Health TrialsbyHealthPanel

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

ConditionItchiness
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAalborg University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy men and women

18-60 years

Speak and understand English

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 intervention

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

  • Cowhage (Mucuna Pruriens)

    Other intervention

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Cream applicationExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

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 1
2

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
3

Superficial blood perfusion

Time frame
Day 1
4

Superficial blood perfusion

Time frame
Day 2

Secondary outcomes

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 1
2

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
3

Perception threshold tracking model (PTT)

Time frame
Day 1
4

Perception threshold tracking model (PTT)

Time frame
Day 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aalborg University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: