Topical-RAPA Use in Inflammation Reversal and Re-setting the Epigenetic Clock (Topical-RAPA)
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|ClinicalTrials.gov Identifier: NCT04608448|
Recruitment Status : Active, not recruiting
First Posted : October 29, 2020
Last Update Posted : May 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|Aging Epigenetics Inflammatory Mediators||Drug: Rapamycin Topical Ointment Other: Placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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.|
|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|
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
Placebo Comparator: Placebo
Placebo ointment is applied to a color coded area on the subject forearm daily.
Petrolatum ointment containing no active ingredient
- 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.
- 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.
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
|United States, Texas|
|San Antonio, Texas, United States, 78220|
|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|