Clinical trial NCT04858360: Inhibition of Non-histaminergic Pruritus Applied Using 3 Different Pruritogens
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Itch
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Measuring itch intensity by computerized Visual Analog Scale Scoring
timeFrame: For 9 minutes
measure: Measuring pain intensity by computerized Visual Analog Scale Scoring
timeFrame: For 9 minutes
measure: Superficial blood perfusion measurement
timeFrame: After 1 hour
measure: Superficial blood perfusion measurement
timeFrame: After 3 hours
measure: Superficial blood perfusion measurement
timeFrame: 10 min after cowhage application
measure: Measuring Alloknesis
timeFrame: After 1 hour
measure: Measuring Alloknesis
timeFrame: After 3 hours
measure: Measuring Alloknesis
timeFrame: 10 min after cowhage application
measure: Measuring Hyperknesis
timeFrame: After 1 hour
measure: Measuring Hyperknesis
timeFrame: After 3 hours
measure: Measuring Hyperknesis
timeFrame: 10 min after cowhage application
Secondary outcomes:
measure: Measuring Erythema
timeFrame: After 1 hour
measure: Measuring Erythema
timeFrame: After 3 hours
measure: Measuring Erythema
timeFrame: 10 min after cowhage application
measure: Measuring Skin Pigmentation
timeFrame: After 1 hour
measure: Measuring Skin Pigmentation
timeFrame: After 3 hours
measure: Measuring Skin Pigmentation
timeFrame: 10 min after cowhage application
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
affiliation: Aalborg University
name: Silvia lo Vecchio
role: PRINCIPAL_INVESTIGATOR
References: