MATERIALS AND METHODS
Phase II Clinical Trials
Three randomized, observer-blinded phase II trials
(identified as phase II a, b, and c for this report) were
designed to determine an optimal treatment regimen for
benzyl alcohol lotion (BAL). In each study, subjects 2–
70 years of age with active infestations (minimum of
three live lice and 10 viable-appearing nits) were inspected
for live lice 1 week following the first treatment
(day 8). Subjects (both active agent and vehicle-treated)
received a 2nd treatment BAL 5% only if they had live
lice at the day 8 visit. The primary efficacy end point was
Treatment Success 1 week postfinal treatment and was
defined as absence of live lice.
Phase IIa compared two concentrations of BAL,
5% and 10%, to vehicle and an active control, a
synergized pyrethrin (RID shampoo, Bayer Consumer
Care, Morristown, NJ). Equal volumes of the
pyrethrin and BAL were applied (4 oz). During this
study, staff observed that the amount of BAL did not