RAPA-Keloid Study of Keloid Regression

Keloid Clinical Trial

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

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Keloid

• NCT number: NCT04049552
• Study type: Interventional
• Source: The University of Texas Health Science Center at San Antonio
• Status: Completed
• Phase: Early Phase 1
• Start date: January 24, 2020
• Completion date: May 2, 2021