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Completed

NCT Number: NCT02769910

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

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.

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Key information

Conditions

Pruritus Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

SMI

Aalborg, NJ, 9220, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Capsaicin 24 Hours

Drug

Dermal patches for transdermal application of Capsaicin, applied for 24 hours

Other names: Qutenza

Capsaicin 1 Hour

Drug

Dermal patches for transdermal application of Capsaicin, applied for 1 hour

Other names: Qutenza

Qutenza Demo Patch

Other

Dermal patches mimicking active Qutenza patches. Used as control in comparison of Capsaicin efficacy. Applied for 24 hours.

Other names: Qutenza Demo

Primary outcomes

  1. Itch intensity

    Time frame: Assessed continuously at 0-10 minutes following itch provocation

    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 outcomes

  1. Neurogenic inflammation

    Time frame: Assessed 11 minutes after itch provocation

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

  2. Changes in sensitivity to touch-evoked itch

    Time frame: Assessed before, and at 12-15 minutes following itch provocation

    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.

  3. Wheal size

    Time frame: Assessed at 10 minutes following itch provocation

    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.

  4. Pain intensity

    Time frame: Assessed continuously at 0-10 minutes following itch provocation

    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.

  5. Pain during capsaicin application

    Time frame: 24 hours after first application of capsaicin patch

    Peak and average numerical rating scale (NRS) scores ('0-10, 'no pain-worst imaginable pain') are reported by subjects for each patch.

Sponsors and collaborators

Lead sponsor

Hjalte Holm Andersen

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 12, 2016
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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