ItchingNCT07017231
Role of Interleukin-13 Pathways on Pain and Itch Sensitivity ( IL-13 )
A study testing histamine dihydrochloride and Cowhage in people with Itching, run by Aalborg University at 1 site in Denmark.
Trial summary
Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms. Research has shown that the proteins interleukins are involved in inflammation and itch in atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Itching
- What is being tested?
- histamine dihydrochloride and Cowhage
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 15 May 2025to 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
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years • The patients should have an AD according to diagnosis by a board-certified dermatologist, with an Eczema Area and Severity Index (EASI), a validated scoring tool that grades the physical signs of AD of at least 7. The project team will be specifically trained and evaluated in the EASI assessment to ensure interindividual consistency.
Who cannot join
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids, or other drugs Moles, wounds, scars, or tattoos in the area to be treated or tested
- Treatment within two weeks before start of the experiment with topical corticosteroids or calcineurin inhibitors.
- Treatment within two weeks before start of the experiment with topical treatments (excluding emollients) on the skin areas selected for testing (eight weeks if treated with systemic treatments for AD such as methotrexate or azathioprine)
- Treatment with antihistamines 72 hours before start of the experiment
- Previous or current history of neurological, musculoskeletal, cardiac disorder, or psychiatric diagnoses that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia, etc.)
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- Current use of medications that may affect the trial such as antihistamines and painkillers (use of antihistamines must be discontinued 72 hours before the experiment and all topical agents and emollients must be discontinued 24 hours before the experiment).
- Use of systemic corticosteroids
- Consumption of alcohol or painkillers 24 hours before the study days and between these
- Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
- Lack of ability to cooperate
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark
Gistrup, 9260
About this study
Official title: The Role of the Interleukin-13 Pathways on Pain and Itch Sensitivity in Patients With Atopic Dermatitis and Healthy Volunteers
Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms. Research has shown that the proteins interleukins are involved in inflammation and itch in atopic dermatitis. The medicinal product called Lebrikizumab, used for treatment of AD, has shown to block the interleukin called IL-13. The purpose of this experiment is to evaluate the role of IL-13 in itch in people with atopic dermatitis.
Read the detailed description
Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms. Research has shown that the interleukin-13 is involved in inflammation and itch in atopic dermatitis by increasing the neuronal sensitivity to pruritogens.
However, the physiological mechanisms by which IL-13 increases the itch sensitivity are unclear. The aim of this project is to use, for the first time in humans, the monoclonal antibody Lebrikizumab that inhibits IL-13 with high affinity as a novel experimental tool to modulate the IL-13 pathway and evaluate its role in the transmission and processing of itch and pain.
- Conditions
- Itching
- Being tested
- histamine dihydrochloride, Cowhage
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
histamine dihydrochlorideOther
A small drop of histamine dihydrochloride (1%, in saline) will be applied to two previously determined areas followed by a prick through the drop.
CowhageOther
Approximately 30-35 cowhage spicules will be manually inserted into the subject's skin.
| Study group | Role | What they receive |
|---|---|---|
| Lebrikizumab | Experimental | The initial doses will be subcutaneous Lebrikizumab 500 mg (two 250 mg injections) at both week 0 (baseline) and week 2, followed by 250 mg administered subcutaneously at week 4. Receives: Other: histamine dihydrochloride; Other: Cowhage |
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
The subjects will be asked 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
Superficial blood perfusion
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Measured: Day 1
Wheal reaction
Wheal reaction measurement will be conducted immediately after the removal of pruritogens by measuring the longest diameter with a ruler.
Measured: Day 1
Average pruritis and pain numerical rating scale (NRS)
The subject will be asked to retrospectively rate the average and worst itch/pain on an 11-point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)experience they had during the last 7 days.
Measured: Day 1
Skin peak pain numerical rating scale (SPP-NRS)
According to the SPP-NRS, the subject will be asked about "worst skin pain" they felt in the past 24 hours on an 11- point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Measured: Day 1
Peak pruritus numerical rating scale (PP-NRS)
The subject will be asked about the "worst itch" they felt in the past 24 hours on an 11-point scale ranging from 0 to 10 (0 = no itch and 10 = worst imaginable itch)
Measured: Day 1
Eczema Area and Severity Index (EASI)
This scale is used for patients with AD to assess severity and extent of the disease. The investigator/physician will assign scores based on redness, scratching, thickness, lichenification and percentage of affected body regions
Measured: Day 1
Dermatology Life Quality Index (DLQI)
This questionnaire is a simple 10-question validated questionnaire that measures the impact of the skin disease on several aspects of the patient's life over the past week. The DLQI sum score is calculated by summing up the score of each item. Questions are scored on a four-point Likert scale: 0, not at all/not relevant; 1, a little; 2, a lot; and 3, very much.
Measured: Day 1
Itch Severity Scale (ISS)
This is a seven items questionnaire: itch description, frequency, effect on sleep, effect on mood, effect on sexual desire/function, itch intensity using Likert scale and body surface area involved
Measured: Day 1
Patient Oriented Eczema Measure (POEM)
POEM is a questionnaire used for patients' self-monitoring of AD severity. It asks about the frequency of seven symptoms (itch, sleep disturbance, dryness, flaking, weeping, or oozing, bleeding, and cracking) in the past seven days, and the patient has to choose between these answers: No days, 1-2 days, 3-4 days, 5-6 days, Every day
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 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 3
Measuring pain by computerized Visual Analog Scale Scoring
The subjects will be asked to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable".
Measured: Day 3
Measuring pain by computerized Visual Analog Scale Scoring
The subjects will be asked to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable".
Measured: Day 4
Superficial blood perfusion
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Measured: Day 3
Superficial blood perfusion
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Measured: Day 4
Wheal reaction
Wheal reaction measurement will be conducted immediately after the removal of pruritogens by measuring the longest diameter with a ruler.
Measured: Day 3
Wheal reaction
Wheal reaction measurement will be conducted immediately after the removal of pruritogens by measuring the longest diameter with a ruler.
Measured: Day 4
Average pruritis and pain numerical rating scale (NRS)
The subject will be asked to retrospectively rate the average and worst itch/pain on an 11-point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)experience they had during the last 7 days.
Measured: Day 3
Average pruritis and pain numerical rating scale (NRS)
The subject will be asked to retrospectively rate the average and worst itch/pain on an 11-point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)experience they had during the last 7 days.
Measured: Day 4
Skin peak pain numerical rating scale (SPP-NRS)
According to the SPP-NRS, the subject will be asked about "worst skin pain" they felt in the past 24 hours on an 11- point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Measured: Day 3
Skin peak pain numerical rating scale (SPP-NRS)
According to the SPP-NRS, the subject will be asked about "worst skin pain" they felt in the past 24 hours on an 11- point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Measured: Day 4
Peak pruritus numerical rating scale (PP-NRS)
The subject will be asked about the "worst itch" they felt in the past 24 hours on an 11-point scale ranging from 0 to 10 (0 = no itch and 10 = worst imaginable itch)
Measured: Day 3
Peak pruritus numerical rating scale (PP-NRS)
The subject will be asked about the "worst itch" they felt in the past 24 hours on an 11-point scale ranging from 0 to 10 (0 = no itch and 10 = worst imaginable itch)
Measured: Day 4
Eczema Area and Severity Index (EASI)
This scale is used for patients with AD to assess severity and extent of the disease. The investigator/physician will assign scores based on redness, scratching, thickness, lichenification and percentage of affected body regions
Measured: Day 3
Eczema Area and Severity Index (EASI)
This scale is used for patients with AD to assess severity and extent of the disease. The investigator/physician will assign scores based on redness, scratching, thickness, lichenification and percentage of affected body regions
Measured: Day 4
Dermatology Life Quality Index (DLQI)
This questionnaire is a simple 10-question validated questionnaire that measures the impact of the skin disease on several aspects of the patient's life over the past week. The DLQI sum score is calculated by summing up the score of each item. Questions are scored on a four-point Likert scale: 0, not at all/not relevant; 1, a little; 2, a lot; and 3, very much.
Measured: Day 3
Dermatology Life Quality Index (DLQI)
This questionnaire is a simple 10-question validated questionnaire that measures the impact of the skin disease on several aspects of the patient's life over the past week. The DLQI sum score is calculated by summing up the score of each item. Questions are scored on a four-point Likert scale: 0, not at all/not relevant; 1, a little; 2, a lot; and 3, very much.
Measured: Day 4
Itch Severity Scale (ISS)
This is a seven items questionnaire: itch description, frequency, effect on sleep, effect on mood, effect on sexual desire/function, itch intensity using Likert scale and body surface area involved
Measured: Day 3
Itch Severity Scale (ISS)
This is a seven items questionnaire: itch description, frequency, effect on sleep, effect on mood, effect on sexual desire/function, itch intensity using Likert scale and body surface area involved
Measured: Day 4
Patient Oriented Eczema Measure (POEM)
POEM is a questionnaire used for patients' self-monitoring of AD severity. It asks about the frequency of seven symptoms (itch, sleep disturbance, dryness, flaking, weeping, or oozing, bleeding, and cracking) in the past seven days, and the patient has to choose between these answers: No days, 1-2 days, 3-4 days, 5-6 days, Every day
Measured: Day 3
Patient Oriented Eczema Measure (POEM)
POEM is a questionnaire used for patients' self-monitoring of AD severity. It asks about the frequency of seven symptoms (itch, sleep disturbance, dryness, flaking, weeping, or oozing, bleeding, and cracking) in the past seven days, and the patient has to choose between these answers: No days, 1-2 days, 3-4 days, 5-6 days, Every day
Measured: Day 4
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 4
Secondary outcomes (24)
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 Sensitivity (MPS)
This test is conducted with the same pinprick set used to test the MPT.
Measured: Day 1
Pressure Pain Thresholds (PPT)
Pressure will be applied by a handheld electronic pressure algometer (Somedic AB, Stockholm, Sweden) on to the supinator muscle on the left forearm.
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 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 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 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 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 3
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 4
Mechanical Pain Sensitivity (MPS)
This test is conducted with the same pinprick set used to test the MPT.
Measured: Day 3
Mechanical Pain Sensitivity (MPS)
This test is conducted with the same pinprick set used to test the MPT.
Measured: Day 4
Pressure Pain Thresholds (PPT)
Pressure will be applied by a handheld electronic pressure algometer (Somedic AB, Stockholm, Sweden) on to the supinator muscle on the left forearm.
Measured: Day 3
Pressure Pain Thresholds (PPT)
Pressure will be applied by a handheld electronic pressure algometer (Somedic AB, Stockholm, Sweden) on to the supinator muscle on the left forearm.
Measured: Day 4
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 3
Heat Pain Thrteshold
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 4
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 3
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 4
Heat Pain Thrteshold
Measured: Day 3
Heat Pain Thrteshold
Measured: Day 4
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 4
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 3
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 4
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 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start15 May 2025
- Primary completion31 Dec 2025
- 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 ItchingStudies 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
- Each participant will be treated with Lebrikizumab and will receive 2 pruritogens: Histamine and cowhage
- Masking
- None (open label)
- Enrolment
- 26 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
- NCT07017231
- Sponsor's protocol ID
- N-20240029 2nd subproject
- Status last verified
- Nov 2026
- First submitted
- 30 May 2025
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Interleukin-13 Pathways on Pain and Itch Sensitivity in Patients With Atopic Dermatitis and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07017231
- Acronym / sponsor ID
- N-20240029 2nd subproject
- Conditions
- Itching
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jun 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.
Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms. Research has shown that the proteins interleukins are involved in inflammation and itch in atopic dermatitis. The medicinal product called Lebrikizumab, used for treatment of AD, has shown to block the interleukin called IL-13. The purpose of this experiment is to evaluate the role of IL-13 in itch in people with atopic dermatitis.
Detailed description
Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms. Research has shown that the interleukin-13 is involved in inflammation and itch in atopic dermatitis by increasing the neuronal sensitivity to pruritogens.
However, the physiological mechanisms by which IL-13 increases the itch sensitivity are unclear. The aim of this project is to use, for the first time in humans, the monoclonal antibody Lebrikizumab that inhibits IL-13 with high affinity as a novel experimental tool to modulate the IL-13 pathway and evaluate its role in the transmission and processing of itch and pain.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will be treated with Lebrikizumab and will receive 2 pruritogens: Histamine and cowhage
| Arm | Type | Receives |
|---|---|---|
| Lebrikizumab | Experimental | Other: histamine dihydrochloride, Other: CowhageThe initial doses will be subcutaneous Lebrikizumab 500 mg (two 250 mg injections) at both week 0 (baseline) and week 2, followed by 250 mg administered subcutaneously at week 4. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-60 years • The patients should have an AD according to diagnosis by a board-certified dermatologist, with an Eczema Area and Severity Index (EASI), a validated scoring tool that grades the physical signs of AD of at least 7. The project team will be specifically trained and evaluated in the EASI assessment to ensure interindividual consistency.
