NCT04049552

RAPA-Keloid Study of Keloid Regression

Effect of Topical Rapamycin Ointment on Keloid Regression: A Pilot Study in Human Subjects (RAPA-Keloid)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

1. To test whether topical rapamycin regresses established keloids in humans by measuring surface area and height changes in the scar over time (6 months) 2. To test safety of product and feasibility of conduct for future clinical trial

Detailed description

This pilot trial will use daily 0.5-1.0 ml applications of 8% RAPA (Rapamycin) in a petrolatum vehicle to treat established keloid lesions in 5 persons with at least 2 chronic keloids in similar body regions (greater than 1-year duration). Treatment will be applied once daily for 6 months. One keloid will receive 8% RAPA ointment and the other keloid will receive petrolatum-only ointment as a control. Surface areas and height of keloids will be monitored pre- and post-treatment to evaluate responses. Keloid surface area and height changes will be measured pre-treatment and thereafter on a monthly basis using standardized digital photography with a tripod-mounted 8MP Canon S5is camera and calipers to measure keloid height (37). Surface areas of all photographed lesions will be measured with Image J (http://rsbweb.nih.gov/ij/index.html), a public image-processing program that was used to analyze preliminary data and this study will use the same approach.

Conditions

• Keloid

Interventions

Type	Name	Description
DRUG	Rapamycin 8% Ointment	A compounded ointment containing 8% rapamycin
DRUG	Placebo	Petrolatum ointment placebo

Timeline

• Start date: 2020-01-24
• Primary completion: 2020-08-24
• Completion: 2021-05-02
• First posted: 2019-08-08
• Last updated: 2021-09-29
• Results posted: 2020-12-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study