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Topaz Pharmaceuticals Announces Positive Data from Topical Ivermectin Trials Presented at Society of Pediatric Dermatology
Date:7/28/2010

ication of live lice at Day 15 compared to vehicle (p less than or equal to 0.003), with 0.5%, the concentration now in Phase 3 studies,  having the greatest efficacy of the three concentrations studied.

"The results from this phase 2 study are very encouraging," said Dr. Meinking. "Head lice can cause families tremendous anxiety and embarrassment, and parents are looking for a treatment that is safe and effective.  Ivermectin has a well-established record in treating other parasitic infections and this easy-to-use formulation shows great promise for treating head lice."

Lydie Hazan, MD, founder and CEO of Impact Clinical Trials, presented two studies in which the pharmacokinetics, safety and effectiveness of this 0.5% ivermectin cream were assessed in head lice-infested children.  Across the studies, children aged 6 months to 10 years were enrolled, including those weighing less than 15kg. Ivermectin was not detected in the plasma of any of the 10 children in the first study who were sampled.  In the second study, using a very sensitive test, detected levels of ivermectin  were less than 1% of those that occur when the tablet form of ivermectin is administered.  In both studies, there was a high level of elimination of head lice infestations in children treated with the 0.5% topical ivermectin formulation.

Impact of Head Lice

Head lice is a common condition that occurs throughout the world.(1)(2)  It is estimated that 6-12 million infestations occur each year in the United States, with infestations typically affecting children between the ages of three and 11.(3)  The social and economic burden of head lice can be significant,(4)(5)(6) and may lead to social ostracism, cause parental anxiety and act as a source of economic loss th
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SOURCE Topaz Pharmaceuticals
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