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

NCT07203274 | Not Yet Recruiting DMC

• 1 other identifier: N-20240054
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Itchiness

Outcome Measures

Primary Outcomes (4)

• 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".

  Day 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".

  Day 2

• Superficial blood perfusion

  Day 1

• Superficial blood perfusion

  Day 2

Secondary Outcomes (18)

• Mechanically evoked itch (MEI)

  Day 1

• Mechanically evoked itch (MEI)

  Day 2

• Perception threshold tracking model (PTT)

  Day 1

• Perception threshold tracking model (PTT)

  Day 2

• Mechanical Pain Thresholds (MPT)

  Day 1

Study Arms (1)

Cream application

EXPERIMENTAL

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

Delgocitinib cream DRUG

Delgocitinib cream

Cream application

lidocaine cream DRUG

Lidocaine cream

Cream application

Lidocaine+Delgocitinib COMBINATION_PRODUCT

The two cream will me mixed togheter

Cream application

Vehicle (placebo) DRUG

Vehicle Cream

Cream application

Histamine Dihydrochloride (HDC) OTHER

One drop of histamine will be applied on the selected areas and pierced with a lancet

Cream application

Cowhage (Mucuna Pruriens) OTHER

About 30 spicules will be applied on the selected areas and inserted manually

Cream application

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men and women
• years
• Speak and understand English

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

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

Gistrup, 9260, Denmark

Location

MeSH Terms

Interventions

Histamine

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Silvia Lo Vecchio

CONTACT

+4521397785; slv@hst.aau.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The participant will be blinded about which cream is applied.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: In each participant, the four different creams will be applied in a randomized position. After the cream removal, itch will be induced using histamine in one session and cowhage in the other session.

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: October 2, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2025-04

Locations

DK (1)