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Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice
This study has been completed.
First Received: October 24, 2005   Last Updated: May 4, 2009   History of Changes
Sponsor: Taro Pharmaceuticals USA
Information provided by: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00244439
  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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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:


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
1: Experimental
MALG
Drug: MALG
30 minute application
2: Active Comparator
Ovide
Drug: Ovide (malathion) lotion 0.05%
8-12 hour application
3: Active Comparator
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
West Palm Beach, Florida, United States
St. Petersburg, Florida, United States
Miami, 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: Taro Pharmaceuticals USA ( Medical Director )
Study ID Numbers: MALG-0506
Study First Received: October 24, 2005
Last Updated: May 4, 2009
ClinicalTrials.gov Identifier: NCT00244439     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:
Head Lice
Pediculosis capitis

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

ClinicalTrials.gov processed this record on November 05, 2009