A Phase 1/2 interventional study of Capsaicin 24 Hours and Capsaicin 1 Hour in Pruritus, sponsored by Hjalte Holm Andersen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-22.
Sponsored by Hjalte Holm Andersen · Phase 1/2, Interventional, and Treatment
The purpose of this project is to investigate the effect of capsaicin-induced neurogenic inflammation with three different intensities on itch subsequently induced by histamine and cowhage. The hypothesis is that capsaicin-induced pre-established neurogenic inflammation significantly increases susceptibility to itch provocations with cowhage and histamine.
354 studies on the registry are indexed under Pruritus; 74 are open to participants now.
This study's enrollment of 16 is below the median of 60 across 294 interventional studies indexed under Pruritus.
Browse Pruritus studies →This is the only study on the registry with Hjalte Holm Andersen as lead sponsor.
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Cowhage is used to induce non-histaminergic itch on the volar forearm at the locations treated with Capsaicin 24 Hours, Capsaicin 1 Hours and Qutenza Demo Patch.
Drug: Capsaicin 24 Hours · Drug: Capsaicin 1 Hour · Other: Qutenza Demo Patch
Histamine is used to induce histaminergic itch on the volar forearm at the locations treated with Capsaicin 24 Hours, Capsaicin 1 Hour and Qutenza Demo Patch.
Drug: Capsaicin 24 Hours · Drug: Capsaicin 1 Hour · Other: Qutenza Demo Patch
Dermal patches for transdermal application of Capsaicin, applied for 24 hours
Also known as: Qutenza
Dermal patches for transdermal application of Capsaicin, applied for 1 hour
Also known as: Qutenza
Dermal patches mimicking active Qutenza patches. Used as control in comparison of Capsaicin efficacy. Applied for 24 hours.
Also known as: Qutenza Demo
Itch intensity
Rating of the perceived itch intensity on a visual analogue scale (VAS) App (Aalborg University) as displayed on a tablet computer with a sample rate of 1 Hz.
Time frame: Assessed continuously at 0-10 minutes following itch provocation
Neurogenic inflammation
Neurogenic inflammation in the treated area is assessed using full-field laser perfusion imaging (FLPI)
Time frame: Assessed 11 minutes after itch provocation
Changes in sensitivity to touch-evoked itch
Three von Frey filaments are applied to the test area before and after itch provocation. Subjects report three NRS scores ('0-10', 'No itch-Worst imaginable itch') for itch induced by von Frey stimulation. Change is calculated by subtracting baseline mean from post-provocation mean NRS scores.
Time frame: Assessed before, and at 12-15 minutes following itch provocation
Wheal size
Histamine wheal size is assessed by measuring the longest diameter of the wheal with a ruler, followed by measuring the orthogonal diameter. The mean of these diameters will represent the wheal size in diameter, reported in mm.
Time frame: Assessed at 10 minutes following itch provocation
Pain intensity
Rating of the perceived pain intensity on a visual analogue scale (VAS) App (Aalborg University) as displayed on a tablet computer with a sample rate of 1 Hz.
Time frame: Assessed continuously at 0-10 minutes following itch provocation
Pain during capsaicin application
Peak and average numerical rating scale (NRS) scores ('0-10, 'no pain-worst imaginable pain') are reported by subjects for each patch.
Time frame: 24 hours after first application of capsaicin patch
Plan to share: No
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This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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