Topical Application of Highly Concentrated Water-in-oil Emulsions: Physiological Skin Parameters and Skin Penetration in Vivo - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Penetrated amount of fluorescein sodium into the skin using tape stripping/fluorescence spectroscopy
研究概览
简要总结
The purpose of this study is to I. determine the effect of repetitive application of newly developed silicone based formulations (placebo water-in-oil emulsions) on transepidermal water loss and other physiological skin parameters and II. investigate the skin penetration of the model drug fluorescein sodium in tape stripping studies to determine the in vivo penetration profile from the water-in-oil emulsions.
详细描述
Water-in-oil emulsions will be applied daily for a period of 4 weeks on the non-dominant volar forearm of voluntary participants. Several physiological skin parameters will be monitored in weekly intervals during the application period. Additional measurements will be carried out immediately before the start of the application and after a treatment-free recovery period of 2 weeks. The untreated forearm will be used as a reference.
Subsequent to the observational study, tape stripping experiments with fluorescein sodium-loaded formulations will be conducted on the non-dominant forearm of the participants.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of subject informed consent
- •Female or male aged between 18 and 65 years
排除标准
- •Pregnancy
- •Chronic skin conditions
结局指标
主要结局
Penetrated amount of fluorescein sodium into the skin using tape stripping/fluorescence spectroscopy
时间窗: week 8
Enhancement of the skin penetration of the model drug fluorescein sodium by the oil component isopropyl myristate in vivo using tape stripping combined with fluorescence spectroscopy
Change in transepidermal water loss
时间窗: 6 weeks
Influence of the application of the water-in-oil emulsions with different oil component - isopropyl myristate (IPM) or liquid paraffin (PAR) - on the transepidermal water loss (TEWL) using the AquaFlux Model AF200 Evaporimeter
次要结局
未报告次要终点
研究者
Lisa Binder
Principal Investigator
University of Vienna