ItchNCT04858360
Inhibition of Non-histaminergic Pruritus Applied Using 3 Different Pruritogens
A study testing Emla 1 hour, EMLA 3 hours and Cowhage in people with Itch, run by Aalborg University at 1 site in Denmark.
Trial summary
With this experiment, we want to use to investigate whether repeated application of EMLA cream as a tool to modulate non-histaminergic itching, which is produced using small needles from the plant mucuna pruriens (it is known that antihistamine does not attenuate this form of itch) and we want to compare the effect of… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Itch
- What is being tested?
- Emla 1 hour, EMLA 3 hours and Cowhage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Nov 2021to 1 Oct 2022
- 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 that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.).
- Lack of ability to cooperate
- Current use of medications that may affect the trial such as antihistamine medications or pain killers.
- Skin diseases
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- Hypersensitivity to papaya and mango fruit, cashew nuts and rubber latex
- 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: Evaluation of the Effect of Repeated Administration of Topical Local Anaesthetic Mixture of Lidocaine and Prilocaine (EMLA) in a Model of Non-histaminergic Itch Induced by Cowhage.
With this experiment, we want to use to investigate whether repeated application of EMLA cream as a tool to modulate non-histaminergic itching, which is produced using small needles from the plant mucuna pruriens (it is known that antihistamine does not attenuate this form of itch) and we want to compare the effect of short (1 hour) and prolonged (3 hours) application of EMLA. The sub-project takes place in 3 sessions over a period of 3 consecutive days (24 hours apart). All sessions will be identical.
- Conditions
- Itch
- Being tested
- Emla 1 hour, EMLA 3 hours, Vehicle cream for 1 hour, Vehicle cream for 3 hours, 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 1 hourDrug
At the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then one area will be pre-treated with cutaneous 2.5% lidocaine/2.5% prilocaine cream (EMLA cream) for 1 hour.
EMLA 3 hoursDrug
At the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then one area will be pre-treated with cutaneous 2.5% lidocaine/2.5% prilocaine cream (EMLA cream) for 3 hours.
Vehicle cream for 1 hourOther
At the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then two area will be pre-treated with a vehicle cream for 1 h.
Vehicle cream for 3 hoursOther
At the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then two area will be pre-treated with a vehicle cream for 3 h.
CowhageOther
Cowhage spicules are 1-2 mm in length and have a diameter of 1-3 μm. The spicules are inserted by gently rubbing 30-35 spicules into a 1 cm diameter skin area.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Drug: Emla 1 hour; Drug: EMLA 3 hours; Other: Vehicle cream for 1 hour; Other: Vehicle cream for 3 hours; Other: Cowhage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring itch intensity by computerized Visual Analog Scale Scoring
We will ask the subjects to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable
Measured: For 9 minutes
Measuring pain intensity by computerized Visual Analog Scale Scoring
We will ask the subjects to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable".
Measured: For 9 minutes
Superficial blood perfusion measurement
Superficial blood perfusion is measured by a Speckle contrast imager
Measured: After 1 hour
Superficial blood perfusion measurement
Superficial blood perfusion is measured by a Speckle contrast imager
Measured: After 3 hours
Superficial blood perfusion measurement
Superficial blood perfusion is measured by a Speckle contrast imager
Measured: 10 min after cowhage application
Measuring Alloknesis
Alloknesis sensation is measured using a standardized sensory brush exerting a force of 200 to 400 mN.
Measured: After 1 hour
Measuring Alloknesis
Alloknesis sensation is measured using a standardized sensory brush exerting a force of 200 to 400 mN.
Measured: After 3 hours
Measuring Alloknesis
Alloknesis sensation is measured using a standardized sensory brush exerting a force of 200 to 400 mN.
Measured: 10 min after cowhage application
Measuring Hyperknesis
Hyperknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Measured: After 1 hour
Measuring Hyperknesis
Hyperknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Measured: After 3 hours
Measuring Hyperknesis
Hyperknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Measured: 10 min after cowhage application
Secondary outcomes (6)
Measuring Erythema
The onset of erythema is measured with a spectrometer (ColorMeter, DSM II; Cortex Technology, Hadsund, Denmark).
Measured: After 1 hour
Measuring Erythema
The onset of erythema is measured with a spectrometer (ColorMeter, DSM II; Cortex Technology, Hadsund, Denmark).
Measured: After 3 hours
Measuring Erythema
The onset of erythema is measured with a spectrometer (ColorMeter, DSM II; Cortex Technology, Hadsund, Denmark).
Measured: 10 min after cowhage application
Measuring Skin Pigmentation
The onset of skin pigmentation is measured with a spectrometer (ColorMeter, DSM II; Cortex Technology, Hadsund, Denmark).
