Retinol on Human Skin Aging in East Asian Descent

Study Overview
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Brief Summary
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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.

Official Title
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Discovery of Effects of Retinol on Human Skin Aging in Individuals of East Asian Descent

Conditions
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Intrinsic Aging of Skin

Intervention / Treatment
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* Drug: Retinol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Older Group Ages 55-75<br>Active and Placebo. Participants received retinol lotion on one arm and placebo to match on the other arm. | Drug: Retinol<br>* Retinol in the form of vitamin A lotion<br>Drug: Placebo<br>* Placebo of Retinol<br>|
| No Intervention: Young Group Ages 18-25<br>Participants in the group will give tissue sample only for comparison. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Older Group, Retinol Versus Placebo) | 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. | Week 12 | 
| Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Younger Group Versus Older Group as Baseline) | 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). | Week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transepidermal Water Loss | Transepidermal Water Loss of arm skin was measured in units of grams/hours/meters squared. | Baseline; Week 12 | 
| Severity of Arm Skin Wrinkling | Wrinkling was assessed by the investigator using a 10-point Likert scale (range 0 to 9, lower scores correspond to less wrinkling). | Baseline; Week 12 | 
| Elasticity on Arm Skin | Elasticity was assessed using cutometry (R2 curve) as millimeters per second | Baseline; week 12 | 
| Count of Participants With Skin and Subcutaneous Adverse Events as a Measure of Type and Severity of Adverse Events | Skin and subcutaneous adverse events were assessed for this outcome and documented and scored according to CTCAE version 4.03. | Baseline through week 12 |