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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taro Pharmaceuticals USA
• Treatments: Malathion; Permethrin

Criteria

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