Abstract: 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 effi-
cacy. 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 UlesfiaTM lotion.
CONCLUSION
Benzyl alcohol lotion 5% is a significant breakthrough
in pediculicide therapy and should be a preferred alternative
to currently approved pesticide products and
ineffective home remedies. It is non-toxic and convenient
to use with a short application time. Benzyl alcohol
lotion 5% is the only FDA-approved pediculicide
tested and found safe in children as young as 6 months
of age, and not contraindicated in pregnant women.
Because this product works by asphyxiating lice,
resistance is unlikely.