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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04608448
Recruitment Status : Active, not recruiting
First Posted : October 29, 2020
Last Update Posted : May 10, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Ellen Kraig, The University of Texas Health Science Center at San Antonio

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
Aging Epigenetics Inflammatory Mediators 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : April 28, 2021
Actual Primary Completion Date : April 15, 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in epigenetic markers [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 95 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04608448


Locations
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United States, Texas
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
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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)

Documents provided by Ellen Kraig, The University of Texas Health Science Center at San Antonio:
Informed Consent Form  [PDF] October 12, 2021

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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 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Unidentified IPD will be shared in publication form in peer-reviewed journals, at national or international meetings and with collaborating investigators at the PIs home institution.

Summary results will be published on ClinicalTrials.gov.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be shared upon study completion.

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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, The University of Texas Health Science Center at San Antonio:
Epigenetic clock
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Sirolimus
Petrolatum
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Emollients
Dermatologic Agents