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

A Mechanistic Evaluation of the Nociceptive Desensitization Induced by Repeated Administration of Topical Local Anaesthetic Mixture of Lidocaine and Prilocaine (EMLA) in a Model of Histaminergic and Non-histaminergic Itch.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04076865
Enrollment
26
Registered
2019-09-03
Start date
2019-10-15
Completion date
2021-01-01
Last updated
2021-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Itch, Lidocaine

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).

Interventions

DRUGEMLA (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.

Sponsors

Aalborg University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

The participant are blind about the location of EMLA and placebo application

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain to Supra-threshold Heat StimuliChange from baseline, up to three days after the first sessionThe tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Superficial blood perfusionChange from baseline, up to three days after the first sessionis measured by a Speckle contrast imager (FLPI, Moor Instruments, England).
Warm Detection Thresholds and Heat Pain ThresholdsChange from baseline, up to three days after the first sessionThe tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Pain ratingonly on day 3 (third session)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'.
AlloknesisChange from baseline, up to three days after the first sessionAlloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Mechanical Pain Thresholds and SensitivityChange from baseline, up to three days after the first sessionThis 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

Secondary

MeasureTime frameDescription
Itch ratingonly on day 3 (third session)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'.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026