Assessment of Skin Barrier Disruption Due to Daily Use of Cleaning Products and Hand Disinfectants
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Skin barrier evaluation
研究概览
简要总结
The goal of this clinical trial is to assess the effects of household detergents and hand disinfectants on human skin barrier integrity among healthy adult volunteers.
The main questions it aims to answer are:
- How does exposure to household detergents and hand disinfectants impact skin barrier function?
- Are there differences in skin barrier disruption between various types of cleaning agents and disinfectants?
Participants will:
Undergo patch testing with controlled amounts of household detergents and hand disinfectants on a small area of their skin.
Be monitored for adverse reactions during and after exposure. Have their skin barrier integrity assessed using electrical impedance spectroscopy at multiple time points post-exposure.
If there is a comparison group:
Researchers will compare the effects of different types of cleaning agents, hand disinfectants, and their ingredients on skin barrier integrity to determine variations in their impact.
详细描述
- Core Message:
Understanding the effects of detergent and disinfectant exposure on skin barrier integrity is crucial for public health, particularly given their widespread use. 2. Supporting Information:
Studies suggest an association between cleaning agents and skin barrier disruption. Skin barrier function can be assessed using various methods, including electrical impedance spectroscopy (EIS). 3. Key Points:
Scientific Question: Investigate how household detergent, hand disinfectant, and their ingredients exposure affect skin barrier function.
Proposed Intervention: Conduct controlled human skin exposure experiments with properly diluted household detergents, hand disinfectants, and their ingredients.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The study population will consist of healthy adult volunteers;
- •age between18 and 65 years,
- •Generally healthy and able to provide written informed consent. The choice of healthy adult volunteers without pre-existing skin conditions on site or allergies against tested products is justified.
排除标准
- •Severe dermatitis, eczema, psoriasis, or other chronic skin conditions.
- •History of hypersensitivity or allergies to tested product ingredients.
- •Current or recent systemic therapy for a skin condition in the past six months.
- •Pregnant or breastfeeding individuals.
- •Use of investigational drugs or participation in another trial in the last 30 days.
- •History of skin cancer or malignancies in the study area.
- •Significant sunburn, open wounds, or active skin infections in the study area.
- •Any medical condition that, per the investigator, might compromise safety or confound results.
- •Inability to follow study instructions or attend required clinic visits.
- •Gender Balance: To ensure gender balance, efforts will be made to recruit an equal number of male and female participants.
研究组 & 干预措施
Exposure arm
Prepared test products, such as household cleaner, hand disinfectant, their ingredients, and control on patch testing tapes will be posted on the selected areas of forearm skin.
干预措施: Cleaning product exposure (Other)
结局指标
主要结局
Skin barrier evaluation
时间窗: before the application (0), right after the removal (5 min), 1, 3, and 24 hours after the treatment
We will measure skin barrier integrity by electrical impedance spectroscopy
次要结局
未报告次要终点