Tea Tree Oil for Treating Ocular Demodex Infestation

茶树油治疗眼部蠕形螨感染

• 批准号: 7666623
• 负责人: SCHEFFER CG TSENG
• 金额: $ 11.24万
• 依托单位: TISSUETECH, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7666623
• 关键词: Address; Adult; Biological Assay; Blepharitis; Clinical Research; Clinical Trials; Conjunctivitis; Cornea; Data; Development; Diagnostic Procedure; Drug Formulations; Drug Prescriptions; Eye; Eye diseases; Eyelash; Eyelid structure; FDA approved; Face; Future; Gland; Goals; Hair follicle structure; Home environment; Hygiene; In Vitro; Inflammation; Lesion; Lipids; Melaleuca; Melaleuca alternifolia; Methods; Microscopic; Mites; Modification; Mono-S; Ocular Rosacea; Oils; Older Population; Oryctolagus cuniculus; Pathogenicity; Pathology; Patients; Phase; Plant Leaves; Public Health; Refractory; Research; Rest; Rosacea; Rosaceae; Safety; Sampling; Self-Administered; Skin; Small Business Innovation Research Grant; Solutions; Steam; Symptoms; Tea; Tea Tree Oil; Terpenes; Therapeutic Agents; Toxic effect; Treatment Protocols; Trees; Vascularization; Vision; Volatile Oils; aging population; base; conventional therapy; cytotoxic; cytotoxicity test; diagnostic accuracy; effective therapy; eye dryness; improved; in vitro Assay; irritation; killings; meibomian gland dysfunction; public health relevance

DESCRIPTION (provided by applicant): Demodex (folliculorum and brevis) mites are microscopic ectoparasites that commonly infest the pilosebaceous unit of the skin. Uncontrolled overgrowth of these mites has been implicated in causing rosacea in the face, blepharitis in the eyelid, and other inflammation-associated conjunctival and corneal abnormalities. We have conducted a number of studies to substantiate the potential pathogenicity of demodex mites in causing eye irritation and inflammation in patients. We have improved the accuracy of diagnosing demodex infestation based on sampling lashes from the patient, and established that lashes harboring cylindrical dandruff are a reliable sign indicative of demodex infestation. Furthermore, we have developed an in vitro assay to screen agents that can potentially kill adult demodex mites. Using this assay, we have discovered that the Baby Shampoo does not, but tea tree oil (TTO), an essential oil distilled from Melaleuca alternifolia does, kill mites. We further showed that weekly office lid scrub with 50% TTO solution followed by daily home lid hygiene with tea tree shampoo can eradicate ocular Demodex in a majority of the suffering patients. However, this regimen achieves eradication of demodex infestation in the majority, but not all, of the patients, generates eye irritation in some patients, and is still not simple enough for patients to self administer it at home. In the SBIR Phase I application, we would like to identify the most active ingredient in TTO that may kill adult demodex mites in vitro, to examine the safety/toxicity of ophthalmic formulations containing this active ingredient in an in vitro cytotoxicity test and rabbit eyes, and to determine the stability of such formulations under different storage conditions and durations. Accomplishment of these three aims will allow us to collect sufficient data for obtaining an IND approval from the FDA so that we may conduct, in Phase II, clinical studies, eventually leading to the development of the first FDA-approved prescription ophthalmic formulation containing the most active ingredient in TTO to eradicate ocular demodex infestation in this most common eye disease. PUBLIC HEALTH RELEVANCE: This research is aimed to developing the first FDA-approved prescription drug containing the most active ingredient in tea tree oil to eradicate Demodicosis (the microscopic infestation of the hair follicle and the oil gland by Demodex mites) commonly occurring in the skin and the eyelid. Demodicosis is one of the leading causes of blepharitis, a common eye disease, for which eradication has not been achieved by any over-the-counter lid scrub regimen. Because Demodex infestation is prevalent in the older population, an effective treatment as such for eradicating Demodicosis for the eye will address an important public health concern when the aging population is increased, and help to develop a similar treatment for the skin in the future.

描述（由申请方提供）：蠕形螨（毛囊螨和短蠕形螨）是显微镜下的体外寄生虫，通常侵染皮肤的毛囊皮脂腺单位。这些螨的不受控制的过度生长与引起面部红斑痤疮、眼睑炎和其他炎症相关的结膜和角膜异常有关。我们已经进行了一些研究，以证实蠕形螨在引起患者眼睛刺激和炎症方面的潜在致病性。我们已经基于从患者的睫毛取样提高了诊断蠕形螨感染的准确性，并且确定了具有圆柱形头皮屑的睫毛是指示蠕形螨感染的可靠体征。此外，我们已经开发了一种体外试验，筛选代理，可以潜在地杀死成年蠕形螨。使用这种分析，我们发现婴儿洗发水没有，但茶树油（TTO），一种从互叶白千层蒸馏的精油，可以杀死螨虫。我们进一步表明，每周用50%TTO溶液擦洗办公室眼睑，然后每天用茶树洗发水进行家庭眼睑卫生，可以根除大多数患病患者的眼部蠕形螨。然而，该方案在大多数但不是全部患者中实现了蠕形螨感染的根除，在一些患者中产生眼睛刺激，并且对于患者在家中自我施用仍然不够简单。在SBIR I期申请中，我们希望确定TTO中可能在体外杀死成年蠕形螨的最有效成分，在体外细胞毒性试验和兔眼中检查含有该活性成分的眼用制剂的安全性/毒性，并确定此类制剂在不同储存条件和持续时间下的稳定性。这三个目标的实现将使我们能够收集足够的数据，以获得FDA的IND批准，以便我们可以在II期临床研究中进行，最终开发出首个FDA批准的处方眼科制剂，其中含有TTO中最有效的成分，以根除这种最常见的眼病中的眼部蠕形螨感染。公共卫生相关性：这项研究的目的是开发第一个FDA批准的处方药，其中含有茶树油中最有效的成分，以根除通常发生在皮肤和眼睑中的蠕形螨病（蠕形螨对毛囊和油腺的微观感染）。蠕形螨病是睑缘炎的主要原因之一，睑缘炎是一种常见的眼部疾病，任何非处方眼睑擦洗方案都无法根除。由于蠕形螨感染在老年人群中普遍存在，因此当老龄人口增加时，用于根除眼部蠕形螨病的有效治疗将解决重要的公共卫生问题，并有助于在未来开发用于皮肤的类似治疗。