Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

This study has been completed.
Information provided by:
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
First received: August 14, 2009
Last updated: December 19, 2013
Last verified: November 2013

In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.

Condition Intervention Phase
Drug: Malathion gel 0.5%
Drug: Permethrin 1% rinse (Nix Crème)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center Phase III Study to Evaluate Malathion Gel 0.5% Formulation, for the Control of Head Lice in Pediatric Subjects and Adult Subjects With Pediculosis Capitis

Resource links provided by NLM:

Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • Proportion of subjects free of any lice [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of adverse events will be compared between treatments [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: August 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Malathion Gel
Malathion gel 0.5% 30 minute application
Drug: Malathion gel 0.5%
Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.
Active Comparator: Nix Crème Rinse
Nix Crème Rinse applied to scalp for 10 minutes
Drug: Permethrin 1% rinse (Nix Crème)
Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present.

Detailed Description:

This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pharmaceuticals.


Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed active head lice infestation

Exclusion Criteria:

  • Allergy to pediculicides or hair care products
  • Scalp conditions other than head lice
  • Previous head lice treatment within the past 4 weeks
  • Current antibiotic treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963508

United States, Arkansas
Investigator Site
Hot Springs, Arkansas, United States
United States, California
Investigator Site
Sacramento, California, United States
United States, Florida
Investigator Site
Kissimmee, Florida, United States
Investigator Site
Miami, Florida, United States
Investigator Site
Ormond Beach, Florida, United States
United States, Mississippi
Investigator Site
Picayune, Mississippi, United States
United States, Texas
Investigator Site
San Antonio, Texas, United States
Sponsors and Collaborators
Taro Pharmaceuticals USA
  More Information

Responsible Party: Medical Director, Taro Pharmaceuticals USA, Inc
ClinicalTrials.gov Identifier: NCT00963508     History of Changes
Other Study ID Numbers: MALG-0816
Study First Received: August 14, 2009
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:
Head Lice

Additional relevant MeSH terms:
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014