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

Purpose

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

Conditions

  • Aging
  • Epigenetics
  • Inflammatory Mediators

Eligibility

Eligible Ages
Between 65 Years and 95 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
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
Treatment
Masking
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.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Topical Rapamycin 		Ointment is applied to a color coded area on the subject forearm daily.
  • Drug: Rapamycin Topical Ointment
    8% topical rapamycin ointment
    Other names:
    • Sirolimus Topical Ointment
    • RAPA Topical Ointment
Placebo Comparator
Placebo 		Placebo ointment is applied to a color coded area on the subject forearm daily.
  • Other: Placebo
    Petrolatum ointment containing no active ingredient
    Other names:
    • Placebo Topical Ointment
    • Petrolatum

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Detailed 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.