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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

October 24, 2005
May 4, 2009
December 2005
October 2006   (final data collection date for primary outcome measure)
Cure of Head Lice [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Cure of Head Lice
Complete list of historical versions of study NCT00244439 on ClinicalTrials.gov Archive Site
Safety of treatments [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
 
 
 
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.
 
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
    MALG
    Intervention: Drug: MALG
  • Active Comparator: 2
    Ovide
    Intervention: Drug: Ovide (malathion) lotion 0.05%
  • Active Comparator: 3
    Permethrin 1%
    Intervention: Drug: Permethrin 1%
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
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
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00244439
MALG-0506
No
Medical Director, Taro Pharmaceuticals USA
Taro Pharmaceuticals USA
 
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
Taro Pharmaceuticals USA
May 2009

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