: The goal of this project is to establish the safety and efficacy of a unique drug delivery system for use as a sustained-release, antifungal skin preparation for the treatment of superficial mycoses. The lifetime risk of acquiring a superficial mycotic infection is estimated to be between 10 and 20 percent. In the U.S., annual treatment costs for superficial mycoses exceed $400 million. Immunocompromised and elderly patients are particularly at risk for opportunistic dermatophyte infection, although superficial mycoses often affect people who are otherwise healthy. With an aging population, the increased use of aggressive immunosuppressive therapies, an increase in organ transplants, and the continued prevalence of the AIDS pandemic, the number of patients affected by superficial fungal infection is expected to rise. Phase I studies demonstrated the feasibility of using novel coating compositions for the treatment of superficial mycoses. The Phase II project is designed to further establish the safety and efficacy of the technology.
The Specific Aims are to determine the final coating composition based on optimization and evaluation of antifungal delivery, to demonstrate safety of coatings in human studies according to FDA guidelines, and to illustrate the efficacy of coatings in a skin-stripping model in humans.