Trial document





This trial has been registered retrospectively.
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  DRKS00012755

Trial Description

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Title

Extended Diagnostics in Cholinergic Urticaria

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Trial Acronym

I-Chol-U

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Blood and skin samples of patients with cholinergic urticaria and helathy controls will be taken and analyzed to find disease specific marker, that can be used for diagnistic or therapeutic reasons.

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Brief Summary in Scientific Language

The aim of the Project is to detect new and disease specific marker for the diagnostik, therapy and pathophysiology of the disease.

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Organizational Data

  •   DRKS00012755
  •   2017/08/02
  •   [---]*
  •   yes
  •   Approved
  •   EA1/242/15, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   L50.5 -  Cholinergic urticaria
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Interventions/Observational Groups

  •   Patients with cholinergic urticaria, undergoing routine diagnostic workup and provocation testing, will have additionally blood- and skin-probes taken. These will be assessed for potentially relevant signal molecules for cholinergic urticária.
  •   Healthy control persons will undergo similar diangostik workup and provocation testing and blood- and skin-probing. This group will serve as control for the laboratory analysis.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Blood and skin samples will be taken and analyzed for singal molecules (e.g. Immunoglobulines, Cytokines, (Cytokin-)receptors, etc.) in comparison: patients v.s. healthy controls.

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Secondary Outcome

Korrelation of clinical parameter like age, sex, duration of disease, etc. with the determined laboratory markers of the skin- and bloodsamples.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/12/01
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

patients with cholinergic urticaria or healthy controls, older than 18 years old, no other dominant skin disease, no other severe systemic disease

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Exclusion Criteria

persons below 18 years, severy systemic disease, other dominant skin disease except cholinergic urticaria

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Addresses

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charite-Universitätsmedizin Berlin, Klinik für Dermatologie und Allergologie
    • Ms.  Dr.  Sabine  Altrichter 
    • Chariteplatz 1
    • 10117  Berlin
    • Germany
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    • Charite-Universitätsmedizin Berlin, Klinik für Dermatologie und Allergologie
    • Ms.  Dr.  Sabine  Altrichter 
    • Chariteplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • 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.