Product A (Test Product), Product B (Control Product) Evaluation of Human Efficacy for Skin Moisturization and Wrinkle Improvement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Evaluation of Human Efficacy for Skin Moisturization Improvement through visual assessment
研究概览
简要总结
All subjects used the placebo sample on the left side of their face and the investigational sample on the right side of their face, respectively. The moisturizing levels were detected before use (0 week), after 2 weeks and after 4 weeks. The wrinkles of subjects were also measured on the same date interval as the skin moisture level test.
详细描述
Twenty-two subjects were initially enrolled in the clinical trial. One subject was excluded by non-compliance with the plan of trials. All subjects used the placebo sample on the left side of their face and the investigational sample on the right side of their face, respectively. The moisturizing levels were detected before use (0 week), after 2 weeks and after 4 weeks. The crow's feet of subjects were also measured on the same date interval as the skin moisture level test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females with dried skin, aged 30-59 years (average=49.2 yrs).
- •The subject has eye wrinkles (crow's feet).
- •A person who has voluntarily signed consent after fully explaining the test purpose and content.
- •Those who can follow up during the test period.
- •A healthy person without acute or chronic physical disease including skin disease.
排除标准
- •Pregnant or lactating women and women of childbearing age who do not agree to the contraceptive method prescribed by the protocol.
- •A person with a lesion at the test site or suffering from an infectious skin disease.
- •People with allergies or hypersensitivity, or irritation to cosmetics, pharmaceuticals, or daily exposure to light.
- •Those who have received systemic steroids or phototherapy within 1 month of participating in the trial, or who have received skin treatment (scaling/botox/filler/laser/tattoo) within 3 months of participating in the trial.
- •Those who have used drugs with similar functions at the research site within 3 months before the start of the study, or have a mental illness, or mental retardation disorder.
- •Other than the above, a person who will make it difficult to conduct a human test based on the judgment of the responsible researcher or the person in charge of the study.
结局指标
主要结局
Evaluation of Human Efficacy for Skin Moisturization Improvement through visual assessment
时间窗: up to 4 weeks
The skin moisture level of subjects were also measured on the 0, 2, 4 weeks. skin moisturizing level was conducted using a Corneometer CM825 (Courage and Khazaka, Köln, Germany). The measurement of skin moisturization used capacitance, and the difference in dielectric constant between water and the measuring material was expressed as a measured value.
Evaluation of Human Efficacy for skin Wrinkle Improvement through visual assessment
时间窗: up to 4 weeks
The skin wrinkles of subjects were measured on the 0, 2, and 4 weeks. Skin wrinkles were approximated by visual assessment using an Antera 3D CS (Miravex, Ireland). The depth (Depth, mm) image of the Wrinkle-small analysis mode was used as evaluation data for skin wrinkle measurement. The measuring device was a device that can measure the condition of the skin's epidermis and dermis using a light emitting diode (LED light source), extract data from three-dimensional shape images, quantify skin conditions, and monitor skin changes over time to measure skin wrinkles.
次要结局
未报告次要终点
研究者
Ji Hye Yoon
Principal Investigator
Sungkyunkwan University