Ultraviolet-C Therapy for Onychomycosis

描述（由申请人提供）：Kerademark LLC和Wellman光疗中心提出了一种全新的甲真菌病治疗方法，使用杀菌辐射代替目前具有显著缺点的药物。甲真菌病是一种指甲真菌感染，影响约30万美国人。美国人每年花费超过10亿美元来治疗这个问题。然而，这一数字并不代表问题的真正严重程度，因为许多人由于现有治疗方法的缺点而不寻求治疗。目前治疗甲真菌病的选择是口服药物-其中最好的总治愈率低于40%，价格昂贵（在1,000美元的范围内），并有严重的副作用，包括心脏和肝脏问题，在某些情况下死亡。本申请旨在开发一种全新的甲真菌病治疗方法;应用杀菌紫外线辐射（UVC）。在Keradeland和Wellman进行的有限测试表明，UVC光疗可以成功治疗患者的甲真菌病。我们建议确定为什么UVC是有效的，并为开发一种非侵入性，安全，高效的甲真菌病治疗方法奠定基础。该应用程序有五个目的：1）构建UVC灭活的生物体往往负责甲真菌病-T的剂量反应曲线。rubrum，T.须癣菌和絮状表皮癣菌。2)测定人指甲相对于UVC的透过率，以确定UVC的适当剂量。3)研究真菌死亡的机制。4)确定皮肤真菌是否可以通过反复循环的次全杀灭和再生长来产生对UVC的抗性。5)确定UVC对感染趾甲的UVC照射期间可能暴露的角质形成细胞的可能副作用。第二阶段的申请将使用第一阶段收集的信息来设计临床试验，以开发一种治疗方法，为估计有3000万患有甲癣的美国人提供低成本，安全和有效的治疗。Keradoro认为，一旦有了安全、有效和低成本的治疗方法，目前每年超过10亿美元的市场将大幅扩大，因为大多数目前受影响的人由于目前治疗方法的缺点而不寻求治疗。

DESCRIPTION (provided by applicant): Keraderm LLC and the Wellman Center for Phototherapy propose a radically new treatment for onychomycosis using germicidal radiation instead of current medications which have significant drawbacks. Onychomycosis is a fungal nail infection that affects approximately 30 million Americans. Americans spend more than $1 Billion per year to treat this problem. However, this number does not represent the true magnitude of the problem since many people do not seek treatment due to the drawbacks of currently available treatments. The current treatments of choice for onychomycosis are oral medications- the best of which have a total cure rate of less than 40%, are expensive (in the range of $1,000), and have serious side effects including heart and liver problems and in some instances death. This application seeks to develop a completely novel therapy for onychomycosis; the application of germicidal UV radiation (UVC). Limited testing at Keraderm and Wellman indicates that UVC phototherapy can successfully treat onychomycosis in patients. We propose to determine why UVC is efficacious and lay the foundation to develop a non-invasive, safe, and highly efficacious treatment for onychomycosis. The application has five aims: 1) Construct dose-response curves for UVC inactivation of the organisms often responsible for onychomycosis -T. rubrum, T. mentagrophytes, and Epidermophyton floccosum. 2) Determine the transmissivity of the human nail with respect to UVC to determine the proper dose of UVC. 3) Investigate the mechanism of fungal death. 4) Determine whether dermatophytes can develop resistance to UVC by repeated cycles of sub-total killing and re-growth. 5) Determine the possible side effects of UVC on keratinocytes that may be exposed during UVC irradiation of infected toenails. The Phase 2 application will use information collected during Phase 1 to design clinical trials to develop a treatment that will provide a low cost, safe, and effective treatment for the estimated thirty million Americans who are afflicted with onychomycosis. Keraderm believes the current market of more than $1 Billion per year will significantly expand once a safe, effective, and low cost treatment is available since the majority of currently affected persons do not seek treatment due to the drawbacks associated with current therapies.