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

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Topical Rapamycin ointment will be applied to participant forearms to test whether epigenetic changes in the skin are elicited.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: National Institute on Aging (NIA)
• Treatments: Petrolatum; Sirolimus

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