Health TrialsbyHealthPanel

A New Model to Induce Itch and Inflammation

ConditionItching
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAalborg University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy men and women

18-60 years

Speak and understand English

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cowhage (Mucuna Pruriens)

    Other intervention

    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 intervention

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

  • Heat

    Other intervention

    45 °C x 5 min

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Active groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Measuring pain by computerized Visual Analog Scale Scoring

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

Time frame
Day 1
2

Measuring Itch by computerized Visual Analog Scale Scoring

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

Time frame
Day 1
3

Measuring pain by computerized Visual Analog Scale Scoring

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

Time frame
Day 2
4

Measuring Itch by computerized Visual Analog Scale Scoring

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

Time frame
Day 2

Secondary outcomes

1

Superficial blood perfusion

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

Time frame
Day 1
2

Superficial blood perfusion

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

Time frame
Day 2
3

Alloknesis

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

Time frame
Day 1
4

Alloknesis

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

Time frame
Day 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aalborg University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: