Retinol on Human Skin Aging in East Asian Descent
- Registration Number
- NCT02906566
- Lead Sponsor
- Stanford University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 110
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Older Group Ages 55-75 Placebo Active and Placebo. Participants received retinol lotion on one arm and placebo to match on the other arm. Older Group Ages 55-75 Retinol Active and Placebo. Participants received retinol lotion on one arm and placebo to match on the other arm.
- Primary Outcome Measures
Name Time Method Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Younger Group Versus Older Group as Baseline) 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) 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.
- Secondary Outcome Measures
Name Time Method Count of Participants With Skin and Subcutaneous Adverse Events as a Measure of Type and Severity of Adverse Events Baseline through week 12 Skin and subcutaneous adverse events were assessed for this outcome and documented and scored according to CTCAE version 4.03.
Severity of Arm Skin Wrinkling Baseline; Week 12 Wrinkling was assessed by the investigator using a 10-point Likert scale (range 0 to 9, lower scores correspond to less wrinkling).
Elasticity on Arm Skin Baseline; week 12 Elasticity was assessed using cutometry (R2 curve) as millimeters per second
Transepidermal Water Loss Baseline; Week 12 Transepidermal Water Loss of arm skin was measured in units of grams/hours/meters squared.
Trial Locations
- Locations (1)
Stanford Dermatology
🇺🇸Redwood City, California, United States