Topical 0.5% ivermectin lotion for treatment of head lice.

BACKGROUND: The emergence of resistance to treatment complicates the public health problem of head-louse infestations and drives the need for continuing development of new treatments. There are limited data on the activity of ivermectin as a topical lousicide.

METHODS: In two multisite, randomized, double-blind studies, we compared a single application of 0.5% ivermectin lotion with vehicle control for the elimination of infestations without nit combing in patients 6 months of age or older. A tube of topical ivermectin or vehicle control was dispensed on day 1, to be applied to dry hair, left for 10 minutes, then rinsed with water. The primary end point was the percentage of index patients (youngest household member with ≥3 live lice) in the intention-to-treat population who were louse-free 1 day after treatment (day 2) and remained so through days 8 and 15.

RESULTS: A total of 765 patients completed the studies. In the intention-to-treat population, significantly more patients receiving ivermectin than patients receiving vehicle control were louse-free on day 2 (94.9% vs. 31.3%), day 8 (85.2% vs. 20.8%), and day 15 (73.8% vs. 17.6%) (P<0.001 for each comparison). The frequency and severity of adverse events were similar in the two groups.

CONCLUSIONS: A single, 10-minute, at-home application of ivermectin was more effective than vehicle control in eliminating head-louse infestations at 1, 7, and 14 days after treatment. (Funded by Topaz Pharmaceuticals [now Sanofi Pasteur]; ClinicalTrials.gov numbers, NCT01066585 and NCT01068158.).