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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

Tracking Information
First Submitted Date  ICMJE February 26, 2016
First Posted Date  ICMJE September 20, 2016
Results First Submitted Date  ICMJE February 27, 2019
Results First Posted Date  ICMJE April 16, 2019
Last Update Posted Date April 16, 2019
Study Start Date  ICMJE November 2015
Actual Primary Completion Date March 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
differences in transcript levels between older untreated and older treated skin [ Time Frame: Up to 2 years ]
assessed on skin tissue
Change History Complete list of historical versions of study NCT02906566 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
  • wrinkling [ Time Frame: up to 2 years ]
    assessed by photography
  • CTCAE v4.03 [ Time Frame: 30 days after last study intervention ]
  • number of participants with grade 2 or higher adverse effects as assessed by CTCAE v4.03 [ Time Frame: 30 days after last study intervention ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Retinol on Human Skin Aging in East Asian Descent
Official Title  ICMJE Discovery of Effects of Retinol on Human Skin Aging in Individuals of East Asian Descent
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Intrinsic Aging of Skin
Intervention  ICMJE
  • Drug: Retinol
    Retinol in the form of vitamin A lotion
  • Drug: Placebo
    Placebo of Retinol
Study Arms  ICMJE
  • Older Group Ages 55-75
    Active and Placebo. Participants received retinol lotion on one arm and placebo to match on the other arm.
    Interventions:
    • Drug: Retinol
    • Drug: Placebo
  • No Intervention: Young Group Ages 18-25
    Participants in the group will give tissue sample only for comparison.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2016)
110
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 9, 2018
Actual Primary Completion Date March 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02906566
Other Study ID Numbers  ICMJE 33762
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No current plan to share data.
Responsible Party Anne Chang, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP