NCT00244439

Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice

A Multi-Center Phase III Study to Evaluate MALG, a Novel Malathion 0.05%Formulation, for the Control of Head Lice in Pediatric and Adult Subjects With Pediculosis Capitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.

Conditions

• Lice Infestations

Interventions

Type	Name	Description
DRUG	MALG	30 minute application
DRUG	Ovide (malathion) lotion 0.05%	8-12 hour application
DRUG	Permethrin 1%	10 minute application

Timeline

• Start date: 2005-12-01
• Primary completion: 2006-10-01
• Completion: 2006-12-01
• First posted: 2005-10-26
• Last updated: 2013-12-23

Locations

6 sites across 1 country: United States