Retinol on Human Skin Aging in East Asian Descent

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

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.

Study Overview

• Status: Completed
• Conditions: Intrinsic Aging of Skin
• Intervention / Treatment: Drug: Retinol; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94603
      • Stanford Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): March 9, 2018
• Study Completion (Actual): March 9, 2018

Study Registration Dates

• First Submitted: February 26, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: March 25, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: 33762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No current plan to share data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No