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: December 19, 2013
Last verified: November 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Investigator Site
Scottsdale, Arizona, United States
United States, Florida
Investigator Site
Miami, Florida, United States
Investigator Site
St. Petersburg, Florida, United States
Investigator Site
West Palm Beach, Florida, United States
United States, New York
Investigator Site
New York, New York, United States
United States, Ohio
Investigator Site
Miamiville, Ohio, United States
Sponsors and Collaborators
Taro Pharmaceuticals USA
  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: December 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:
Head Lice
Pediculosis capitis

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

ClinicalTrials.gov processed this record on October 01, 2014