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

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Aging; Inflammatory Mediators; Epigenetics

Treatments: Other: Placebo; Drug: Rapamycin Topical Ointment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04608448

HSC20200720H

1R21AG068731-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 65 to 95 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

Topical Rapamycin

Active Comparator group

Description:

Ointment is applied to a color coded area on the subject forearm daily.

Treatment:

Drug: Rapamycin Topical Ointment

Placebo

Placebo Comparator group

Description:

Placebo ointment is applied to a color coded area on the subject forearm daily.

Treatment:

Other: Placebo