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Completed

NCT Number: NCT04608448

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.

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Key information

Conditions

Aging Epigenetics Inflammatory Mediators

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UTHSCSA

San Antonio, Texas, 78220, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapamycin Topical Ointment

Drug

8% topical rapamycin ointment

Other names: Sirolimus Topical Ointment, RAPA Topical Ointment

Placebo

Other

Petrolatum ointment containing no active ingredient

Other names: Placebo Topical Ointment, Petrolatum

Primary outcomes

  1. Change in Epigenetic Markers

    Time frame: Baseline to 6 months

    A set of DNA methylation marks that correlate with chronological age will be used to measure rejuvenation of the "epigenetic clock" due to drug treatment compared to placebo. Using Illumina EPIC arrays, CpG methylation will be assessed and then the predicted age, based on the combined methylation at the set of 391 marks (the "epigenetic clock" as defined by Dr. Steven Horvath, UCLA), will be determined.

Secondary outcomes

  1. Change in Inflammatory Marker IL-6

    Time frame: Baseline to 6 months

    A measure of inflammatory markers will include analytes that are affected either by aging or oral rapamycin. Inflammatory markers are measured using Enzyme-Linked Immuno-Sorbant Assays (ELISA). The marker to be measured is IL-6.

  2. Change in Inflammatory Marker CRP

    Time frame: Baseline to 6 months

    A measure of inflammatory markers will include analytes that are affected either by aging or oral rapamycin. Inflammatory markers are measured using Enzyme-Linked Immuno-Sorbant Assays (ELISA). The marker to be measured is CRP. No data were obtained from this measure due to the low blister fluid volume.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: Topical-RAPA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 29, 2020
Registry last updated
Jul 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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