NCT04608448

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 65 Years – 95 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Aging
• Epigenetics
• Inflammatory Mediators

Interventions

Type	Name	Description
DRUG	Rapamycin Topical Ointment	8% topical rapamycin ointment
OTHER	Placebo	Petrolatum ointment containing no active ingredient

Timeline

• Start date: 2021-04-28
• Primary completion: 2022-04-15
• Completion: 2022-04-15
• First posted: 2020-10-29
• Last updated: 2023-07-19
• Results posted: 2023-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study