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NCT Number: NCT07395882

A New Model to Induce Itch and Inflammation

This project aims to create a reliable, long-lasting itch model by synergistically combining thermal pre-conditioning with the application of histamine or cowhage.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark

Aalborg, 9620, Denmark

Location contact

Silvia Lo Vecchio, PhD

CONTACT

[email protected]

21397785 ext. 0045

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Histamine

Other

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

Heat

Other

45 °C x 5 min

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Superficial blood perfusion

    Time frame: Day 1

    Superficial blood perfusion (SBP) is measured by a Speckle contrast imager

  2. Superficial blood perfusion

    Time frame: Day 2

    Superficial blood perfusion (SBP) is measured by a Speckle contrast imager

  3. Alloknesis

    Time frame: Day 1

    Measured using a standardized sensory brush exerting a force of 200 to 400 mN.

  4. Alloknesis

    Time frame: Day 2

    Measured using a standardized sensory brush exerting a force of 200 to 400 mN.

  5. Mechanically evoked itch (MEI)

    Time frame: Day 1

    MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).

  6. Mechanically evoked itch (MEI)

    Time frame: Day 2

    MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).

  7. Mechanical Pain Thresholds (MPT)

    Time frame: Day 1

    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.

  8. Mechanical Pain Thresholds (MPT)

    Time frame: Day 2

    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.

  9. Mechanical Pain Sensitivity (MPS)

    Time frame: Day 1

    This test is conducted with the same pinprick set used to test the MPT.

  10. Mechanical Pain Sensitivity (MPS)

    Time frame: Day 2

    This test is conducted with the same pinprick set used to test the MPT.

  11. Cold Detection Thresholds (CDT)

    Time frame: Day 1

    The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  12. Cold Detection Thresholds (CDT)

    Time frame: Day 2

    The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  13. Warm Detection Thresholds (WDT)

    Time frame: Day 1

    The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  14. Warm Detection Thresholds (WDT)

    Time frame: Day 2

    The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  15. Cold Pain Thresholds (CPT)

    Time frame: Day 1

    The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  16. Cold Pain Thresholds (CPT)

    Time frame: Day 2

    The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  17. Heat Pain Thresholds (HPT)

    Time frame: Day 1

    The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  18. Heat Pain Thresholds (HPT)

    Time frame: Day 2

    The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  19. Pain to Supra-threshold Heat Stimuli (STHS)

    Time frame: Day 1

    The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  20. Pain to Supra-threshold Heat Stimuli (STHS)

    Time frame: Day 2

    The tests of thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

Study contacts

Contact information is provided by the study sponsor or research team.

Silvia Lo Vecchio, PhD

CONTACT

[email protected]

21397785 ext. 0045

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

Investigating the Neurophysiology of Itch

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 9, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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