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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-28

Study Completion Date

2022-04-15

Brief Summary

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

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Detailed Description

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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

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Aging Epigenetics Inflammatory Mediators

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be their own control, either right or left arm will be randomized to treatment or placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Randomization will be performed by the compounding pharmacy. Ointment dispensers will be color-coded for left and right arm for each subject.

Study Groups

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Topical Rapamycin

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

Group Type ACTIVE_COMPARATOR

Rapamycin Topical Ointment

Intervention Type DRUG

8% topical rapamycin ointment

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Petrolatum ointment containing no active ingredient

Interventions

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Rapamycin Topical Ointment

8% topical rapamycin ointment

Intervention Type DRUG

Placebo

Petrolatum ointment containing no active ingredient

Intervention Type OTHER

Other Intervention Names

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Sirolimus Topical Ointment RAPA Topical Ointment Placebo Topical Ointment Petrolatum

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes