Retinol on Human Skin Aging in East Asian Descent

NCT ID: NCT02906566

Last Updated: 2019-04-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-03-09

Brief Summary

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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

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Conditions

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Intrinsic Aging of Skin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Older Group Ages 55-75

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

Group Type OTHER

Retinol

Intervention Type DRUG

Retinol in the form of vitamin A lotion

Placebo

Intervention Type DRUG

Placebo of Retinol

Young Group Ages 18-25

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Retinol

Retinol in the form of vitamin A lotion

Intervention Type DRUG

Placebo

Placebo of Retinol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Anne Chang

Associate Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford Dermatology

Redwood City, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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33762

Identifier Type: -

Identifier Source: org_study_id

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