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Retinol on Human Skin Aging in East Asian Descent

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ClinicalTrials.gov Identifier: NCT02906566
Recruitment Status : Completed
First Posted : September 20, 2016
Results First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Anne Chang, 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.

Condition or disease Intervention/treatment Phase
Intrinsic Aging of Skin Drug: Retinol Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Discovery of Effects of Retinol on Human Skin Aging in Individuals of East Asian Descent
Study Start Date : November 2015
Actual Primary Completion Date : March 9, 2018
Actual Study Completion Date : March 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906566


Locations
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United States, California
Stanford Dermatology
Redwood City, California, United States, 94603
Sponsors and Collaborators
Stanford University
  Study Documents (Full-Text)

Documents provided by Anne Chang, Stanford University:

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Responsible Party: Anne Chang, Associate Professor of Dermatology, Stanford University
ClinicalTrials.gov Identifier: NCT02906566     History of Changes
Other Study ID Numbers: 33762
First Posted: September 20, 2016    Key Record Dates
Results First Posted: April 16, 2019
Last Update Posted: April 16, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan to share data.

Additional relevant MeSH terms:
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Vitamin A
Retinol palmitate
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents