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

NCT07017231 | Active Not Recruiting DMC

• 1 other identifier: N-20240029 2nd subproject
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Itching

Outcome Measures

Primary Outcomes (33)

• 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".

  Day 1

• Superficial blood perfusion

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

  Day 1

• Wheal reaction

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

  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.

  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)

  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)

  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

  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.

  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

  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

  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).

  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).

  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".

  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".

  Day 4

• Superficial blood perfusion

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

  Day 3

• Superficial blood perfusion

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

  Day 4

• Wheal reaction

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

  Day 3

• Wheal reaction

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

  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.

  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.

  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)

  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)

  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)

  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)

  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

  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

  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.

  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.

  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

  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

  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

  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

  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).

  Day 4

Secondary Outcomes (24)

• Mechanical Pain Thresholds (MPT)

  Day 1

• Mechanical Pain Sensitivity (MPS)

  Day 1

• Pressure Pain Thresholds (PPT)

  Day 1

• Cold Detection Thresholds (CDT)

  Day 1

• Warm Detection Thresholds (WDT)

  Day 1

Study Arms (1)

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.

Other: histamine dihydrochloride; Other: Cowhage

Interventions

histamine dihydrochloride OTHER

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

Lebrikizumab

Cowhage OTHER

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

Lebrikizumab

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University: lead

Study Sites (1)

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

Gistrup, 9260, Denmark

Location

MeSH Terms

Conditions

Pruritus

Interventions

Histamine

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Each participant will be treated with Lebrikizumab and will receive 2 pruritogens: Histamine and cowhage

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 12, 2025
• Study Start: May 15, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-05

Locations

DK (1)