Drug Delivery System for Superficial Mycoses

描述(由申请人提供)：本项目的目标是 建立一种独特的药物输送系统的安全性和有效性，用于 缓释抗真菌皮肤制剂治疗浅表性皮肤溃疡 真菌病。感染浅部真菌感染的终生风险是 估计在10%到20%之间。在美国，每年的治疗费用 用于浅部真菌病的费用超过4亿美元。免疫功能低下和老年人 患者尤其面临机会性皮肤真菌感染的风险， 尽管浅部真菌病通常会影响其他方面健康的人。 随着人口老龄化，积极免疫抑制剂的使用增加 治疗，器官移植的增加，以及持续流行的 艾滋病大流行，受浅表真菌影响的患者数量 预计感染人数将会上升。第一阶段研究证明了 使用新型涂层组合物治疗浅部真菌病。这个 第二阶段项目旨在进一步确定 这项技术。具体目标是确定最终涂层 基于抗真菌递送的优化和评价的组合物 根据FDA指南在人体试验中证明涂层的安全性， 并在人体皮肤剥离模型中说明涂层的功效。 建议的商业应用： 不可用

DESCRIPTION (Provided by the applicant): 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. PROPOSED COMMERCIAL APPLICATION: Not Available