Key exclusion criteria (11 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 |
|---|---|---|
| histamine dihydrochlorideA small drop of histamine dihydrochloride (1%, in saline) will be applied to two previously determined areas followed by a prick through the drop. | Other | Lebrikizumab |
| CowhageApproximately 30-35 cowhage spicules will be manually inserted into the subject's skin. | Other | Lebrikizumab |
Primary outcome
Measuring itch by computerized Visual Analog Scale Scoring
Time frame: Day 1
The subjects will be asked 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 (SBP) is measured by a Speckle contrast imager
Wheal reaction
Time frame: Day 1
Wheal reaction measurement will be conducted immediately after the removal of pruritogens by measuring the longest diameter with a ruler.
Average pruritis and pain numerical rating scale (NRS)
Time frame: Day 1
The subject will be asked to retrospectively rate the average and worst itch/pain on an 11-point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)experience they had during the last 7 days.
Skin peak pain numerical rating scale (SPP-NRS)
Time frame: Day 1
According to the SPP-NRS, the subject will be asked about "worst skin pain" they felt in the past 24 hours on an 11- point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Peak pruritus numerical rating scale (PP-NRS)
Time frame: Day 1
The subject will be asked about the "worst itch" they felt in the past 24 hours on an 11-point scale ranging from 0 to 10 (0 = no itch and 10 = worst imaginable itch)
Eczema Area and Severity Index (EASI)
Time frame: Day 1
This scale is used for patients with AD to assess severity and extent of the disease. The investigator/physician will assign scores based on redness, scratching, thickness, lichenification and percentage of affected body regions
Dermatology Life Quality Index (DLQI)
Time frame: Day 1
This questionnaire is a simple 10-question validated questionnaire that measures the impact of the skin disease on several aspects of the patient's life over the past week. The DLQI sum score is calculated by summing up the score of each item. Questions are scored on a four-point Likert scale: 0, not at all/not relevant; 1, a little; 2, a lot; and 3, very much.
Itch Severity Scale (ISS)
Time frame: Day 1
This is a seven items questionnaire: itch description, frequency, effect on sleep, effect on mood, effect on sexual desire/function, itch intensity using Likert scale and body surface area involved
Patient Oriented Eczema Measure (POEM)
Time frame: Day 1
POEM is a questionnaire used for patients' self-monitoring of AD severity. It asks about the frequency of seven symptoms (itch, sleep disturbance, dryness, flaking, weeping, or oozing, bleeding, and cracking) in the past seven days, and the patient has to choose between these answers: No days, 1-2 days, 3-4 days, 5-6 days, Every day
Mechanically evoked itch (MEI)
Time frame: 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).
Mechanically evoked itch (MEI)
Time frame: Day 3
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Measuring pain by computerized Visual Analog Scale Scoring
Time frame: Day 3
The subjects will be asked to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable".
Measuring pain by computerized Visual Analog Scale Scoring
Time frame: Day 4
The subjects will be asked to rate the sensation of pain on a 100 mm VAS scale ranging from 0 to 100 where 0 indicates "no pain" and 100 indicates "worst pain imaginable".
Superficial blood perfusion
Time frame: Day 3
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Superficial blood perfusion
Time frame: Day 4
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Wheal reaction
Time frame: Day 3
Wheal reaction measurement will be conducted immediately after the removal of pruritogens by measuring the longest diameter with a ruler.
Wheal reaction
Time frame: Day 4
Wheal reaction measurement will be conducted immediately after the removal of pruritogens by measuring the longest diameter with a ruler.
Average pruritis and pain numerical rating scale (NRS)
Time frame: Day 3
The subject will be asked to retrospectively rate the average and worst itch/pain on an 11-point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)experience they had during the last 7 days.
Average pruritis and pain numerical rating scale (NRS)
Time frame: Day 4
The subject will be asked to retrospectively rate the average and worst itch/pain on an 11-point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)experience they had during the last 7 days.
