NCT00291057

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

Phase II, Multi-center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 6 Months – 24 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Lice Infestations

Interventions

Type	Name	Description
DRUG	MALG	30 minute application

Timeline

• Start date: 2006-02-01
• Primary completion: 2006-10-01
• Completion: 2006-12-01
• First posted: 2006-02-13
• Last updated: 2013-12-23

Locations

5 sites across 1 country: United States