According to a Pharmalive report, the U.S. Food and Drug Administration (FDA) has approved Sklice® (ivermectin) lotion, 0.5% for the topical treatment of head lice, in patients 6 months of age and older. The treatment involves a single 10-minute application without nit combing.
The approval was based on results of two randomized, double-blind phase III clinical trials that compared Sklice Lotion with a vehicle control (placebo) in 781 patients from the United States who were 6 months of age and older. More subjects in the treatment group were louse-free without any nit combing after two weeks and less than 1% of patients experienced adverse events, which included conjunctivitis, ocular hyperaemia, eye irritation, dandruff, dry skin and skin-burning sensation. [No further absolute data available within PharmaLive report.]