ItchIL-13NCT06503510
Role of Interleukin-13 Pathways on Pain and Itch Sensitivity
A study testing Histamine, Cowhage and bovine adrenal medulla (BAM8-22) in people with Itch, run by Aalborg University at 3 sites 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 yearsHealthy volunteers can take part
- Conditions the study is for
- Itch
- What is being tested?
- Histamine, Cowhage and bovine adrenal medulla (BAM8-22)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesDenmark
- Study dates
- 6 Jan 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women
- 18-60 years
Who cannot join
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids, or other drugs
- 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 pain killers (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
Show all 10Show fewer
- Consumption of alcohol or painkillers 24 hours before the study days and between these
- Acute or chronic pain
- 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
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 2 recruiting
- Not yet recruiting
Aalborg University
Aalborg, Denmark, 9260
Silvia Lo Vecchio
- Recruiting
Aalborg University
Gistrup, Aalborg, 9260
Silvia Lo Vecchio, PhD, 21397785, slv@hst.aau.dk
Botilla Markussen, 20567502, bam@hst.aau.dk
- Active, not recruiting
CNAP
Gistrup, Aalborg, 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 both healthy subjects and 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
- Itch
- Being tested
- Histamine, Cowhage, bovine adrenal medulla (BAM8-22)
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HistamineOther
A small drop of histamine dihydrochloride (1%, in saline) will be applied to a previously determined area on the volar forearm followed by a prick through the drop.
CowhageOther
Approximately 30-35 cowhage spicules will be manually inserted into the subject's skin.
bovine adrenal medulla (BAM8-22)Other
A small drop of BAM8-22 solution will be applied to a previously determined area on the volar forearm followed by a prick through the drop.
| 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; Other: Cowhage; Other: bovine adrenal medulla (BAM8-22) |
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: 1 minute after every itch induction
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: 1 minute after every itch induction
Superficial blood perfusion
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Measured: Baseline
Superficial blood perfusion
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Measured: 10 minute after every itch induction
Wheal reaction
Wheal reaction measurement will be conducted immediately after the removal of pruritogens by measuring the longest diameter with a ruler.
Measured: 10 minute after every itch induction
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: Baseline
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: Baseline
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: Baseline
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: Baseline
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: 10 minutes after every itch induction
Secondary outcomes (8)
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: Baseline
Mechanical Pain Sensitivity (MPS)
This test is conducted with the same pinprick set used to test the MPT.
Measured: Baseline
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: Baseline
Cold Detection Thresholds (CDT)
The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device
Measured: Baseliene
Warm Detection Thresholds (WDT)
The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testingdevice
Measured: Baseline
Cold Pain Thresholds (CPT)
The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device
Measured: Baseline
Heat Pain Thresholds (HPT)
The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device
Measured: Baseline
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: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start6 Jan 2025
- Primary completion31 Dec 2025 (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 ItchStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant will be treated with Lebrikizumab and will receive 3 pruritogens: Histamine, cowhage and BAM8-22.
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT06503510
- Sponsor's protocol ID
- N-20240029
- Acronym
- IL-13
- Status last verified
- Jan 2025
- First submitted
- 10 Jul 2024
- Last updated
- 4 Jun 2025
- 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 4 Jun 2025. 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
- NCT06503510
- Acronym / sponsor ID
- IL-13 / N-20240029
- Conditions
- Itch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Jul 2024 (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 both healthy subjects and 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
- Treatment
- 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 3 pruritogens: Histamine, cowhage and BAM8-22.
| Arm | Type | Receives |
|---|---|---|
| Lebrikizumab | Experimental | Other: Histamine, Other: Cowhage, Other: bovine adrenal medulla (BAM8-22)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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men and women
- 18-60 years
Key exclusion criteria (10 listed)
- Pregnancy or lactation
- Drug addiction defined as any use of cannabis, opioids, or other drugs
- 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 pain killers (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).
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 |
|---|---|---|
| HistamineA small drop of histamine dihydrochloride (1%, in saline) will be applied to a previously determined area on the volar forearm 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 |
| bovine adrenal medulla (BAM8-22)A small drop of BAM8-22 solution will be applied to a previously determined area on the volar forearm followed by a prick through the drop. | Other | Lebrikizumab |
Primary outcome
Measuring itch by computerized Visual Analog Scale Scoring
Time frame: 1 minute after every itch induction
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".
Measuring pain by computerized Visual Analog Scale Scoring
Time frame: 1 minute after every itch induction
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: Baseline
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Superficial blood perfusion
Time frame: 10 minute after every itch induction
Superficial blood perfusion (SBP) is measured by a Speckle contrast imager
Wheal reaction
Time frame: 10 minute after every itch induction
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: Baseline
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: Baseline
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: Baseline
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)
Mechanically evoked itch (MEI)
Time frame: Baseline
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: 10 minutes after every itch induction
MEI is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
8 secondary outcomes
Mechanical Pain Thresholds (MPT)
Time frame: Baseline
Mechanical Pain Sensitivity (MPS)
Time frame: Baseline
Pressure Pain Thresholds (PPT)
Time frame: Baseline
Cold Detection Thresholds (CDT)
Time frame: Baseliene
Warm Detection Thresholds (WDT)
Time frame: Baseline
Cold Pain Thresholds (CPT)
Time frame: Baseline
Heat Pain Thresholds (HPT)
Time frame: Baseline
Pain to Supra-threshold Heat Stimuli (STHS)
Time frame: Baseline
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 4 Jun 2025.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Histamine, Cowhage and bovine adrenal medulla (BAM8-22) in people with Itch, run by Aalborg University at 3 sites 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 2 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 (21397785, 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: 1 minute after every itch induction). The study lists 10 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 4 Jun 2025.