A Single-center, Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate the Superiority of Peroral Sodium Hyaluronate to Placebo in Improving the Skin Hydration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in skin hydration
研究概览
简要总结
A single-center, double-blind, randomized, parallel-group, placebo-controlled study to evaluate the superiority of peroral sodium hyaluronate to placebo in improving the skin hydration and other skin-related parameters.
详细描述
Study type:
- Single-center, randomized, placebo-controlled, double-blind, parallel-group study.
- Participants will be stratified based on their sex (males/females) and age (young 18-39 years and old 40-60 years, max difference in median age between males and females 2 years), and randomly assigned to receive either the SH dietary supplements (lower concentration, daily dose 60 mg (SH60); and higher concentration, daily dose 120 mg (SH120)) or placebo in a 1:1:1 ratio.
- The study will follow a superiority framework, aiming to demonstrate that the SH60 and SH120 dietary supplements are superior to placebo in improving facial skin hydration.
- This study is a parallel-group trial: The three groups of participants (SH60/SH120/placebo group) will receive the treatments and will be assessed for their outcomes at the same time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects
- •Skin type: Caucasian, Fitzpatrick I-III
- •Sex: male and female
- •Age: 18 - 60 years.
- •No acute or chronic skin diseases affecting the face or volar forearm.
- •No acute or chronic gastrointestinal diseases.
- •Willing to keep their standard facial skincare routine and avoid any new products or procedures affecting facial or volar forearm skin during the study period.
- •Willing to avoid excessive UV exposure (tanning beds, excessive sunbathing) during the study period.
- •Willing to avoid longer stays in significantly different climates (will be assessed on a case-by-case basis)
- •Willing to avoid taking other dietary supplements containing SH
排除标准
- •Subjects with known allergies to any ingredients in the dietary supplement.
- •Pregnant or lactating individuals.
- •Significant facial skin conditions or disorders.
- •Acute or chronic disease affecting the skin or gastrointestinal system.
- •Subjects currently using topical or oral medications affecting the gastrointestinal system or the skin.
- •Subjects who are taking or has taken diet pills or supplements containing SH within the past 3 months.
- •Subjects who are taking or has taken oral antibiotics in the last 3 months.
- •Subjects with diabetes mellitus
- •Subjects with increased bleeding tendency, poor superficial veins in the antecubital fossa, and those with a fear of blood draws that makes blood draw impossible
结局指标
主要结局
Change in skin hydration
时间窗: 0, 1, 2 , 3 months
* Measurement site: forehead, volar forearm * Measurement time points: 0, 1, 2, 3 months * Measurement site: cheek * Measurement time points: 0, 1, 2 months * Measurement device: Corneometer CM 825 * Parameter unit: AU (arbitrary unit) * Number of measurements at each time point: at least 5 * Outcome measure: Change from baseline * Method of analysis: * Mean, standard deviation and confidence intervals will be calculated. * Normality of the data distribution will be assessed. * Comparison between HA group and placebo group will be assessed using independent sample T-test or Mann-Whitney U test as a nonparametric alternative.
Change in skin hydration
时间窗: 0, 1, 2 , 3 months
* Measurement site: forehead, volar forearm * Measurement time points: 0, 1, 2, 3 months * Measurement site: cheek * Measurement time points: 0, 1, 2 months * Measurement device: Corneometer CM 825 * Parameter unit: AU (arbitrary unit) * Number of measurements at each time point: at least 5 * Outcome measure: Change from baseline * Method of analysis: * Mean, standard deviation and confidence intervals will be calculated. * Normality of the data distribution will be assessed. * Comparison between HA group and placebo group will be assessed using independent sample T-test or Mann-Whitney U test as a nonparametric alternative.
次要结局
- Change in TEWL(0, 1, 2, 3 months)
- Change in skin elasticity(0, 1, 2, 3 months)
- Change in wrinkle depth(0, 1, 2, 3 months)
- Change in TEWL(0, 1, 2, 3 months)
- Change in skin elasticity(0, 1, 2, 3 months)
- Change in wrinkle depth(0, 1, 2, 3 months)