Role of Interleukin-13 Pathways on Pain and Itch Sensitivity

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (8)

• Mechanical Pain Thresholds (MPT) [Срок оценки: Baseline]
• Mechanical Pain Sensitivity (MPS) [Срок оценки: Baseline]
• Pressure Pain Thresholds (PPT) [Срок оценки: Baseline]
• Cold Detection Thresholds (CDT) [Срок оценки: Baseliene]
• Warm Detection Thresholds (WDT) [Срок оценки: Baseline]
• Cold Pain Thresholds (CPT) [Срок оценки: Baseline]
• Heat Pain Thresholds (HPT) [Срок оценки: Baseline]
• Pain to Supra-threshold Heat Stimuli (STHS) [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Healthy men and women
• 18-60 years

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 3 центра

• Aalborg University — Gistrup
• CNAP — Gistrup
• Aalborg University — Aalborg

Идентификаторы

NCT: NCT06503510 · N-20240029

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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