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

NCT ID: NCT02769910

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pruritus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Capsaicin 24 Hours

Intervention Type DRUG

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

Capsaicin 1 Hour

Intervention Type DRUG

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

Qutenza Demo Patch

Intervention Type OTHER

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

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.

Group Type OTHER

Capsaicin 24 Hours

Intervention Type DRUG

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

Capsaicin 1 Hour

Intervention Type DRUG

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

Qutenza Demo Patch

Intervention Type OTHER

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

Interventions

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Capsaicin 24 Hours

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

Intervention Type DRUG

Capsaicin 1 Hour

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

Intervention Type DRUG

Qutenza Demo Patch

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

Intervention Type OTHER

Other Intervention Names

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Qutenza Qutenza Qutenza Demo

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hjalte Holm Andersen

OTHER

Sponsor Role lead

Responsible Party

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Hjalte Holm Andersen

MSc. Med., Phd. Stud.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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SMI

Aalborg, NJ, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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N-20160026

Identifier Type: -

Identifier Source: org_study_id