European Network on Assessment of Severity and Burden of Pruritus (PruNet) - Validation study of pruritus assessment tools

Transcription

1 Trial Description Title European Network on Assessment of Severity and Burden of Pruritus (PruNet) - Validation study of pruritus assessment tools Trial Acronym PruNet URL of the trial [---]* Brief Summary in Lay Language The detection of chronic itching is still in its infancy. Itching is a subjective symptom and can currently only be detected based on patient reports. As a result, patient information can not be compared, nor can progress be reliably evaluated. In, measuring instruments currently used to measure the intensity of itch (visual analog scale [VAS], numerical rating scale [NRS], verbal rating scale [VRS]) have already been validated. These instruments are also used in Europe, yet they are only validated in Poland. In skin diseases, the itching symptom is often found to be part of the disease complex. In the clinical routine, the progression of the disease is mainly assessed by dermatologists in terms of healing of the skin lesions. The progression of itching is frequently neglected. From the patient s perspective is this symptom the very factor that affects quality of life and sleep the most. Therefore, from the patient s perspective, is the recording of itch progression of as much importance as the treatment of the skin disease itself. Bringing more attention to the progression of itch during routine dermatologic treatment can be reached through validation and establishment of current instruments used to record pruritus in European centers. The aim is validation of selected itching measuring instruments in the English, Polish, French, German, Italian, Spanish and Turkish languages and their storage on an online database. Brief Summary in Scientific Language The detection of chronic pruritus is still in its infancy. Pruritus is a subjective symptom and can currently only be detected based on patient information. As a result, neither information between patients, the course will be compared yet be reliably assessed. In, currently used instruments for measuring the intensitya of itch (visual analogue scale-vas, numerical rating scale-nrs, verbal rating scale VRS) already validated in a first project as a paper version. In Europe, the instruments are also used, but they are validated only in Poland. In case of skin diseases, there is very often a symptom of pruritus as part of the disease complex. So eczema, urticaria, prurigo, mastocytosis occurs mandatory on with pruritus; in psoriasis, contact dermatitis, lichen planus, and other a large part (90%) of the patients are affected. In routine clinical course of the disease by dermatologists is mainly assessed in terms of healing of the skin lesions. The Page 1 of

2 history of pruritus is frequently neglected. However, from the patient's perspective, the symptom is the factor that affects the quality of life and sleep the most. Therefore, from the patient's perspective is the recording of the course of pruritus and treatment orientation of importance to it as well as the treatment of skin disease in itself. About a validation and establishment of common instruments for measuring itch in European centers, the target is to be achieved, greater attention in the routine dermatological treatment on the course of pruritus. The aim is to validate selected pruritus measuring instruments (three intensity scales: visual analogue scale-vas, numerical rating scale-nrs, verbal rating scale (VRS two questions) and the detection of the quality of life by means of for pruritus developed instrument ItchyQol (22 questions) in English, Polish, French, German, Italian, Spanish and Turkish and leave this pruritus measuring instruments on an online database. In an amendment more languages and countries have been added (Russia, Austria, Switzerland, Finnland) and the number of participants increased (November 2015). Organizational Data Investigator Sponsored/Initiated Trial (IST/IIT): yes Ethics Approval/Approval of the Ethics Committee: Approved (leading) Ethics Committee Nr.: f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster Secondary IDs Health condition or Problem studied ICD10: L Pruritus, unspecified Interventions/Observational Groups Arm 1: The validation of the measuring instruments is still the same at the trial centers. It is planned that each trial center recruites patients with itchy skin conditions. The following diagnostics should be included: atopic dermatitis, contact dermatitis, psoriasis, lichen planus, prurigo nodularis, cutaneous T-cell lymphoma (mycosis fungoides / Sezary syndrome) each with a intensity of itch of at least 3 on the numeric rating scale (0-10). Data acquisition is primarily computer-based (Tablet PC, ipad) carried out. A medical graduate student from Münster (trained on the ipad and acquisition systems) will travel to each clinical site and supervise the study in collaboration with the Page 2 of

