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

This study has been completed.
Sponsor:
Information provided by:
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00244439
First received: October 24, 2005
Last updated: May 4, 2009
Last verified: May 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Lice Infestations
 Drug: MALG
Drug: Ovide (malathion) lotion 0.05%
Drug: Permethrin 1%
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • Cure of Head Lice [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of treatments [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 360
Study Start Date: December 2005
Study Completion Date: December 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244439

Locations
United States, Arizona
Scottsdale, Arizona, United States
United States, Florida
Miami, Florida, United States
St. Petersburg, Florida, United States
West Palm Beach, Florida, United States
United States, New York
New York, New York, United States
United States, Ohio
Miamiville, Ohio, United States
Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
Principal Investigator: John Goodman, MD Hill Top Research
Principal Investigator: Robert E Lewine, MD Hill Top Research
Principal Investigator: Wanda M Boote, MD Hill Top Research
Principal Investigator: Jan Fu, MD, PhD Hill Top Research
Principal Investigator: Terri Meinking Global Health Associates Miami
Principal Investigator: Micheal J Alaimo, RPh, DO Hill Top Research
  More Information

No publications provided

Responsible Party: Medical Director, Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00244439     History of Changes
Other Study ID Numbers: MALG-0506
Study First Received: October 24, 2005
Last Updated: May 4, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:
Head Lice
Pediculosis capitis

Additional relevant MeSH terms:
Lice Infestations
Parasitic Diseases
Ectoparasitic Infestations
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Malathion
Permethrin
 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 June 13, 2013