Skip to main content
OpenTrials
Completed

NCT Number: NCT02906566

Retinol on Human Skin Aging in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intrinsic Aging of Skin

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Stanford Dermatology

Redwood City, California, 94603, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retinol

Drug

Retinol in the form of vitamin A lotion

Placebo

Drug

Placebo of Retinol

Primary outcomes

  1. Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Older Group, Retinol Versus Placebo)

    Time frame: 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.

  2. Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Younger Group Versus Older Group as Baseline)

    Time frame: 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).

Secondary outcomes

  1. Transepidermal Water Loss

    Time frame: Baseline; Week 12

    Transepidermal Water Loss of arm skin was measured in units of grams/hours/meters squared.

  2. Severity of Arm Skin Wrinkling

    Time frame: 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).

  3. Elasticity on Arm Skin

    Time frame: Baseline; week 12

    Elasticity was assessed using cutometry (R2 curve) as millimeters per second

  4. Count of Participants With Skin and Subcutaneous Adverse Events as a Measure of Type and Severity of Adverse Events

    Time frame: Baseline through week 12

    Skin and subcutaneous adverse events were assessed for this outcome and documented and scored according to CTCAE version 4.03.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 20, 2016
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.