ItchELITNCT05195177
Testing Protocol to Efficiently Induce Itch
A study testing Anti-histamine cream 1 hour and Local anesthetic cream 1 hour in people with Itch, run by Aalborg University at 1 site in Denmark.
Trial summary
This subproject aims to evaluate a new nerve excitability protocol to induce itch in healthy controls by electrical stimulation. Itch has many similarities with pain, and the nerve fibers that mediate the two sensations probably have the same morphological and excitability properties. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Itch
- What is being tested?
- Anti-histamine cream 1 hour and Local anesthetic cream 1 hour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 25 Nov 2021to 20 Dec 2023
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women in the age 18-80 years who speak and understand
Who cannot join
- Pregnancy or breast feeding
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous and present neurologic, musculoskeletal or mental illnesses (e.g., epilepsy, neuropathy, fibromyalgia and depression)
- Skin diseases
- Past history of conditions possibly leading to neuropathy
- Inability to cooperate
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- Current use of medications that may affect the study, e.g., analgesics
- Previous traumatic experience of an electrical accident
- Consumption of alcohol or painkillers within the last 24 hours
- Participation in other pain studies throughout the study period
- Patients with cardiac diseases (e.g., pacemaker).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nerve Excitability Testing Protocol to Efficiently Induce Itch
This subproject aims to evaluate a new nerve excitability protocol to induce itch in healthy controls by electrical stimulation. Itch has many similarities with pain, and the nerve fibers that mediate the two sensations probably have the same morphological and excitability properties. The method used in this project will be the same as our research group uses for studying nociceptor fibers (PTT technique), but the focus is on the itch sensation. Since the itch fibers also terminate in the epidermis, our PTT technique should also be able to activate itch fibers, similar to pain fibers. If itch could be effectively induced by electrical stimulation, this would generate a valuable tool for studying itch in healthy controls. The sub-project takes place in 2 sessions (2 hours each).
- Conditions
- Itch
- Being tested
- Anti-histamine cream 1 hour, Local anesthetic cream 1 hour
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-histamine cream 1 hourDrug
At the start of session 1, one area of the middle forearms of the participant will be located (4x4cm). On the area, anti-histamine cream will be applied for approximately 1 hour.
Local anesthetic cream 1 hourDrug
At the start of session 2, one area of the middle forearms of the participant will be located (4x4cm). On the area, local anesthetic cream (2.5% lidocain/2.5 prilocaine) will be applied for approximately 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Not described Receives: Drug: Anti-histamine cream 1 hour; Drug: Local anesthetic cream 1 hour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception threshold for pulse shape 1
The perception threshold will be estimated for the electrical stimuli with pulse shape 1. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Measured: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Perception threshold for pulse shape 2
The perception threshold will be estimated for the electrical stimuli with pulse shape 2. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Measured: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Perception threshold for pulse shape 3
The perception threshold will be estimated for the electrical stimuli with pulse shape 3. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Measured: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Perception threshold for pulse shape 4
The perception threshold will be estimated for the electrical stimuli with pulse shape 4. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Measured: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Perception threshold for pulse shape 1 when antihistamine cream has been applied
The perception threshold will be estimated for the electrical stimuli with pulse shape 1 when anti-histamine cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Measured: This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
Perception threshold for pulse shape 2 when anti-histamine cream has been applied
The perception threshold will be estimated for the electrical stimuli with pulse shape 2 when anti-histamine cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Measured: This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
Perception threshold for pulse shape 3 when anti-histamine cream has been applied
The perception threshold will be estimated for the electrical stimuli with pulse shape 3 when anti-histamine cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Measured: This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
Perception threshold for pulse shape 4 when anti-histamine cream has been applied
The perception threshold will be estimated for the electrical stimuli with pulse shape 4 when anti-histamine cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Measured: This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
Perception threshold for pulse shape 1 when local anaesthetic cream has been applied
The perception threshold will be estimated for the electrical stimuli with pulse shape 1 when local anaesthetic cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Measured: This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
Perception threshold for pulse shape 2 when local anaesthetic cream has been applied
The perception threshold will be estimated for the electrical stimuli with pulse shape 2 when local anaesthetic cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Measured: This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
Perception threshold for pulse shape 3 when local anaesthetic cream has been applied
The perception threshold will be estimated for the electrical stimuli with pulse shape 3 when local anaesthetic cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Measured: This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
Perception threshold for pulse shape 4 when local anaesthetic cream has been applied
The perception threshold will be estimated for the electrical stimuli with pulse shape 4 when local anaesthetic cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Measured: This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
Sensation for pulse 1
The investigator will ask the participant to rate the sensation of electrical stimulation with pulse 1 for the three different conditions. The conditions are: control (not active cream), antihistamine cream, and local anesthetic cream. The scale is 0-10 for the three sensations touch, itch, and pain. Zero means no sensation, and ten is the worst pain/touch/itch imaginable.
