Itchiness
Conditions
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.
Interventions
Delgocitinib cream
DRUGlidocaine cream
Lidocaine cream
COMBINATION_PRODUCTLidocaine+Delgocitinib
The two cream will me mixed togheter
Vehicle Cream
One drop of histamine will be applied on the selected areas and pierced with a lancet
About 30 spicules will be applied on the selected areas and inserted manually
Sponsors
Aalborg University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
The participant will be blinded about which cream is applied.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measuring itch by computerized Visual Analog Scale Scoring | Day 1 | 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. |
| Superficial blood perfusion | Day 1 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Pain Thresholds (MPT) | Day 1 | 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. |
| Mechanical Pain Sensitivity (MPS) | Day 1 | This test is conducted with the same pinprick set used to test the MPT. |
| Warm Detection Thresholds (WDT) | Day 1 | The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device |
| Mechanically evoked itch (MEI) | Day 1 | MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force). |
| Cold Pain Thresholds (CPT) | Day 1 | The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device |
| Heat Pain Thresholds (HPT) | Day 1 | The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device |
| Pain to Supra-threshold Heat Stimuli (STHS) | Day 1 | The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device |
| Cold Detection Thresholds (CDT) | Day 1 | The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device |
| Perception threshold tracking model (PTT) | Day 1 | — |
Countries
Denmark
Contacts
Primary ContactSilvia Lo Vecchio
Outcome results
None listed