Trial document





This trial has been registered retrospectively.
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  DRKS00012318

Trial Description

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Title

Development and Validation of disease-specific Quality of Life Questionaires for patients with chronic inducible urticaria

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Trial Acronym

n.a.

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Background: The chronic inducible urticaria is a subgroup of chronic urticaria. In chronic inducible urticaria, wheals, skin redness, and itching on the skin are triggered by external factors (e.g. effort, pressure, friction, cold, heat, light, vibration). About 0.1-0.2% of the general population is affected. The urticaria factitia (triggered by friction), the cold urticaria (caused by cold contact) and the cholinergic urticaria (caused by physical exertion and / or passive heating) are the three most common forms of the chronic inducible urticaria. The complaints show a great variability in the intensity of the symptoms. In addition to itching, skin redness and wheals, angioedema (deep swelling in the skin) can occur. Until now, the therapy of chronic inducible urticaria is avoiding the triggering factors, but it has often been insufficient, as well as a symptom-relieving treatment, e.g. with H1-antihistamines (often called antiallergic drugs).

Aim: The assessment of disease activity and quality of life of the affected patients is important for a better assessment of the disease situation and treatment results, to be able to adapt the therapy to the individual patient in a better way and to assess the progress of the disease and the quality of life of the patients. Until now this is only possible to a very limited extent, because there is no reliable disease-specific questionnaire for this purpose. The aim of the present project is to develop disease-specific questionnaire instruments for the detection of the disease activity and quality of life of patients with chronic inducible urticaria.

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Brief Summary in Scientific Language

The planned survey is a patient survey without invasive examinations.
Background: The chronic inducible urticaria (CIndU) is a subgroup of chronic urticaria. At the CIndU, wheals, skin redness and itching on the skin are triggered by external factors (effort, pressure, friction, cold, heat, light, vibration). About 0.1-0.2% of the general population is affected by a CIndU. The urticaria factitia (triggered by friction), the cold urticaria (caused by cold contact) and the cholinergic urticaria (caused by physical exertion and / or passive heating) are the three most common forms of the chronic inducible urticaria. The complaints show a great variability in the intensity of the symptoms. In addition to itching, skin redness and wheals, angioedema can occur. Until now, the therapy of chronic inducible urticaria is avoiding the triggering factors, but it has often been insufficient, as well as a symptom-relieving treatment, e.g. with H1-antihistamines. The assessment of disease activity and quality of life of the affected patients is important to make treatment results detectable, to be able to adapt the therapy to the individual patient in a better way and to assess the progress of the disease and the quality of life of the patients. Until now this is only possible to a very limited extent, because there is no reliable disease-specific instrument for this purpose.
Aim: The aim of the present project is to develop disease-specific questionnaire instruments for the detection of the disease activity and quality of life of patients with chronic inducible urticaria.

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Organizational Data

  •   DRKS00012318
  •   2017/05/17
  •   [---]*
  •   yes
  •   Approved
  •   EA1/385/13, 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
  •   L50.3 -  Dermatographic urticaria
  •   L50.2 -  Urticaria due to cold and heat
  •   L50.4 -  Vibratory urticaria
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Interventions/Observational Groups

  •   Patients with chronic inducible urticaria are asked to document their impairment in different aspekts of their qualtiy of life.
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Characteristics

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

Development of quality of life instruments for the subgroups of chronic inducible urticaria

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Secondary Outcome

N/A

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/05/07
  •   900
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

chronic inducible urticaria

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Exclusion Criteria

Younger than 18 years

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Addresses

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • PD Dr.  Petra  Staubach 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • Charité Campus Charité Mitte
    • Mr.  Prof.  Marcus  Maurer 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité Campus Charité Mitte
    • Mr.  Prof.  Marcus  Maurer 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Allergie-Centrum-Charité/i²DEAL
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    •   +4930 450 518 419
    •   +4930 450 518 959
    •   [---]*
    •   http://i2deal.net/
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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