Repetitive Applications of Pruritogens and Effects of a Cutaneous-induced Pain Stimulation on Nonhistaminergic Itch Perception
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Assessment of itch
研究概览
简要总结
In This experiment, the investigators would like to design a new itch model based on the temporal summation of pruritic stimuli. The hypothesis behind this study (temporal summation) is that two overlapped applications of pruritogens will result in a higher itch sensation compared with a single application.
详细描述
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 multiple applications of pruritogens (temporal 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 with two overlapped applications of the pruritogens on the same area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Participant will be blinded about application of pruritogens
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •18-60 years
- •Speak and understand Englis
排除标准
- •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)
结局指标
主要结局
Assessment of itch
时间窗: 1 minute after every itch inductions
Immediately following the itch provocations, participants will be instructed to rate the itch intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no itch' and 100 'worst itch imaginable'.
Assessment of pain
时间窗: 1 minute after every itch inductions
Immediately following the itch provocations, participants will be instructed to rate the pain intensity for 10 minutes using a digital visual analogue scale (VAS; eVAS Software: Aalborg, University, Denmark), on a tablet. The scale will be measured from 0 to 100, where 0 represents 'no pain' and 100 'worst pain imaginable'
次要结局
- Microvascular reactivity(10 minutes after every itch inductions)
- Alloknesis(12 minutes after every itch inductions)
- Mechanically evoked itch(15 minutes after every itch inductions)
研究者
Silvia Lo Vecchio
Associate Professor
Aalborg University