Aalborg University
Aalborg, 9260, Denmark
Location status: Recruiting
NCT Number: NCT06328543
In This experiment, the investigators would like to design a new itch model based on the temporal summation of pruritic stimuli. The hypothesis behind this study (temporal summation) is that two overlapped applications of pruritogens will result in a higher itch sensation compared with a single application.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Aalborg, 9260, Denmark
Location status: Recruiting
Chronic itch affects approximately a fifth of the global population and is associated with substantial negative consequences for the affected individuals. Furthermore, there is a lack of efficient treatment options for chronic itch. In order to mimic a clinical itch condition as presented in patients, the aim of the project is to investigate a new itch model based on the multiple applications of pruritogens (temporal summation). In particular, the purpose is to evaluate if a single application of cowhage/histamine (non-histaminergic and histaminergic itch, respectively) results in a lower itch sensation compared with two overlapped applications of the pruritogens on the same area.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 1 minute after every itch inductions
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
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: 10 minutes after every itch inductions
The evoked cutaneous inflammation (quantified by superficial blood perfusion) will be measured by full-field laser perfusion imaging.
Time frame: 12 minutes after every itch inductions
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: 15 minutes after every itch inductions
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").
Contact information is provided by the study sponsor or research team.
Giulia Erica Aliotta, PhD
CONTACT
Silvia Lo Vecchio, PhD
CONTACT
Aalborg University
Other
Repetitive Applications of Pruritogens and Effects of a Cutaneous-induced Pain Stimulation on Nonhistaminergic Itch Perception
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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