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Benzyl alcohol lotion 5% was recently approved by the FDA for the treatment of head lice and is safe for patients 6 months of age and older.
Benzyl alcohol lotion 5% (BAL 5%), known as UlesfiaTM and recently approved by the FDA, may be a successful new treatment for head lice that is non-neurotoxic and is safe for use in humans six months of age and up.
Lead researcher Terri L. Meinking, PhD, of the Global Health Associates of Miami, and her fellow researchers tested the efficacy of BAL 5% in two phase III, multi-center, randomized, double-blind, placebo-controlled trials. The 250 patients who participated in the trials were placed in treatment or vehicle groups, the latter of which treated patients with lotion that did not include the active ingredients. Treatment was administered on Day One and Day Seven, and patients were evaluated for the success of the treatment on Day Eight and Day 14.
According to the researchers, “on day eight, the treatment group had a success rate of 91.2% as an average of both trials, and a 75.6% success rate on day 14; in the vehicle group the success rates were 27.9% and 15.5%, respectively.”
The study was also published in Pediatric Dermatology, which described the efficacy of BAL 5%.
“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,” according to the abstract. “Initial phase II trials compared this novel product to RID® using identical volumes of treatment (4 oz/application) and yielding, almost, identical efficacy.”
Meinking and her research team are confident about the efficacy of the drug.
"Existing over-the-counter head lice treatments contain neurotoxic pesticides as active ingredients, resulting in potential toxicity and other problems, including lengthy applications, odor, ineffective treatment," said Meinking. "Since the most popular products have been made readily available, their overuse has caused lice to become resistant just as bacteria have become resistant to many antibiotics. Because benzyl alcohol lotion kills by suffocation, resistance should not be an issue."