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

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ClinicalTrials.gov Identifier: NCT00244439
Recruitment Status : Completed
First Posted : October 26, 2005
Last Update Posted : December 23, 2013
Sponsor:
Information provided by:
Taro Pharmaceuticals USA

Brief Summary:
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 or disease Intervention/treatment Phase
Lice Infestations Drug: MALG Drug: Ovide (malathion) lotion 0.05% Drug: Permethrin 1% Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : December 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : December 2006

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Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Cure of Head Lice [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Safety of treatments [ Time Frame: 4 weeks ]


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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
  • 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

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): 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

Responsible Party: Medical Director, Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00244439     History of Changes
Other Study ID Numbers: MALG-0506
First Posted: October 26, 2005    Key Record Dates
Last Update Posted: December 23, 2013
Last Verified: November 2013

Keywords provided by Taro Pharmaceuticals USA:
Head Lice
Pediculosis capitis

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