Effects of Halophyte-based Cream Skin Application in a Human Experimental Model of Pain and Itch
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Superficial blood perfusion
研究概览
简要总结
In this study the investigators wish to investigate whether halophyte-based cream applied to the skin can reduce itch applied by means of small needles from the plant mucuna pruriens (also called cowhage) or by histamine (an itch-evoking substance formed in the human body). Further, the investigators wishes to investigate whether long-term application of halophyte-based cream has a pain-relieving effect on heat/cold and pinprick stimulations.
详细描述
Salt-tolerant plants (also called halophytes) can grow in saline soil or directly in salt water (e.g. along coasts). For centuries, these plants have been used in folk medicine, and among other things they are believed to have pain-relieving and anti-inflammatory effect.
Even though experiments have already investigated halophytes as a pain relieving substance, the mechanisms in relation to pain and/or itch are still unknown. Therefore, the investigators wish to investigate whether halophyte-based cream applied to the skin can reduce itch applied by means of small needles from the plant mucuna pruriens (also called cowhage) or by histamine (an itch-evoking substance formed in the human body). Further, the investigators wishes to investigate whether long-term application of halophyte-based cream has a pain-relieving effect on heat/cold and pinprick stimulations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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 English
排除标准
- •Pregnancy or lactation
- •Drug addiction defined as any use of cannabis, opioids or other drugs
- •Previous or current neurologic, musculoskeletal or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.)
- •Lack of ability to cooperate
- •Current use of medications that may affect the trial such as antihistamine medications or pain killers
- •Skin diseases
- •Consumption of alcohol or painkillers 24 hours before the study days and between these
- •Acute or chronic pain
- •Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
结局指标
主要结局
Superficial blood perfusion
时间窗: 48 hours after cream application
Superficial blood perfusion is measured by a Speckle contrast imager (FLPI, Moor Instruments, England).
Pain intensity
时间窗: 48 hours after cream application
The subject will rate the pain sensation on a 100 millimeter Visual Analog Scale from 0 to 100., where 0"indicates no pain and "100" worst pain imaginable
Itch intensity
时间窗: 48 hours after cream application
The subject will rate the itch sensation on a 100 millimeter Visual Analog Scale from 0 to 100., where 0"indicates no itch and "100" worst itch imaginable
Measuring Alloknesis
时间窗: 48 hours after cream application
Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Trans-epidermal Water Loss (TEWL)
时间窗: 48 hours after cream application
TEWL is a non-invasive and pain free measuring technique in which a 2x2 cm hollow probe with two small humidity gauges and two thermometers is placed lightly on the skin for 10-25 seconds. These collectively establish a precise humidity gradient in a 2 cm vicinity of the skin, representative for the point-loss of water though the epidermis.
次要结局
- Measurement of Mechanical Pain Sensitivity (MPS)(48 hours after cream application)
- Measurement of Warm Detection Thresholds (WDT)(48 hours after cream application)
- Measurement of Cold Pain Thresholds (CPT)(48 hours after cream application)
- Measurement of Mechanical Pain Thresholds (MPT)(48 hours after cream application)
- Measurement of Pain to Supra-threshold Heat Stimuli:(48 hours after cream application)
- Measurement of Cold Detection Thresholds (CDT)(48 hours after cream application)
- Measurement of Heat Pain Thresholds (HPT)(48 hours after cream application)
研究者
Rocco Giordano
Principal Investigator
Aalborg University