This clinical study is designed to evaluate the clinical (therapeutic) effect of a generic
ivermectin lotion 0.5% (Actavis Laboratories UT, Inc.) relative to that of the Food and Drug
Administration (FDA) Reference Listed Drug (RLD) SKLICEĀ® (ivermectin) lotion, 0.5% (Arbor
Pharmaceuticals, LLC) in participants with active head lice infestation. Additionally, both
the test and reference (that is; the RLD) treatments were tested for superiority to a
placebo.