Measured: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Sensation for pulse 2
The investigator will ask the participant to rate the sensation of electrical stimulation with pulse 2 for the three different conditions. The conditions are: control (not active cream), antihistamine cream, and local anesthetic cream. The scale is 0-10 for the three sensations touch, itch, and pain. Zero means no sensation, and ten is the worst pain/touch/itch imaginable.
Measured: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Sensation for pulse 3
The investigator will ask the participant to rate the sensation of electrical stimulation with pulse 3 for the three different conditions. The conditions are: control (not active cream), antihistamine cream, and local anesthetic cream. The scale is 0-10 for the three sensations touch, itch, and pain. Zero means no sensation, and ten is the worst pain/touch/itch imaginable.
Measured: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Sensation for pulse 4
The investigator will ask the participant to rate the sensation of electrical stimulation with pulse 4 for the three different conditions. The conditions are: control (not active cream), antihistamine cream, and local anesthetic cream. The scale is 0-10 for the three sensations touch, itch, and pain. Zero means no sensation, and ten is the worst pain/touch/itch imaginable.
Measured: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start25 Nov 2021
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Tigerholm, Aalborg University
- Investigators
- Jenny Tigerholm, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195177
- Sponsor's protocol ID
- N-2020001 4-sub-project
- Acronym
- ELIT
- Status last verified
- Aug 2023
- First submitted
- 23 Nov 2021
- Last updated
- 2 Aug 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 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nerve Excitability Testing Protocol to Efficiently Induce Itch
- ClinicalTrials.gov ID
- NCT05195177
- Acronym / sponsor ID
- ELIT / N-2020001 4-sub-project
- Conditions
- Itch
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 18 Jan 2022 (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.
This subproject aims to evaluate a new nerve excitability protocol to induce itch in healthy controls by electrical stimulation. Itch has many similarities with pain, and the nerve fibers that mediate the two sensations probably have the same morphological and excitability properties. The method used in this project will be the same as our research group uses for studying nociceptor fibers (PTT technique), but the focus is on the itch sensation. Since the itch fibers also terminate in the epidermis, our PTT technique should also be able to activate itch fibers, similar to pain fibers. If itch could be effectively induced by electrical stimulation, this would generate a valuable tool for studying itch in healthy controls. The sub-project takes place in 2 sessions (2 hours each).
