Effects of High-concentration Topical Capsaicin on Histaminergic and Non-histaminergic Itch

The Role of Pre-established Skin Inflammation on the Susceptibility to Histamine and Cowhage-induced Itch in Healthy Humans

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.

Study Overview

• Status: Completed
• Conditions: Pruritus
• Intervention / Treatment: Drug: Capsaicin 24 Hours; Drug: Capsaicin 1 Hour; Other: Qutenza Demo Patch

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Denmark
  • NJ
    • Aalborg, NJ, Denmark, 9220
      • SMI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy men and women
• 18-60 years
• Caucasian descent
• Speak and understand English

Exclusion Criteria:

• Pregnancy or lactation
• Drug addiction defined as any use of cannabis, opioids or other drugs
• Previous or current neurologic, musculoskeletal or mental illnesses
• Lack of ability to cooperate
• Current use of medications that may affect the trial
• Skin diseases
• Consumption of alcohol or painkillers 24 hours before the study days and between these
• Moles or tattoos in the area to be irradiated
• Exposure of the irradiated area to UV radiation (e.g., sun) 48 hours before the study days and between these
• Acute or chronic pain
• Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cowhage; 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; Dermal patches for transdermal application of Capsaicin, applied for 24 hours; Other Names: Qutenza; Drug: Capsaicin 1 Hour; Dermal patches for transdermal application of Capsaicin, applied for 1 hour; Other Names: Qutenza; Other: Qutenza Demo Patch; Dermal patches mimicking active Qutenza patches. Used as control in comparison of Capsaicin efficacy. Applied for 24 hours.; Other Names: Qutenza Demo
Other: Histamine; 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; Dermal patches for transdermal application of Capsaicin, applied for 24 hours; Other Names: Qutenza; Drug: Capsaicin 1 Hour; Dermal patches for transdermal application of Capsaicin, applied for 1 hour; Other Names: Qutenza; Other: Qutenza Demo Patch; Dermal patches mimicking active Qutenza patches. Used as control in comparison of Capsaicin efficacy. Applied for 24 hours.; Other Names: Qutenza Demo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assessed continuously at 0-10 minutes following itch provocation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurogenic inflammation	Neurogenic inflammation in the treated area is assessed using full-field laser perfusion imaging (FLPI)	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.	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.	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.	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.	24 hours after first application of capsaicin patch

Collaborators and Investigators

• Sponsor: Hjalte Holm Andersen

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 19, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Pruritus; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: N-20160026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No