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RecruitingNCT07203274Updated Nov 9, 2026

The Role of Janus Kinase (JAK) and Voltage-gated Sodium Channels (Nav) on Pain and Itch

An interventional study of Delgocitinib cream and lidocaine cream in Itchiness, sponsored by Aalborg University. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

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

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Updated Nov 9, 2026Now RecruitingSite recruiting status changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

It is well known that itch and pain have many communalities in terms of pathways and molecules involved. Therefore, it is very important to investi-gate different substances that work against both pain and itching. The substances delgocitinib and lidocaine have both been shown to relieve various types of pain. We therefore assume that these creams will be also able to relieve itching. The purpose of this trial experiment is therefore to investigate the effect of delgocitinib, lidocaine and their combination on experimentally induced itching.

02

Conditions studied

  • Itchiness
03

In context

Lead sponsor

Aalborg University is the lead sponsor of 182 studies on the registry; 31 are open to participants now.

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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 drugs that may cause addiction.
    • Previous or current history of neurological, dermatological (e.g., AD, psoriasis, etc.), immunological, musculoskeletal, cardiac disorder or psychiatric diagnoses that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia, etc.)
    • 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 and painkillers
    • 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).
    • Use of systemic and topical
    • Previous traumatic experience of an electrical accident
    • Application of moisturizing lotion of the volar site of the forearms (24 hours before study start)
    • Skin diseases
    • Consumption of alcohol or painkillers 24 hours before the study days and between these
    • Acute or chronic pain and itch
    • Known allergy/intolerance to lidocaine/phenytoin/mepyramine
    • Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical studies)
    • Lack of ability to cooperate
Terms in these criteria, in plain language(1)

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.

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
    Cream application

    This subproject will be conducted in two sessions one week apart. Each session will last 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 four different creams will be applied in randomized position for 1 hour. After the cream removal, itch will be induced using histamine in one session and cowhage in the other session (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: Delgocitinib cream · Drug: lidocaine cream · Combination Product: Lidocaine+Delgocitinib · Drug: Vehicle (placebo) · Other: Histamine Dihydrochloride (HDC) · Other: Cowhage (Mucuna Pruriens)

Interventions

  • DrugDelgocitinib cream

    Delgocitinib cream

  • Druglidocaine cream

    Lidocaine cream

  • Combination productLidocaine+Delgocitinib

    Drug pages: Lidocaine · Delgocitinib

    The two cream will me mixed togheter

  • DrugVehicle (placebo)

    Vehicle Cream

  • 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 "no itch" and 100 indicates "worst itch imaginable".

    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 mm VAS scale ranging from 0 to 100 where 0 indicates "no itch" and 100 indicates "worst itch imaginable".

    Time frame: Day 2

  3. Superficial blood perfusion

    Time frame: Day 1

  4. Superficial blood perfusion

    Time frame: Day 2

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: Day 1

  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: Day 2

  3. Perception threshold tracking model (PTT)

    Time frame: Day 1

  4. Perception threshold tracking model (PTT)

    Time frame: Day 2

  5. 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

  6. 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

  7. Mechanical Pain Sensitivity (MPS)

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

    Time frame: Day 1

  8. Mechanical Pain Sensitivity (MPS)

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

    Time frame: Day 2

  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: Day 1

  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: Day 2

  11. 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: Day 1

  12. 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: Day 2

  13. 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: Day 1

  14. 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: Day 2

  15. 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: Day 1

  16. 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: Day 2

  17. 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: Day 1

  18. 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: Day 2

07

Study locations

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

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 9, 2026
Sites
Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark is now Recruiting
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    Not yet recruiting→Recruiting
    Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark is now Recruiting
    + 2 other changes: verification date and date precision

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
NCT07203274
Lead sponsor
Aalborg University
Responsible party
Silvia Lo Vecchio (Associate professor, Aalborg University) — Principal investigator
First posted
Oct 2, 2025
Start date
May 1, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 9, 2026

Study contacts

Silvia Lo Vecchio
Contact
slv@hst.aau.dk
+4521397785

Oversight

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

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Studies of the drugs tested here: Delgocitinib · Lidocaine

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