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
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|Condition or disease||Intervention/treatment||Phase|
|Intrinsic Aging of Skin||Drug: Retinol Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Older Group Ages 55-75
Active and Placebo. Participants received retinol lotion on one arm and placebo to match on the other arm.
Retinol in the form of vitamin A lotion
Placebo of Retinol
No Intervention: Young Group Ages 18-25
Participants in the group will give tissue sample only for comparison.
- 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.
- 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).
- Transepidermal Water Loss [ Time Frame: Baseline; Week 12 ]Transepidermal Water Loss of arm skin was measured in units of grams/hours/meters squared.
- 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).
- Elasticity on Arm Skin [ Time Frame: Baseline; week 12 ]Elasticity was assessed using cutometry (R2 curve) as millimeters per second
- 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|
- 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
- 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
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
|United States, California|
|Redwood City, California, United States, 94603|
Documents provided by Anne Chang, Stanford University:
|Responsible Party:||Anne Chang, Associate Professor of Dermatology, Stanford University|
|Other Study ID Numbers:||
|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.|
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