Trial document




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  DRKS00005383

Trial Description

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Title

Validation of a prurigo activity score

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Trial Acronym

PAS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Using a prurigo activity score we want to access the kind and the activity of chronic scratch lesions. This score should help in clinical trials and in clinical routine to judge the prurigo activity and the therapy outcome. These data will be registered to get statistical data about prurigo lesions. We want to validate our score by comparing results to validated questionnaires.

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Brief Summary in Scientific Language

By using the prurigo activity score we would like to assess the kind and the activity of prurigo lesions. The score defines the type of efflorescences and the activity is measured by the flattening of prurigo nodules and the percentage of crusts on prurigo lesions. These data will be registered for further statistical analysis. The score is designed for clinical trials and clinical routine.

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Organizational Data

  •   DRKS00005383
  •   2013/10/31
  •   [---]*
  •   yes
  •   Approved
  •   2007-413-f-S, Amendment 9 , Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   L28.1 -  Prurigo nodularis
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Interventions/Observational Groups

  •   1) In a clinical examination of the patient we assess the prurigo lesions (using the PAS sheet), we count the lesions and take a photograph of the patient. 2) Everytime the patient represents we repeat the procedure 3) The existing PAS sheet will be improved and feasibility assessed. 4) For validation of the PAS we let the patients fill out other questionnaires (DLQI, HADS).

    No invasive methods are being used.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Validation of the prurigo activity score (PAS) by comparison to other questionnaires (DLQI, HADS)

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Secondary Outcome

Definition of the clinic, dynamics and forms of prurigo

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/10/07
  •   350
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Prurigo

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Exclusion Criteria

Pruritus on normal skin

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Addresses

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    • Universitätsklinikum Münster
    • Domagkstraße 5
    • 48149  Münster
    • Germany
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    • Universitätshautklinik Münster
    • Ms.  Dr.  Fiona  Schedel 
    • Von-Esmarch-Str. 58
    • 48149  Münster
    • Germany
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    • Universitätshautklinik Münster
    • Ms.  Dr.  Fiona  Schedel 
    • Von-Esmarch-Str. 58
    • 48149  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Münster
    • Domagkstraße 5
    • 48149  Münster
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.