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.
Abstract: Benzyl alcohol lotion 5% (BAL 5%) is a non-neurotoxic topicalhead lice treatment that is safe and effective in children as young as6 months of age. The safety and efficacy of this pediculicide has been studiedin 695 (confirm number) subjects in all phases of clinical development.Scanning electron micrographs (SEM) demonstrated that the active agentappears to stun the breathing spiracles open, enabling the vehicle to penetratethe respiratory mechanism (spiracles), therefore asphyxiating the lice.Initial phase II trials compared this novel product to RID using identicalvolumes of treatment (4 oz ⁄ application) and yielding, almost, identical effi-cacy. This outcome pointed to the significant importance of completelysaturating the hair with the product in order to achieve maximum treatmentsuccess. A second phase II trial, which allowed the use of sufficient productto saturate the hair, resulted in 100% efficacy after both 10 and 30 minutetreatments. A third phase II trial verified an effective dose. Phase III trialscompared BAL 5% to vehicle placebo for two 10-minute applications. Itproved to be safe and effective (p < 0.001) for treatment of head lice and isthe first FDA-approved non-neurotoxic lice treatment, now available in theUnited States as UlesfiaTM lotion.CONCLUSIONBenzyl alcohol lotion 5% is a significant breakthroughin pediculicide therapy and should be a preferred alternativeปัจจุบันการอนุมัติผลิตภัณฑ์สารกำจัดศัตรูพืช และเยียวยาที่บ้านไม่ได้ผล มัน เป็นพิษการใช้ ด้วยเวลาสั้นประยุกต์ ลแอลกอฮอล์โลชั่น 5% คือ pediculicide ได้รับการอนุมัติจากองค์การอาหารและยาเท่านั้นปลอดภัยผ่านการทดสอบ และพบในเด็กเป็น 6 เดือนและไม่ห้ามในหญิงมีครรภ์เนื่องจากการใช้งาน โดยทาให้หมดสติเหาความต้านทานไม่น่า
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