ItchinessNCT07203274
The Role of Janus Kinase (JAK) and Voltage-gated Sodium Channels (Nav) on Pain and Itch
A study testing Delgocitinib cream, lidocaine cream and Lidocaine+Delgocitinib in people with Itchiness, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Itchiness
- What is being tested?
- Delgocitinib cream, lidocaine cream and Lidocaine+Delgocitinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- 18-60 years
- Speak and understand English
Who cannot join
- 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).
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark
Gistrup, 9260
Silvia Lo Vecchio, +4521397785, silvia.lovecchio@icloud.com
About this study
Official title: The Role of Janus Kinase (JAK) and Voltage-gated Sodium Channels (Nav) on Pain and Itch Sensitivity in Healthy Volunteers
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.
- Conditions
- Itchiness
- Being tested
- Delgocitinib cream, lidocaine cream, Lidocaine+Delgocitinib, Vehicle (placebo), Histamine Dihydrochloride (HDC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delgocitinib creamDrug
Delgocitinib cream
lidocaine creamDrug
Lidocaine cream
Lidocaine+DelgocitinibCombination 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Delgocitinib cream; Drug: lidocaine cream; Combination Product: Lidocaine+Delgocitinib; Drug: Vehicle (placebo); Other: Histamine Dihydrochloride (HDC); Other: Cowhage (Mucuna Pruriens) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: Day 2
Superficial blood perfusion
Measured: Day 1
Superficial blood perfusion
Measured: Day 2
Secondary outcomes (18)
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).
Measured: 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).
Measured: Day 2
Perception threshold tracking model (PTT)
Measured: Day 1
Perception threshold tracking model (PTT)
Measured: 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.
Measured: 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.
Measured: Day 2
Mechanical Pain Sensitivity (MPS)
This test is conducted with the same pinprick set used to test the MPT.
Measured: Day 1
Mechanical Pain Sensitivity (MPS)
This test is conducted with the same pinprick set used to test the MPT.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ItchinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Lo Vecchio, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203274
- Sponsor's protocol ID
- N-20240054
- Status last verified
- Apr 2025
- First submitted
- 28 May 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Janus Kinase (JAK) and Voltage-gated Sodium Channels (Nav) on Pain and Itch Sensitivity in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07203274
- Acronym / sponsor ID
- N-20240054
- Conditions
- Itchiness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cream application | Experimental | Drug: Delgocitinib cream, Drug: lidocaine cream, Combination Product: Lidocaine+Delgocitinib, Drug: Vehicle (placebo), Other: Histamine Dihydrochloride (HDC), Other: Cowhage (Mucuna Pruriens)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women
Key exclusion criteria (15 listed)
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delgocitinib creamDelgocitinib cream | Drug | Cream application |
| lidocaine creamLidocaine cream | Drug | Cream application |
| Lidocaine+DelgocitinibThe two cream will me mixed togheter | Combination product | Cream application |
| Vehicle (placebo)Vehicle Cream | Drug | Cream application |
| Histamine Dihydrochloride (HDC)One drop of histamine will be applied on the selected areas and pierced with a lancet | Other | Cream application |
| Cowhage (Mucuna Pruriens)About 30 spicules will be applied on the selected areas and inserted manually | Other | Cream application |
Primary outcome
Measuring itch by computerized Visual Analog Scale Scoring
Time frame: 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".
Measuring itch by computerized Visual Analog Scale Scoring
Time frame: Day 2
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
Time frame: Day 1
Superficial blood perfusion
Time frame: Day 2
18 secondary outcomes
Mechanically evoked itch (MEI)
Time frame: Day 1
Mechanically evoked itch (MEI)
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)
Time frame: Day 1
Mechanical Pain Thresholds (MPT)
Time frame: Day 2
Mechanical Pain Sensitivity (MPS)
Time frame: Day 1
Mechanical Pain Sensitivity (MPS)
Time frame: Day 2
Warm Detection Thresholds (WDT)
Time frame: Day 1
Warm Detection Thresholds (WDT)
Time frame: Day 2
Cold Detection Thresholds (CDT)
Time frame: Day 1
Cold Detection Thresholds (CDT)
Time frame: Day 2
Cold Pain Thresholds (CPT)
Time frame: Day 1
Cold Pain Thresholds (CPT)
Time frame: Day 2
Heat Pain Thresholds (HPT)
Time frame: Day 1
Heat Pain Thresholds (HPT)
Time frame: Day 2
Pain to Supra-threshold Heat Stimuli (STHS)
Time frame: Day 1
Pain to Supra-threshold Heat Stimuli (STHS)
Time frame: Day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delgocitinib cream, lidocaine cream and Lidocaine+Delgocitinib in people with Itchiness, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Lo Vecchio (+4521397785, slv@hst.aau.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring itch by computerized Visual Analog Scale Scoring (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.