Itch Clinical Trial
Official title:
Evaluation of the Effect of Repeated Administration of Topical Local Anaesthetic Mixture of Lidocaine and Prilocaine (EMLA) in a Model of Non-histaminergic Itch Induced by Cowhage.
Verified date | January 2023 |
Source | Aalborg University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
With this experiment, we want to use to investigate whether repeated application of EMLA cream as a tool to modulate non-histaminergic itching, which is produced using small needles from the plant mucuna pruriens (it is known that antihistamine does not attenuate this form of itch) and we want to compare the effect of short (1 hour) and prolonged (3 hours) application of EMLA. The sub-project takes place in 3 sessions over a period of 3 consecutive days (24 hours apart). All sessions will be identical.
Status | Completed |
Enrollment | 22 |
Est. completion date | October 1, 2022 |
Est. primary completion date | August 1, 2022 |
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 drugs - Previous or current neurologic, musculoskeletal 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 antihistamine medications or pain killers. - Skin diseases - Hypersensitivity to papaya and mango fruit, cashew nuts and 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) - Known history of anaphylactic shock, or local allergy (contact dermatitis) to lidocaine, prilocaine or other local anaesthetics of the amide type. |
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University | Aalborg |
Lead Sponsor | Collaborator |
---|---|
Aalborg University |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measuring itch intensity by computerized Visual Analog Scale Scoring | 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 | For 9 minutes | |
Primary | Measuring pain intensity by computerized Visual Analog Scale Scoring | 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". | For 9 minutes | |
Primary | Superficial blood perfusion measurement | Superficial blood perfusion is measured by a Speckle contrast imager | After 1 hour | |
Primary | Superficial blood perfusion measurement | Superficial blood perfusion is measured by a Speckle contrast imager | After 3 hours | |
Primary | Superficial blood perfusion measurement | Superficial blood perfusion is measured by a Speckle contrast imager | 10 min after cowhage application | |
Primary | Measuring Alloknesis | Alloknesis sensation is measured using a standardized sensory brush exerting a force of 200 to 400 mN. | After 1 hour | |
Primary | Measuring Alloknesis | Alloknesis sensation is measured using a standardized sensory brush exerting a force of 200 to 400 mN. | After 3 hours | |
Primary | Measuring Alloknesis | Alloknesis sensation is measured using a standardized sensory brush exerting a force of 200 to 400 mN. | 10 min after cowhage application | |
Primary | Measuring Hyperknesis | Hyperknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force). | After 1 hour | |
Primary | Measuring Hyperknesis | Hyperknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force). | After 3 hours | |
Primary | Measuring Hyperknesis | Hyperknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force). | 10 min after cowhage application | |
Secondary | Measuring Erythema | The onset of erythema is measured with a spectrometer (ColorMeter, DSM II; Cortex Technology, Hadsund, Denmark). | After 1 hour | |
Secondary | Measuring Erythema | The onset of erythema is measured with a spectrometer (ColorMeter, DSM II; Cortex Technology, Hadsund, Denmark). | After 3 hours | |
Secondary | Measuring Erythema | The onset of erythema is measured with a spectrometer (ColorMeter, DSM II; Cortex Technology, Hadsund, Denmark). | 10 min after cowhage application | |
Secondary | Measuring Skin Pigmentation | The onset of skin pigmentation is measured with a spectrometer (ColorMeter, DSM II; Cortex Technology, Hadsund, Denmark). | After 1 hour | |
Secondary | Measuring Skin Pigmentation | The onset of skin pigmentation is measured with a spectrometer (ColorMeter, DSM II; Cortex Technology, Hadsund, Denmark). | After 3 hours | |
Secondary | Measuring Skin Pigmentation | The onset of skin pigmentation is measured with a spectrometer (ColorMeter, DSM II; Cortex Technology, Hadsund, Denmark). | 10 min after cowhage application |
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