Retinol on Human Skin Aging in East Asian Descent

Intrinsic Aging of Skin Clinical Trial

Official title:

Discovery of Effects of Retinol on Human Skin Aging in Individuals of East Asian Descent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906566
• Other study ID #: 33762
• Status: Completed
• Phase: Phase 4
• Start date: November 2015
• Est. completion date: March 9, 2018

Study information

• Verified date: March 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 9, 2018
• Est. primary completion date: March 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Intrinsic Aging of Skin

Intervention

Drug:
• Retinol
Retinol in the form of vitamin A lotion
• Placebo
Placebo of Retinol

Locations

Country	Name	City	State
United States	Stanford Dermatology	Redwood City	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Transepidermal Water Loss	Transepidermal Water Loss of arm skin was measured in units of grams/hours/meters squared.	Baseline; Week 12
Secondary	Severity of Arm Skin Wrinkling	Wrinkling was assessed by the investigator using a 10-point Likert scale (range 0 to 9, lower scores correspond to less wrinkling).	Baseline; Week 12
Secondary	Elasticity on Arm Skin	Elasticity was assessed using cutometry (R2 curve) as millimeters per second	Baseline; week 12
Secondary	Count of Participants With Skin and Subcutaneous Adverse Events as a Measure of Type and Severity of Adverse Events	Skin and subcutaneous adverse events were assessed for this outcome and documented and scored according to CTCAE version 4.03.	Baseline through week 12