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Not yet recruiting NCT07203274

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

No phase Interventional Itchiness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Delgocitinib cream, lidocaine cream, Lidocaine+Delgocitinib, Vehicle (placebo).
Who it may be relevant to
Registry conditions: Itchiness. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Delgocitinib cream
    Delgocitinib cream
  • Drug lidocaine cream
    Lidocaine cream
  • Combination product Lidocaine+Delgocitinib
    The two cream will me mixed togheter
  • Drug Vehicle (placebo)
    Vehicle Cream
  • Other Histamine Dihydrochloride (HDC)
    One drop of histamine will be applied on the selected areas and pierced with a lancet
  • Other Cowhage (Mucuna Pruriens)
    About 30 spicules will be applied on the selected areas and inserted manually

Primary outcome measures

  • Measuring itch by computerized Visual Analog Scale Scoring [Time frame: Day 1]
  • Measuring itch by computerized Visual Analog Scale Scoring [Time frame: Day 2]
  • Superficial blood perfusion [Time frame: Day 1]
  • Superficial blood perfusion [Time frame: Day 2]
Secondary outcome measures (12)
  • Mechanically evoked itch (MEI) [Time frame: Day 1]
  • Mechanically evoked itch (MEI) [Time frame: Day 2]
  • Perception threshold tracking model (PTT) [Time frame: Day 1]
  • Perception threshold tracking model (PTT) [Time frame: Day 2]
  • Mechanical Pain Thresholds (MPT) [Time frame: Day 1]
  • Mechanical Pain Thresholds (MPT) [Time frame: Day 2]
  • Mechanical Pain Sensitivity (MPS) [Time frame: Day 1]
  • Mechanical Pain Sensitivity (MPS) [Time frame: Day 2]
  • Warm Detection Thresholds (WDT) [Time frame: Day 1]
  • Warm Detection Thresholds (WDT) [Time frame: Day 2]
  • Cold Detection Thresholds (CDT) [Time frame: Day 1]
  • Cold Detection Thresholds (CDT) [Time frame: Day 2]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Denmark · 1 center
  • Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløf — Gistrup

Identifiers

NCT: NCT07203274 · N-20240054

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