Itch Sensation Induced by Simultaneous Application of Pruritogens (Spatial Summation)

Официальное название

Repetitive Applications of Pruritogens and Effects of a Cutaneous-induced Pain Stimulation on Nonhistaminergic Itch Perception

Обзор

In This experiment, the investigators would like to design a new itch model based on the spatial summation of pruritic stimuli. The hypothesis behind this study (spatial summation) is that two simultaneous applications of pruritogens will result in higher itch sensation compared with a single application of pruritogen.

Подробное описание

Chronic itch affects approximately a fifth of the global population and is associated with substantial negative consequences for the affected individuals. Furthermore, there is a lack of efficient treatment options for chronic itch. In order to mimic a clinical itch condition as presented in patients, the aim of the project is to investigate a new itch model based on the spatial summation of pruritic stimuli. The aim of this experiment is to assess the itch sensation induced by simultaneous application of pruritogens (spatial summation). In particular, the purpose is to evaluate if a single application of cowhage/histamine (non-histaminergic and histaminergic itch respectively) results in a lower itch sensation compared to two simultaneous applications of the pruritogens, on the same arm or in different arms.

Вмешательства

• Другое Cowhage
  25 spicules will be inserted in the center of the predefined skin area on the mandibular area. The spicules will be gently rubbed for 15-20 seconds in circular motion to facilitate epidermal penetration.
• Другое Histamine
  Histaminergic itch will be evoked by a 1% histamine solution. A droplet of histamine solution will be placed on the predetermined area on the forearm, and the SPT lancet will be pierced through the histamine with 120 g of pressure for 1-2 seconds.

Первичные конечные точки

• Assessment of itch [Срок оценки: 1 minute after every itch inductions]
• Assessment of pain [Срок оценки: 1 minute after every itch inductions]

Вторичные конечные точки (2)

• Alloknesis [Срок оценки: 12 minutes after every itch inductions]
• Mechanically evoked itch [Срок оценки: 15 minutes after every itch inductions]

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 addictive drugs
• Previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis) musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder, or mental illnesses that may affect the results
• Lack of ability to cooperate
• Current use of medications that may affect the trial such as antihistamines, antipsychotics, and pain killers, as well as systemic or topical steroids
• Skin diseases (e.g. atopic dermatitis, pruritus nodularis, eczema, psoriasis)
• Moles, scars, or tattoos in the area to be treated or tested.
• 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)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Фундаментальное исследование

Центры проведения

Дания · 1 центр

• Aalborg University — Aalborg

Идентификаторы

NCT: NCT06328530 · N-20210046 3rd project

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