Skin peak pain numerical rating scale (SPP-NRS)
Time frame: Day 3
According to the SPP-NRS, the subject will be asked about "worst skin pain" they felt in the past 24 hours on an 11- point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Skin peak pain numerical rating scale (SPP-NRS)
Time frame: Day 4
According to the SPP-NRS, the subject will be asked about "worst skin pain" they felt in the past 24 hours on an 11- point scale ranging from 0 to 10 (0 = no pain and 10 = worst imaginable pain)
Peak pruritus numerical rating scale (PP-NRS)
Time frame: Day 3
The subject will be asked about the "worst itch" they felt in the past 24 hours on an 11-point scale ranging from 0 to 10 (0 = no itch and 10 = worst imaginable itch)
Peak pruritus numerical rating scale (PP-NRS)
Time frame: Day 4
The subject will be asked about the "worst itch" they felt in the past 24 hours on an 11-point scale ranging from 0 to 10 (0 = no itch and 10 = worst imaginable itch)
Eczema Area and Severity Index (EASI)
Time frame: Day 3
This scale is used for patients with AD to assess severity and extent of the disease. The investigator/physician will assign scores based on redness, scratching, thickness, lichenification and percentage of affected body regions
Eczema Area and Severity Index (EASI)
Time frame: Day 4
This scale is used for patients with AD to assess severity and extent of the disease. The investigator/physician will assign scores based on redness, scratching, thickness, lichenification and percentage of affected body regions
Dermatology Life Quality Index (DLQI)
Time frame: Day 3
This questionnaire is a simple 10-question validated questionnaire that measures the impact of the skin disease on several aspects of the patient's life over the past week. The DLQI sum score is calculated by summing up the score of each item. Questions are scored on a four-point Likert scale: 0, not at all/not relevant; 1, a little; 2, a lot; and 3, very much.
Dermatology Life Quality Index (DLQI)
Time frame: Day 4
This questionnaire is a simple 10-question validated questionnaire that measures the impact of the skin disease on several aspects of the patient's life over the past week. The DLQI sum score is calculated by summing up the score of each item. Questions are scored on a four-point Likert scale: 0, not at all/not relevant; 1, a little; 2, a lot; and 3, very much.
Itch Severity Scale (ISS)
Time frame: Day 3
This is a seven items questionnaire: itch description, frequency, effect on sleep, effect on mood, effect on sexual desire/function, itch intensity using Likert scale and body surface area involved
Itch Severity Scale (ISS)
Time frame: Day 4
This is a seven items questionnaire: itch description, frequency, effect on sleep, effect on mood, effect on sexual desire/function, itch intensity using Likert scale and body surface area involved
Patient Oriented Eczema Measure (POEM)
Time frame: Day 3
POEM is a questionnaire used for patients' self-monitoring of AD severity. It asks about the frequency of seven symptoms (itch, sleep disturbance, dryness, flaking, weeping, or oozing, bleeding, and cracking) in the past seven days, and the patient has to choose between these answers: No days, 1-2 days, 3-4 days, 5-6 days, Every day
Patient Oriented Eczema Measure (POEM)
Time frame: Day 4
POEM is a questionnaire used for patients' self-monitoring of AD severity. It asks about the frequency of seven symptoms (itch, sleep disturbance, dryness, flaking, weeping, or oozing, bleeding, and cracking) in the past seven days, and the patient has to choose between these answers: No days, 1-2 days, 3-4 days, 5-6 days, Every day
Mechanically evoked itch (MEI)
Time frame: Day 4
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
24 secondary outcomes
Mechanical Pain Thresholds (MPT)
Time frame: Day 1
Mechanical Pain Sensitivity (MPS)
Time frame: Day 1
Pressure Pain Thresholds (PPT)
Time frame: Day 1
Cold Detection Thresholds (CDT)
Time frame: Day 1
Warm Detection Thresholds (WDT)
Time frame: Day 1
Cold Pain Thresholds (CPT)
Time frame: Day 1
Pain to Supra-threshold Heat Stimuli (STHS)
Time frame: Day 1
Mechanical Pain Thresholds (MPT)
Time frame: Day 3
Mechanical Pain Thresholds (MPT)
Time frame: Day 4
Mechanical Pain Sensitivity (MPS)
Time frame: Day 3
Mechanical Pain Sensitivity (MPS)
Time frame: Day 4
Pressure Pain Thresholds (PPT)
Time frame: Day 3
Pressure Pain Thresholds (PPT)
Time frame: Day 4
Cold Detection Thresholds (CDT)
Time frame: Day 3
Heat Pain Thrteshold
Time frame: Day 1
Cold Detection Thresholds (CDT)
Time frame: Day 4
Warm Detection Thresholds (WDT)
Time frame: Day 3
Warm Detection Thresholds (WDT)
Time frame: Day 4
Heat Pain Thrteshold
Time frame: Day 3
Heat Pain Thrteshold
Time frame: Day 4
Pain to Supra-threshold Heat Stimuli (STHS)
Time frame: Day 4
Cold Pain Thresholds (CPT)
Time frame: Day 3
Cold Pain Thresholds (CPT)
Time frame: Day 4
Pain to Supra-threshold Heat Stimuli (STHS)
Time frame: Day 3
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 6 Nov 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing histamine dihydrochloride and Cowhage in people with Itching, 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 1 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 33 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 6 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.