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Not yet recruitingNCT07932366Updated Nov 12, 2026

Effect of Pre-heat Conditioning on Histaminergic Itch

An interventional study of Heat application and Histamine 1 drop in ITCH and Heat, sponsored by Aalborg University. Not yet recruiting at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.

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

Updated Nov 12, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This project aims to create a reliable, long-lasting itch model by synergistically combining thermal pre-conditioning with the application of histamine in one or multiple injection sites

02

Conditions studied

  • ITCH
  • Heat
03

In context

Lead sponsor

Aalborg University is the lead sponsor of 183 studies on the registry; 32 are open to participants now.

Browse Aalborg University studies →

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
  • 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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Heat pre-conditioning

    38 °C x 5 min

    Other: Heat application · Other: Histamine 1 drop · Other: Histamine 2 drops

Interventions

  • OtherHeat application

    38 °C x 5 min

  • OtherHistamine 1 drop

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

  • OtherHistamine 2 drops

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

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

    Time frame: During Histamine application

  2. Superficial blood perfusion

    Time frame: Before pruritogen application

  3. Superficial blood perfusion

    Time frame: 1 minute after pruritogen removal

Secondary outcomes

  1. Alloknesis

    is measured by using a brush

    Time frame: Before pruritogen application

  2. Alloknesis

    is measured by using a brush

    Time frame: 2 minutes after pruritogen removal

  3. 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: Before pruritogen application

  4. 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: 5 minute after 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

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.

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

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Nov 9, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2028
Last update
Nov 12, 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.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 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
NCT07932366
Lead sponsor
Aalborg University
Responsible party
Silvia Lo Vecchio (Associate professor, Aalborg University) — Principal investigator
First posted
Nov 12, 2026
Start date
Nov 9, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Nov 12, 2026

Study contacts

Silvia Lo Vecchio
Contact
slv@hst.aau.dk
21397785

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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