An 8-week Full Face HUT Design, Single Center, Double Blinded, Controlled and Randomized Study to Evaluate Different Product Regimens' Performance on Protecting Skin With Resilience Under Tracked City Environmental Aggressors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Skin surface moisture content
研究概览
简要总结
- To investigate the product regiments' performance on moisturization related skin healthy signs (skin moisturization, barrier function, elasticity, translucency, roughness and skin conditions) through instrumental evaluation, clinical grading and self-assessment before, during and after 8 weeks' home usage under city environmental aggressors (Sun, change of temperature and humidity, wind and air pollution) among 3 product regimens and Non-treatment control;
- To explore the linkage among products efficacy, ambient aggressors, and life habits;
- To investigate product regimens' tolerance and safety via Home Use Test;
- To collect skin microflora/microbiome samples for potential research on skin microbiome distribution change as impacted by product application and/or environmental aggressors change (data will be analyzed and reported separately).
详细描述
This is a single center, double blinded, controlled and randomized 8-week home use clinical trial.
Subjects will be randomly and evenly divided into 3 groups (40subjects/group) with different facial care regimens during the 8-week home use study.
Group 1: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel Group 2: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel Group 3: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion There will be a 3-day wash-in period after subject's enrollment. During the period, no product will be allowed to be applied on the face and upper chest but only water washes twice per day in the morning and evening for 3 days before baseline (BL) measurement.
After baseline (BL) measurement, the product regimens will be applied on face at site under site instruction according to the randomization. Measurements will be taken at 2-4 hours and 8 hours after product regimens' application. Upper chest area will be measured as no treatment control.
A set of product regimen includes a facial cleanser and a facial cream will be distributed to each subject according to grouping and applied on the face at home for 8 weeks. Both cleanser and cream products will be applied twice a day in the morning and evening on the whole face. For the upper chest area, use water wash only twice per day in the morning and evening, no any other product is allowed.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Since this will be a blind study, the product randomization codes will be generated by study team member different from Study Manager, Study Director, Principle Investigator and any data producers or influencer. The product randomization codes and the corresponding product information (i.e. product name, formula number, batch number, manufacturing/expiry date, etc.) will be sealed in an envelope and before study filed work complete kept by PI until there is a unblinding needs due to medical emergency or report drafting.
In this study, in total 4 IPs include 3 facial creams and 1 facial cleanser will be evaluated. Subjects will be assigned to 3 groups randomly and evenly with different facial product regimens (one cleanser + one cream). The product regimens will be applied on the whole face for on-site study and the 8-week HUT. For each subject, left or right cheek area will be randomly chosen as experimental area for evaluation and middle upper chest will be the untreated control area
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Skin surface moisture content
时间窗: 9 weeks
Skin surface moisture content is measured by skin capacitance measurement.
次要结局
- Skin softness(9 weeks)
- Skin hydration(9 weeks)
- Clogged pores(9 weeks)
- Skin microbiome(9 weeks)
- Skin deep layer moisture content(9 weeks)
- Life habits(9 weeks)
- Temperature(9 weeks)
- PM 2.5(9 weeks)
- Quality of Life(9 weeks)
- Skin smoothness(9 weeks)
- Subject Self-assessment(9 weeks)
- Humidity(9 weeks)
- Skin barrier function(9 weeks)
- Skin roughness(9 weeks)
- Skin firmness(9 weeks)
- Skin radiance(9 weeks)
- Pimple(9 weeks)
- Skin fine lines(9 weeks)
- Skin elasticity(9 weeks)
- Skin translucency(9 weeks)