Clinical trial NCT04608448: Topical-RAPA Use in Inflammation Reversal and Re-setting the Epigenetic Clock
Official title: An Innovative Proof-of-concept Approach to Identify Age-modulating Drugs Capable of Reversing Inflammation and Re-setting the Epigenetic Clock (Topical-RAPA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Aging
Epigenetics
Inflammatory Mediators
Keywords: Epigenetic clock
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-10-29
Enrollment: 22
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be their own control, either right or left arm will be randomized to treatment or placebo.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Epigenetic Markers
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in Inflammatory Marker IL-6
timeFrame: Baseline to 6 months
measure: Change in Inflammatory Marker CRP
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UTHSCSA
state: Texas
Study officials:
affiliation: University of Texas Health at San Antonio
name: Ellen Kraig, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Health at San Antonio
name: Dean L Kellogg, Jr., MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: