Intrinsic Aging of SkinPhase 4NCT02906566
Retinol on Human Skin Aging in East Asian Descent
A Phase 4 study testing Retinol in people with Intrinsic Aging of Skin, run by Stanford University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrinsic Aging of Skin
- What is being tested?
- Retinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 9 Mar 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Dermatology
Redwood City, California, 94603
About this study
Official title: Discovery of Effects of Retinol on Human Skin Aging in Individuals of East Asian Descent
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
- Being tested
- Retinol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetinolDrug
Retinol in the form of vitamin A lotion
PlaceboDrug
Placebo of Retinol
| Study group | Role | What they receive |
|---|---|---|
| Older Group Ages 55-75 | Other | Active and Placebo. Participants received retinol lotion on one arm and placebo to match on the other arm. Receives: Drug: Retinol; Drug: Placebo |
| Young Group Ages 18-25 | No intervention | Participants in the group will give tissue sample only for comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Week 1
Secondary outcomes (4)
Transepidermal Water Loss
Transepidermal Water Loss of arm skin was measured in units of grams/hours/meters squared.
Measured: Baseline; Week 12
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).
Measured: Baseline; Week 12
Elasticity on Arm Skin
Elasticity was assessed using cutometry (R2 curve) as millimeters per second
Measured: Baseline; week 12
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.
Measured: Baseline through week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startNov 2015
- Primary completion9 Mar 2018
- Study completion9 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intrinsic Aging of SkinStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Chang, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906566
- Sponsor's protocol ID
- 33762
- Status last verified
- Mar 2019
- First submitted
- 26 Feb 2016
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No current plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery of Effects of Retinol on Human Skin Aging in Individuals of East Asian Descent
- ClinicalTrials.gov ID
- NCT02906566
- Acronym / sponsor ID
- 33762
- Conditions
- Intrinsic Aging of Skin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 9 Mar 2018 (actual)
- Study completion
- 9 Mar 2018 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Posted 16 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Older Group Ages 55-75 | Other | Drug: Retinol, Drug: PlaceboActive and Placebo. Participants received retinol lotion on one arm and placebo to match on the other arm. |
| Young Group Ages 18-25 | No intervention | –Participants in the group will give tissue sample only for comparison. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RetinolRetinol in the form of vitamin A lotion | Drug | Older Group Ages 55-75 |
| PlaceboPlacebo of Retinol | Drug | Older Group Ages 55-75 |
Primary outcome
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.
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).
4 secondary outcomes
Transepidermal Water Loss
Time frame: Baseline; Week 12
Severity of Arm Skin Wrinkling
Time frame: Baseline; Week 12
Elasticity on Arm Skin
Time frame: Baseline; week 12
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No current plan to share data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Retinol in people with Intrinsic Aging of Skin, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Genes Upregulated or Downregulated as Assessed by RNA Sequencing (Older Group, Retinol Versus Placebo) (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.