drugset / Trial / NCT03403621

Hypertrophic Scar Prevention by Novel Topical Gel Application

NCT03403621

Phase 1/2 Terminated 6 enrolled Mayo Clinic
RandomizedParallel-groupTriple-blindPrevention

Summary

Researchers are trying to find out more about the side effects of topical (applied to the skin) Pentamidine, to determine if it is safe for use in people. They also want to find out if topical use of Pentamidine can help treat hypertrophic scars. Pentamidine is a medicine that is currently used to treat certain kinds of infection. It is most often given by intravenous (into a vein) or inhalation (through a breathing device). This medication is approved by the U.S. Food and Drug Administration (FDA) for use in these forms. Everyone in this study will receive topical Pentamidine (TP) in a silicone based gel (PCCA Pracasil Plus). Topical treatment of Pentamidine is still experimental and has not been formally tested for safety or effectiveness in a randomized control trial within the United States. The FDA has allowed the use of topical Pentamidine in this research study.

Timeline

Start
2018-03-05
Primary completion
2020-02-26
Completion
2020-02-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Pentamidine isethionate Unknown 1.8 ml Topical