Early Phase 1
N=22
Topical-RAPA Use in Inflammation Reversal and Re-setting the Epigenetic Clock
Aging · Epigenetics · Inflammatory Mediators
Bottom Line
View on ClinicalTrials.gov: NCT04608448 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Change in Epigenetic Markers — 84.4; 82.8 years
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Rapamycin Topical Ointment (Drug); Placebo (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Epigenetic Markers |
84.4; 82.8 | — |
| SECONDARY Change in Inflammatory Marker IL-6 |
1.44; 1.57 | — |
| SECONDARY Change in Inflammatory Marker CRP |
— | — |
Summary
Topical Rapamycin ointment will be applied to participant forearms to test whether epigenetic changes in the skin are elicited.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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).
- 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
Data sourced from ClinicalTrials.gov (NCT04608448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.