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

Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02769910
• Other study ID #: N-20160026
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 10, 2016
• Last updated: November 19, 2016
• Start date: May 2016
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research EthicsDenmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pruritus

Intervention

Drug:
• Capsaicin 24 Hours
Dermal patches for transdermal application of Capsaicin, applied for 24 hours
• Capsaicin 1 Hour
Dermal patches for transdermal application of Capsaicin, applied for 1 hour

Other:
• Qutenza Demo Patch
Dermal patches mimicking active Qutenza patches. Used as control in comparison of Capsaicin efficacy. Applied for 24 hours.

Locations

Country	Name	City	State
Denmark	SMI	Aalborg	NJ

Sponsors (1)

Lead Sponsor	Collaborator
Hjalte Holm Andersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Neurogenic inflammation	Neurogenic inflammation in the treated area is assessed using full-field laser perfusion imaging (FLPI)	Assessed 11 minutes after itch provocation	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No