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: Anti-histamine cream 1 hour, Drug: Local anesthetic cream 1 hour |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy men and women in the age 18-80 years who speak and understand
Key exclusion criteria (11 listed)
- Pregnancy or breast feeding
- Drug addiction defined as the use of cannabis, opioids or other drugs
- Previous and present neurologic, musculoskeletal or mental illnesses (e.g., epilepsy, neuropathy, fibromyalgia and depression)
- Skin diseases
- Past history of conditions possibly leading to neuropathy
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 |
|---|---|---|
| Anti-histamine cream 1 hourAt the start of session 1, one area of the middle forearms of the participant will be located (4x4cm). On the area, anti-histamine cream will be applied for approximately 1 hour. | Drug | Study group |
| Local anesthetic cream 1 hourAt the start of session 2, one area of the middle forearms of the participant will be located (4x4cm). On the area, local anesthetic cream (2.5% lidocain/2.5 prilocaine) will be applied for approximately 1 hour. | Drug | Study group |
Primary outcome
Perception threshold for pulse shape 1
Time frame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
The perception threshold will be estimated for the electrical stimuli with pulse shape 1. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 2
Time frame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
The perception threshold will be estimated for the electrical stimuli with pulse shape 2. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 3
Time frame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
The perception threshold will be estimated for the electrical stimuli with pulse shape 3. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 4
Time frame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
The perception threshold will be estimated for the electrical stimuli with pulse shape 4. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 1 when antihistamine cream has been applied
Time frame: This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
The perception threshold will be estimated for the electrical stimuli with pulse shape 1 when anti-histamine cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 2 when anti-histamine cream has been applied
Time frame: This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
The perception threshold will be estimated for the electrical stimuli with pulse shape 2 when anti-histamine cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 3 when anti-histamine cream has been applied
Time frame: This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
The perception threshold will be estimated for the electrical stimuli with pulse shape 3 when anti-histamine cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 4 when anti-histamine cream has been applied
Time frame: This outcome measurement will be estimated during session one. The outcome measure takes approximately 5 minutes to estimate.
The perception threshold will be estimated for the electrical stimuli with pulse shape 4 when anti-histamine cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 1 when local anaesthetic cream has been applied
Time frame: This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
The perception threshold will be estimated for the electrical stimuli with pulse shape 1 when local anaesthetic cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 2 when local anaesthetic cream has been applied
Time frame: This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
The perception threshold will be estimated for the electrical stimuli with pulse shape 2 when local anaesthetic cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 3 when local anaesthetic cream has been applied
Time frame: This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
The perception threshold will be estimated for the electrical stimuli with pulse shape 3 when local anaesthetic cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Perception threshold for pulse shape 4 when local anaesthetic cream has been applied
Time frame: This outcome measurement will be estimated during session two. The outcome measure takes approximately 5 minutes to estimate.
The perception threshold will be estimated for the electrical stimuli with pulse shape 4 when local anaesthetic cream has been applied for approximately an hour. The perception threshold is defined as the transcutaneous electrical current needed for the participant to perceive the stimulus. The electrode will be placed on the arm. The perception threshold will be estimated by the method of limits and the psi method.
Sensation for pulse 1
Time frame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
The investigator will ask the participant to rate the sensation of electrical stimulation with pulse 1 for the three different conditions. The conditions are: control (not active cream), antihistamine cream, and local anesthetic cream. The scale is 0-10 for the three sensations touch, itch, and pain. Zero means no sensation, and ten is the worst pain/touch/itch imaginable.
Sensation for pulse 2
Time frame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
The investigator will ask the participant to rate the sensation of electrical stimulation with pulse 2 for the three different conditions. The conditions are: control (not active cream), antihistamine cream, and local anesthetic cream. The scale is 0-10 for the three sensations touch, itch, and pain. Zero means no sensation, and ten is the worst pain/touch/itch imaginable.
Sensation for pulse 3
Time frame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
The investigator will ask the participant to rate the sensation of electrical stimulation with pulse 3 for the three different conditions. The conditions are: control (not active cream), antihistamine cream, and local anesthetic cream. The scale is 0-10 for the three sensations touch, itch, and pain. Zero means no sensation, and ten is the worst pain/touch/itch imaginable.
Sensation for pulse 4
Time frame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.
The investigator will ask the participant to rate the sensation of electrical stimulation with pulse 4 for the three different conditions. The conditions are: control (not active cream), antihistamine cream, and local anesthetic cream. The scale is 0-10 for the three sensations touch, itch, and pain. Zero means no sensation, and ten is the worst pain/touch/itch imaginable.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 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.
Jenny Tigerholm 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 Anti-histamine cream 1 hour and Local anesthetic cream 1 hour 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 1 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: status not confirmed, as of the sponsor's last update on 2 Aug 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?
Results are not available in the source record.
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?
Perception threshold for pulse shape 1 (time frame: This outcome measurement will be estimated during sessions one and two. The outcome measure takes approximately 5 minutes to estimate.). The study lists 16 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 2 Aug 2023.