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Not yet recruiting NCT07255092

Mechanisms Underlying the Nocibo Effect of Contagious Itch. in Both Histaminergic and Nonhistaminergic Itch

No phase Interventional ITCH

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Histamine, Cowhage (Mucuna Pruriens), Placebo.
Who it may be relevant to
Registry conditions: ITCH. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Pain and Itch Neuromodulation: Effects of Offset Analgesia, Placebo, and Nocebo and Topographical Distribution of Itch and Pain Receptors

Overview

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.

Interventions

  • Other Histamine
    To deliver histamine, standard allergy skin prick test (SPT) lancets are applied
  • Other Cowhage (Mucuna Pruriens)
    The spicules will be manually inserted. Approximately 30-35 spicules are gently rubbed into a 1 cm diameter skin area on the forearm/face
  • Other Placebo
    To deliver steril water, standard allergy skin prick test (SPT) lancets are applied

Primary outcome measures

  • Measuring pain by computerized Visual Analog Scale Scoring [Time frame: Immediately after the intervention]
  • Measuring itch by computerized Visual Analog Scale Scoring [Time frame: Immediately after the intervention]
Secondary outcome measures (8)
  • Pain Catastrophizing Scale (PCS). [Time frame: Baseline]
  • Itch Catastrophizing Scale (ICS) [Time frame: Baseline]
  • Learned Helplessness Scale (LHS) [Time frame: Baseline]
  • Depression, Anxiety, Stress Scale (DASS-21) [Time frame: Baseline]
  • Reinforcement Sensitivity Theory - Personality Questionnaire (RST-PQ). [Time frame: Baseline]
  • Positive And Negative Affect Schedule (PANAS) [Time frame: Baseline]
  • Difficulties in Emotion Regulation Scale Short Form (DERS-SF) [Time frame: Baseline]
  • Emotion Regulation Questionnaire (ERQ) [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • 18-60 years
  • Speak and understand English

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Denmark · 1 center
  • Aalborg University — Gistrup

Identifiers

NCT: NCT07255092 · N-20250017 Project 3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