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
- 25
- 试验地点
- 1
- 主要终点
- Change in Trans Epidermal Water loss (TEWL)
研究概览
简要总结
The main aim of this study is to describe the effects of dry or wet incontinence pad material on the skin barrier function by measuring the changes of the stratum corneum on healthy participants due to the application of pads with varying wetness level to the forearm. Study findings have relevance for product development of absorbing incontinence products to further protect the skin from the damaging effects of excess moisture. Participants are subject to baseline measures of TEWL, SH, pH and water profile. Dry or wet pads are then added to the forearm skin and worn for two hours. After a recovery period, the SSWL, SH and water profile is measured. The study is conducted over a single 4h visit. As this is an explorative study no hypothesis is intended to be tested.
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.
研究组 & 干预措施
Test patches
Application of test patches. Each subject wear both low pH formula patches (intervention) and control patches without formula.
干预措施: Test patches (Device)
结局指标
主要结局
Change in Trans Epidermal Water loss (TEWL)
时间窗: 2 hours
TEWL is measured at baseline and then after 2h of dry patch use the unit is g/m2\*h. For the wet patches the follow up measurement is on skin surface water loss (SSWL) as the skin is not dry the unit is the same as for TEWL.
次要结局
- Change in skin hydration(2 hours)
- Change in skin surface pH(2 hours)
- Change skin water profile(2 hours)