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

Sponsor
Aalborg University (Other)
Overall Status
Completed
CT.gov ID
NCT04076865
Collaborator
(none)
26
Enrollment
1
Location
1
Arm
14.6
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: EMLA (lidocaine) +Itch (Histamine and cowhage)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
The participant are blind about the location of EMLA and placebo application
Primary Purpose:
Basic Science
Official Title:
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.
Actual Study Start Date :
Oct 15, 2019
Actual Primary Completion Date :
Oct 1, 2020
Actual Study Completion Date :
Jan 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: EMLA

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.

Outcome Measures

Primary Outcome Measures

  1. Superficial blood perfusion [Change from baseline, up to three days after the first session]

    is measured by a Speckle contrast imager (FLPI, Moor Instruments, England).

  2. Warm Detection Thresholds and Heat Pain Thresholds [Change from baseline, up to three days after the first session]

    The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  3. Pain to Supra-threshold Heat Stimuli [Change from baseline, up to three days after the first session]

    The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device

  4. Alloknesis [Change from baseline, up to three days after the first session]

    Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).

  5. Mechanical Pain Thresholds and Sensitivity [Change from baseline, up to three days after the first session]

    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

  6. Pain rating [only 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'.

Secondary Outcome Measures

  1. Itch rating [only 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'.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aalborg University Aalborg Nordjylland Denmark 92200

Sponsors and Collaborators

  • Aalborg University

Investigators

  • Principal Investigator: Silvia Lo Vecchio, Aalborg University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Silvia Lo Vecchio, Principal Investigator, Aalborg University
ClinicalTrials.gov Identifier:
NCT04076865
Other Study ID Numbers:
  • N-20190043
First Posted:
Sep 3, 2019
Last Update Posted:
Jan 15, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lidocaine
Histamine

Study Results

No Results Posted as of Jan 15, 2021