ItchingNCT07395882
A New Model to Induce Itch and Inflammation
A study testing Cowhage (Mucuna Pruriens), Histamine and Heat in people with Itching, run by Aalborg University at 1 site in Denmark.
Trial summary
This project aims to create a reliable, long-lasting itch model by synergistically combining thermal pre-conditioning with the application of histamine or cowhage. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Itching
- What is being tested?
- Cowhage (Mucuna Pruriens), Histamine and Heat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Speak and understand English
Who cannot join
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids, or other addictive drugs
- Previous or current history of neurological (e.g., neuropathy), immunological (e.g., asthma, immune deficiencies, arthritis), musculoskeletal (e.g., muscular pain in the upper extremities), cardiac disorder (e.g., stroke), or psychiatric diagnoses (e.g., depression, bipolar disorders, acute and chronic psychosis) that may affect the results
- Current use of medications that may affect the trial, such as antihistamines, antipsychotics, painkillers, and systemic or topical steroids
- Skin diseases (e.g., atopic dermatitis, pruritus nodularis, eczema, psoriasis)
- Moles, scars, or tattoos in the area to be treated or tested (forearm/hand).
Show all 14Show fewer
- Consumption of alcohol or painkillers 24 hours before the study days and between these
- Acute or chronic pain
- Unable to answer the "Transcranial Magnetic Stimulation Adult Safety Screen" (subprojects 2-4)
- Contraindications to transcranial magnetic stimulation (TMS) application (history of epilepsy, metal implants in head or jaw, etc.) (subprojects 2-4)
- Presence of implanted hearing aids or metal implants on the face, including permanent makeup or tattoos (subprojects 2-4)
- Contraindications to capsaicin, including intolerance to chili or burns or wounds at the application sites (subprojects 2, 3, and 4)
- Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
- The subject is assessed as unable to engage in the necessary cooperation required by the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark
Aalborg, Aalborg, 9620
Silvia Lo Vecchio, PhD, 21397785 ext. 0045, slv@hst.aau.dk
About this study
Official title: Investigating the Neurophysiology of Itch
This project aims to create a reliable, long-lasting itch model by synergistically combining thermal pre-conditioning with the application of histamine or cowhage.
Read the detailed description
Two areas (4x4 cm, one on each forearm), will be selected. Initially, superficial blood perfusion will be measured in each area, followed by pruritogens application. During the 10 minutes of the application of the pruritogens, itch will be continuously monitored using a VAS scale. After the pruritogens application, assessment of the superficial blood perfusion (SBP), mechanical sensitivity, and thermal sensitivity will be conducted. The session will be identical to the first session, but pre-heat conditioning will be applied prior to pruritogens application.
- Conditions
- Itching
- Being tested
- Cowhage (Mucuna Pruriens), Histamine, Heat
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cowhage (Mucuna Pruriens)Other
The spicules will be manually inserted. Approximately 30-35 spicules are gently rubbed into a 1 cm diameter skin area on the forearm/face
HistamineOther
To deliver histamine, standard allergy skin prick test (SPT) lancets are applied
HeatOther
45 °C x 5 min
| Study group | Role | What they receive |
|---|---|---|
| Active group | Experimental | Heath will be applied prior pruritogens application Receives: Other: Cowhage (Mucuna Pruriens); Other: Histamine; Other: Heat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring pain by computerized Visual Analog Scale Scoring
We will ask the subjects to rate the sensation of pain on a 100
Measured: Day 1
Measuring Itch by computerized Visual Analog Scale Scoring
We will ask the subjects to rate the sensation of itch on a 100
Measured: Day 1
Measuring pain by computerized Visual Analog Scale Scoring
We will ask the subjects to rate the sensation of pain on a 100
Measured: Day 2
Measuring Itch by computerized Visual Analog Scale Scoring
We will ask the subjects to rate the sensation of itch on a 100
Measured: Day 2
Secondary outcomes (20)
Superficial blood perfusion
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Measured: Day 1
Superficial blood perfusion
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Measured: Day 2
Alloknesis
Measured using a standardized sensory brush exerting a force of 200 to 400 mN.
Measured: Day 1
Alloknesis
Measured using a standardized sensory brush exerting a force of 200 to 400 mN.
Measured: Day 2
Mechanically evoked itch (MEI)
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Measured: Day 1
Mechanically evoked itch (MEI)
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Measured: Day 2
Mechanical Pain Thresholds (MPT)
This test is conducted using a pinprick set. The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN.
Measured: Day 1
Mechanical Pain Thresholds (MPT)
This test is conducted using a pinprick set. The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN.
Measured: Day 2
Mechanical Pain Sensitivity (MPS)
This test is conducted with the same pinprick set used to test the MPT.
Measured: Day 1
Mechanical Pain Sensitivity (MPS)
This test is conducted with the same pinprick set used to test the MPT.
