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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00244439
Recruitment Status : Completed
First Posted : October 26, 2005
Last Update Posted : December 23, 2013
Information provided by:
Taro Pharmaceuticals USA

October 24, 2005
October 26, 2005
December 23, 2013
December 2005
October 2006   (Final data collection date for primary outcome measure)
Cure of Head Lice [ Time Frame: 4 weeks ]
Cure of Head Lice
Complete list of historical versions of study NCT00244439 on Archive Site
Safety of treatments [ Time Frame: 4 weeks ]
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Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice
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
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.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Lice Infestations
  • Drug: MALG
    30 minute application
  • Drug: Ovide (malathion) lotion 0.05%
    8-12 hour application
  • Drug: Permethrin 1%
    10 minute application
  • Experimental: 1
    Intervention: Drug: MALG
  • Active Comparator: 2
    Intervention: Drug: Ovide (malathion) lotion 0.05%
  • Active Comparator: 3
    Permethrin 1%
    Intervention: Drug: Permethrin 1%
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2006
October 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Medical Director, Taro Pharmaceuticals USA
Taro Pharmaceuticals USA
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Taro Pharmaceuticals USA
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP