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Active, not recruitingNCT07887906Updated Oct 22, 2026

Pain Sensitivity and Pruritus of Peripheral Nerves

An interventional study of Mepyramine cream and Histamine Dihydrochloride (HDC) in ITCH, sponsored by Aalborg University. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Aalborg University · Not applicable, Interventional, and Basic science

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • ITCH
03

In context

Lead sponsor

Aalborg University is the lead sponsor of 182 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy men and women aged 18-60 years
  • Speak and understand English

Exclusion criteria

Exclusion Criteria:

  • 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.
    • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Interventions

    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.

    Drug: Mepyramine cream · Other: Histamine Dihydrochloride (HDC) · Other: Cowhage (Mucuna Pruriens)

Interventions

  • DrugMepyramine cream

    Mepyramine cream 2%

  • OtherHistamine Dihydrochloride (HDC)

    One drop of histamine will be applied on the selected areas and pierced with a lancet.

  • OtherCowhage (Mucuna Pruriens)

    About 30 spicules will be applied on the selected areas and inserted manually

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: During Histamine/cowhage application

  2. Superficial blood perfusion

    Time frame: Before pruritogen application

  3. Superficial blood perfusion

    Time frame: 1 minute after pruritogen removal

  4. Superficial blood perfusion

    Time frame: 1 minute after cream+pruritogen removal

  5. Perception threshold tracking model (PTT)

    Time frame: Before cream application

  6. Perception threshold tracking model (PTT)

    Time frame: 1 minute after cream removal

Secondary outcomes

  1. 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).

    Time frame: 2 minute after pruritogen removal

  2. 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).

    Time frame: 2 minute after cream+pruritogen removal

  3. 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.

    Time frame: 5 minute after pruritogen removal

  4. 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.

    Time frame: 5 minute after cream+pruritogen removal

  5. Mechanical Pain Sensitivity (MPS)

    This test is conducted with the same pinprick set used to test the MPT.

    Time frame: 8 minute after pruritogen removal

  6. Mechanical Pain Sensitivity (MPS)

    This test is conducted with the same pinprick set used to test the MPT.

    Time frame: 8 minute after cream+pruritogen removal

  7. Cold Detection Thresholds (CDT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: 10 minute after pruritogen removal

  8. Cold Detection Thresholds (CDT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: 10 minute after cream+pruritogen removal

  9. Warm Detection Thresholds (WDT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: 10 minute after pruritogen removal

  10. Warm Detection Thresholds (WDT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: 10 minute after cream+pruritogen removal

  11. Cold Pain Thresholds (CPT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: 10 minute after pruritogen removal

  12. Cold Pain Thresholds (CPT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: 10 minute after cream+pruritogen removal

  13. Heat Pain Thresholds (HPT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: 10 minute after pruritogen removal

  14. Heat Pain Thresholds (HPT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: 10 minute after cream+pruritogen removal

  15. 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

    Time frame: 10 minute after pruritogen removal

  16. 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

    Time frame: 10 minute after cream+pruritogen removal

07

Study locations

1 site
  • Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark
    Gistrup, Aalborg 9260, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07887906
Lead sponsor
Aalborg University
Responsible party
Silvia Lo Vecchio (Associate professor, Aalborg University) — Principal investigator
First posted
Oct 22, 2026
Start date
Oct 15, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 22, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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