A Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects

Phase 3 Completed 371 enrolled Topaz Pharmaceuticals Inc

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective treatment for head lice infestations.

Timeline

Start: 2010-03
Primary completion: 2010-06
Completion: 2010-07

Outcome

Met primary endpoint

paper 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%), PMID 23113480 ↗

paper day 15 (73.8% vs. 17.6%) (P<0.001 for each comparison). PMID 23113480 ↗

Publications

Pariser DM, Meinking TL, Bell M, Ryan WG. Topical 0.5% ivermectin lotion for treatment of head lice. N Engl J Med. 2012 Nov 1;367(18):1687-93. doi: 10.1056/NEJMoa1200107.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ivermectin	Small molecule	0.5 %	Topical