Drug Delivery System for Superficial Mycoses

浅表真菌病的药物输送系统

• 批准号: 6406028
• 负责人: H. RALPH RAWLS
• 金额: $ 36.54万
• 依托单位: BIOMEDICAL DEVELOPMENT CORPORATION
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-15 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6406028
• 关键词: antifungal agents; dermatomycosis; drug delivery systems; human subject; method development; patient oriented research; topical drug application

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

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， 用于治疗表浅性皮肤病的缓释抗真菌皮肤制剂 真菌病获得浅表性肌层感染的终生风险是 估计在百分之十到二十之间。在美国，年治疗费用 用于治疗浅表真菌病的费用超过4亿美元。免疫功能低下和老年人 患者特别有机会性皮肤真菌感染的危险， 尽管表面真菌病经常影响其他方面健康的人。 随着人口老龄化，越来越多地使用积极的免疫抑制剂， 治疗，器官移植的增加，以及 艾滋病大流行，受浅表真菌感染的患者人数 预计感染率将上升。第一阶段研究证明了 使用新型涂料组合物治疗浅表真菌病。的 II期项目旨在进一步确定 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，证明涂层在人体研究中的安全性， 并说明涂层在人体皮肤剥脱模型中的功效。 拟定商业应用： 不可用