Investigation of a New Human Model for Itch
- Conditions
- Itch
- Interventions
- Other: PapainOther: HistamineOther: CowhageOther: L-menthol
- Registration Number
- NCT04711044
- Lead Sponsor
- Aalborg University
- Brief Summary
This third sub-project aims to evaluate the interaction between the TRPM8 receptor and pruritus by studying the anti-pruritic effect of TPRM8-agonist L-menthol on histaminergic and non-histaminergic itch induced using three different pruritogens: histamine, cowhage and papain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Healthy men and women
- 18-60 years
- Speak and understand English
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids or other addictive drugs
- Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.).
- Lack of ability to cooperate
- Current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers, as well as systemic or topical steroids.
- Skin diseases
- Moles, scars or tattoos in the area to be treated or tested.
- Hypersensitivity to papaya and mango fruit, cashew nuts, rubber latex
- Consumption of alcohol or painkillers 24 hours before the study days and between these
- Acute or chronic pain
- Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study group Histamine - Study group Papain - Study group Cowhage - Study group L-menthol -
- Primary Outcome Measures
Name Time Method Measuring Alloknesis 15 minutes Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 milliNewton of force).
Measuring itch intensity by computerized Visual Analog Scale Scoring For 15 minutes We 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
Measuring pain intensity by computerized Visual Analog Scale Scoring For 15 minutes We 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".
Superficial blood perfusion measurement After 15 minutes Superficial blood perfusion is measured by a Speckle contrast imager
- Secondary Outcome Measures
Name Time Method Measurement of Heat Pain Thresholds (HPT) 15 minutes The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
Measurement of Mechanical Pain Sensitivity (MPS) 15 minutes This test is conducted using a pin-prick set.
Touch Pleasantness (TP) 15 minutes Pleasant touch sensation measured using a standardized sensory brush
Measurement of Cold PainThresholds (CPT) 15 minutes The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
Measurement of Cold Detection Thresholds (CDT) 15 minutes The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
Measurement of Pain to Supra-threshold Heat Stimuli 15 minutes The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
Measurement of Warm Detection Thresholds (WDT) 15 minutes The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device.
Measurement of Mechanical Pain Thresholds (MPT) 15 minutes This test is conducted using a pin-prick set.
Trial Locations
- Locations (1)
Aalborg University
🇩🇰Aalborg, Nordjylland, Denmark