NCT07255092

Brief Summary

The study consists of one experimental session of approximately 1½ hours. The participant will fill in a series of questionnaires about how you perceive itch and pain, and about some traits of your personality, such as depression, anxiety and stress. Afterwards, three areas will be selected on each forearm of the subjects. Two areas will be treated with histamine, two with cowhage, and two with vehicle. One application of each substance will be conducted including the contagious itch component. During the 10 minutes of the application of the pruritogens, itch and pain will be continuously monitored using a VAS scale.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
33mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Dec 2025Dec 2028

First Submitted

Initial submission to the registry

November 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

November 20, 2025

Last Update Submit

November 27, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Measuring pain by computerized Visual Analog Scale Scoring

    The investigators will ask the subjects to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates" no pain" and 100 indicates "worst pain imaginable".

    Immediately after the intervention

  • Measuring itch by computerized Visual Analog Scale Scoring

    The investigators will ask the subjects to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable".

    Immediately after the intervention

Secondary Outcomes (8)

  • Pain Catastrophizing Scale (PCS).

    Baseline

  • Itch Catastrophizing Scale (ICS)

    Baseline

  • Learned Helplessness Scale (LHS)

    Baseline

  • Depression, Anxiety, Stress Scale (DASS-21)

    Baseline

  • Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ).

    Baseline

  • +3 more secondary outcomes

Study Arms (1)

Contagious itch

EXPERIMENTAL

A contagious itch will be induced by a video (without audio) showing people scratching.

Other: HistamineOther: Cowhage (Mucuna Pruriens)Other: Placebo

Interventions

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

Contagious itch

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

Contagious itch
PlaceboOTHER

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

Contagious itch

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • Speak and understand English

You may not qualify if:

  • Pregnancy or lactation
  • Drug addiction defined as any use of cannabis, opioids, or other drugs
  • Previous or current history of neurological, immunological, musculoskeletal, cardiac disorder or psychiatric diagnoses that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia, etc.)
  • Moles, wounds, scars, or tattoos in the area to be treated or tested
  • Current use of medications that may affect the trial such as antihistamines and pain killers
  • Skin diseases
  • Consumption of alcohol or painkillers 24 hours before the study days and between these
  • Acute or chronic pain and itch
  • Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical studies)
  • Contraindications to capsaicin, including intolerance to chili or burns or wounds at the application site
  • The subject is assessed as unable to engage in the necessary cooperation required by the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University

Gistrup, Denmark, 9620, Denmark

Location

MeSH Terms

Interventions

Histamine

Intervention Hierarchy (Ancestors)

Biogenic MonoaminesBiogenic AminesAminesOrganic ChemicalsEthylaminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAutacoidsInflammation MediatorsBiological Factors

Central Study Contacts

Silvia Lo Vecchio, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

November 20, 2025

First Posted

November 28, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

December 4, 2025

Record last verified: 2025-11

Locations