ItchNCT03576053
A Mechanistic Evaluation of the Interactions Between Thermoceptive and Pruriceptive Sensory Processing
A study testing Lidocaine, Histamine and Cowhage in people with Itch and Thermal Stimulation, run by Aalborg University at 1 site in Denmark.
Trial summary
The purpose of this human experimental study is to evaluate the pattern of itch intensity over time in response to strong, short-term heat stimulation in two different models of histamine and cowhage-induced itch. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Itch, Thermal Stimulation, Histamine
- What is being tested?
- Lidocaine, Histamine and Cowhage
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2018to 28 Aug 2019
- Phase
- Interventional
- 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
- Age 18-60 years
- Able to speak and understand English
Who cannot join
- Suffering from chronic disease
- Pregnancy or lactation
- Prior experience of adverse effects from anaesthetic, specifically Lidocaine
- Drug addiction defined as the use of cannabis, opioids or other drugs - 5 -
- Previous neurologic, musculoskeletal or mental illnesses
- Lack of ability to cooperate
Show all 10Show fewer
- Current use of medications that may affect the trial
- Active skin diseases
- Active participation in other experiments currently ongoing or within the last 14 days
- Tattoos on volar forearms that will interfere with local skin measurements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: En Mekanistisk undersøgelse af Interaktioner Imellem Det Thermoceptive og Det Pruriceptive Sensoriske System
The purpose of this human experimental study is to evaluate the pattern of itch intensity over time in response to strong, short-term heat stimulation in two different models of histamine and cowhage-induced itch. Moreover, the purpose is to evaluate the effect of mild pre-heating of the skin in human experimental models of histamine, cowhage and serotonin. Finally, we want to investigate the effect of short-term intense heat stimulation on previously anesthetized skin.
- Conditions
- Itch, Thermal Stimulation, Histamine, Cowhage, Serotonine
- Being tested
- Lidocaine, Histamine, Cowhage, Heat stimulation, Pre-heating
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Lidocaine intradermal injection
HistamineOther
Skin Prick Test with Histamine
CowhageOther
Manually skin insertion of cowhage spicules
Heat stimulationOther
Short heat stimulation
Pre-heatingOther
Mild skin pre-heating
SerotoninOther
Serotonin electrophoresis
| Study group | Role | What they receive |
|---|---|---|
| Histamine+cowhage+heat | Experimental | Not described Receives: Other: Histamine; Other: Cowhage; Other: Heat stimulation |
| Histamine+cowhage+serotonin+pre-heating | Experimental | Not described Receives: Other: Histamine; Other: Cowhage; Other: Pre-heating; Other: Serotonin |
| lidocaine and saline+heat | Placebo comparator | Not described Receives: Drug: Lidocaine; Other: Heat stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
eVAS Itch
Electronic Visual Analog Scale for itch sensation. 0-100 scale, it measures the self-estimated itch the subject experience on a scale where 0 correspond to "No itch" and 100 "Worst itch imaginable".
Measured: 10 minutes
Skin temperature
Infrared skin thermometer
Measured: 5 seconds
eVAS Pain
Electronic Visual Analog Scale for pain sensation. 0-100 scale, it measures the self-estimated pain the subject experience on a scale where 0 correspond to "No pain" and 100 "Worst pain imaginable".
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start1 Jul 2018
- Primary completion31 Jul 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ItchStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Riccio, Aalborg University
- Investigators
- Daniele Riccio, MSc, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576053
- Sponsor's protocol ID
- N-20180035
- Status last verified
- Jul 2020
- First submitted
- 22 Jun 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- En Mekanistisk undersøgelse af Interaktioner Imellem Det Thermoceptive og Det Pruriceptive Sensoriske System
- ClinicalTrials.gov ID
- NCT03576053
- Acronym / sponsor ID
- N-20180035
- Conditions
- Itch, Thermal Stimulation, Histamine, Cowhage, Serotonine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 3 Jul 2018 (actual)
- 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 human experimental study is to evaluate the pattern of itch intensity over time in response to strong, short-term heat stimulation in two different models of histamine and cowhage-induced itch. Moreover, the purpose is to evaluate the effect of mild pre-heating of the skin in human experimental models of histamine, cowhage and serotonin. Finally, we want to investigate the effect of short-term intense heat stimulation on previously anesthetized skin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Histamine+cowhage+heat | Experimental | Other: Histamine, Other: Cowhage, Other: Heat stimulation |
| Histamine+cowhage+serotonin+pre-heating | Experimental | Other: Histamine, Other: Cowhage, Other: Pre-heating, Other: Serotonin |
| lidocaine and saline+heat | Placebo comparator | Drug: Lidocaine, Other: Heat stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women
- Age 18-60 years
- Able to speak and understand English
Key exclusion criteria (10 listed)
- Suffering from chronic disease
- Pregnancy or lactation
- Prior experience of adverse effects from anaesthetic, specifically Lidocaine
- Drug addiction defined as the use of cannabis, opioids or other drugs - 5 -
- Previous neurologic, musculoskeletal or mental illnesses
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 |
|---|---|---|
| LidocaineLidocaine intradermal injection | Drug | lidocaine and saline+heat |
| HistamineSkin Prick Test with Histamine | Other | Histamine+cowhage+heat, Histamine+cowhage+serotonin+pre-heating |
| CowhageManually skin insertion of cowhage spicules | Other | Histamine+cowhage+heat, Histamine+cowhage+serotonin+pre-heating |
| Heat stimulationShort heat stimulation | Other | Histamine+cowhage+heat, lidocaine and saline+heat |
| Pre-heatingMild skin pre-heating | Other | Histamine+cowhage+serotonin+pre-heating |
| SerotoninSerotonin electrophoresis | Other | Histamine+cowhage+serotonin+pre-heating |
Primary outcome
eVAS Itch
Time frame: 10 minutes
Electronic Visual Analog Scale for itch sensation. 0-100 scale, it measures the self-estimated itch the subject experience on a scale where 0 correspond to "No itch" and 100 "Worst itch imaginable".
Skin temperature
Time frame: 5 seconds
Infrared skin thermometer
eVAS Pain
Time frame: 10 minutes
Electronic Visual Analog Scale for pain sensation. 0-100 scale, it measures the self-estimated pain the subject experience on a scale where 0 correspond to "No pain" and 100 "Worst pain imaginable".
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 8 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Itch
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Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
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Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
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Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
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Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
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Topographical Distribution of Itch and Pain Receptors
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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.
Daniele Riccio, MSc principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine, Histamine and Cowhage in people with Itch and Thermal Stimulation, run by Aalborg University 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 3 inclusion and 10 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 8 Jul 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
eVAS Itch (time frame: 10 minutes). The study lists 3 primary outcomes in all. 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 8 Jul 2020.