Ivermectin in the Treatment of Head Lice

NCT00819520 ↗

Phase 3 Completed 812 enrolled Johnson & Johnson Consumer and Personal Products Worldwide

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare 2 single doses of ivermectin as tablets with 2 single applications of malathion 0.5% lotion (Days 1 and 8) in clearing head lice, in patients who have recently used standard head lice treatments without success.

Timeline

Start: 2004-02
Primary completion: 2004-09
Completion: 2004-10

Outcome

Met primary endpoint

paper 95.2% of patients receiving ivermectin were lice-free on day 15, as compared with 85.0% of those receiving malathion (absolute difference, 10.2 percentage points PMID 20220184 ↗

paper 95% confidence interval [CI], 4.6 to 15.7; P<0.001 PMID 20220184 ↗

Publications

Chosidow O, Giraudeau B, Cottrell J, Izri A, Hofmann R, Mann SG, Burgess I. Oral ivermectin versus malathion lotion for difficult-to-treat head lice. N Engl J Med. 2010 Mar 11;362(10):896-905. doi: 10.1056/NEJMoa0905471.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ivermectin	Small molecule	400 ug/kg	Oral
Comparator	Malathion	Small molecule	0.5 %	Topical