A Randomized Controlled Trial on the Efficacy and Safety of Virgin Coconut Oil Compared to Mineral Oil in the Treatment of Uremic Xerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Change in baseline overall dry skin score
研究概览
简要总结
Among adult patients with chronic kidney disease undergoing hemodialysis, what is the efficacy and safety of virgin coconut oil compared to mineral oil as a therapeutic moisturizer for uremic xerosis?
详细描述
Objectives of the Study: The general objective of this study is to assess the efficacy and safety of virgin coconut oil (VCO) compared to mineral oil as a therapeutic moisturizer for uremic xerosis. The specific objectives are as follows: 1) to determine and compare changes in the over-all dry skin score within and between treatment groups at baseline, 2 weeks-post and 4-weeks post application; 2) to quantitatively measure the following skin parameters at baseline, 2-weeks and 4-weeks post application (skin hydration using a corneometer, skin lipids using a sebumeter); 3) to determine and compare changes in quality of life scores within and between treatment groups at baseline, and 4-weeks post application; and 4) to identify the adverse effects of virgin coconut oil and mineral oil when used as moisturizer for uremic xerosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults undergoing maintenance hemodialysis who have mild to severe uremic xerosis
排除标准
- •Patients with known hypersensitivity to the tests oils were excluded from the study as well as patients with open wounds, erosions, and ulcers on the test site and paraplegics and patients with altered sensation on the test sites.
- •Patients with xerosis associated with other dermatologic conditions antedating renal failure were excluded from the study.
结局指标
主要结局
Change in baseline overall dry skin score
时间窗: 4 weeks
Change in baseline corneometer readings
时间窗: 4 weeks
Measurement of skin hydration
Change in baseline sebumeter readings
时间窗: 4 weeks
Measurement of skin lipids
次要结局
- Change in Quality of life scores(4 weeks)
- Patient-assessed efficacy(4 weeks)
- Adverse events(4 weeks)
研究者
Jacqueline Michelle G. de las Alas, M.D.
Medical Officer III
University of the Philippines