Ozone Reaction Products and Their Acute Effects on Skin Health: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in chemical exposome level on the forearm skin
研究概览
简要总结
This is a randomized controlled human exposure study. Investigators aim to investigate the products of ozone-sebum reactions and their acute effects on skin health of healthy young adults.
详细描述
The investigators will conduct a randomized, controlled human exposure study involving 40 healthy young adults in Shanghai, China. Each participant will have both forearms simultaneously exposed-one in a clean air chamber and the other in an ozone chamber-for 2 hours. The ozone concentration at the ozone chamber inlet will be maintained at 200 ppb. The temperature and relative humidity in both chambers will be maintained at 27±2℃ and 45%±5%, respectively. Health examinations will be conducted at three time points: immediately before exposure, immediately after exposure, and 24 hours after exposure. These examinations will include skin measurements and sampling.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Living in Shanghai during the study period;
- •Having healthy skin conditions on both forearms.
排除标准
- •Subjects with a history of smoking and alcohol abuse;
- •Subjects with a regular use of medication and dietary supplements within 2 months prior to enrollment;
- •Subjects with severe skin diseases, such as atopic dermatitis, eczema, or severe acne;
- •Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, or atopy, or history of allergic reactions within 2 months prior to enrollment;
- •Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, or hypertension;
- •Subjects with respiratory diseases, such as asthma, acute or chronic bronchitis, or pneumonia;
- •Subjects with chronic diseases, such as diabetes, chronic hepatitis, or kidney disease;
- •Subjects with cutaneous abnormalities on forearm, such as severe pigmentation, multiple nevus, or tattooing;
- •Subjects who underwent cosmetic intervention on forearms within 2 months prior to enrollment, such as whitening treatments, UV exposure therapies, depigmentation procedures, or tanning;
- •Females in pregnancy or lactation status.
研究组 & 干预措施
Exposure group
The forearm assigned to this group will be exposed to 200 ppb ozone for 2 hours.
干预措施: Ozone exposure (Other)
Control group
The forearm assigned to this group will be exposed to clean air for 2 hours.
干预措施: Clean air exposure (Other)
结局指标
主要结局
Changes in chemical exposome level on the forearm skin
时间窗: Immediately before exposure and immediately after exposure.
Changes in the amount and level of chemical contaminants between ozone and clean air exposures, which will be detected using non-targeted or targeted methods.
次要结局
- Changes in skin hydration(Immediately before exposure, immediately after exposure, and 24 hours after exposure.)
- Changes in TEWL(Immediately before exposure, immediately after exposure, and 24 hours after exposure.)
- Changes in pH(Immediately before exposure, immediately after exposure, and 24 hours after exposure.)