Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice
Phase 3
Completed
- Conditions
- Lice Infestations
- Interventions
- Registration Number
- NCT00244439
- Lead Sponsor
- Taro Pharmaceuticals USA
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Permethrin 1% Permethrin 1% 2 Ovide (malathion) lotion 0.05% Ovide 1 MALG MALG
- Primary Outcome Measures
Name Time Method Cure of Head Lice 4 weeks
- Secondary Outcome Measures
Name Time Method Safety of treatments 4 weeks
Trial Locations
- Locations (1)
Investigator Site
🇺🇸Miamiville, Ohio, United States