Phase 4
N=34
Retinol on Human Skin Aging in East Asian Descent
Intrinsic Aging of Skin
Bottom Line
View on ClinicalTrials.gov: NCT02906566 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Older Group, Retinol Versus Placebo) — 23; 21 genes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Retinol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Older Group, Retinol Versus Placebo) |
23; 21 | — |
| PRIMARY Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Younger Group Versus Older Group as Baseline) |
775; 587 | — |
| SECONDARY Transepidermal Water Loss |
17.1; 16.2; 9.4; 10.2 | — |
| SECONDARY Severity of Arm Skin Wrinkling |
5.15; 5.5; 4.85; 5.175 | — |
| SECONDARY Elasticity on Arm Skin |
0.8623; 0.8753; 0.8587; 0.8576 | — |
| SECONDARY Count of Participants With Skin and Subcutaneous Adverse Events as a Measure of Type and Severity of Adverse Events |
1; 1; 0; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02906566). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.