Measured: After 1 hour
Measuring Skin Pigmentation
The onset of skin pigmentation is measured with a spectrometer (ColorMeter, DSM II; Cortex Technology, Hadsund, Denmark).
Measured: After 3 hours
Measuring Skin Pigmentation
The onset of skin pigmentation is measured with a spectrometer (ColorMeter, DSM II; Cortex Technology, Hadsund, Denmark).
Measured: 10 min after cowhage application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start15 Nov 2021
- Primary completion1 Aug 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ItchStudies 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
- 22 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
- NCT04858360
- Sponsor's protocol ID
- N-20200073 1st sub-project
- Status last verified
- Jan 2023
- First submitted
- 21 Apr 2021
- Last updated
- 18 Jan 2023
- 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 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Repeated Administration of Topical Local Anaesthetic Mixture of Lidocaine and Prilocaine (EMLA) in a Model of Non-histaminergic Itch Induced by Cowhage.
- ClinicalTrials.gov ID
- NCT04858360
- Acronym / sponsor ID
- N-20200073 1st sub-project
- Conditions
- Itch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 26 Apr 2021 (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.
With this experiment, we want to use to investigate whether repeated application of EMLA cream as a tool to modulate non-histaminergic itching, which is produced using small needles from the plant mucuna pruriens (it is known that antihistamine does not attenuate this form of itch) and we want to compare the effect of short (1 hour) and prolonged (3 hours) application of EMLA. The sub-project takes place in 3 sessions over a period of 3 consecutive days (24 hours apart). All sessions will be identical.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Emla 1 hour, Drug: EMLA 3 hours, Other: Vehicle cream for 1 hour, Other: Vehicle cream for 3 hours, Other: 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 (11 listed)
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids or other drugs
- Previous or current neurologic, musculoskeletal or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.).
- Lack of ability to cooperate
- Current use of medications that may affect the trial such as antihistamine medications or pain killers.
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 1 hourAt the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then one area will be pre-treated with cutaneous 2.5% lidocaine/2.5% prilocaine cream (EMLA cream) for 1 hour. | Drug | Study group |
| EMLA 3 hoursAt the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then one area will be pre-treated with cutaneous 2.5% lidocaine/2.5% prilocaine cream (EMLA cream) for 3 hours. | Drug | Study group |
| Vehicle cream for 1 hourAt the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then two area will be pre-treated with a vehicle cream for 1 h. | Other | Study group |
| Vehicle cream for 3 hoursAt the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then two area will be pre-treated with a vehicle cream for 3 h. | Other | Study group |
| CowhageCowhage spicules are 1-2 mm in length and have a diameter of 1-3 μm. The spicules are inserted by gently rubbing 30-35 spicules into a 1 cm diameter skin area. | Other | Study group |
Primary outcome
Measuring itch intensity by computerized Visual Analog Scale Scoring
Time frame: For 9 minutes
We will ask the subjects to rate the sensation of itch on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable
Measuring pain intensity by computerized Visual Analog Scale Scoring
Time frame: For 9 minutes
We will ask the subjects to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable".
Superficial blood perfusion measurement
Time frame: After 1 hour
Superficial blood perfusion is measured by a Speckle contrast imager
Superficial blood perfusion measurement
Time frame: After 3 hours
Superficial blood perfusion is measured by a Speckle contrast imager
Superficial blood perfusion measurement
Time frame: 10 min after cowhage application
Superficial blood perfusion is measured by a Speckle contrast imager
Measuring Alloknesis
Time frame: After 1 hour
Alloknesis sensation is measured using a standardized sensory brush exerting a force of 200 to 400 mN.
Measuring Alloknesis
Time frame: After 3 hours
Alloknesis sensation is measured using a standardized sensory brush exerting a force of 200 to 400 mN.
Measuring Alloknesis
Time frame: 10 min after cowhage application
Alloknesis sensation is measured using a standardized sensory brush exerting a force of 200 to 400 mN.
Measuring Hyperknesis
Time frame: After 1 hour
Hyperknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Measuring Hyperknesis
Time frame: After 3 hours
Hyperknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Measuring Hyperknesis
Time frame: 10 min after cowhage application
Hyperknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
6 secondary outcomes
Measuring Erythema
Time frame: After 1 hour
Measuring Erythema
Time frame: After 3 hours
Measuring Erythema
Time frame: 10 min after cowhage application
Measuring Skin Pigmentation
Time frame: After 1 hour
Measuring Skin Pigmentation
Time frame: After 3 hours
Measuring Skin Pigmentation
Time frame: 10 min after cowhage application
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 18 Jan 2023.
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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 1 hour, EMLA 3 hours and Cowhage in people with 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 11 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 18 Jan 2023. 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?
Measuring itch intensity by computerized Visual Analog Scale Scoring (time frame: For 9 minutes). The study lists 11 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 18 Jan 2023.