Discovery of Effects of Retinol on Human Skin Aging in Individuals of East Asian Descent
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Younger Group Versus Older Group as Baseline)
研究概览
简要总结
There has been increasing evidence for different rates of natural aging in humans and one of the best organs to study human aging is skin. Studies have demonstrated anti-aging effects of topical agents (such as creams, gels, lotions, or ointments) and one of them, retinol or vitamin A, was shown to decrease fine wrinkling in skin of older individuals. Additionally, studies of retinol in humans have largely occurred in white populations and so this study aims to focus on skin aging in individuals of East Asian descent as they represent a majority of the world population. This study aims to better characterize the molecular basis of rejuvenation effects and to potentially discover new topical agents with similar and/or more effective preservation of skin youthfulness.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •able to provide written informed consent
- •older group: age between 50 and 75 years
- •young group: age 18 to 25 years
- •all four grandparents of Han Chinese, Japanese, Korean descent
- •body mass index within normal or overweight range
- •no history of weight loss of >20 lbs within past 5 years
排除标准
- •skin condition in the areas of skin biopsy that would obscure results of analysis
- •topical creams or treatment to arms 2 weeks prior to study baseline visit
- •individuals with known hypersensitivity to retinoid class of agents (older group only)
- •prior anti-aging treatments to arms including retinol, microdermabrasion within 2 weeks of baseline visit
- •prior laser therapy or surgical procedure to arms
- •prior radiation or other trauma (extensive burns or abrasions) to arm skin
- •hormone-based therapy within 4 weeks of enrollment
研究组 & 干预措施
Older Group Ages 55-75
Active and Placebo. Participants received retinol lotion on one arm and placebo to match on the other arm.
干预措施: Retinol (Drug)
Older Group Ages 55-75
Active and Placebo. Participants received retinol lotion on one arm and placebo to match on the other arm.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Younger Group Versus Older Group as Baseline)
时间窗: Week 1
Differences in transcript levels are reported as the number of genes that were upregulated or downregulated in the Younger Group participant tissue samples, as compared to a baseline provided by tissue samples collected from the Older Group (prior to their treatment).
Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Older Group, Retinol Versus Placebo)
时间窗: Week 12
Differences in transcript levels are reported as the number that were upregulated or downregulated in the participant's retinol-treated arm versus their placebo-treated arm.
次要结局
- Count of Participants With Skin and Subcutaneous Adverse Events as a Measure of Type and Severity of Adverse Events(Baseline through week 12)
- Severity of Arm Skin Wrinkling(Baseline; Week 12)
- Elasticity on Arm Skin(Baseline; week 12)
- Transepidermal Water Loss(Baseline; Week 12)
研究者
Anne Chang
Associate Professor of Dermatology
Stanford University