Placebo-Contolled, Randomized of Creams With or Without Urea Influenceon the Hydration of the Skin of the Foot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparison of hydration of study areas in placebo vs. 20% groups as determined using corneometer UA (water per mg stratum corneum)
研究概览
简要总结
The skin is the most external organ of our body and one of its main functions is to provide protection in terms of possible infections.
Hydration is related to the proper functioning of the skin, being more difficult the appearance of wounds or cracks, which lead to the appearance of infections or other dermatological alterations.
The skin of the feet is thicker than in the rest of the body, due to the load it supports, being more complicated to maintain it.
With this study what is intended is to assess the effectiveness of different concentrations of urea (5% and 20%) in the hydration of the foot
详细描述
The measuring device of the Corneometer is constituted by a cylindrical probe, which contains at its distal end two parallel circuits in the form of capacitors covered by a plastic membrane. The probe should be placed perpendicularly on the surface of the skin. The pressure exerted on it must always be the same, therefore the probe has an internal hydraulic mechanism that, regardless of the pressure exerted by the manipulator, maintains a constant pressure.
Once the probe is placed in the place of measurement and the pressure is exerted on the skin, the circuit is closed and the conductance or capacitance is determined depending on the device, in a fraction of a second. Usually, between 3 and 10 measurements are made for each determination and entered in a computer record to obtain their averages.
The capacity of the condenser depends on the material, most of the materials increase the capacity compared to the vacuum by a factor of more than seven (dielectric constant); Water, however, increases the capacity by a factor of 81. Therefore, variations in the water content in the skin produce strong modifications in the measuring range of the Corneometer CM 825.
The Corneometer uses relative units proportional to the degree of corneal wetting. One AU corresponds to 0.2-0.9 mg of water per mg of anhydrous stratum corneum.
The study will be carried out to young people (20 -26 years old) from Practicum I of the Podiatry Clinic University of Plasencia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •those people who want to voluntarily participate in the study.
排除标准
- •suffer from structural, functional or traumatic alterations that affect the morphology and function of the lower limb
- •who do not fall within the age range of the study
- •who have used creams or any type of lotion the night before on the feet
结局指标
主要结局
Comparison of hydration of study areas in placebo vs. 20% groups as determined using corneometer UA (water per mg stratum corneum)
时间窗: 3 hours after the application
It is compared if the hydration of the different study areas depending on the type of cream that has been used.
Pre-hydration of the study areas
时间窗: 5 minutes
Measurement of the hydration of the three study areas (first metatarsal head, fifth metatarsal head and heel). The measure that the corneometer gives us is UA (water per mg stratum corneum)
Pre and Post of all study areas
时间窗: 5 MINUTES
Measurement of the hydration of the three study areas (first metatarsal head, fifth metatarsal head and heel) after the application of the different creams. The measure that the corneometer gives us is UA (water per mg stratum corneum).
Comparison of hydration of study areas in placebo vs. 5% groups as determined using corneometer UA (water per mg stratum corneum)
时间窗: 3 hours after the application
It is compared if the hydration of the different study areas depending on the type of cream that has been used.
Comparison of hydration of study areas in 20% vs. 5% groups as determined using corneometer UA (water per mg stratum corneum)
时间窗: 3 hours after the application
It is compared if the hydration of the different study areas depending on the type of cream that has been used.
次要结局
未报告次要终点
研究者
PAULA COBOS MORENO
Principal Investigator
University of Extremadura