Trial document





This trial has been registered retrospectively.
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  DRKS00005379

Trial Description

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Title

Relationship betweenn sensory qualities and emotions (Itch induction by means of cowhage)

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Trial Acronym

JRS-C

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In studies, in which itch was induced experimentally, most of the time chemical methods were used. These methods are partially invasive and in any case go ahead with a direct skin manipulation. In our research group a non-invasive method of itch induction was developed and established, which does not need a direct skin manipulation. Itch is induced mentally by a presentation of audiovisual stimuli. The effectivity of this new method shall now be compared to a widely used method of itch induction, the application of cowhage onto the skin. Four groups are being compared: A placebo is applied to the first group, which is also shown the control video; a placebo is also applied to the second group, which is shown an itch-inducing experimental video; cowhage is applied to the third group, which is also shown a control video, while the fourt group receives a cowhage-application and is presented an itch inducing experimental video.

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Brief Summary in Scientific Language

In studies, in which itch is induced experimentally, mostly substance-dependent methods like the prick-test, iontophoresis or rubbing substances onto the skin are used (e.g. van Laarhoven et al., 2011; 2012; Fjellner & Arnetz, 1985; Papoiu et al., 2011; Bin-Saif et al., 2011). Itch inducing substances (pruritogens) that are used in these studies, are frequently histamine or capsaicin (van Laarhoven et al., 2011; 2012; Fjellner & Arnetz, 1985; Wang et al., 2010), which induce itch by activating different transduction-paths (Biro et al., 2007; Baraniuk et al., 2012; Raap et al., 2011; Paus et al., 2006). The needles of a itch-bean, which has the latin name "mucuna pruriens" and is called cowhage in english-speking countries, also act itch inducing (Papoui et al., 2011; Bin-Saif et al., 2012). Cowhage affects PAR2-receptors. When being rubbed onto the skin for 45 seconds and staying there for 4,5 minutes, it leads to a higher itch intensity than 1%-histamine applied for 30 seconds. This has been shown for skin healthy as well as for patients with atopic dermatitis (Papoiu et al., 2011). The maximum of experienced itch intensity after histamine application was at ca. 40, while the score for cowhage was at ca. 62 (range of the VAS in any case from 0 - 100; Papoiu et al., 2011). From studies of our own research group, we know, that itch can also be induced mentally, by the presentation of audiovisual material. In skin healthy controls as well as in patients with different skin diseases (atopic dermatitis, urticaria, psoriasis) the presentation of a video on crawling insects (flee, ants, moskitos) leads to a significant increase in itch intensity and the number of scratch movements compared to the itch intensity due to the presentation of a control video. The itch increase due to the presentation of the experimental video was ca. 2,3 - 2,9 in skin healthy controls (on a VAS ranging from 0 - 10). If one compares the itch intensity, which in other studies was produced by the application of cowhage, with the itch intensity, which we induced by the presentation of audiovisual stimulus material, the itch intensity due to cowhage is more intensive, but so far the named methods, have never been compared concerning their effectivity. Thus, the question occurs whether the methods are differently appropriate to induce it. This shall be examined with this study.

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Organizational Data

  •   DRKS00005379
  •   2013/10/17
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  •   yes
  •   Approved
  •   47/13, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

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Health Condition or Problem studied

  •   Healthy participants
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Interventions/Observational Groups

  •   Placebo + control video
  •   Placebo + experimental video
  •   Cowhage + control video
    about 30 - 50 cowhage-spicules were rubbed into the skin for 45 seconds and stayed there during the video-presentation, which lasted 9.30 minutes
  •   Cowhage + experimental video
    about 30 - 50 cowhage-spicules were rubbed into the skin for 45 seconds and stayed there during the video-presentation, which lasted 9.30 minutes
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Placebo
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The experience of the itch intensity is measured immediately after the treatment by means of a visual analog scale (0 - 10)

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Secondary Outcome

The number of scratch movements during the treatment is counted by two independent persons.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/09/05
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   30   Years
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Additional Inclusion Criteria

18 - 30 years of age, healthy

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Exclusion Criteria

Exclusion criteria is the occurence of a chronic somatic or psychiatric disease as well as the occurence of an itch-associated (skin-)disease during the last five years or in the present. The occurence of moskito bites at the current time also leads to exclusion.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Med. Psychologie
    • Mr.  PD Dr.  Jörg  Kupfer 
    • Friedrichstraße 36
    • 35392  Gießen
    • Germany
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    • Institut für Med. Psychologie
    • Mr.  PD Dr.  Jörg  Kupfer 
    • Friedrichstraße 36
    • 35392  Gießen
    • Germany
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    • Institut für Med. Psychologie
    • Ms.  Lisa  Wilhelm 
    • Friedrichstraße 36
    • 35392  Gießen
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Med. Psychologie
    • Mr.  PD Dr.  Jörg  Kupfer 
    • Friedrichstraße 36
    • 35392  Gießen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/10/11
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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.