Retinol on Human Skin Aging in East Asian Descent

NCT02906566 | Completed Phase 4 Results

• 1 other identifier: 33762
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrinsic Aging of Skin

Outcome Measures

Primary Outcomes (2)

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

  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.

  Week 12

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

  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).

  Week 1

Secondary Outcomes (4)

• Transepidermal Water Loss

  Baseline; Week 12

• Severity of Arm Skin Wrinkling

  Baseline; Week 12

• Elasticity on Arm Skin

  Baseline; week 12

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

  Baseline through week 12

Study Arms (2)

Older Group Ages 55-75

OTHER

Active and Placebo. Participants received retinol lotion on one arm and placebo to match on the other arm.

Drug: Retinol; Drug: Placebo

Young Group Ages 18-25

NO INTERVENTION

Participants in the group will give tissue sample only for comparison.

Interventions

Retinol DRUG

Retinol in the form of vitamin A lotion

Older Group Ages 55-75

Placebo DRUG

Placebo of Retinol

Older Group Ages 55-75

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Dermatology

Redwood City, California, 94603, United States

Location

MeSH Terms

Interventions

Vitamin A

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Results Point of Contact

• Title: Dr. Anne L. Chang
• Organization: Stanford University

alschang@stanford.edu

650-721-7195

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: September 20, 2016
• Study Start: November 1, 2015
• Primary Completion: March 9, 2018
• Study Completion: March 9, 2018
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)