Trial document




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  DRKS00012734

Trial Description

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Title

Cowhage in Lesional Skin of Atopic Dermatitis

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Trial Acronym

CLAD

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URL of the Trial

[---]*

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Brief Summary in Lay Language

A comparison of the itching and the skin reaction after the provocation with cowhage spicules in affected and unaffected skin of patients with atopic dermatitis compared to patients with urticaria, psoriasis and to healthy controls.

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Brief Summary in Scientific Language

The overall objective of this study is to compare the intensity and quality of experimentally induced itch in lesional skin of patients with atopic dermatitis and psoriasis with non-lesional skin as well as with healthy volunteers. The underlying hypothesis is that there are characteristic itch parameters that are typical for each chronic inflammatory skin diseases. This could, on the one hand, be used for differential diagnosis and, on the other hand, for a better understanding of the pathomechanisms of itching in chronic inflammatory skin diseases.

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Organizational Data

  •   DRKS00012734
  •   2017/07/13
  •   [---]*
  •   yes
  •   Approved
  •   EA2/036/17, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   L50.8 -  Other urticaria
  •   L40 -  Psoriasis
  •   L20.9 -  Atopic dermatitis, unspecified
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Interventions/Observational Groups

  •   No intervention. In all patients and subjects, itching is induced in non-lesional and lesional skin (in patients). For this purpose, cowhage spicules are applied to the skin and the resulting itch is detected by means of a visual analogue scale. The itch intensity is then compared between lesional and non-lesional skin as well as between the healthy skin.
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Characteristics

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

Itch intensity (VAS) in lesional skin of patients compared with non-lesional skin or healthy skin. The investigation takes place only at a time.

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/07/28
  •   80
  •   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

The subjects and patients must be 18 years or older.
Subjects and patients must be able to communicate with the investigator.
Subjects and patients must be able to understand the contents of the study and have to consent to participate in the study.
In patients, the diagnosis of eczema, urticaria and psoriasis vulgaris must be confirmed by clinical examination and the history
Existing health insurance (so that for example biopsy-related complications can be taken care of)

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Exclusion Criteria

Current or previous treatment with immunosuppressants (e.g., prednisolone, ciclosporin A, methotrexate, dapsone or others) 4 weeks or 5 half-lives, whichever is longer, before the start of the study.
Intake of antihistamines 5 days and leukotriene antagonists 7 days before study.
Diagnosis of another skin disease associated with chronic itching, as well as chronic itching due to other diseases.
Pregnant or lactating women.
A history of hypersensitivity or allergy to local anesthetics (in subjects and patients in whom skin biopsy is taken).
Intake of blood thinners
Existing allergy to the local anesthetic

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Addresses

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    • Charité Campus Charité Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Charité - Universitätsmedizin BerlinKlinik für Dermatologie, venerologie und Allergologie
    • Mr.  Prof. Dr. med.  Martin  Metz 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Klinik für Dermatologie und Allergologie Charité - Universitätsmedizin Berlin
    • Ms.  Hesna  Gözlükaya 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • LEO Pharma A/S
    • 2750  Ballerup
    • Denmark
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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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.