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Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With 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: NCT00291057
Recruitment Status : Terminated (Lack of enrollment)
First Posted : February 13, 2006
Last Update Posted : December 23, 2013
Sponsor:
Information provided by:
Taro Pharmaceuticals USA

Tracking Information
First Submitted Date  ICMJE February 10, 2006
First Posted Date  ICMJE February 13, 2006
Last Update Posted Date December 23, 2013
Study Start Date  ICMJE February 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
Change in cholinesterase level [ Time Frame: 1 day ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2006)
Change in cholinesterase level
Change History Complete list of historical versions of study NCT00291057 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2008)
  • Clinical evidence of cholinesterase inhibition [ Time Frame: 1 day ]
  • Local tolerability [ Time Frame: 1 day ]
  • Cure of head lice 14 days after last treatment [ Time Frame: 2 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2006)
  • Clinical evidence of cholinesterase inhibition
  • Local tolerability
  • Cure of head lice 14 days after last treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice
Official Title  ICMJE Phase II, Multi-center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis
Brief Summary

In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population.

The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lice Infestations
Intervention  ICMJE Drug: MALG
30 minute application
Study Arms  ICMJE Experimental: 1
MALG
Intervention: Drug: MALG
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 Terminated
Estimated Enrollment  ICMJE
 (submitted: February 10, 2006)
30
Original Enrollment  ICMJE Same as current
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
  • Parent or guardian must be able to apply treatment

Exclusion Criteria:

  • Allergy to pediculicides or hair care products
  • Scalp conditions other than head lice
  • Previous head lice treatment within the past 4 weeks
  • Current antibiotic treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 24 Months   (Child)
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 NCT00291057
Other Study ID Numbers  ICMJE MALG-0508
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