3 local doctors. First, the patients are informed by the graduate student or team of doctors at each trial center in the research project in oral and written form. The student will enter the center number, date of birth and age of the patients at inclusion in the study, the patient's sex, date of examination and the Prob. number on the ipad. Thereafter, the student collects the duration of itchy skin disease and examines the inclusion criteria. After that the patient has to answer the questionnaires on the ipad (intensitiy scales of itch (VAS, NRS and VRS; 6 questions), Itchyqol (22 questions), DLQI (10 questions), pruritus questionnaire (part of the AGP; 6 questions)). In addition, the patient's assessment of questionnaires and their handling on the ipad based on a feasibility questionaire. Then, after at least 30 minutes the patient should re-answer the questionnaires on the ipad (Pruritusintensitätsskalen (VAS, NRS and VRS; 6 questions), Itchyqol (22 questions)). Characteristics Study Type: Non-interventional Study Type Non-Interventional: Observational study Allocation: Single arm study Blinding: [---]* Who is blinded: [---]* Control: Uncontrolled/Single arm Purpose: Other Assignment: Single (group) Phase: N/A Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A Primary Outcome Validation of intensity scales for itch (VAS, NRS and VRS) in English, Polish, French, German, Italian, Spanish and Turkish and leave this pruritus measuring instruments on an online database Secondary Outcome Validation of a questionnaire to assess quality of life in patients with itch (ItchyQol; 22 questions) in English, Polish, French, German, Italian, Spanish and Turkish and leave this pruritus measuring instrument on an online database. Countries of recruitment PL Poland CH Switzerland ES Spain Page 3 of

4 FR France AT Austria TR Turkey IT Italy RU Russian Federation DE Locations of Recruitment Medical Center Department of Dermatology, Venereology and Allergology, Wroclaw; Polen Medical Center Kantonsspital Arau, Aarau; Schweiz University Medical Center Policlinico Universitario Agostino Gemelli, Lazio; Italien Medical Center Service de dermatologie, hospital Morvan, Brest, Frankreich University Medical Center Department of Dermatology, Faculty od Medicine Adnan Menderes Universitiy, Aydin, Türkei University Medical Center Universitätsklinik für Dermatologie und Venerologie Graz Auenbruggerplatz Graz, Österreich, Graz University Medical Center Cautaneous Allergy Unit, Department of Deramtology, Hospital Sant Pau, Universitat Autonoma Barcelona, Barcelona, Spanien University Medical Center Krgiganovskogo St , Moscow Russia, Moskau Medical Center UKM, KCP, Münster Recruitment Planned/Actual: Actual (Anticipated or Actual) Date of First Enrollment: 2015/08/03 Target Sample Size: 600 Monocenter/Multicenter trial: Multicenter trial National/International: International Inclusion Criteria Gender: Both, male and female Minimum Age: 18 Years Maximum Age: no maximum age Additional Inclusion Criteria Inclusion criteria: Page 4 of

5 The patient must be 18 years old. The patient must suffer pruritus with an emphasis on the NRS 3 There must be one of the following skin conditions: atopic dermatitis Contact dermatitis nodular prurigo psoriasis vulgaris Lichen Planus Mycosis fungoides / Sezary syndrome Exclusion criteria lack of understanding of the language; Reading disabilities / visual impairment, under 18 years Addresses Primary Sponsor Klinik für Hautkrankheiten und Kompentenzzentrum Chronischer Pruritus Ms. Prof. Sonja Ständer Telephone: Fax: sonja.staender at ukmuenster.de Contact for Scientific Queries Klinik für Hautkrankheiten und Kompentenzzentrum Chronischer Pruritus Ms. Prof. Sonja Ständer Telephone: Fax: sonja.staender at ukmuenster.de Contact for Public Queries Klinik für Hautkrankheiten und Kompetenzzentrum Chronischer Pruritus Ms. Emily Rose Burnett Page 5 of

6 Contact for Public Queries Klinik für Hautkrankheiten und Kompetenzzentrum Chronischer Pruritus Ms. Emily Rose Burnett Telephone: Fax: juckreizambulanz at ukmuenster.de Sources of Monetary or Material Support Public funding institutions financed by tax money/government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.) EADV - European Academy of Dermatology and VenereologySuccursale belge Ave General de Gaulle Brussels Belgium Telephone: Fax: office at eadv.org URL: Institutional budget, no external funding (budget of sponsor/pi) Klinik für Hautkrankheiten und Kompentenzzentrum Chronischer Pruritus Ms. Prof. Sonja Ständer Telephone: Fax: sonja.staender at ukmuenster.de Status Recruitment Status: Recruiting ongoing Study Closing (LPLV): [---]* Page 6 of

7 Trial Publications, Results and other documents Abstract European EADV Network on Assessment of Severity and Burden of Pruritus (PruNet). Presentation on the 8th World Congress of Itch, Nara, Japan, September 2015 Paper Ständer S, Zeidler C, Riepe C, Steinke S, Fritz F, Bruland P, Soto-Rey I, Storck M, Agner T, Augustin M, Blome C, Dalgard F, Evers AWM, Garcovich S, Gonçalo M, Lambert J, Legat FJ, Leslie T, Misery L, Raap U, Reich A, Şavk E, Streit M, Serra-Baldrich E, Szepietowski J, Wallengren J, Weisshaar E, Dugas M. European EADV Network on Assessment of Severity and Burden of Pruritus (PruNet): First Meeting on Outcome Tools. JEADV 2015, in press * This entry means the parameter is not applicable or has not been set. *** This entry means that data is not displayed due to insufficient data privacy clearing. Page of