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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21AG068731-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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Topical Rapamycin ointment will be applied to participant forearms to test whether epigenetic changes in the skin are elicited.
Rapamycin 8% ointment will be applied topically to one of the participant's forearms and matching placebo to the opposite forearm daily for a total of 6 months. After consenting, screening and randomization of arms, the participants will be monitored at monthly visits until study completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Rapamycin | Active Comparator | Ointment is applied to a color coded area on the subject forearm daily. |
|
| Placebo | Placebo Comparator | Placebo ointment is applied to a color coded area on the subject forearm daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapamycin Topical Ointment | Drug | 8% topical rapamycin ointment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Epigenetic Markers | A set of DNA methylation marks that correlate with chronological age will be used to measure rejuvenation of the "epigenetic clock" due to drug treatment compared to placebo. Using Illumina EPIC arrays, CpG methylation will be assessed and then the predicted age, based on the combined methylation at the set of 391 marks (the "epigenetic clock" as defined by Dr. Steven Horvath, UCLA), will be determined. | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inflammatory Marker IL-6 | A measure of inflammatory markers will include analytes that are affected either by aging or oral rapamycin. Inflammatory markers are measured using Enzyme-Linked Immuno-Sorbant Assays (ELISA). The marker to be measured is IL-6. | Baseline to 6 months |
| Change in Inflammatory Marker CRP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Kraig, PhD | University of Texas Health at San Antonio | Principal Investigator |
| Dean L Kellogg, Jr., MD, PhD | University of Texas Health at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTHSCSA | San Antonio | Texas | 78220 | United States |
Unidentified IPD will be shared in publication form in peer-reviewed journals, at national or international meetings and with collaborating investigators at the PIs home institution.
Summary results will be published on ClinicalTrials.gov.
Data will be shared upon study completion.
Will be provided upon formal request to PI and/or included in publications.
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Subjects acted as their own controls, one forearm had rapamycin ointment applied and the other placebo, thus there were 20 participants who had both rapamycin applied to one arm and placebo to the other.
| ID | Title | Description |
|---|---|---|
| FG000 | Topical Rapamycin Applied to One Arm and Placebo Applied to the Opposite Arm | Ointment is applied to a color coded area on the subject forearm daily. Rapamycin Topical Ointment: 8% topical rapamycin ointment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Each subject applied either an ointment containing the mTOR inhibitor rapamycin or a vehicle-only control ointment to a 1 cm patch of skin on the forearm daily for 6 months and a placebo applied to the opposite arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Rapamycin | Ointment is applied to a color coded area on the subject forearm daily. Rapamycin Topical Ointment: 8% topical rapamycin ointment to one arm and Petrolatum ointment containing no active ingredient to the opposite arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Each subject applied either an ointment containing the mTOR inhibitor rapamycin or a vehicle-only control ointment to a 1 cm patch of skin on the forearm daily for 6 months. |
| 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 | Change in Epigenetic Markers | A set of DNA methylation marks that correlate with chronological age will be used to measure rejuvenation of the "epigenetic clock" due to drug treatment compared to placebo. Using Illumina EPIC arrays, CpG methylation will be assessed and then the predicted age, based on the combined methylation at the set of 391 marks (the "epigenetic clock" as defined by Dr. Steven Horvath, UCLA), will be determined. | DNA prepared from the placebo and rapamycin-treated skin sites was analyzed for methylation at specific sites known to change with age. | Posted | Mean | Full Range | years | Baseline to 6 months | Forearm of participant | Forearm of participant |
|
Adverse events were collected from baseline to 6 months
Adverse events are reported per subject arm, since each subject had both rapamycin applied to one arm and placebo to the other arm
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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 | Topical Rapamycin | Ointment is applied to a color coded area on the subject forearm daily. Rapamycin Topical Ointment: 8% topical rapamycin ointment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash/redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Rash at site of application |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Kraig, PhD | UT Health San Antonio | 210-567-3818 | kraig@uthscsa.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 | Aug 17, 2021 | Apr 13, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 12, 2021 | May 4, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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Participants will be their own control, either right or left arm will be randomized to treatment or placebo.
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Randomization will be performed by the compounding pharmacy. Ointment dispensers will be color-coded for left and right arm for each subject.
| Placebo | Other | Petrolatum ointment containing no active ingredient |
|
|
A measure of inflammatory markers will include analytes that are affected either by aging or oral rapamycin. Inflammatory markers are measured using Enzyme-Linked Immuno-Sorbant Assays (ELISA). The marker to be measured is CRP. No data were obtained from this measure due to the low blister fluid volume. |
| Baseline to 6 months |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Placebo ointment is applied to a color coded area on the subject forearm daily. Placebo: Petrolatum ointment containing no active ingredient |
|
|
| Secondary | Change in Inflammatory Marker IL-6 | A measure of inflammatory markers will include analytes that are affected either by aging or oral rapamycin. Inflammatory markers are measured using Enzyme-Linked Immuno-Sorbant Assays (ELISA). The marker to be measured is IL-6. | Recovery of blister fluid from some subjects was lower than anticipated so a Luminex-based array assay, which uses much lower sample volumes than ELISAs, was performed and the cytokine levels on the rapamycin treated side were compared to the placebo levels. | Posted | Mean | Full Range | pg/ml | Baseline to 6 months | Blisters | Blisters |
|
|
|
| Secondary | Change in Inflammatory Marker CRP | A measure of inflammatory markers will include analytes that are affected either by aging or oral rapamycin. Inflammatory markers are measured using Enzyme-Linked Immuno-Sorbant Assays (ELISA). The marker to be measured is CRP. No data were obtained from this measure due to the low blister fluid volume. | Not Posted | Baseline to 6 months | Participants |
| 0 |
| 22 |
| 0 |
| 22 |
| 4 |
| 22 |
| EG001 | Placebo | Placebo ointment is applied to a color coded area on the subjects' opposite forearm daily. | 0 | 22 | 0 | 22 | 4 | 22 |
|
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