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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 November 2016
• Main ID: NCT02769910
• Date of registration: 10/05/2016
• Prospective Registration: No
• Primary sponsor: Hjalte Holm Andersen
• Public title: Effects of High-concentration Topical Capsaicin on Histaminergic and Non-histaminergic Itch
• Scientific title: The Role of Pre-established Skin Inflammation on the Susceptibility to Histamine and Cowhage-induced Itch in Healthy Humans
• Date of first enrolment: May 2016
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02769910
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Denmark

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pruritus

Intervention(s)

Drug: Capsaicin 1 Hour

Drug: Capsaicin 24 Hours

Other: Qutenza Demo Patch

Primary Outcome(s)

Itch intensity [Time Frame: Assessed continuously at 0-10 minutes following itch provocation]

Secondary Outcome(s)

Wheal size [Time Frame: Assessed at 10 minutes following itch provocation]

Pain during capsaicin application [Time Frame: 24 hours after first application of capsaicin patch]

Pain intensity [Time Frame: Assessed continuously at 0-10 minutes following itch provocation]

Changes in sensitivity to touch-evoked itch [Time Frame: Assessed before, and at 12-15 minutes following itch provocation]

Neurogenic inflammation [Time Frame: Assessed 11 minutes after itch provocation]

Secondary ID(s)

N-20160026

Source(s) of Monetary Support

Please refer to primary and secondary sponsors