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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.
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

Tracking Information
First Submitted Date  ICMJE October 24, 2005
First Posted Date  ICMJE October 26, 2005
Last Update Posted Date December 23, 2013
Study Start Date  ICMJE December 2005
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2008)
Cure of Head Lice [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2005)
Cure of Head Lice
Change History Complete list of historical versions of study NCT00244439 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2008)
Safety of treatments [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lice Infestations
Intervention  ICMJE
  • Drug: MALG
    30 minute application
  • Drug: Ovide (malathion) lotion 0.05%
    8-12 hour application
  • Drug: Permethrin 1%
    10 minute application
Study Arms  ICMJE
  • 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%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2006)
360
Original Enrollment  ICMJE
 (submitted: October 24, 2005)
575
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00244439
Other Study ID Numbers  ICMJE MALG-0506
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Director, Taro Pharmaceuticals USA
Study Sponsor  ICMJE Taro Pharmaceuticals USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taro Pharmaceuticals USA
Verification Date November 2013

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