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NCT Number: NCT07203274

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

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.

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Key information

Conditions

Itchiness

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Gistrup, 9260, Denmark

Location contact

Silvia Lo Vecchio

CONTACT

[email protected]

+4521397785

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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 corticosteroids
  • 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

Treatment and study plan

Delgocitinib cream

Drug

Delgocitinib cream

Lidocaine Cream

Drug

Lidocaine cream

Lidocaine+Delgocitinib

Combination Product

The two cream will me mixed togheter

Vehicle (placebo)

Drug

Vehicle Cream

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

Primary outcomes

  1. Measuring itch by computerized Visual Analog Scale Scoring

    Time frame: Day 1

    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".

  2. Measuring itch by computerized Visual Analog Scale Scoring

    Time frame: Day 2

    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".

  3. Superficial blood perfusion

    Time frame: Day 1

  4. Superficial blood perfusion

    Time frame: Day 2

Secondary outcomes

  1. Mechanically evoked itch (MEI)

    Time frame: Day 1

    MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).

  2. Mechanically evoked itch (MEI)

    Time frame: Day 2

    MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).

  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)

    Time frame: Day 1

    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.

  6. Mechanical Pain Thresholds (MPT)

    Time frame: Day 2

    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.

  7. Mechanical Pain Sensitivity (MPS)

    Time frame: Day 1

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

  8. Mechanical Pain Sensitivity (MPS)

    Time frame: Day 2

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

  9. Warm Detection Thresholds (WDT)

    Time frame: Day 1

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

  10. Warm Detection Thresholds (WDT)

    Time frame: Day 2

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

  11. Cold Detection Thresholds (CDT)

    Time frame: Day 1

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

  12. Cold Detection Thresholds (CDT)

    Time frame: Day 2

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

  13. Cold Pain Thresholds (CPT)

    Time frame: Day 1

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

  14. Cold Pain Thresholds (CPT)

    Time frame: Day 2

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

  15. Heat Pain Thresholds (HPT)

    Time frame: Day 1

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

  16. Heat Pain Thresholds (HPT)

    Time frame: Day 2

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

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

    Time frame: Day 1

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

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

    Time frame: Day 2

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

Study contacts

Contact information is provided by the study sponsor or research team.

Silvia Lo Vecchio

CONTACT

[email protected]

+4521397785

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.