Impact to Skin Due to Wet Pad Application. Skin Status and Change in the Stratum Corneum as Measured With 4 Instruments in an Elderly Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in Skin water profile
研究概览
简要总结
The clinical study aims to measure the changes in the stratum corneum on older healthy participants due to the application of a wet pad on the forearm. Participants are subject to baseline measures of TransEpidermalWaterLoss (TEWL), skin hydration (SH), pH and water profile (raman spectroscopy). Dry or wet pads are then added to the skin and worn for two hours. After a recovery period, the SkinSurfaceWaterLoss (SSWL) and skin hydration and water profile is measured. The study is conducted over a single visit. Pads on the arms consist of incontinence product cutouts and are loaded to 50% or 100% capacity. The endpoints are the changes in stratum corneum as measured by the instruments during the visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women ≥ 65 years.
- •Mentally and physically able to participate in this study.
- •Written informed consent to participate in this study.
- •Intact skin on the volar forearms without skin irritation.
排除标准
- •Have any known allergies or intolerances to one or several components of the absorbing incontinence product.
- •Suffer from excessive sweating, hyperhidrosis.
- •Have any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator.
- •Not be of childbearing potential.
- •Have an alcohol and/or drug dependency.
结局指标
主要结局
Change in Skin water profile
时间窗: 2 hours
As measured Confocal raman microspectometry. The water content of skin at different depths.
Change Trans Epidermal Water loss
时间窗: 2 hours
As measured by Dermalab instrument. Transepidermal water loss (TEWL) from dry skin and the subsequent skin surface water loss (SSWL) from wet skin
Change in skin hydration
时间窗: 2 hours
Skin hydration (SH) as measured with moisturemeter instrument
次要结局
- Change in skin surface pH(2 hours)