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

Hjalte Holm Andersen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pruritus

Treatments: Drug: Capsaicin 24 Hours; Other: Qutenza Demo Patch; Drug: Capsaicin 1 Hour

Study type: Interventional

Funder types: Other

Identifiers

NCT02769910

N-20160026

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Cowhage

Other group

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.

Treatment:

Drug: Capsaicin 1 Hour

Other: Qutenza Demo Patch

Drug: Capsaicin 24 Hours

Histamine

Other group

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.

Treatment:

Drug: Capsaicin 1 Hour

Other: Qutenza Demo Patch

Drug: Capsaicin 24 Hours