PruritusPhase 1/2NCT02769910
Effects of High-concentration Topical Capsaicin on Histaminergic and Non-histaminergic Itch
A Phase 1/2 study testing Capsaicin 24 Hours, Capsaicin 1 Hour and Qutenza Demo Patch in people with Pruritus, run by Hjalte Holm Andersen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pruritus
- What is being tested?
- Capsaicin 24 Hours, Capsaicin 1 Hour and Qutenza Demo Patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- May 2016to Jul 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- 18-60 years
- Caucasian descent
- Speak and understand English
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Pre-established Skin Inflammation on the Susceptibility to Histamine and Cowhage-induced Itch in Healthy Humans
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.
- Conditions
- Pruritus
- Being tested
- Capsaicin 24 Hours, Capsaicin 1 Hour, Qutenza Demo Patch
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin 24 HoursDrug
Also called Qutenza
Dermal patches for transdermal application of Capsaicin, applied for 24 hours
Capsaicin 1 HourDrug
Also called Qutenza
Dermal patches for transdermal application of Capsaicin, applied for 1 hour
Qutenza Demo PatchOther
Also called Qutenza Demo
Dermal patches mimicking active Qutenza patches. Used as control in comparison of Capsaicin efficacy. Applied for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Cowhage | Other | 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. Receives: Drug: Capsaicin 24 Hours; Drug: Capsaicin 1 Hour; Other: Qutenza Demo Patch |
| Histamine | Other | 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. Receives: Drug: Capsaicin 24 Hours; Drug: Capsaicin 1 Hour; Other: Qutenza Demo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed continuously at 0-10 minutes following itch provocation
Secondary outcomes (5)
Neurogenic inflammation
Neurogenic inflammation in the treated area is assessed using full-field laser perfusion imaging (FLPI)
Measured: Assessed 11 minutes after itch provocation
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.
Measured: Assessed before, and at 12-15 minutes following itch provocation
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.
Measured: Assessed at 10 minutes following itch provocation
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.
Measured: Assessed continuously at 0-10 minutes following itch provocation
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.
Measured: 24 hours after first application of capsaicin patch
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hjalte Holm Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hjalte Holm Andersen, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769910
- Sponsor's protocol ID
- N-20160026
- Status last verified
- Nov 2016
- First submitted
- 10 May 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pre-established Skin Inflammation on the Susceptibility to Histamine and Cowhage-induced Itch in Healthy Humans
- ClinicalTrials.gov ID
- NCT02769910
- Acronym / sponsor ID
- N-20160026
- Conditions
- Pruritus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hjalte Holm AndersenUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cowhage | Other | Drug: Capsaicin 24 Hours, Drug: Capsaicin 1 Hour, Other: Qutenza Demo PatchCowhage 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 | Other | Drug: Capsaicin 24 Hours, Drug: Capsaicin 1 Hour, Other: Qutenza Demo PatchHistamine 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy men and women
- 18-60 years
- Caucasian descent
- Speak and understand English
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaicin 24 HoursAlso: QutenzaDermal patches for transdermal application of Capsaicin, applied for 24 hours | Drug | Cowhage, Histamine |
| Capsaicin 1 HourAlso: QutenzaDermal patches for transdermal application of Capsaicin, applied for 1 hour | Drug | Cowhage, Histamine |
| Qutenza Demo PatchAlso: Qutenza DemoDermal patches mimicking active Qutenza patches. Used as control in comparison of Capsaicin efficacy. Applied for 24 hours. | Other | Cowhage, Histamine |
Primary outcome
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.
5 secondary outcomes
Neurogenic inflammation
Time frame: Assessed 11 minutes after itch provocation
Changes in sensitivity to touch-evoked itch
Time frame: Assessed before, and at 12-15 minutes following itch provocation
Wheal size
Time frame: Assessed at 10 minutes following itch provocation
Pain intensity
Time frame: Assessed continuously at 0-10 minutes following itch provocation
Pain during capsaicin application
Time frame: 24 hours after first application of capsaicin patch
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Capsaicin 24 Hours, Capsaicin 1 Hour and Qutenza Demo Patch in people with Pruritus, run by Hjalte Holm Andersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Itch intensity (time frame: Assessed continuously at 0-10 minutes following itch provocation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.