LidocaineNCT04076865
Evaluation of the Effect Induced by Repeated Administration of Topical Local Anaesthetic (EMLA) on Itch
A study testing EMLA (lidocaine) +Itch (Histamine and cowhage) in people with Lidocaine and Itch, run by Aalborg University at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- EMLA (lidocaine) +Itch (Histamine and cowhage)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Oct 2019to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- 18-60 years
- Speak and understand English
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
- Being tested
- EMLA (lidocaine) +Itch (Histamine and cowhage)
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| EMLA | Experimental | Not described Receives: Drug: EMLA (lidocaine) +Itch (Histamine and cowhage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superficial blood perfusion
is measured by a Speckle contrast imager (FLPI, Moor Instruments, England).
Measured: 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
Measured: 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
Measured: 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).
Measured: 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
Measured: 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'.
Measured: only on day 3 (third session)
Secondary outcomes (1)
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'.
Measured: only on day 3 (third session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start15 Oct 2019
- Primary completion1 Oct 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LidocaineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Lo Vecchio, Aalborg University
- Investigators
- Silvia Lo Vecchio, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076865
- Sponsor's protocol ID
- N-20190043
- Status last verified
- Jan 2021
- First submitted
- 30 Aug 2019
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04076865
- Acronym / sponsor ID
- N-20190043
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMLA | Experimental | Drug: EMLA (lidocaine) +Itch (Histamine and cowhage) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women
- 18-60 years
- Speak and understand English
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | EMLA |
Primary outcome
Superficial blood perfusion
Time frame: Change from baseline, up to three days after the first session
is measured by a Speckle contrast imager (FLPI, Moor Instruments, England).
Warm Detection Thresholds and Heat Pain Thresholds
Time frame: 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
Pain to Supra-threshold Heat Stimuli
Time frame: 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
Alloknesis
Time frame: 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).
Mechanical Pain Thresholds and Sensitivity
Time frame: 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
Pain rating
Time frame: 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'.
1 secondary outcome
Itch rating
Time frame: only on day 3 (third session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Lo Vecchio principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMLA (lidocaine) +Itch (Histamine and cowhage) in people with Lidocaine and Itch, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superficial blood perfusion (time frame: Change from baseline, up to three days after the first session). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.