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）。该技术以一种新颖的方式利用两种成熟的临床能源，旨在治疗由生物膜（细菌产生的黏液层）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，并经常引起慢性炎症反应。生物膜直接增加了治疗许多顽固性细菌疾病的难度，包括中度至重度痤疮和特应性皮炎（湿疹），这些疾病严重影响了美国超过2500万儿童、青少年和成年人。目前针对这些疾病的药物和治疗方法可能存在安全性问题，并不总是有效，价格昂贵，可能导致耐药性，并且不针对潜在的生物膜。由于无法破坏这些疾病的生物膜成分，很少有新的治疗方法可以提高安全性或有效性。然而，这两种疾病都是改变生活的疾病，需要新的治疗方案。同时应用治疗性、杀菌剂蓝/紫光与超声波将协同作用每种已证明的有益特性，并创造一种技术上的新方法来靶向和消除生物膜。CLENS治疗有可能显著且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是可行的。拟议的第一阶段研究计划包括开发一种灵活的测试暴露系统，能够在一系列蓝/紫光和低强度超声输出条件下，以及一种在适当的体外系统中产生生物膜的方法，用于治疗测试。然后将彻底测试曝光系统对一系列体外生物膜的有效性，并确定光和超声波的最佳曝光条件。接下来，体外杀菌效果将被证明达到预测临床应用所必需的水平（减少1000:1）。最后，这些数据将用于临床原型CLENS系统的设计。在这个融资周期结束时，Sonic Tech将准备建造一个手持式临床CLENS单元，适用于特应性皮炎和痤疮患者进行人体概念验证评估（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).