Health TrialsbyHealthPanel

Itch Sensation Induced by Simultaneous Application of Pruritogens (Spatial Summation)

ConditionsHistamineCowhage
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAalborg University

About this trial

In This experiment, the investigators would like to design a new itch model based on the spatial summation of pruritic stimuli. The hypothesis behind this study (spatial summation) is that two simultaneous applications of pruritogens will result in higher itch sensation compared with a single application of pruritogen.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy men and women

18-60 years

Speak and understand English

Disqualifiers

Pregnancy or lactation

Drug addiction defined as any use of cannabis, opioids, or other addictive drugs

Previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis) musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder, or mental illnesses that may affect the results

Lack of ability to cooperate

Trial design

Design model

Single group

Treatments tested in this trial

  • Cowhage

    Other intervention

    25 spicules will be inserted in the center of the predefined skin area on the mandibular area. The spicules will be gently rubbed for 15-20 seconds in circular motion to facilitate epidermal penetration.

  • Histamine

    Other intervention

    Histaminergic itch will be evoked by a 1% histamine solution. A droplet of histamine solution will be placed on the predetermined area on the forearm, and the SPT lancet will be pierced through the histamine with 120 g of pressure for 1-2 seconds.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: 1st pruritogenExperimental treatment 1 intervention
Group B: 2nd pruritogenOther 1 intervention

Trial outcomes

Primary outcomes

1

Assessment of itch

Immediately following the itch provocations, participants will be instructed to rate the itch intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no itch' and 100 'worst itch imaginable'.

Time frame
1 minute after every itch inductions
2

Assessment of pain

Immediately following the itch provocations, participants will be instructed to rate the pain intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no pain' and 100 'worst pain imaginable'.

Time frame
1 minute after every itch inductions

Secondary outcomes

1

Alloknesis

Alloknesis sensation is measured using a standardized sensory brush (SENSELab Brush-05, Somedic AB, Hörby, Sweden) exerting a force of 200 to 400 mN.

Time frame
12 minutes after every itch inductions
2

Mechanically evoked itch

Mechanically evoked itch is measured using three von Frey filaments of 4.08, 4.16 and 4.31 (1.0, 1.4, 2.0 g, respectively) (North Coast Medical, Gilroy, CA). The center of the skin area is stimulated by 3 pricks, repeated 3 times in short succession. After a total of 9 stimulations, the participants will report the itch elicited on a numerical rating scale (NRS) from 0 to 10 (0 = "no itch"; 10 = "worst imaginable itch").

Time frame
15 minutes after every itch inductions

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aalborg University

Lead sponsor

Source ClinicalTrials.gov
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