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

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04608448
Collaborator
National Institute on Aging (NIA) (NIH)
50
Enrollment
1
Location
2
Arms
23.1
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Rapamycin Topical Ointment
  • Other: Placebo
 Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
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.Participants will be their own control, either right or left arm will be randomized to treatment or placebo.
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.
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Apr 28, 2021
Actual Primary Completion Date :
Apr 15, 2022
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in epigenetic markers [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 Outcome Measures

    1. Change in inflammatory markers [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 markers to be measured are CRP and IL-6.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 95 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UTHSCSA San Antonio Texas United States 78220

    Sponsors and Collaborators

    • The University of Texas Health Science Center at San Antonio
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Ellen Kraig, PhD, University of Texas Health at San Antonio
    • Principal Investigator: Dean L Kellogg, Jr., MD, PhD, University of Texas Health at San Antonio

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Ellen Kraig, Prof & Deputy Chair of Faculty Development Cell Systems & Anatomy, The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT04608448
    Other Study ID Numbers:
    • HSC20200720H
    • 1R21AG068731-01
    First Posted:
    Oct 29, 2020
    Last Update Posted:
    May 10, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Ellen Kraig, Prof & Deputy Chair of Faculty Development Cell Systems & Anatomy, The University of Texas Health Science Center at San Antonio
    Epigenetic clock
    Additional relevant MeSH terms:
    Inflammation
    Sirolimus
    Petrolatum

    Study Results

    No Results Posted as of May 10, 2022