Topical-RAPA Use in Inflammation Reversal and Re-setting the Epigenetic Clock
Topical Rapamycin ointment will be applied to participant forearms to test whether epigenetic changes in the skin are elicited.
- Inflammatory Mediators
- Eligible Ages
- Between 65 Years and 95 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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)
- 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
- Early Phase 1
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants will be their own control, either right or left arm will be randomized to treatment or placebo.
- Primary Purpose
- Double (Participant, Investigator)
- Masking Description
- Randomization will be performed by the compounding pharmacy. Ointment dispensers will be color-coded for left and right arm for each subject.
|Ointment is applied to a color coded area on the subject forearm daily.||
|Placebo ointment is applied to a color coded area on the subject forearm daily.||
- The University of Texas Health Science Center at San Antonio
Study ContactEllen Kraig, PhD
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.