Meinking Terri L, Villar Maria E, Vicaria Maureen, Eyerdam Debbie H, Paquet Diane, Mertz-Rivera Kamara, Rivera Hector F, Hiriart Javier, Reyna Susan
Global Health Associates of Miami, Miami, Florida, USA.
Pediatr Dermatol. 2010 Jan-Feb;27(1):19-24. doi: 10.1111/j.1525-1470.2009.01059.x.
Benzyl alcohol lotion 5% (BAL 5%) is a non-neurotoxic topical head lice treatment that is safe and effective in children as young as 6 months of age. The safety and efficacy of this pediculicide has been studied in 695 (confirm number) subjects in all phases of clinical development. Scanning electron micrographs (SEM) demonstrated that the active agent appears to stun the breathing spiracles open, enabling the vehicle to penetrate the respiratory mechanism (spiracles), therefore asphyxiating the lice. Initial phase II trials compared this novel product to RID using identical volumes of treatment (4 oz/application) and yielding, almost, identical efficacy. This outcome pointed to the significant importance of completely saturating the hair with the product in order to achieve maximum treatment success. A second phase II trial, which allowed the use of sufficient product to saturate the hair, resulted in 100% efficacy after both 10 and 30 minute treatments. A third phase II trial verified an effective dose. Phase III trials compared BAL 5% to vehicle placebo for two 10-minute applications. It proved to be safe and effective (p < 0.001) for treatment of head lice and is the first FDA-approved non-neurotoxic lice treatment, now available in the United States as Ulesfia lotion.
5%苄醇洗剂（BAL 5%）是一种非神经毒性的局部治疗头虱药物，对6个月大的儿童也安全有效。这种灭虱剂的安全性和有效性已在695名（确认数字）受试者的临床开发各阶段进行了研究。扫描电子显微镜图像（SEM）显示，活性剂似乎能使呼吸气门张开，使载体能够穿透呼吸机制（气门），从而使虱子窒息。最初的II期试验将这种新产品与RID进行了比较，使用相同体积的治疗药物（每次涂抹4盎司），疗效几乎相同。这一结果表明，用该产品完全浸透头发对于取得最大治疗成功至关重要。第二项II期试验允许使用足够的产品使头发浸透，在10分钟和30分钟治疗后疗效均达到100%。第三项II期试验验证了有效剂量。III期试验将BAL 5%与赋形剂安慰剂进行了两次10分钟涂抹的比较。结果证明其治疗头虱安全有效（p < 0.001），是首个获得美国食品药品监督管理局批准的非神经毒性虱子治疗药物，现以Ulesfia洗剂的名称在美国上市。
