Benzyl Alcohol Lotion 5% Suffocates Head Lice

Fran Lowry

February 26, 2010

February 26, 2010 — Benzyl alcohol lotion 5% (BAL 5%), a non-neurotoxic topical treatment that kills head lice by suffocating them, is safe and effective in children as young as 6 months and is the first non-neurotoxic compound to win approval by the US Food and Drug Administration (FDA), investigators report in a study published online February 23 in Pediatric Dermatology.

"Prescription and ...FDA approved over-the-counter (OTC) pediculicides contain neurotoxic pesticides as active ingredients, resulting in potential toxicity and other problems," write Terri L. Meinking, PhD, from Global Health Associates of Miami, Miami, Florida, and colleagues. "This leaves practitioners, parents and patients hoping for a safe, nonneurotoxic cure."

There is growing resistance to OTC products such as permethrin and synergized pyrethrins, which are currently recommended as first-line treatments by the Centers for Disease Control and Prevention and the American Academy of Pediatrics.

As an alternative to these pesticidal products, attempts have been made to suffocate head lice with mayonnaise, olive oil, and petroleum jelly. These home remedies appear to kill the lice, but later a "resurrection effect" occurs after rinsing because lice can resist asphyxiation, the study authors write.

Trials Leading to Drug Approval

In their report, the investigators reviewed 3 randomized, observer-blinded phase 2 trials and 2 multicenter, randomized, double-blind, placebo-controlled phase 3 trials that included approximately 700 subjects.

The phase 2 trials, which compared the BAL 5% and BAL 15% (Ulesfia; Sciele Pharma, Inc., A Shionogi Company, Atlanta, Georgia) vs a synergized pyrethrin (RID; Bayer Consumer Care, Morristown, New Jersey), showed equal efficacy with both treatments and established that full saturation of the hair with BAL 5% for 10 minutes was required for treatment success and that the amount of the compound used should not be limited.

The phase 3 trials, which were done at 10 geographically diverse sites, compared BAL 5% vs vehicle placebo in two 10-minute applications that were done 1 week apart. A total of 127 subjects (intent-to-treat) were randomly assigned to BAL 5%, and 123 subjects (intent-to-treat) were randomly assigned to vehicle. BAL 5% showed statistically greater treatment success (P < .001).

"BAL 5% is a significant breakthrough for head lice therapy, because all currently FDA-approved pediculicides contain chemical pesticides, bearing the potential for human toxicity," the study authors write.

A low incidence of mild eye and skin irritation was observed with the compound. This finding contrasts with the stinging or aggravation of preexisting excoriation caused by head lice infestation when pediculicides are applied, they note.

The new compound "should be a preferred alternative to currently approved pesticide products and ineffective home remedies," the study authors conclude. It is safe in young children and is not contraindicated in pregnant women, and "because this product works by asphyxiating lice, resistance is unlikely."

Great Alternative but Some Downsides, Commentator States

"I think it's great to have an alternative because resistance to the permethrin and pyrethrin products has become an issue. It looks like this has more evidence to back up its effectiveness for suffocation than just using Vaseline and those kinds of things, so it’s nice to see," Barbara Frankowski, MD, professor of pediatrics at the University of Vermont College of Medicine and a practicing pediatrician in Burlington, Vermont, told Medscape Pediatrics.

One downside, however, is that using BAL 5% seems to be complicated, said Dr. Frankowski, when asked by Medcsape Pediatrics to provide independent commentary about this study.

"You are supposed to use different amounts, based on how long the hair is. I'm not sure I understand that, because live lice for most people are not going to be on the ends of the hair, they are right next to the scalp. So if you have very long hair, you will have to use many bottles for one treatment. That is expensive, and it is a little bit of a mystery as to why, but if it works, it works," she said.

"People also need to understand that the product is not ovicidal, so a second treatment is necessary 7 days after the first. This means that baby lice will hatch from the eggs, but re-treatment has to wait. Waiting could be a problem for some children who may be sent home from school."

"If you are in district that is excluding kids for lice and eggs and nits, your kid could be barred from attending school. The American Academy of Pediatrics is against no-nit policies as is the National Association of School Nurses, but a lot of times the school boards decide to enact such a policy despite the science and the facts. But still, this is something people should know," Dr. Frankowski said.

Another potential issue is the product is available by prescription only, and insurance may not cover it, at least until it becomes more widely used, she said.

"My final comment would be that it looks promising, especially if it is going to be more effective than over-the-counter products. But then you have to think about how many bottles you have to use and will the average person with head lice be able to afford it and will their insurance cover it, and is it going to be a problem to do two treatments. We also have to make sure that schools are not going to penalize kids if they are using this product."

Data analysis was conducted by Summers Laboratories Inc, Collegeville, Pennsylvania. The study authors and Dr. Frankowski have disclosed no relevant financial relationships.

Pediatr Dermatol. Published online February 23, 2010.