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
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).
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- 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