Dermostyx (IB1) - High efficacy and safe topical skin protectant against percutaneous toxic agents
Dermostyx (IB1) - High efficacy and safe topical skin protectant against percutaneous toxic agents
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DOI：
10.1016/j.cbi.2016.07.010
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发表时间：
2017-04-01
影响因子：
5.1
通讯作者：
Kadar, Tamar
中科院分区：
文献类型：
--
作者：
Dachir, Shlomit;Barness, Izhak;Kadar, Tamar
防止有毒物质通过皮肤渗透对军队和平民都至关重要。我们开发了一种新的局部皮肤保护剂（TSP），编码为IB1，作为Dermostyx保护溶液（Rekah Pharm，以色列）上市。该配方对化学战剂（如芥子气（SM）和VX (2LD50)）、杀虫剂（如对硫磷）和刺激物（如丙烯醛）提供了显著的保护。通过临床、组织学和生化监测，在猪模型上评价该保护剂的疗效。在接触有毒物质之前，单次局部应用可显著减少皮肤损伤的大小和严重程度，改善或预防全身临床症状。IB1的屏障特性在使用后立即生效，并在至少12小时内保持有效。它被皮肤角质层吸收并保持在那里，直到用水冲洗，但成分不会被人体吸收。该配方是一种亲水的水基溶液，由硫酸镁和甘油组成，广泛用于化妆品和医药，在临床前和I期临床研究中被证明是安全的。建议的作用方式是基于甘油与角质层的独特相互作用，改变其亲水性质和硫酸镁的“盐析”作用。TSP的预期用途是必要时涂抹在暴露的皮肤区域和敏感皮肤部位（如腋窝、腹股沟、腰部）。10毫升的量足以覆盖约20%的体表面积。该制剂已被以色列卫生部批准用于人类使用，并于最近在欧洲颁发了CE标志证书（I类）。Dermostyx已被IDF和急救人员采用，作为特殊需求的皮肤保护剂。2016爱思唯尔爱尔兰有限公司版权所有。
Prevention of the penetration of toxic agents through the skin is crucial for both military troops and civilian populations. We have developed a novel topical skin protectant (TSP), coded as IB1 and commercially available as Dermostyx protective solution (Rekah Pharm, Israel). The formulation afforded significant protection against chemical warfare agents such as sulfur mustard (SM) and VX (2LD50), pesticides such as parathion and irritants such as acrolein. The efficacy of the protectant was evaluated in the pig model using clinical, histological and biochemical monitoring. A single topical application prior to exposure to the toxic agents reduced significantly the size and severity of skin lesions and ameliorated or prevented systemic clinical symptoms. The barrier properties of IB1 are immediate upon application and remain effective for at least 12 h. It is absorbed into the stratum corneum of the skin and remains there until rinsing with water, yet the ingredients are not absorbed into the body. The formulation is a hydrophilic water-based solution, composed of magnesium sulfate and glycerin that are widely used in cosmetic and medicine, and was shown to be safe in preclinical and in Phase I clinical studies. The suggested mode of action is based on the unique interaction of glycerin with the stratum corneum, changing its properties to hydrophilic and on the "salting out" effect of magnesium sulfate. The expected use of the TSP is by application on exposed skin areas and sensitive skin sites (e.g. armpits, groin, waist), when necessary. A quantity of 10 ml is sufficient for one application covering approximately 20% of the body surface area. The formulation was approved for human use by the Israel Ministry of Health and a CE mark certificate in Europe has been recently issued (Class I). Dermostyx has been adopted by the IDF and first responders as a skin protectant for special needs. (C) 2016 Elsevier Ireland Ltd. All rights reserved.