Evaluation of the Effect Induced by Repeated Administration of Topical Local Anaesthetic (EMLA) on Itch

NCT04076865 | Completed DMC

• 1 other identifier: N-20190043
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Lidocaine; Itch

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Itch rating

  only on day 3 (third session)

Study Arms (1)

EMLA

EXPERIMENTAL

Drug: EMLA (lidocaine) +Itch (Histamine and cowhage)

Interventions

EMLA (lidocaine) +Itch (Histamine and cowhage) DRUG

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.

EMLA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women
• years
• Speak and understand English

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

Aalborg University

Aalborg, North Denmark, 92200, Denmark

Location

MeSH Terms

Conditions

Pruritus

Interventions

Lidocaine, Prilocaine Drug Combination; Lidocaine; UBE3A protein, human; Histamine

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations; Biogenic Monoamines; Biogenic Amines; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Silvia Lo Vecchio

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The participant are blind about the location of EMLA and placebo application
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 3, 2019
• Study Start: October 15, 2019
• Primary Completion: October 1, 2020
• Study Completion: January 1, 2021
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

DK (1)