Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00010255

Trial Description

start of 1:1-Block title

Title

Development of a questionnaire for the assessment of Itch-Free-Days

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

SST-Pr-10-2007

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Many patients with longstanding itch (Latin: Pruritus) report a heavy fluctuation of symptoms and different factors that influence the symptom. There are daily fluctuations during which pruritus is slightly, or not at all, present (so-called itch-free days- Itch-Free Day). The goal of this study is to develop and validate a measuring instrument in the form of a questionnaire that collects data on itch-free days. The development will take place in several steps (interviews, definition of the terms ‘itch-free’ and ‘itch-poor’, questionnaire development, questionnaire validation). For this purpose, it is necessary to achieve a change in the severity of the pruritus through therapy so that a change of course can be measured. In the context of an outpatient presentation, we intend for patients to complete questionnaires about their itch-free days, as well as life quality and pruritus intensity. In the last step (validation), the questionnaires are to be filled out once more after an hour and following a two-week topical therapy with moisturizing, itch-relieving cream.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

To measure the clinical, pruritus-specific parameters, some new, but still inadequately sensitive, instruments are already available that determine the different dimensions of pruritus. The currently used intensity scales assess only a single point value for a defined period, but no fluctuations or periods in which the pruritus has completely abated. With the development and validation of the Itch-Free Days (IFD) questionnaire, pruritus will be better representable in the course of routine and studies. Patients with chronic pruritus answer, in open and structured interviews, questions on the definition of an itch-free day. After an hour and interval of two weeks with a topical basis therapy, they complete the IFD and life quality questionnaire, as well as questions on pruritus intensity (such as VAS, NRS, VRS), HADS, ItchyQol, DLQI, and feasibility, and a questionnaire for assessing the condition of the skin.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00010255
  •   2016/04/11
  •   [---]*
  •   yes
  •   Approved
  •   2007-413-f-S, Amendment 8, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   L28.1 -  Prurigo nodularis
  •   L29.8 -  Other pruritus
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients with chronic pruritus (n=90) will be asked to describe an itch-free day in an open interview.
  •   Patients with chronic pruritus (n=60) receive a questionnaire about the definition of an itch-free day and a pilot questionnaire.
  •   Patients with chronic pruritus (n=60) will, after an interval of two weeks, fill out the IFD questionnaire and life quality questionnaire, as well as questions about pruritus intensity (such as VAS, NRS, VRS), HADS, ItchyQol, DLQI and feasibility, and a questionnaire for assessing the condition of the skin. Patients received a topical emollient therapy over the two weeks.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Validation of the IFD (Itch free days) questionnaire

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Determination of a score for itch free days

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/01/17
  •   210
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Pruritus intensity of at least NRS 3 (numeric rating scale 0-10)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Pregnancy, breast feeding, Drug consumption, prescription drug abuse, Topical application of steroids, calcineurin inhibitors within the past week, Cutaneous infections, systemic therapy unchanged

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Kompetenzzentrum chronischer Pruritus (KCP) und Klinik für Hautkrankheiten Universitätsklinikum Münster
    • Ms.  Prof. Dr.  Sonja  Ständer 
    • Von-Esmarch-Str. 58
    • 48149  Münster
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik für Hautkrankheiten und Kompetenzzentrum Chronischer Pruritus
    • Ms.  Emil Rose  Burnett 
    • Von-Esmarch-Straße 58
    • 48149  Münster
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Hautkrankheiten und Kompetenzzentrum Chronischer Pruritus
    • Ms.  Emil Rose  Burnett 
    • Von-Esmarch-Straße 58
    • 48149  Münster
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Kompetenzzentrum chronischer Pruritus (KCP) und Klinik für Hautkrankheiten Universitätsklinikum Münster
    • Ms.  Prof. Dr.  Sonja  Ständer 
    • Von-Esmarch-Str. 58
    • 48149  Münster
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2016/03/15
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.