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.

Study Overview

• Status: Completed
• Conditions: Lice Infestations
• Intervention / Treatment: Drug: MALG; Drug: Ovide (malathion) lotion 0.05%; Drug: Permethrin 1%

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States
      • Investigator site
  • Florida
    • Miami, Florida, United States
      • Investigator site
    • St. Petersburg, Florida, United States
      • Investigator site
    • West Palm Beach, Florida, United States
      • Investigator site
  • New York
    • New York, New York, United States
      • Investigator site
  • Ohio
    • Miamiville, Ohio, United States
      • Investigator site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; MALG	Drug: MALG; 30 minute application
Active Comparator: 2; Ovide	Drug: Ovide (malathion) lotion 0.05%; 8-12 hour application
Active Comparator: 3; Permethrin 1%	Drug: Permethrin 1%; 10 minute application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cure of Head Lice	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety of treatments	4 weeks

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: October 24, 2005
• First Submitted That Met QC Criteria: October 24, 2005
• First Posted (Estimate): October 26, 2005

Study Record Updates

• Last Update Posted (Estimate): December 23, 2013
• Last Update Submitted That Met QC Criteria: December 19, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Head Lice; Pediculosis capitis
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Permethrin; Malathion
• Other Study ID Numbers: MALG-0506

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No