ClinicalTrials.gg
CompletedNCT07395882Updated Nov 9, 2026

A New Model to Induce Itch and Inflammation

An interventional study of Cowhage (Mucuna Pruriens) and Histamine in Itching, sponsored by Aalborg University. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Aalborg University · Not applicable, Interventional, and Other

Updated Nov 9, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 25 studies in Pruritus by Aalborg University — 4 open to participants now, 6 under way, none of them phase 3. Pruritus · Aalborg University.

Enrollment
9th of 25
28 · median 25
Started
2026
the only one that year
No phase
25 of 25
4 open now
Registered
25th of 25
by date

Among the 25 studies in Pruritus by Aalborg University, this one is the 9th largest by enrollment, is the only one that started in 2026, is one of 25 with no phase, and was the 25th registered.

Pruritus

491 studies on the registry are indexed under Pruritus; 94 are open to participants now.

Browse Pruritus studies →

Open to participants now

4 of the 25 studies in Pruritus by Aalborg University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 54 Pruritus studies recruiting now, 22 (41%) set no upper age limit and 24 (44%) stop at 75 or younger; 15 take children under 18; 10 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 25 studies in Pruritus by Aalborg University, or all of them as a file.
02

Study summary

This project aims to create a reliable, long-lasting itch model by synergistically combining thermal pre-conditioning with the application of histamine or cowhage.

Read the detailed description

Two areas (4x4 cm, one on each forearm), will be selected. Initially, superficial blood perfusion will be measured in each area, followed by pruritogens application. During the 10 minutes of the application of the pruritogens, itch will be continuously monitored using a VAS scale. After the pruritogens application, assessment of the superficial blood perfusion (SBP), mechanical sensitivity, and thermal sensitivity will be conducted. The session will be identical to the first session, but pre-heat conditioning will be applied prior to pruritogens application.

03

Conditions studied

  • Itching

Browse trials for

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
  • 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 addictive drugs
  • Previous or current history of neurological (e.g., neuropathy), immunological (e.g., asthma, immune deficiencies, arthritis), musculoskeletal (e.g., muscular pain in the upper extremities), cardiac disorder (e.g., stroke), or psychiatric diagnoses (e.g., depression, bipolar disorders, acute and chronic psychosis) that may affect the results
  • Current use of medications that may affect the trial, such as antihistamines, antipsychotics, painkillers, and systemic or topical
  • Skin diseases (e.g., atopic dermatitis, pruritus nodularis, eczema, psoriasis)
  • Moles, scars, or tattoos in the area to be treated or tested (forearm/hand).
  • Consumption of alcohol or painkillers 24 hours before the study days and between these
  • Acute or chronic pain
  • Unable to answer the "Transcranial Magnetic Stimulation Adult Safety Screen" (subprojects 2-4)
  • to transcranial magnetic stimulation (TMS) application (history of epilepsy, metal implants in head or jaw, etc.) (subprojects 2-4)
  • Presence of implanted hearing aids or metal implants on the face, including permanent makeup or tattoos (subprojects 2-4)
  • Contraindications to capsaicin, including intolerance to chili or burns or wounds at the application sites (subprojects 2, 3, and 4)
  • Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
  • The subject is assessed as unable to engage in the necessary cooperation required by the study
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Active group

    Heath will be applied prior pruritogens application

    Other: Cowhage (Mucuna Pruriens) · Other: Histamine · Other: Heat

Interventions

  • OtherCowhage (Mucuna Pruriens)

    The spicules will be manually inserted. Approximately 30-35 spicules are gently rubbed into a 1 cm diameter skin area on the forearm/face

  • OtherHistamine

    To deliver histamine, standard allergy skin prick test (SPT) lancets are applied

  • OtherHeat

    45 °C x 5 min

06

What researchers measure

Primary outcomes

  1. Measuring pain by computerized Visual Analog Scale Scoring

    We will ask the subjects to rate the sensation of pain on a 100

    Time frame: Day 1

  2. Measuring Itch by computerized Visual Analog Scale Scoring

    We will ask the subjects to rate the sensation of itch on a 100

    Time frame: Day 1

  3. Measuring pain by computerized Visual Analog Scale Scoring

    We will ask the subjects to rate the sensation of pain on a 100

    Time frame: Day 2

  4. Measuring Itch by computerized Visual Analog Scale Scoring

    We will ask the subjects to rate the sensation of itch on a 100

    Time frame: Day 2

Secondary outcomes

  1. Superficial blood perfusion

    Superficial blood perfusion (SBP) is measured by a Speckle contrast imager

    Time frame: Day 1

  2. Superficial blood perfusion

    Superficial blood perfusion (SBP) is measured by a Speckle contrast imager

    Time frame: Day 2

  3. Alloknesis

    Measured using a standardized sensory brush exerting a force of 200 to 400 mN.

    Time frame: Day 1

  4. Alloknesis

    Measured using a standardized sensory brush exerting a force of 200 to 400 mN.

    Time frame: Day 2

  5. 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: Day 1

  6. 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: Day 2

  7. 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: Day 1

  8. 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: Day 2

  9. Mechanical Pain Sensitivity (MPS)

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

    Time frame: Day 1

  10. Mechanical Pain Sensitivity (MPS)

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

    Time frame: Day 2

  11. Cold Detection Thresholds (CDT)

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

    Time frame: Day 1

  12. Cold Detection Thresholds (CDT)

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

    Time frame: Day 2

  13. Warm Detection Thresholds (WDT)

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

    Time frame: Day 1

  14. Warm Detection Thresholds (WDT)

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

    Time frame: Day 2

  15. Cold Pain Thresholds (CPT)

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

    Time frame: Day 1

  16. Cold Pain Thresholds (CPT)

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

    Time frame: Day 2

  17. Heat Pain Thresholds (HPT)

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

    Time frame: Day 1

  18. Heat Pain Thresholds (HPT)

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

    Time frame: Day 2

  19. Pain to Supra-threshold Heat Stimuli (STHS)

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

    Time frame: Day 1

  20. Pain to Supra-threshold Heat Stimuli (STHS)

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

    Time frame: Day 2

07

Study locations

1 site
  • Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark
    Aalborg, Aalborg 9620, Denmark
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2026 to primary completion in Sep 2026, 7 months.

Of 85 non-industry interventional studies with no phase under Pruritus, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's 7 months is close to that.

Counting every sponsor, half of 101 studies reached it within 7 months; a quarter within 3 and three quarters within 13.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 9, 2026: primary completion Dec 2028 → Sep 2026 and completion Dec 2029 → Sep 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2026
First posted
Feb 9, 2026
StartActual
Feb 15, 2026
Primary completionActual
Sep 30, 2026was Dec 2028
CompletionActual
Sep 30, 2026was Dec 2029
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Completed
changed Nov 9, 2026
Primary completion
Dec 31, 2028→Sep 30, 2026 (actual)
Nov 9, 2026
Study completion
Dec 31, 2029→Sep 30, 2026 (actual)
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Not yet recruiting→Completed
    Primary completion Dec 31, 2028→Sep 30, 2026 (now actual)
    Study completion Dec 31, 2029→Sep 30, 2026 (now actual)
    + 1 other change: contact details

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 ↗

09

Registry details

Key details

Study ID
NCT07395882
Lead sponsor
Aalborg University
Responsible party
Silvia Lo Vecchio (Associate Professor, Aalborg University) — Principal investigator
First posted
Feb 9, 2026
Start date
Feb 15, 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026
Last update
Nov 9, 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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