Measured: Day 2
Cold Detection Thresholds (CDT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 1
Cold Detection Thresholds (CDT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 2
Warm Detection Thresholds (WDT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 1
Warm Detection Thresholds (WDT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 2
Cold Pain Thresholds (CPT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 1
Cold Pain Thresholds (CPT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 2
Heat Pain Thresholds (HPT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 1
Heat Pain Thresholds (HPT)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 2
Pain to Supra-threshold Heat Stimuli (STHS)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 1
Pain to Supra-threshold Heat Stimuli (STHS)
The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ItchingStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Lo Vecchio, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395882
- Sponsor's protocol ID
- N-20250026 Project 1
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Neurophysiology of Itch
- ClinicalTrials.gov ID
- NCT07395882
- Acronym / sponsor ID
- N-20250026 Project 1
- Conditions
- Itching
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 9 Feb 2026 (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.
This project aims to create a reliable, long-lasting itch model by synergistically combining thermal pre-conditioning with the application of histamine or cowhage.
Detailed description
Two areas (4x4 cm, one on each forearm), will be selected. Initially, superficial blood perfusion will be measured in each area, followed by pruritogens application. During the 10 minutes of the application of the pruritogens, itch will be continuously monitored using a VAS scale. After the pruritogens application, assessment of the superficial blood perfusion (SBP), mechanical sensitivity, and thermal sensitivity will be conducted. The session will be identical to the first session, but pre-heat conditioning will be applied prior to pruritogens application.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active group | Experimental | Other: Cowhage (Mucuna Pruriens), Other: Histamine, Other: HeatHeath will be applied prior pruritogens application |
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
- 18-60 years
- Speak and understand English
Key exclusion criteria (14 listed)
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids, or other addictive drugs
- Previous or current history of neurological (e.g., neuropathy), immunological (e.g., asthma, immune deficiencies, arthritis), musculoskeletal (e.g., muscular pain in the upper extremities), cardiac disorder (e.g., stroke), or psychiatric diagnoses (e.g., depression, bipolar disorders, acute and chronic psychosis) that may affect the results
- Current use of medications that may affect the trial, such as antihistamines, antipsychotics, painkillers, and systemic or topical steroids
- Skin diseases (e.g., atopic dermatitis, pruritus nodularis, eczema, psoriasis)
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 |
|---|---|---|
| Cowhage (Mucuna Pruriens)The spicules will be manually inserted. Approximately 30-35 spicules are gently rubbed into a 1 cm diameter skin area on the forearm/face | Other | Active group |
| HistamineTo deliver histamine, standard allergy skin prick test (SPT) lancets are applied | Other | Active group |
| Heat45 °C x 5 min | Other | Active group |
Primary outcome
Measuring pain by computerized Visual Analog Scale Scoring
Time frame: Day 1
We will ask the subjects to rate the sensation of pain on a 100
Measuring Itch by computerized Visual Analog Scale Scoring
Time frame: Day 1
We will ask the subjects to rate the sensation of itch on a 100
Measuring pain by computerized Visual Analog Scale Scoring
Time frame: Day 2
We will ask the subjects to rate the sensation of pain on a 100
Measuring Itch by computerized Visual Analog Scale Scoring
Time frame: Day 2
We will ask the subjects to rate the sensation of itch on a 100
20 secondary outcomes
Superficial blood perfusion
Time frame: Day 1
Superficial blood perfusion
Time frame: Day 2
Alloknesis
Time frame: Day 1
Alloknesis
Time frame: Day 2
Mechanically evoked itch (MEI)
Time frame: Day 1
Mechanically evoked itch (MEI)
Time frame: Day 2
Mechanical Pain Thresholds (MPT)
Time frame: Day 1
Mechanical Pain Thresholds (MPT)
Time frame: Day 2
Mechanical Pain Sensitivity (MPS)
Time frame: Day 1
Mechanical Pain Sensitivity (MPS)
Time frame: Day 2
Cold Detection Thresholds (CDT)
Time frame: Day 1
Cold Detection Thresholds (CDT)
Time frame: Day 2
Warm Detection Thresholds (WDT)
Time frame: Day 1
Warm Detection Thresholds (WDT)
Time frame: Day 2
Cold Pain Thresholds (CPT)
Time frame: Day 1
Cold Pain Thresholds (CPT)
Time frame: Day 2
Heat Pain Thresholds (HPT)
Time frame: Day 1
Heat Pain Thresholds (HPT)
Time frame: Day 2
Pain to Supra-threshold Heat Stimuli (STHS)
Time frame: Day 1
Pain to Supra-threshold Heat Stimuli (STHS)
Time frame: Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
Related trials for Itching
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Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
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Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
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Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cowhage (Mucuna Pruriens), Histamine and Heat in people with Itching, 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 14 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: opening soon, as of the sponsor's last update on 11 Feb 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Lo Vecchio, PhD (21397785 ext. 0045, slv@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring pain by computerized Visual Analog Scale Scoring (time frame: Day 1). The study lists 4 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 11 Feb 2026.