Pharmaceutical Prophylaxis of Scarring with Emphasis on Burns: A Review of Preclinical and Clinical Studies.

The worldwide estimate of burns requiring medical attention each year is 11 million. Each year in the United States, ∼486,000 burn injuries receive medical attention, including 40,000 hospitalizations. Scars resulting from burns can be disfiguring and impair functions. The development of prophylactic drugs for cutaneous scarring could improve the outcomes for burns, traumatic lacerations (>6 million/year treated in U.S. emergency rooms), and surgical incisions (∼250 million/year worldwide). Antiscar pharmaceuticals have been estimated to have a market of $12 billion. Many small molecules, cells, proteins/polypeptides, and nucleic acids have mitigated scarring in animal studies and clinical trials, but none have received Food and Drug Administration (FDA) approval yet. The development of antiscar pharmaceuticals involves the identification of the proper dose, frequency of application, and window of administration postwounding for the indicated wound. Risks of infection and impaired healing must be considered. Scar outcome needs to be evaluated after scars have matured. Once treatments have demonstrated safety and efficacy in rodent and/or rabbit and porcine wound models, human testing can begin, such as on artificially created wounds on healthy subjects and on bilateral-surgical wounds, comparing treatments versus vehicle controls on patient-matched wounds, before testing on separate cohorts of patients. Given the progress made in the past 20 years, FDA-approved drugs for improving scar outcomes may be expected.