Clinical trial NCT07017231: Role of Interleukin-13 Pathways on Pain and Itch Sensitivity ( IL-13 )
Official title: The Role of the Interleukin-13 Pathways on Pain and Itch Sensitivity in Patients With Atopic Dermatitis and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Itching
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant will be treated with Lebrikizumab and will receive 2 pruritogens:

Histamine and cowhage
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Measuring itch by computerized Visual Analog Scale Scoring
timeFrame: Day 1
measure: Superficial blood perfusion
timeFrame: Day 1
measure: Wheal reaction
timeFrame: Day 1
measure: Average pruritis and pain numerical rating scale (NRS)
timeFrame: Day 1
measure: Skin peak pain numerical rating scale (SPP-NRS)
timeFrame: Day 1
measure: Peak pruritus numerical rating scale (PP-NRS)
timeFrame: Day 1
measure: Eczema Area and Severity Index (EASI)
timeFrame: Day 1
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Day 1
measure: Itch Severity Scale (ISS)
timeFrame: Day 1
measure: Patient Oriented Eczema Measure (POEM)
timeFrame: Day 1
measure: Mechanically evoked itch (MEI)
timeFrame: Day 1
measure: Mechanically evoked itch (MEI)
timeFrame: Day 3
measure: Measuring pain by computerized Visual Analog Scale Scoring
timeFrame: Day 3
measure: Measuring pain by computerized Visual Analog Scale Scoring
timeFrame: Day 4
measure: Superficial blood perfusion
timeFrame: Day 3
measure: Superficial blood perfusion
timeFrame: Day 4
measure: Wheal reaction
timeFrame: Day 3
measure: Wheal reaction
timeFrame: Day 4
measure: Average pruritis and pain numerical rating scale (NRS)
timeFrame: Day 3
measure: Average pruritis and pain numerical rating scale (NRS)
timeFrame: Day 4
measure: Skin peak pain numerical rating scale (SPP-NRS)
timeFrame: Day 3
measure: Skin peak pain numerical rating scale (SPP-NRS)
timeFrame: Day 4
measure: Peak pruritus numerical rating scale (PP-NRS)
timeFrame: Day 3
measure: Peak pruritus numerical rating scale (PP-NRS)
timeFrame: Day 4
measure: Eczema Area and Severity Index (EASI)
timeFrame: Day 3
measure: Eczema Area and Severity Index (EASI)
timeFrame: Day 4
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Day 3
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Day 4
measure: Itch Severity Scale (ISS)
timeFrame: Day 3
measure: Itch Severity Scale (ISS)
timeFrame: Day 4
measure: Patient Oriented Eczema Measure (POEM)
timeFrame: Day 3
measure: Patient Oriented Eczema Measure (POEM)
timeFrame: Day 4
measure: Mechanically evoked itch (MEI)
timeFrame: Day 4
Secondary outcomes:
measure: Mechanical Pain Thresholds (MPT)
timeFrame: Day 1
measure: Mechanical Pain Sensitivity (MPS)
timeFrame: Day 1
measure: Pressure Pain Thresholds (PPT)
timeFrame: Day 1
measure: Cold Detection Thresholds (CDT)
timeFrame: Day 1
measure: Warm Detection Thresholds (WDT)
timeFrame: Day 1
measure: Cold Pain Thresholds (CPT)
timeFrame: Day 1
measure: Pain to Supra-threshold Heat Stimuli (STHS)
timeFrame: Day 1
measure: Mechanical Pain Thresholds (MPT)
timeFrame: Day 3
measure: Mechanical Pain Thresholds (MPT)
timeFrame: Day 4
measure: Mechanical Pain Sensitivity (MPS)
timeFrame: Day 3
measure: Mechanical Pain Sensitivity (MPS)
timeFrame: Day 4
measure: Pressure Pain Thresholds (PPT)
timeFrame: Day 3
measure: Pressure Pain Thresholds (PPT)
timeFrame: Day 4
measure: Cold Detection Thresholds (CDT)
timeFrame: Day 3
measure: Heat Pain Thrteshold
timeFrame: Day 1
measure: Cold Detection Thresholds (CDT)
timeFrame: Day 4
measure: Warm Detection Thresholds (WDT)
timeFrame: Day 3
measure: Warm Detection Thresholds (WDT)
timeFrame: Day 4
measure: Heat Pain Thrteshold
timeFrame: Day 3
measure: Heat Pain Thrteshold
timeFrame: Day 4
measure: Pain to Supra-threshold Heat Stimuli (STHS)
timeFrame: Day 4
measure: Cold Pain Thresholds (CPT)
timeFrame: Day 3
measure: Cold Pain Thresholds (CPT)
timeFrame: Day 4
measure: Pain to Supra-threshold Heat Stimuli (STHS)
timeFrame: Day 3
Other outcomes:
Locations:
city: Gistrup
country: Denmark
facility: Center for Neuroplasticity and Pain Faculty of Medicine, Aalborg University Selma Lagerløfs Vej 249 9260 Gistrup, Denmark
Study officials:
References: