RAPA-Keloid Study of Keloid Regression

• Status: Completed
• Trial end date: 2021-05-02
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: Everolimus; Petrolatum; Sirolimus

Criteria

Inclusion Criteria:

• Subject must have at least 2 keloid scars (for at least 1 year) in similar body locations that are easy to reach to apply ointment to

• Subject will be in good health with all chronic diseases (such as hypertension, coronary artery disease, etc.) clinically stable

• Cognitive functioning sufficient to provide informed consent

• Physically able to apply ointment to keloids daily

• Able to attend monthly clinic visits for 6 months

Exclusion Criteria:

• Diagnosis of diabetes

• Subjects taking the following medications: systemic steroid or immunosuppressant therapy within the past 6 months

• Local area steroidal treatment within the past 3 months

• History of allergy to rapamycin of petrolatum-based products