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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 2006

Interventions

  • Drug: MALG
    • 30 minute application
  • Drug: Ovide (malathion) lotion 0.05%
    • 8-12 hour application
  • Drug: Permethrin 1%
    • 10 minute application

Arms, Groups and Cohorts

  • Experimental: 1
    • MALG
  • Active Comparator: 2
    • Ovide
  • Active Comparator: 3
    • Permethrin 1%

Clinical Trial Outcome Measures

Primary Measures

  • Cure of Head Lice
    • Time Frame: 4 weeks

Secondary Measures

  • Safety of treatments
    • Time Frame: 4 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Taro Pharmaceuticals USA
  • Provider of Information About this Clinical Study
    • Medical Director, Taro Pharmaceuticals USA

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