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Идёт набор NCT07122973

Topographical Distribution of Itch and Pain Receptors

Без фазы С лечением Pain Itch

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Histamine, Cowhage, Capsaicin 8% Patch, Demo patch.
Кому может быть актуально
Состояния в реестре: Pain, Itch. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pain and Itch Neuromodulation: Effects of Offset Analgesia, Placebo, and Nocebo and Topographical Distribution of Itch and Pain Receptors

Обзор

The experiment consists of three experimental sessions conducted on three consecutive days. In all experimental sessions, the participant will fill in a series of questionnaires about how you perceive itch and pain, and about some traits of your personality, such as depression, anxiety and stress. In the first session, we will mark six test areas in your face (three on each side on jaw, cheek, and temple, respectively). Thent a series of measure-ments in each test area will be conducted:measurement of the blood flow in the skin and sensitivity tests to pressure, pinprick and stroke with a brush. In the second session, histamine will be applied in one side of the face. On the other side, cowhage spicules will be applied. After 10 minutes, all the tests will be conducted again. The third session will be identical to the second. However, instead of histamine and spicules, patches containing capsaicin will be applied. In the other side, we will apply patches with placebo (i.e., a non-active patch). After 20 minutes all the tests will be conducted again.

Вмешательства

  • Другое Histamine
    To deliver histamine, standard allergy skin prick test (SPT) lancets are applied
  • Другое Cowhage
    The spicules will be manually inserted. Approximately 30-35 spicules are gently rubbed into a 1 cm diameter skin area on the forearm/face
  • Другое Capsaicin 8% Patch
    Capsaicin patches (dosage form: transdermal patch 8% Qutenza, Astellas) will be applied on 3 squared areas in the face.
  • Другое Demo patch
    Placebo patch (demo patch, containing the same formulation as the active treatment with the exception of capsaicin) will be applied on 3 squared areas in the face.

Первичные конечные точки

  • Measuring pain by computerized Visual Analog Scale Scoring [Срок оценки: Baseline]
  • Measuring itch by computerized Visual Analog Scale Scoring [Срок оценки: Baseline]
  • Measuring pain by computerized Visual Analog Scale Scoring [Срок оценки: Immediately after the intervention]
  • Measuring itch by computerized Visual Analog Scale Scoring [Срок оценки: Immediately after the intervention]
Вторичные конечные точки (12)
  • Superficial blood perfusion [Срок оценки: Baseline]
  • Superficial blood perfusion [Срок оценки: Immediately after the intervention]
  • Alloknesis [Срок оценки: Baseline]
  • Alloknesis [Срок оценки: Immediately after the intervention]
  • Mechanically evoked itch (MEI) [Срок оценки: Baseline]
  • Mechanically evoked itch (MEI) [Срок оценки: Immediately after the intervention]
  • Mechanical Pain Thresholds (MPT) [Срок оценки: Baseline]
  • Mechanical Pain Thresholds (MPT) [Срок оценки: Immediately after the intervention]
  • Mechanical Pain Sensitivity (MPS) [Срок оценки: Baseline]
  • Mechanical Pain Sensitivity (MPS) [Срок оценки: Immediately after the intervention]
  • Cold Detection Thresholds (CDT) [Срок оценки: Baseline]
  • Cold Detection Thresholds (CDT) [Срок оценки: Immediately after the intervention]

Критерии участия

Критерии включения

  • Healthy men and women
  • 18-60 years
  • Speak and understand English

Критерии исключения

  • Pregnancy or lactation
  • Drug addiction defined as any use of cannabis, opioids, or other drugs
  • Previous or current history of neurological, 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
  • Skin diseases
  • Consumption of alcohol or painkillers 24 hours before the study days and between these
  • Acute or chronic pain and itch
  • Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical studies)
  • Contraindications to capsaicin, including intolerance to chili or burns or wounds at the application site
  • The subject is assessed as unable to engage in the necessary cooperation required by the study

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
Фундаментальное исследование

Центры проведения

Дания · 1 центр
  • Aalborg University — Gistrup

Идентификаторы

NCT: NCT07122973 · N-20250017 Project 4

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