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

Aging Clinical Trial

— Topical-RAPA  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04608448
• Other study ID #: HSC20200720H
• Secondary ID: 1R21AG068731-01
• Status: Completed
• Phase: Early Phase 1
• Start date: April 28, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: June 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 15, 2022
• Est. primary completion date: April 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Epigenetics
• Inflammation
• Inflammatory Mediators

Intervention

Drug:
• Rapamycin Topical Ointment
8% topical rapamycin ointment

Other:
• Placebo
Petrolatum ointment containing no active ingredient

Locations

Country	Name	City	State
United States	UTHSCSA	San Antonio	Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Epigenetic Markers	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.	Baseline to 6 months
Secondary	Change in Inflammatory Marker IL-6	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.	Baseline to 6 months
Secondary	Change in Inflammatory Marker CRP	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.	Baseline to 6 months