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Recruiting NCT06503510

Role of Interleukin-13 Pathways on Pain and Itch Sensitivity

No phase Interventional Itch

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Histamine, Cowhage, bovine adrenal medulla (BAM8-22).
Who it may be relevant to
Registry conditions: Itch. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Role of the Interleukin-13 Pathways on Pain and Itch Sensitivity in Patients With Atopic Dermatitis and Healthy Volunteers

Overview

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.

Interventions

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

Primary outcome measures

  • Measuring itch by computerized Visual Analog Scale Scoring [Time frame: 1 minute after every itch induction]
  • Measuring pain by computerized Visual Analog Scale Scoring [Time frame: 1 minute after every itch induction]
  • Superficial blood perfusion [Time frame: Baseline]
  • Superficial blood perfusion [Time frame: 10 minute after every itch induction]
  • Wheal reaction [Time frame: 10 minute after every itch induction]
  • Average pruritis and pain numerical rating scale (NRS) [Time frame: Baseline]
  • Skin peak pain numerical rating scale (SPP-NRS) [Time frame: Baseline]
  • Peak pruritus numerical rating scale (PP-NRS) [Time frame: Baseline]
  • Mechanically evoked itch (MEI) [Time frame: Baseline]
  • Mechanically evoked itch (MEI) [Time frame: 10 minutes after every itch induction]
Secondary outcome measures (8)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 3 centers
  • Aalborg University — Gistrup
  • CNAP — Gistrup
  • Aalborg University — Aalborg

Identifiers

NCT: NCT06503510 · N-20240029

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