Assessment of the Effect of Micellar Solution on Measures of Skin Barrier Function
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in TransEpidermal Water Loss (TEWL)
研究概览
简要总结
The goal of this clinical trial is to assess how micellar water affects the skin barrier in healthy adult volunteers. The main questions it aims to answer are:
- Does leaving micellar water on the skin affect skin barrier function differently than rinsing it off?
- Are there measurable differences in transepidermal water loss (TEWL), skin hydration, and erythema between the two application methods?
Researchers will compare the effects of micellar water left on the skin versus rinsed off after application.
Participants will:
- Be randomly assigned to one of two groups
- Apply micellar water to their forehead once daily for 21 days
- Either leave the micellar water on or rinse it off, depending on their group
- Undergo non-invasive measurements of TEWL, skin hydration, and erythema before and after the intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Healthy adult volunteers aged 18 years and older. Willingness and ability to comply with study procedures. Signed informed consent indicating understanding of study participation, rights, and potential risks and benefits. No current skin diseases or conditions at the test site. Ability to attend all study visits and follow instructions
排除标准
- •Participants with skin diseases, skin cancers, or sun damage at the test site will be excluded. Use of immunomodulators, corticosteroids, or antihistamines within 30 days prior to the study start is exclusionary. Application of emollient creams within 3 days before the trial is not permitted. Other exclusion criteria include protocol non-compliance, excessive exposure to natural or artificial ultraviolet radiation, pregnancy or lactation, history of vitiligo, melasma, or other hyperpigmentation or photosensitive disorders, immunosuppression, and allergy to any ingredient of the micellar solution used in the intervention. Before starting the study, participants will be asked if they have ever experienced adverse reactions to any components of the micellar solution.
结局指标
主要结局
Change in TransEpidermal Water Loss (TEWL)
时间窗: Four measurements total: one at baseline (before application), and one at the start of each week during the 3-week intervention (Days 0, 7, 14, and 21).
Measurement of transepidermal water loss on the forehead to assess skin barrier function.
Change in Skin Hydration
时间窗: Four measurements total: one at baseline (before application), and one at the start of each week during the 3-week intervention (Days 0, 7, 14, and 21).
Measurement of skin hydration levels on the forehead before and after micellar water application.
Change in Erythema
时间窗: Four measurements total: one at baseline (before application), and one at the start of each week during the 3-week intervention (Days 0, 7, 14, and 21).
Assessment of skin redness (erythema) on the forehead before and after of micellar water application.
次要结局
未报告次要终点