WEDNESDAY, Feb. 8, 2012 (MedPage Today) — The FDA has approved the topical ivermectin 0.5 percent lotion (Sklice) for the treatment of head lice in patients 6 months and older.
The lotion is applied once for 10 minutes and works without nit combing.
The antiparasitic agent works by binding to invertebrate nerve and muscle cells, causing paralysis and death in lice, but not in mammals, according to a statement from drugmaker Sanofi Pasteur.
Approval was based on two phase III trials that measured efficacy and safety of the lotion in 781 patients ages 6 months and up. Patients randomized to treatment were significantly more likely to be lice-free than those in the placebo group after two weeks.
Topical ivermectin was well tolerated in the treatment group, with less than 1 percent of patients affected by adverse events. When reactions did occur, they included conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and burning sensation of the skin.
An oral formulation of ivermectin is used to treat certain infections caused by roundworms, including strongyloidiasis and onchocerciasis.