An Innovative Proof-of-concept Approach to Identify Age-modulating Drugs Capable of Reversing Inflammation and Re-setting the Epigenetic Clock (Topical-RAPA)

HSC20200720H

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

2021-04-28

2022-04-15

2022-04-15

Completed

Early phase I

22

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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be their own control, either right or left arm will be randomized to treatment or placebo.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Randomization will be performed by the compounding pharmacy. Ointment dispensers will be color-coded for left and right arm for each subject.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 22, 'type': 'ACTUAL'}}

2023-07-19