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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Older Group Ages 55-75 | Other | Active 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retinol | Drug | Retinol in the form of vitamin A lotion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Transepidermal Water Loss | Transepidermal Water Loss of arm skin was measured in units of grams/hours/meters squared. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Dermatology | Redwood City | California | 94603 | United States |
No current plan to share data.
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110 participants were consented; 34 participants were assigned to a study arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Older Group Ages 55-75 | Participants received retinol lotion on one arm and placebo to match on the other arm. |
| FG001 | Young Group Ages 18-25 | Participants in the group will give a tissue sample from one arm only for comparison. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who were assigned to a treatment arm were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Older Group Ages 55-75 | Participants received retinol lotion on one arm and placebo to match on the other arm. |
| BG001 | Young Group Ages 18-25 | Participants in the group will give a tissue sample from one arm only for comparison. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants in the "Young Group Ages 18-25" attended a single study visit at week 1 to provide tissue samples for comparison purposes, and are not included in this analysis. | Posted | Number | genes | Week 12 | genes | genes |
|
|
Up to 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Older Group Ages 55-75 | Participants received retinol lotion on one arm and placebo to match on the other arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anne L. Chang | Stanford University | 650-721-7195 | alschang@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2016 | Feb 20, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014801 | Vitamin A |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Placebo |
| Drug |
Placebo of Retinol |
|
| Baseline; Week 12 |
| Elasticity on Arm Skin | Elasticity was assessed using cutometry (R2 curve) as millimeters per second | 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. | Baseline through week 12 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
| genes |
|
|
| Secondary | Transepidermal Water Loss | Transepidermal Water Loss of arm skin was measured in units of grams/hours/meters squared. | Participants in the "Young Group Ages 18-25" attended a single study visit at week 1 to provide tissue samples for comparison purposes, and are not included in this analysis. | Posted | Mean | Standard Deviation | g/h/m^2 | 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). | Participants in the "Young Group Ages 18-25" attended a single study visit at week 1 to provide tissue samples for comparison purposes, and are not included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline; Week 12 |
|
|
|
| Secondary | Elasticity on Arm Skin | Elasticity was assessed using cutometry (R2 curve) as millimeters per second | Participants in the "Young Group Ages 18-25" attended a single study visit at week 1 to provide tissue samples for comparison purposes, and are not included in this analysis. | Posted | Mean | Standard Deviation | 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. | Participants in the "Young Group Ages 18-25" attended a single study visit at week 1 to provide tissue samples for comparison purposes, and are not included in this analysis. | Posted | Count of Participants | Participants | Baseline through 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). | Only the participants in "Younger Group (ages 18-25)" are included in the analysis, since a comparison of the baseline data for the "Older Group (ages 55-75)" against itself is not clinically meaningful. | Posted | Number | genes | Week 1 | genes | genes |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 4 |
| 24 |
| EG001 | Young Group Ages 18-25 | Participants in the group will give a tissue sample from one arm only for comparison. | 0 | 10 | 0 | 10 | 0 | 10 |
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D004224 | Diterpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |