We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Retinol on Human Skin Aging in East Asian Descent

This study is currently recruiting participants.
Verified June 2017 by Anne Chang, Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02906566
First Posted: September 20, 2016
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Anne Chang, Stanford University
  Purpose
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 Intervention Phase
Intrinsic Aging of Skin Drug: Retinol Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Anne Chang, Stanford University:

Primary Outcome Measures:
  • differences in transcript levels between older untreated and older treated skin by deep sequencing [ Time Frame: Up to 2 years ]
    assessed on skin tissue


Secondary Outcome Measures:
  • transepidermal water loss [ Time Frame: up to 2 years ]
    in units of grams/hours/meters squared measured on arm skin

  • severity of arm skin wrinkling [ Time Frame: up to 2 years ]
    assessed using Likert scale

  • elasticity on arm skin [ Time Frame: up to 2 years ]
    elasticity will be assessed using cutometry (R2 curve) as millimeters per second

  • type and severity of adverse events [ Time Frame: up to 2 years ]
    the type and severity of adverse events after retinol usage will be documented and scored according to CTCAE version 4.03


Estimated Enrollment: 110
Study Start Date: November 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Older Group Ages 55-75
Active and Placebo
Drug: Retinol
Retinol in the form of vitamin A lotion
Drug: Placebo
Placebo of Retinol
Placebo Comparator: Young Group Ages 18-25
Placebo
Drug: Placebo
Placebo of Retinol

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906566


Contacts
Contact: Anne Chang, MD 650 721 7151 alschang@stanford.edu
Contact: Linna Guan, BS 650 721 7195 linna@stanford.edu

Locations
United States, California
Stanford Dermatology Recruiting
Redwood City, California, United States, 94603
Contact: Anne Chang, MD    650-721-7151    alschang@stanford.edu   
Contact: Linna Guan, BS    650 721 7195    linna@stanford.edu   
Sponsors and Collaborators
Stanford University
  More Information

Responsible Party: Anne Chang, Associate Professor of Dermatology, Stanford University
ClinicalTrials.gov Identifier: NCT02906566     History of Changes
Other Study ID Numbers: 33762
First Submitted: February 26, 2016
First Posted: September 20, 2016
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Vitamin A
Retinol palmitate
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents