Clinical trial NCT06503510: Role of Interleukin-13 Pathways on Pain and Itch Sensitivity
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: RECRUITING
Phase: NA
Conditions: Itch
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each participant will be treated with Lebrikizumab and will receive 3 pruritogens: Histamine, cowhage and BAM8-22.
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* 18-60 years

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Measuring itch by computerized Visual Analog Scale Scoring
timeFrame: 1 minute after every itch induction
measure: Measuring pain by computerized Visual Analog Scale Scoring
timeFrame: 1 minute after every itch induction
measure: Superficial blood perfusion
timeFrame: Baseline
measure: Superficial blood perfusion
timeFrame: 10 minute after every itch induction
measure: Wheal reaction
timeFrame: 10 minute after every itch induction
measure: Average pruritis and pain numerical rating scale (NRS)
timeFrame: Baseline
measure: Skin peak pain numerical rating scale (SPP-NRS)
timeFrame: Baseline
measure: Peak pruritus numerical rating scale (PP-NRS)
timeFrame: Baseline
measure: Mechanically evoked itch (MEI)
timeFrame: Baseline
measure: Mechanically evoked itch (MEI)
timeFrame: 10 minutes after every itch induction
Secondary outcomes:
measure: Mechanical Pain Thresholds (MPT)
timeFrame: Baseline
measure: Mechanical Pain Sensitivity (MPS)
timeFrame: Baseline
measure: Pressure Pain Thresholds (PPT)
timeFrame: Baseline
measure: Cold Detection Thresholds (CDT)
timeFrame: Baseliene
measure: Warm Detection Thresholds (WDT)
timeFrame: Baseline
measure: Cold Pain Thresholds (CPT)
timeFrame: Baseline
measure: Heat Pain Thresholds (HPT)
timeFrame: Baseline
measure: Pain to Supra-threshold Heat Stimuli (STHS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Gistrup
country: Denmark
facility: Aalborg University
state: Aalborg
city: Gistrup
country: Denmark
facility: CNAP
state: Aalborg
city: Aalborg
country: Denmark
facility: Aalborg University
Study officials:
References: