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Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice

NCT00291057 ↗

Phase 2 Terminated 30 enrolled Sun Pharmaceutical Industries, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population. The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.

Timeline

Start
2006-02
Primary completion
2006-10
Completion
2006-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Malathion Small molecule 0.5 % —

Indications

lice infestation