Topical-RAPA Use in Inflammation Reversal and Re-setting the Epigenetic Clock

Early Phase 1CompletedNCT04608448

The University of Texas Health Science Center at San Antonio22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Aging Epigenetics Inflammatory Mediators

Interventions

Rapamycin Topical OintmentDRUG

8% topical rapamycin ointment

PlaceboOTHER

Petrolatum ointment containing no active ingredient

Eligibility

Sex: ALLMin age: 65 YearsMax age: 95 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UTHSCSA

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 6 months

Secondary Outcomes

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.

Time frame: Baseline to 6 months

Change in Inflammatory Marker CRP

Time frame: Baseline to 6 months

Data from ClinicalTrials.gov

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