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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delgocitinib cream | Drug | Delgocitinib cream |
| |
| lidocaine cream |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 1 |
| Mechanically evoked itch (MEI) |
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Inclusion Criteria:
Healthy men and women
Exclusion Criteria:
Pregnancy or lactation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvia Lo Vecchio | Contact | +4521397785 | slv@hst.aau.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark | Gistrup | 9260 | Denmark |
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| ID | Term |
|---|---|
| D006632 | Histamine |
| ID | Term |
|---|---|
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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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.
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The participant will be blinded about which cream is applied.
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| Drug |
Lidocaine cream |
|
| Lidocaine+Delgocitinib | Combination Product | The two cream will me mixed togheter |
|
| Vehicle (placebo) | Drug | Vehicle Cream |
|
| Histamine Dihydrochloride (HDC) | Other | One drop of histamine will be applied on the selected areas and pierced with a lancet |
|
| Cowhage (Mucuna Pruriens) | Other | About 30 spicules will be applied on the selected areas and inserted manually |
|
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
| Day 2 |
| Perception threshold tracking model (PTT) | Day 1 |
| Perception threshold tracking model (PTT) | Day 2 |
| Mechanical Pain Thresholds (MPT) | This test is conducted using a pinprick set. The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN. | Day 1 |
| Mechanical Pain Thresholds (MPT) | This test is conducted using a pinprick set. The set consists of 7 needles each with a diameter of 0.6 mm and different force applications: 8, 16, 32, 64, 128, 256, and 512 mN. | Day 2 |
| Mechanical Pain Sensitivity (MPS) | This test is conducted with the same pinprick set used to test the MPT. | Day 1 |
| Mechanical Pain Sensitivity (MPS) | This test is conducted with the same pinprick set used to test the MPT. | Day 2 |
| Warm Detection Thresholds (WDT) | The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device | Day 1 |
| Warm Detection Thresholds (WDT) | The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device | Day 2 |
| Cold Detection Thresholds (CDT) | The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device | Day 1 |
| Cold Detection Thresholds (CDT) | The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device | Day 2 |
| Cold Pain Thresholds (CPT) | The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device | Day 1 |
| Cold Pain Thresholds (CPT) | The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device | Day 2 |
| Heat Pain Thresholds (HPT) | The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device | Day 1 |
| Heat Pain Thresholds (HPT) | The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device | Day 2 |
| Pain to Supra-threshold Heat Stimuli (STHS) | The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device | Day 1 |
| Pain to Supra-threshold Heat Stimuli (STHS) | The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device | Day 2 |
| D005021 |
| Ethylamines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |