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

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.

Inclusion Criteria:

• Confirmed active head lice infestation
• Patient, parent or guardian must be able to apply the treatment
• Entire household must be screened
• All infested persons must agree to participate

Exclusion Criteria:

• Allergy to pediculicides, hair care products or chrysanthemums
• Scalp conditions other than head lice
• Previous head lice treatment within the past 4 weeks
• Female patients who are pregnant or nursing