ITCHNCT07887906
Pain Sensitivity and Pruritus of Peripheral Nerves
A study testing Mepyramine cream, Histamine Dihydrochloride (HDC) and Cowhage (Mucuna Pruriens) in people with ITCH, run by Aalborg University at 1 site in Denmark.
Trial summary
Previous research has demonstrated that itch and pain share several underlying neural pathways and signaling molecules. Understanding these common mechanisms is important for developing more effective therapeutic strategies targeting both sensations. 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?
- Mepyramine cream, Histamine Dihydrochloride (HDC) and Cowhage (Mucuna Pruriens)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Oct 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 aged 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 that may cause addiction.
- History of peripheral or chronic pain conditions, neuropathy, neurological, dermatological, or psychiatric diagnoses that may affect the results.
- Moles, wounds, scars, or tattoos in the area to be treated or tested
- Current use of medications that may affect the trial such as antihistamines, painkillers, antidepressants, or anticonvulsants
- Use of antihistamines should be discontinued 72 hours before the experiment and all topical agents and emollients should be discontinued 24 hours before the experiment.
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- Application of moisturizing lotion of the volar site of the forearms (24 hours before study start)
- Previous traumatic experience of an electrical accident
- Participation in any other research projects/studies 7 days before study start
- Known allergy/intolerance to mepyramine
- The subject is assessed as unable to engage in the necessary cooperation required by the study
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark
Gistrup, Aalborg, 9260
About this study
Official title: Pain Sensitivity and Pruritus of Peripheral Nerves - Can we Differentiate These Signals by Use of Pharmacological Modulation and Human Experimental Research?
Previous research has demonstrated that itch and pain share several underlying neural pathways and signaling molecules. Understanding these common mechanisms is important for developing more effective therapeutic strategies targeting both sensations. Mepyramine, an antihistamine, has been reported to exert effects on both itch and pain perception. In this study, we aim to investigate these effects using established experimental models of itch and pain. Itch will be induced using histamine, a naturally occurring substance in the human body, and spicules from the plant Mucuna pruriens (cowhage), while electrical stimulation will be used to assess pain-related responses. By combining these experimental approaches, we aim to better understand how mepyramine influences different sensory mechanisms. The overall purpose of this study is to evaluate the effects of mepyramine on experimentally induced itch and pain in healthy volunteers.
- Conditions
- ITCH
- Being tested
- Mepyramine cream, Histamine Dihydrochloride (HDC), Cowhage (Mucuna Pruriens)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepyramine creamDrug
Mepyramine cream 2%
Histamine Dihydrochloride (HDC)Other
One drop of histamine will be applied on the selected areas and pierced with a lancet.
Cowhage (Mucuna Pruriens)Other
About 30 spicules will be applied on the selected areas and inserted manually
| Study group | Role | What they receive |
|---|---|---|
| Interventions | Experimental | This subproject will be conducted in one single session lasting approximately 4-5 hours. In each forearm of the participant, two 4x4 cm areas will be selected as Area of Interest (AOI). In these selected areas, the same cream will be applied for 1 hour. After the cream removal, itch will be induced using histamine and cowhage (the order of histamine and cowhage will be randomized). During the application of the substances, the itch/pain elicited will be monitored for 10 minutes using a VAS (Visual analog scale). After the removal of the substances, measurements of SBP, MEI, PTT MPT, MPS, and thermal sensitivity will be conducted. Receives: Drug: Mepyramine cream; Other: Histamine Dihydrochloride (HDC); Other: Cowhage (Mucuna Pruriens) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring itch 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
Measured: During Histamine/cowhage application
Superficial blood perfusion
Measured: Before pruritogen application
Superficial blood perfusion
Measured: 1 minute after pruritogen removal
Superficial blood perfusion
Measured: 1 minute after cream+pruritogen removal
Perception threshold tracking model (PTT)
Measured: Before cream application
Perception threshold tracking model (PTT)
Measured: 1 minute after cream removal
Secondary outcomes (16)
Mechanically evoked itch (MEI)
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Measured: 2 minute after pruritogen removal
Mechanically evoked itch (MEI)
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Measured: 2 minute after cream+pruritogen removal
Mechanical Pain Thresholds (MPT)
This test is conducted using a pinprick set. The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN.
Measured: 5 minute after pruritogen removal
Mechanical Pain Thresholds (MPT)
This test is conducted using a pinprick set. The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN.
Measured: 5 minute after cream+pruritogen removal
Mechanical Pain Sensitivity (MPS)
This test is conducted with the same pinprick set used to test the MPT.
Measured: 8 minute after pruritogen removal
Mechanical Pain Sensitivity (MPS)
This test is conducted with the same pinprick set used to test the MPT.
