Coincident light/ultrasound therapy to treat acne vulgaris and atopic dermatitis

描述（由申请人提供）：Sonic Tech Inc.正在开发一种独特的基于能量的疗法，称为CLENS（重合光能和非聚焦超声）。该技术以一种新的方式使用两种成熟的临床能源，旨在治疗由生物膜（一种细菌产生的粘液层）引起的皮肤疾病。生物膜保护细菌免受抗生素和免疫系统的攻击，并经常诱导慢性炎症反应。生物膜直接导致治疗许多难治性细菌性疾病的困难，包括中度至重度痤疮和特应性皮炎（湿疹），这些疾病严重影响美国总计超过2500万儿童、青少年和成人。目前用于这些疾病的药物和治疗可能存在安全性问题，并不总是有效，成本高，可能导致耐药性，并且不靶向潜在的生物膜。由于无法破坏这些疾病的生物膜组分，因此几乎没有改善安全性或有效性的新治疗方法。然而，这两种疾病都是改变生活的疾病，需要新的治疗选择。同时应用治疗，杀菌蓝/紫光与超声波将协同每一个已证明的有益特性，并创造一种技术上的新方法来靶向和消除生物膜。CLENS治疗有可能显着，安全地改善大量患者的症状，痛苦，生活质量和经济负担。初步数据表明该方法的可行性。拟议的第一阶段研究计划包括开发一种灵活的测试曝光系统，能够在一系列蓝/紫光和低强度超声输出条件下进行测试，以及在适当的体外系统中生产生物膜进行治疗测试的方法。然后将彻底测试暴露系统对一系列体外生物膜的有效性，并确定光和超声的最佳暴露条件。接下来，将证明体外杀菌有效性达到预测临床效用所需的水平（1000：1降低）。最后，这些数据将用于创建临床原型CLENS系统的设计。在这个融资周期结束时，Sonic Tech将准备建立一个手持式临床CLENS单元，适用于特应性皮炎和痤疮患者的人类概念验证评估（在第二阶段）。

DESCRIPTION (provided by applicant): Sonic Tech Inc. is developing a unique energy-based therapy called CLENS" (Coincident Light Energy and Non-focused ultraSound). Using two well-established clinical energy sources in a novel way, the technology is intended to treat dermal diseases caused by biofilms, a bacterially generated slime layer. Biofilms shield bacteria from attack by both antibiotics and the immune system, and often induce a chronic inflammatory response. Biofilms contribute directly to the difficulty of treating many recalcitrant bacterial diseases including moderate to severe acne and atopic dermatitis (eczema), which severely affect, in total, over 25 million children, teens, and adults in the US. Current drugs and treatments for these diseases may have safety issues, are not always effective, are costly, may lead to drug resistance, and do not target the underlying biofilm. Due to the inability to disrupt the biofilm component of these disease, there have been few novel treatments which improve safety or effectiveness. However both are life-altering diseases for which new treatment options are needed. Simultaneous application of therapeutic, biocidal blue/violet light with ultrasound will synergize the demonstrated beneficial properties of each, and create a technologically new method to target and eliminate biofilms. CLENS treatment has the potential to significantly, and safely, improve the symptoms, suffering, quality of life, and economic burden of a large patient population. Preliminary data indicate the feasibility of the approach. The proposed Phase I research program includes developing a flexible test exposure system capable of a range of blue/violet light and low intensity ultrasound output conditions, and a method for producing biofilms in an appropriate in vitro system for treatment testing. The exposure system will then be thoroughly tested for effectiveness against a range of in vitro biofilms, and the optimal exposure conditions of light and ultrasound will be determined. Next, in vitro bactericidal effectiveness wil be demonstrated to a level (1000:1 reduction) that is necessary to predict clinical utility. Finall, the data will be used to create the design for a clinical prototype CLENS system. At the end of this funding cycle, Sonic Tech will be ready to build a hand held clinical CLENS unit suitable for testing in atopic dermatitis and acne patients for human Proof of Concept evaluation(during Phase II).