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

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ClinicalTrials.gov Identifier: NCT00963508
Recruitment Status : Completed
First Posted : August 21, 2009
Results First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Pediculosis Drug: Malathion gel 0.5% Drug: Permethrin 1% rinse (Nix Crème) Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 403 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : August 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF) [ Time Frame: 3 weeks ]

    The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7)

    Treatment Success in the Efficacy ITT (LOCF)

    index subjects: 150 from 403 randomized (the youngest subject in the household that met the index case criteria (having nits and at least 3 live lice))



Secondary Outcome Measures :
  1. Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF). [ Time Frame: 3 weeks ]

    The secondary efficacy variable was the proportion of subjects who were considered a Treatment Success 14 days after their first treatment.

    Treatment Success in the Efficacy ITT (LOCF)



Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963508


Locations
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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
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Publications of Results:

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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00963508    
Other Study ID Numbers: MALG-0816
First Posted: August 21, 2009    Key Record Dates
Results First Posted: June 13, 2014
Last Update Posted: June 13, 2014
Last Verified: May 2014
Keywords provided by Taro Pharmaceuticals USA:
Head Lice
Additional relevant MeSH terms:
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Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases
Permethrin
 Malathion
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinesterase Inhibitors
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs