 60 months2
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.
Time frame
up to 60 months3
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.
Time frame
up to 60 months4
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.
Time frame
up to 60 monthsSponsors and contacts
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Source ClinicalTrials.gov