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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04076865
Other study ID # N-20190043
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 15, 2019
Est. completion date January 1, 2021

Study information

Verified date January 2021
Source Aalborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this experiment, the investigators would like to study if the repeated application of local cuaneous anaesthetic EMLA cream will reduce itch induced by small needles from the plant mucuna pruriens (also known as cowhage) and histamine (an itch proving substance formed in the body).


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date January 1, 2021
Est. primary completion date October 1, 2020
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 - Lack of ability to cooperate - Current use of medications that may affect the trial - Skin diseases - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
EMLA (lidocaine) +Itch (Histamine and cowhage)
Cutaneous anaesthesia: will be topically induced by using EMLA cream 5%, a local anaesthetic cream consisting of equal parts of lidocaine and prilocaine (1g contains 25 mg of lidocaine and 25 mg of prilocaine, AstraZeneca A/S, Albertslund, Denmark). Histamine: To deliver histamine, standard allergy skin prick test (SPT) lancets are applied. Cowhage: Cowhage spicules are 1-2 mm in length and have diameter of 1-3 um at their tip, once inserted into the epidermis, the spicules evoke a moderate sensation of itch and to a lesser extent sensations of burning and stinging pain.

Locations

Country Name City State
Denmark Aalborg University Aalborg Nordjylland

Sponsors (1)

Lead Sponsor Collaborator
Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Superficial blood perfusion is measured by a Speckle contrast imager (FLPI, Moor Instruments, England). Change from baseline, up to three days after the first session
Primary Warm Detection Thresholds and Heat Pain Thresholds The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device Change from baseline, up to three days after the first session
Primary Pain to Supra-threshold Heat Stimuli The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device Change from baseline, up to three days after the first session
Primary Alloknesis Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force). Change from baseline, up to three days after the first session
Primary Mechanical Pain Thresholds and Sensitivity This test is performed using a pin-prick set (Aalborg University, Aalborg). The set consists of 8 needles each having a diameter of 0.6 mm and different force applications: 0.8, 1.6, 3.2, 6.4, 12.8, 25.6, 50.1 and 60.0 g Change from baseline, up to three days after the first session
Primary Pain rating The subject will rate the pain for 9 min by using a a visual analog scale (VAS) on a tablet. This scale goes from 0 to 100. 0 indicates 'no pain' and 100 indicates 'worst imaginable pain'. only on day 3 (third session)
Secondary Itch rating The subject will rate the itch for 9 min by using a a visual analog scale (VAS) on a tablet. This scale goes from 0 to 100. 0 indicates 'no itch' and 100 indicated 'worst imaginable itch'. only on day 3 (third session)
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