A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating The Safety And Efficacy Of An Oral Supplement Containing Astaxanthin (2 mg) + Lycopene (1.8 mg) + D-Alpha-Tocopherol (10 IU) For The Treatment Of Skin Aging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of subjects within each treatment group with a significant decrease in skin wrinkling measured by a validated Crow's Feet Wrinkle scale.
研究概览
简要总结
The purpose of this study is to determine the clinical efficacy of a combination of Astaxanthin (2 mg), Lycopene (1.8 mg), and d-alpha-Tocopherol (10 IU) in terms of its skin anti-aging properties. Specifically, the investigators aim to determine the increase in hydration levels of the skin, decrease in atypical skin pigmentation, and reduction of signs of photoaging, particularly facial fine lines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals age 30 to 60 years old
- •Fitzpatrick Skin Type I-IV
- •Crow's Feet Wrinkle Scale Class 1-2
- •Subjects willing to provide written informed consent
排除标准
- •Use of topical or oral anti-aging drug therapy 1 month prior to the study
- •History of allergy to cosmetics and anti-aging drugs
- •History of photosensitivity reactions
- •Any current or past medical condition, including seizures and stroke
- •History of pigmentation disorder such as but not limited to vitiligo and leukoderma
- •Immunocompromised state
- •Pregnant or lactating (pregnancy kit will be used to check)
- •Patients who have undergone laser, radiofrequency, peeling, and other procedural therapies for anti-aging in the month prior to the study.
- •Patients with current inflammatory or infectious skin disease on the face, or history of such in the month prior to the study.
- •Patients taking OCDs and other photosensitizing drugs (e.g. tetracycline).
- •Not willing to provide informed consent
研究组 & 干预措施
Placebo
干预措施: Placebo (Dietary Supplement)
Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)
干预措施: Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU) (Dietary Supplement)
结局指标
主要结局
Proportion of subjects within each treatment group with a significant decrease in skin wrinkling measured by a validated Crow's Feet Wrinkle scale.
时间窗: 12 weeks
The scale ratings are 0 for no wrinkles, 1 for very fine wrinkles, 2 for fine wrinkles, 3 for moderate wrinkles, and 4 for severe wrinkles.
次要结局
- Proportion of subjects within each treatment group with a significant increase in skin hydration measured by a corneometer.(12 weeks)
- Proportion of subjects within each treatment group with a significant decrease in pigmentation measured by a mexameter.(12 weeks)