Local Changes of Skin Characteristics During and After an Application of a Topical Product With a Warming or Cooling Effect - a Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Local Skin Perfusion
研究概览
简要总结
The use of topical over-the-counter (OTC) products with a warming or cooling effect is widespread in the fields of sport, physiotherapy and in private households. Advertisements for such products promise pain relief when suffering from musculoskeletal disorders such as muscle tension, rheumatism or acute injuries, e.g. sprains. In literature, there are only little information about the efficacy and the physiological mechanisms of topical warming or cooling products. Therefore, the aim of this study is to investigate the local skin characteristics during and after an application of a topical product with a warming or cooling effect.
详细描述
The use of topical products for local pain relief in chronic or acute musculoskeletal disorders is widely used. Despite the widespread use of these products, there is missing information on the physiological mechanisms and efficacy of topical warming and cooling ointments. Most of the existing literature is about the efficacy of topical non-steroidal anti-inflammatory drug (NSAID)-products on chronic pain in osteoarthritis. Furthermore, one study tested the cooling effect of gels with different menthol concentrations. They found that, regardless of the concentration, the skin temperature was reduced up to one hour post application in the area of application.
The aim of our study is to evaluate the change of skin characteristics after a single application of a warming or cooling topical product on healthy subjects. Outcome parameters include skin perfusion, temperature, skin redness and subjective thermal sensation. We only selected products in form of alcohol based ointments, menthol or wintergreen oil. Sprays and patches were excluded.
The application area is the unilateral lumbar back region, whereas the contralateral side serves as control area. After an acclimatization period, baseline measurements are performed, followed by standardized application of the topical product. The local skin responses are measured in 10 mins time increments up to one hour.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no existing musculoskeletal disorders in the region of interest
- •no surgery in the region of interest in the last year
- •healthy skin conditions in the region of interest
排除标准
- •fear of treatment
- •regular intake of drugs, excluding contraceptives
- •metal implants in the region between C7 and sacrum, including hip joints
- •lack of epicritic and protopathic skin sensitivity
- •renal insufficiency
- •bronchial asthma
- •pregnancy/lactation
- •type 1 or 2 diabetes mellitus
- •polyneuropathy
研究组 & 干预措施
Perskindol Classic Gel control
No product application. The contralateral lumbar back side acts as a Perskindol Classic Gel control.
Axanova hot gel
Intervention: Axanova hot gel is a topical product with a warming effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
干预措施: Axanova hot gel (Other)
Axanova hot gel control
No product application. The contralateral lumbar back side acts as a Axanova hot gel control.
Axanova activ gel
Intervention: Axanova activ gel is a topical product with a revulsive effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
干预措施: Axanova activ gel (Other)
Axanova activ gel control
No product application. The contralateral lumbar back side acts as a Axanova activ gel control.
Perskindol Dolo Gel
Intervention: Perskindol Dolo Gel is a topical product with a warming effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
干预措施: Perskindol Dolo Gel (Other)
Perskindol Dolo Gel control
No product application. The contralateral lumbar back side acts as a Perskindol Dolo Gel control.
Perskindol Classic Gel
Intervention: Perskindol Classic Gel is a topical product with a revulsive effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
干预措施: Perskindol Classic Gel (Other)
Perskindol Cool Kühl-Gel
Intervention: Perskindol Cool Kühl-Gel is a topical product with a cooling effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
干预措施: Perskindol Cool Kühl-Gel (Other)
Perskindol Cool Kühl-Gel control
No product application. The contralateral lumbar back side acts as a Perskindol Cool Kühl-Gel control.
Dolor-X Cool Gel control
No product application. The contralateral lumbar back side acts as a Dolor-X Cool Gel control.
Dolor-X Hot Gel
Intervention: Dolor-X Hot Gel is a topical product with a warming effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
干预措施: Dolor-X Hot Gel (Other)
Dolor-X Hot Gel control
No product application. The contralateral lumbar back side acts as a Dolor-X Hot Gel control.
Dolor-X Classic Gel
Intervention: Dolor-X Classic Gel is a topical product with a revulsive effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
干预措施: Dolor-X Classic Gel (Other)
Dolor-X Classic Gel control
No product application. The contralateral lumbar back side acts as a Dolor-X Classic Gel control.
Dolor-X Cool Gel
Intervention: Dolor-X Cool Gel is a topical product with a cooling effect. In a single application 3g of the product is applied in an area of 10cm x 10cm on the unilateral lumbar back until it has been completely absorbed by the skin.
干预措施: Dolor-X Cool Gel (Other)
结局指标
主要结局
Local Skin Perfusion
时间窗: during 45min post application
Local skin perfusion was measured with laser speckle contrast imaging (LSCI). The LSCI system uses arbitrary units to express the mean flux in the specified regions of interest which is related to the concentration of circulating erythrocytes in the tissue sample volume, scaled from blue (low perfusion) to red (high perfusion).
Skin Surface Temperature
时间窗: At baseline and during 45 minutes post application
skin surface temperature will be measured with thermochrons, infrared thermometer and thermal imaging camera
Local Muscle Tissue Oxygenation
时间窗: At baseline and during 45 min post application
local muscle tissue oxygenation will be measured with near infrared spectroscopy
Subjective Temperature Sensation
时间窗: At baseline and during 45 minutes post application
Thermal sensation ("How does this feel like?") was assessed in each skin area according to the ISO 10551 standard using the following 9-point Likert scale: 4 = very hot, 3 = hot, 2 = warm, 1 = slightly warm, 0 = neutral,-1 = slightly cool,-2 = cool,-3 = cold,-4 = very cold.
Subjective Thermal Comfort
时间窗: At baseline and during 45 minutes post application
Thermal comfort was assessed ("Do you find this. . .?") in each skin area according to the ISO 10551 standard using using a 5-point Likert scale with 0 = comfortable, 1 = slightly uncomfortable, 2 = uncomfortable, 3 = very uncomfortable, 4 = extremely uncomfortable.
次要结局
未报告次要终点