Measured: 8 minute after cream+pruritogen removal
Cold Detection Thresholds (CDT)
The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device
Measured: 10 minute after pruritogen removal
Cold Detection Thresholds (CDT)
The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device
Measured: 10 minute after cream+pruritogen removal
Warm Detection Thresholds (WDT)
The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device
Measured: 10 minute after pruritogen removal
Warm Detection Thresholds (WDT)
The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device
Measured: 10 minute after cream+pruritogen removal
Cold Pain Thresholds (CPT)
The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device
Measured: 10 minute after pruritogen removal
Cold Pain Thresholds (CPT)
The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device
Measured: 10 minute after cream+pruritogen removal
Heat Pain Thresholds (HPT)
The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device
Measured: 10 minute after pruritogen removal
Heat Pain Thresholds (HPT)
The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device
Measured: 10 minute after cream+pruritogen removal
Pain to Supra-threshold Heat Stimuli (STHS)
The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device
Measured: 10 minute after pruritogen removal
Pain to Supra-threshold Heat Stimuli (STHS)
The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device
Measured: 10 minute after cream+pruritogen removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start15 Oct 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (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
- Model description
- In each participant, the same cream will be applied. After the cream removal, itch will be induced using histamine and cowhage.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Lo Vecchio, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887906
- Sponsor's protocol ID
- N-20260019
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Sensitivity and Pruritus of Peripheral Nerves - Can we Differentiate These Signals by Use of Pharmacological Modulation and Human Experimental Research?
- ClinicalTrials.gov ID
- NCT07887906
- Acronym / sponsor ID
- N-20260019
- Conditions
- ITCH
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Oct 2026 (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.
Previous research has demonstrated that itch and pain share several underlying neural pathways and signaling molecules. Understanding these common mechanisms is important for developing more effective therapeutic strategies targeting both sensations. Mepyramine, an antihistamine, has been reported to exert effects on both itch and pain perception. In this study, we aim to investigate these effects using established experimental models of itch and pain. Itch will be induced using histamine, a naturally occurring substance in the human body, and spicules from the plant Mucuna pruriens (cowhage), while electrical stimulation will be used to assess pain-related responses. By combining these experimental approaches, we aim to better understand how mepyramine influences different sensory mechanisms. The overall purpose of this study is to evaluate the effects of mepyramine on experimentally induced itch and pain in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In each participant, the same cream will be applied. After the cream removal, itch will be induced using histamine and cowhage.
| Arm | Type | Receives |
|---|---|---|
| Interventions | Experimental | Drug: Mepyramine cream, Other: Histamine Dihydrochloride (HDC), Other: Cowhage (Mucuna Pruriens)This subproject will be conducted in one single session lasting approximately 4-5 hours. In each forearm of the participant, two 4x4 cm areas will be selected as Area of Interest (AOI). In these selected areas, the same cream will be applied for 1 hour. After the cream removal, itch will be induced using histamine and cowhage (the order of histamine and cowhage will be randomized). During the application of the substances, the itch/pain elicited will be monitored for 10 minutes using a VAS (Visual analog scale). After the removal of the substances, measurements of SBP, MEI, PTT MPT, MPS, and thermal sensitivity will be conducted. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women aged 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 that may cause addiction.
- History of peripheral or chronic pain conditions, neuropathy, neurological, dermatological, or psychiatric diagnoses that may affect the results.
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 |
|---|---|---|
| Mepyramine creamMepyramine cream 2% | Drug | Interventions |
| Histamine Dihydrochloride (HDC)One drop of histamine will be applied on the selected areas and pierced with a lancet. | Other | Interventions |
| Cowhage (Mucuna Pruriens)About 30 spicules will be applied on the selected areas and inserted manually | Other | Interventions |
Primary outcome
Measuring itch by computerized Visual Analog Scale Scoring
Time frame: During Histamine/cowhage application
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
Superficial blood perfusion
Time frame: Before pruritogen application
Superficial blood perfusion
Time frame: 1 minute after pruritogen removal
Superficial blood perfusion
Time frame: 1 minute after cream+pruritogen removal
Perception threshold tracking model (PTT)
Time frame: Before cream application
Perception threshold tracking model (PTT)
Time frame: 1 minute after cream removal
16 secondary outcomes
Mechanically evoked itch (MEI)
Time frame: 2 minute after pruritogen removal
Mechanically evoked itch (MEI)
Time frame: 2 minute after cream+pruritogen removal
Mechanical Pain Thresholds (MPT)
Time frame: 5 minute after pruritogen removal
Mechanical Pain Thresholds (MPT)
Time frame: 5 minute after cream+pruritogen removal
Mechanical Pain Sensitivity (MPS)
Time frame: 8 minute after pruritogen removal
Mechanical Pain Sensitivity (MPS)
Time frame: 8 minute after cream+pruritogen removal
Cold Detection Thresholds (CDT)
Time frame: 10 minute after pruritogen removal
Cold Detection Thresholds (CDT)
Time frame: 10 minute after cream+pruritogen removal
Warm Detection Thresholds (WDT)
Time frame: 10 minute after pruritogen removal
Warm Detection Thresholds (WDT)
Time frame: 10 minute after cream+pruritogen removal
Cold Pain Thresholds (CPT)
Time frame: 10 minute after pruritogen removal
Cold Pain Thresholds (CPT)
Time frame: 10 minute after cream+pruritogen removal
Heat Pain Thresholds (HPT)
Time frame: 10 minute after pruritogen removal
Heat Pain Thresholds (HPT)
Time frame: 10 minute after cream+pruritogen removal
Pain to Supra-threshold Heat Stimuli (STHS)
Time frame: 10 minute after pruritogen removal
Pain to Supra-threshold Heat Stimuli (STHS)
Time frame: 10 minute after cream+pruritogen removal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
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Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepyramine cream, Histamine Dihydrochloride (HDC) and Cowhage (Mucuna Pruriens) 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 2 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: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 by computerized Visual Analog Scale Scoring (time frame: During Histamine/cowhage application). 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 22 Oct 2026.