Itch Clinical Trial
Official title:
Characterization of New Human Models of Non-histaminergic Itch and Their Interaction With the TRPM8 Receptor
Verified date | July 2021 |
Source | Aalborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this experiment the investigators would like to test a new new human itch model based on papain, and to characterize the sensory quality and temporary aspects of papain skin prick test (SPT) in comparison to the inactivated-cowhage delivery system.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 1, 2021 |
Est. primary completion date | June 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Healthy men and women - 18-60 years - Speak and understand English Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University | Aalborg | Nordjylland |
Lead Sponsor | Collaborator |
---|---|
Aalborg University |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Superficial blood perfusion | Superficial blood perfusion is measured by a Speckle contrast imager (FLPI, Moor Instruments, England). | 15 minutes | |
Primary | Measuring itch intensity by computerized Visual Analog Scale Scoring | The subjects will 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" and similarly for sensations of stinging/pricking and burning, both of which are frequently associated with the sensation of itch. | 15 minutes | |
Primary | Measuring pain intensity by computerized Visual Analog Scale Scoring | The subjects will 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". | 15 minutes | |
Primary | Measuring Alloknesis | Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 milliNewton of force). This stimulator is applied 0.5 cm outside the area of itch provocation. | 15 minutes | |
Secondary | Measurement of Cold Detection Thresholds (CDT) | The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. During the first 8 seconds, the temperature decreases 1°C per second from a starting temperature of 32°C until the subject perceives a temperature change (cold sensation) and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s. A cut-off temperature of 0°C will be used. | 15 minutes | |
Secondary | Measurement of Cold Pain Thresholds (CPT) | The tests for thermal sensation will all be conducted using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. During the first 8 seconds, the temperature decreases 1°C per second from a starting temperature of 32°C until the subject perceives a temperature change (cold sensation) and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s. A cut-off temperature of 0°C will be used. | 15 minutes | |
Secondary | Measurement of Warm Detection Thresholds (WDT) | The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. During the first 8 seconds, the temperature raises 1°C per second from a starting temperature of 32°C until the subject detects a painful sensation and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s. A cut-off temperature of 52°C will be used. | 15 minutes | |
Secondary | Measurement of Heat Pain Thresholds (HPT) | The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. During the first 8 seconds, the temperature raises 1°C per second from a starting temperature of 32°C until the subject detects a painful sensation and presses a button that will terminate the measurement and return the temperature to baseline at a rate of 5°C /s. A cut-off temperature of 52°C will be used. | 15 minutes | |
Secondary | Measurement of Pain to Supra-threshold Heat Stimuli | The tests will be conducted by using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device. A thermode stimulator of 3x3 cm will be placed on the treated/placebo areas and kept in place by means of Velcro tape. The subjects will have to rate the pain to two suprathreshold heat pain stimuli (starting and ending at 32°C with an increase and decrease of 5°C and 3 s plateau at 50°C). | 15 minutes | |
Secondary | Measurement of Mechanical Pain Thresholds (MPT) | This test is conducted using a pin-prick set (Aalborg University, Aalborg). | 15 minutes | |
Secondary | Measurement of Mechanical Pain Sensitivity (MPS) | This test is conducted using a pin-prick set (Aalborg University, Aalborg). | 15 minutes | |
Secondary | Touch Pleasantness (TP) | Pleasant touch sensation measured using a standardized sensory brush (SENSELab Brush-05, Somedic AB, Hörby, Sweden) exerting a force of 200 to 400 mN. | 15 minutes |
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