Retinol on Human Skin Aging in East Asian Descent

• 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: Stanford University
• Information provided by (Responsible Party): Anne Chang, Stanford University

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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:

Study Protocol and Statistical Analysis Plan  [PDF] October 12, 2016

More Information

• Responsible Party: Anne Chang, Associate Professor of Dermatology, Stanford University
• ClinicalTrials.gov Identifier: NCT02906566
• Other Study ID Numbers: 33762
• First Posted: September 20, 2016
• 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:

Vitamin A; Vitamins; Micronutrients; Physiological Effects of Drugs