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

Primary Purpose

Pruritus

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Capsaicin 24 Hours
Capsaicin 1 Hour
Qutenza Demo Patch
Sponsored by
Hjalte Holm Andersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • SMI

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Cowhage

Histamine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Neurogenic inflammation
Neurogenic inflammation in the treated area is assessed using full-field laser perfusion imaging (FLPI)
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.
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.
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.
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.

Full Information

First Posted
May 10, 2016
Last Updated
November 19, 2016
Sponsor
Hjalte Holm Andersen
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1. Study Identification

Unique Protocol Identification Number
NCT02769910
Brief Title
Effects of High-concentration Topical Capsaicin on Histaminergic and Non-histaminergic Itch
Official Title
The Role of Pre-established Skin Inflammation on the Susceptibility to Histamine and Cowhage-induced Itch in Healthy Humans
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hjalte Holm Andersen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cowhage
Arm Type
Other
Arm Description
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.
Arm Title
Histamine
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Capsaicin 24 Hours
Other Intervention Name(s)
Qutenza
Intervention Description
Dermal patches for transdermal application of Capsaicin, applied for 24 hours
Intervention Type
Drug
Intervention Name(s)
Capsaicin 1 Hour
Other Intervention Name(s)
Qutenza
Intervention Description
Dermal patches for transdermal application of Capsaicin, applied for 1 hour
Intervention Type
Other
Intervention Name(s)
Qutenza Demo Patch
Other Intervention Name(s)
Qutenza Demo
Intervention Description
Dermal patches mimicking active Qutenza patches. Used as control in comparison of Capsaicin efficacy. Applied for 24 hours.
Primary Outcome Measure Information:
Title
Itch intensity
Description
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
Secondary Outcome Measure Information:
Title
Neurogenic inflammation
Description
Neurogenic inflammation in the treated area is assessed using full-field laser perfusion imaging (FLPI)
Time Frame
Assessed 11 minutes after itch provocation
Title
Changes in sensitivity to touch-evoked itch
Description
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
Title
Wheal size
Description
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
Title
Pain intensity
Description
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
Title
Pain during capsaicin application
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
SMI
City
Aalborg
State/Province
NJ
ZIP/Postal Code
9220
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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