AgingEarly Phase 1Topical-RAPANCT04608448
Topical-RAPA Use in Inflammation Reversal and Re-setting the Epigenetic Clock
A Early Phase 1 study testing Rapamycin Topical Ointment in people with Aging and Epigenetics, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Topical Rapamycin ointment will be applied to participant forearms to test whether epigenetic changes in the skin are elicited. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Epigenetics, Inflammatory Mediators
- What is being tested?
- Rapamycin Topical Ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2021to 15 Apr 2022
- Phase
- Early Phase 1
- 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 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65-95 years of age.
- Good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable.
- Selected subjects will be in good health (Per the World Health Organization, good health will be defined as complete physical, mental, and social well-being and not merely the absence of disease or infirmity).
- All diseases or infirmities will be clinically stable whether managed by medications or not.
- CLOX score of 10 or greater
- Women will be postmenopausal
- Postmenopausal women taking hormone replacement will be included if they have been on a stable dose for ≥6 months
- Live within a 20 mile drive of the UTHSA campus (7703 Floyd Curl Drive, San Antonio, TX)
Who cannot join
- Diabetes.
- History of skin ulcers or poor wound healing, or keloid formers.
- Smoking.
- Liver disease.
- Coumadin anti-coagulation.
- Treatment with drugs known to affect cytochrome P450 3A (diltiazem, erythromycin, etc. - due to role in rapamycin metabolism).
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- Treatment with an immunosuppressant (prednisone, etc.) within 6 months.
- History of recent (within 6 months) Myocardial Infarction or active Coronary Disease.
- Hypersensitivity to rapamycin or petrolatum (ointment vehicle)
- Arm tattoos or scars in application area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Innovative Proof-of-concept Approach to Identify Age-modulating Drugs Capable of Reversing Inflammation and Re-setting the Epigenetic Clock (Topical-RAPA)
Topical Rapamycin ointment will be applied to participant forearms to test whether epigenetic changes in the skin are elicited.
Read the detailed description
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.
- Conditions
- Aging, Epigenetics, Inflammatory Mediators
- Being tested
- Rapamycin Topical Ointment, Placebo
- Keywords
- Epigenetic clock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapamycin Topical OintmentDrug
Also called Sirolimus Topical Ointment, RAPA Topical Ointment
8% topical rapamycin ointment
PlaceboOther
Also called Placebo Topical Ointment, Petrolatum
Petrolatum ointment containing no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Topical Rapamycin | Active comparator | Ointment is applied to a color coded area on the subject forearm daily. Receives: Drug: Rapamycin Topical Ointment |
| Placebo | Placebo comparator | Placebo ointment is applied to a color coded area on the subject forearm daily. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Secondary outcomes (2)
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.
Measured: Baseline to 6 months
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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start28 Apr 2021
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
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 AgingStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be their own control, either right or left arm will be randomized to treatment or placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Ellen Kraig, The University of Texas Health Science Center at San Antonio
- Investigators
- Ellen Kraig, PhD, Principal investigator, University of Texas Health at San AntonioDean L Kellogg, Jr., MD, PhD, Principal investigator, University of Texas Health at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04608448
- Sponsor's protocol ID
- HSC20200720H
- Other IDs
- 1R21AG068731-01
- Acronym
- Topical-RAPA
- Status last verified
- Jun 2023
- First submitted
- 21 Oct 2020
- Last updated
- 19 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Proof-of-concept Approach to Identify Age-modulating Drugs Capable of Reversing Inflammation and Re-setting the Epigenetic Clock (Topical-RAPA)
- ClinicalTrials.gov ID
- NCT04608448
- Acronym / sponsor ID
- Topical-RAPA / HSC20200720H
- Conditions
- Aging, Epigenetics, Inflammatory Mediators
- Keywords
- Epigenetic clock
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Posted 19 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Topical Rapamycin ointment will be applied to participant forearms to test whether epigenetic changes in the skin are elicited.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be their own control, either right or left arm will be randomized to treatment or placebo.
| Arm | Type | Receives |
|---|---|---|
| Topical Rapamycin | Active comparator | Drug: Rapamycin Topical OintmentOintment is applied to a color coded area on the subject forearm daily. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo ointment is applied to a color coded area on the subject forearm daily. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 65-95 years of age.
- Good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable.
- Selected subjects will be in good health (Per the World Health Organization, good health will be defined as complete physical, mental, and social well-being and not merely the absence of disease or infirmity).
- All diseases or infirmities will be clinically stable whether managed by medications or not.
- CLOX score of 10 or greater
Key exclusion criteria (10 listed)
- Diabetes.
- History of skin ulcers or poor wound healing, or keloid formers.
- Smoking.
- Liver disease.
- Coumadin anti-coagulation.
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 |
|---|---|---|
| Rapamycin Topical OintmentAlso: Sirolimus Topical Ointment, RAPA Topical Ointment8% topical rapamycin ointment | Drug | Topical Rapamycin |
| PlaceboAlso: Placebo Topical Ointment, PetrolatumPetrolatum ointment containing no active ingredient | Other | Placebo |
Primary outcome
Change in Epigenetic Markers
Time frame: Baseline to 6 months
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.
2 secondary outcomes
Change in Inflammatory Marker IL-6
Time frame: Baseline to 6 months
Change in Inflammatory Marker CRP
Time frame: Baseline to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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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.
Ellen Kraig, PhD principal investigator
University of Texas Health at San Antonio
Dean L Kellogg, Jr., MD, PhD principal investigator
University of Texas Health at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rapamycin Topical Ointment in people with Aging and Epigenetics, run by The University of Texas Health Science Center at San Antonio 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 8 inclusion and 10 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 19 Jul 2023. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 19 Jul 2023). 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?
Change in Epigenetic Markers (time frame: Baseline to 6 months). 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 19 Jul 2023.