A New Model to Induce Itch and Inflammation

NCT07395882 | Not Yet Recruiting DMC

• 1 other identifier: N-20250026 Project 1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Itching

Outcome Measures

Primary Outcomes (4)

• Measuring pain by computerized Visual Analog Scale Scoring

  We will ask the subjects to rate the sensation of pain on a 100

  Day 1

• Measuring Itch by computerized Visual Analog Scale Scoring

  We will ask the subjects to rate the sensation of itch on a 100

  Day 1

• Measuring pain by computerized Visual Analog Scale Scoring

  We will ask the subjects to rate the sensation of pain on a 100

  Day 2

• Measuring Itch by computerized Visual Analog Scale Scoring

  We will ask the subjects to rate the sensation of itch on a 100

  Day 2

Secondary Outcomes (20)

• Superficial blood perfusion

  Day 1

• Superficial blood perfusion

  Day 2

• Alloknesis

  Day 1

• Alloknesis

  Day 2

• Mechanically evoked itch (MEI)

  Day 1

Study Arms (1)

Active group

EXPERIMENTAL

Heath will be applied prior pruritogens application

Other: Cowhage (Mucuna Pruriens); Other: Histamine; Other: Heat

Interventions

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

Active group

Histamine OTHER

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

Active group

Heat OTHER

45 °C x 5 min

Active group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women
• years
• Speak and understand English

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

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

Aalborg, Aalborg, 9620, Denmark

Location

MeSH Terms

Conditions

Pruritus

Interventions

Histamine; Hot Temperature

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors; Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Central Study Contacts

Silvia Lo Vecchio, PhD

CONTACT

21397785; slv@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

DK (1)