Skip to content

A New Model to Induce Itch and Inflammation

Investigating the Neurophysiology of Itch

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07395882
Enrollment
28
Registered
2026-02-09
Start date
2026-02-15
Completion date
2029-12-31
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Itching

Brief 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.

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.

Interventions

The spicules will be manually inserted. Approximately 30-35 spicules are gently rubbed into a 1 cm diameter skin area on the forearm/face

OTHERHistamine

To deliver histamine, standard allergy skin prick test (SPT) lancets are applied

OTHERHeat

45 °C x 5 min

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy men and women * 18-60 years * Speak and understand English

Exclusion criteria

* 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). * 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

Design outcomes

Primary

MeasureTime frameDescription
Measuring pain by computerized Visual Analog Scale ScoringDay 1We will ask the subjects to rate the sensation of pain on a 100
Measuring Itch by computerized Visual Analog Scale ScoringDay 1We will ask the subjects to rate the sensation of itch on a 100

Secondary

MeasureTime frameDescription
Superficial blood perfusionDay 1Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
AlloknesisDay 1Measured using a standardized sensory brush exerting a force of 200 to 400 mN.
Mechanically evoked itch (MEI)Day 1MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Mechanical Pain Thresholds (MPT)Day 1This 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.
Mechanical Pain Sensitivity (MPS)Day 1This test is conducted with the same pinprick set used to test the MPT.
Cold Detection Thresholds (CDT)Day 1The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Warm Detection Thresholds (WDT)Day 1The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Cold Pain Thresholds (CPT)Day 1The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Heat Pain Thresholds (HPT)Day 1The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Pain to Supra-threshold Heat Stimuli (STHS)Day 1The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

Countries

Denmark

Contacts

CONTACTSilvia Lo Vecchio, PhD
slv@hst.aau.dk21397785

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026