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Active, not recruitingNCT07017231Updated Jun 12, 2025

Role of Interleukin-13 Pathways on Pain and Itch Sensitivity ( IL-13 )

An interventional study of histamine dihydrochloride and Cowhage in Itching, sponsored by Aalborg University. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-06-12.

Sponsored by Aalborg University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Itching

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03

In context

Pruritus

354 studies on the registry are indexed under Pruritus; 74 are open to participants now.

This study's planned enrollment of 26 is below the median of 60 across 294 interventional studies indexed under Pruritus.

Browse Pruritus studies →

Lead sponsor

Aalborg University is the lead sponsor of 178 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.)
    • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    Lebrikizumab

    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.

    Other: histamine dihydrochloride · Other: Cowhage

Interventions

  • Otherhistamine dihydrochloride

    A small drop of histamine dihydrochloride (1%, in saline) will be applied to two previously determined areas followed by a prick through the drop.

  • OtherCowhage

    Approximately 30-35 cowhage spicules will be manually inserted into the subject's skin.

06

What researchers measure

Primary outcomes

  1. 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".

    Time frame: Day 1

  2. Superficial blood perfusion

    Superficial blood perfusion (SBP) is measured by a Speckle contrast imager

    Time frame: Day 1

  3. Wheal reaction

    Wheal reaction measurement will be conducted immediately after the removal of pruritogens by measuring the longest diameter with a ruler.

    Time frame: Day 1

  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.

    Time frame: Day 1

  5. 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)

    Time frame: Day 1

  6. 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)

    Time frame: Day 1

  7. 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

    Time frame: Day 1

  8. 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.

    Time frame: Day 1

  9. 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

    Time frame: Day 1

  10. 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

    Time frame: Day 1

  11. 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).

    Time frame: Day 1

  12. 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).

    Time frame: Day 3

  13. 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".

    Time frame: Day 3

  14. 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".

    Time frame: Day 4

  15. Superficial blood perfusion

    Superficial blood perfusion (SBP) is measured by a Speckle contrast imager

    Time frame: Day 3

  16. Superficial blood perfusion

    Superficial blood perfusion (SBP) is measured by a Speckle contrast imager

    Time frame: Day 4

  17. Wheal reaction

    Wheal reaction measurement will be conducted immediately after the removal of pruritogens by measuring the longest diameter with a ruler.

    Time frame: Day 3

  18. Wheal reaction

    Wheal reaction measurement will be conducted immediately after the removal of pruritogens by measuring the longest diameter with a ruler.

    Time frame: Day 4

  19. 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.

    Time frame: Day 3

  20. 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.

    Time frame: Day 4

  21. 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)

    Time frame: Day 3

  22. 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)

    Time frame: Day 4

  23. 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)

    Time frame: Day 3

  24. 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)

    Time frame: Day 4

  25. 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

    Time frame: Day 3

  26. 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

    Time frame: Day 4

  27. 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.

    Time frame: Day 3

  28. 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.

    Time frame: Day 4

  29. 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

    Time frame: Day 3

  30. 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

    Time frame: Day 4

  31. 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

    Time frame: Day 3

  32. 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

    Time frame: Day 4

  33. 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).

    Time frame: Day 4

Secondary outcomes

  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.

    Time frame: Day 1

  2. Mechanical Pain Sensitivity (MPS)

    This test is conducted with the same pinprick set used to test the MPT.

    Time frame: Day 1

  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.

    Time frame: Day 1

  4. Cold Detection Thresholds (CDT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: Day 1

  5. Warm Detection Thresholds (WDT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: Day 1

  6. Cold Pain Thresholds (CPT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: Day 1

  7. 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

    Time frame: Day 1

  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.

    Time frame: Day 3

  9. 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.

    Time frame: Day 4

  10. Mechanical Pain Sensitivity (MPS)

    This test is conducted with the same pinprick set used to test the MPT.

    Time frame: Day 3

  11. Mechanical Pain Sensitivity (MPS)

    This test is conducted with the same pinprick set used to test the MPT.

    Time frame: Day 4

  12. 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.

    Time frame: Day 3

  13. 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.

    Time frame: Day 4

  14. Cold Detection Thresholds (CDT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: Day 3

  15. Heat Pain Thrteshold

    Time frame: Day 1

  16. Cold Detection Thresholds (CDT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: Day 4

  17. Warm Detection Thresholds (WDT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: Day 3

  18. Warm Detection Thresholds (WDT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: Day 4

  19. Heat Pain Thrteshold

    Time frame: Day 3

  20. Heat Pain Thrteshold

    Time frame: Day 4

  21. 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

    Time frame: Day 4

  22. Cold Pain Thresholds (CPT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: Day 3

  23. Cold Pain Thresholds (CPT)

    The tests of thermal sensation will all be conducted using a TSA2 (Medoc Ltd, Israel) thermal sensory testing device

    Time frame: Day 4

  24. 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

    Time frame: Day 3

07

Study locations

1 site
  • Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark
    Gistrup, 9260, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07017231
Lead sponsor
Aalborg University
Responsible party
Silvia Lo Vecchio (Associate Professor, Aalborg University) — Principal investigator
First posted
Jun 12, 2025
Start date
May 15, 2025
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 12, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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