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

N/ANot Yet RecruitingNCT07203274

Aalborg University30 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Itchiness

Interventions

Delgocitinib creamDRUG

Delgocitinib cream

lidocaine creamDRUG

Lidocaine cream

Lidocaine+DelgocitinibCOMBINATION_PRODUCT

The two cream will me mixed togheter

Vehicle (placebo)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

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

Gistrup, Denmark

Outcomes

Primary Outcomes

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

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

Superficial blood perfusion

Time frame: Day 1

Superficial blood perfusion

Time frame: Day 2

Secondary Outcomes

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

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

Perception threshold tracking model (PTT)

Time frame: Day 1

Perception threshold tracking model (PTT)

Time frame: Day 2

Mechanical Pain Thresholds (MPT)

Central Contacts

Silvia Lo Vecchio

CONTACT

+4521397785 slv@hst.aau.dk

Data from ClinicalTrials.gov

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