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

Aalborg University

Status: Not yet enrolling

Conditions: Itchiness

Treatments: Other: Cowhage (Mucuna Pruriens); Drug: lidocaine cream; Other: Histamine Dihydrochloride (HDC); Combination Product: Lidocaine+Delgocitinib; Drug: Delgocitinib cream; Drug: Vehicle (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT07203274

N-20240054

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Cream application

Experimental group

Description:

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.

Treatment:

Drug: Vehicle (placebo)

Drug: Delgocitinib cream

Combination Product: Lidocaine+Delgocitinib

Other: Histamine Dihydrochloride (HDC)

Drug: lidocaine cream

Other: Cowhage (Mucuna Pruriens)