Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice
NCT ID: NCT00752973
Last Updated: 2014-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
12 participants
INTERVENTIONAL
2008-09-30
2012-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment arm
MALG treatment
MALG (malathion) Treatment
MALG applied for 30 minutes
Interventions
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MALG (malathion) Treatment
MALG applied for 30 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Scalp conditions other than head lice
* Previous head lice treatment within the past 4 weeks
* Current antibiotic treatment
6 Months
24 Months
ALL
No
Sponsors
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Sun Pharmaceutical Industries, Inc.
INDUSTRY
Responsible Party
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Locations
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Investigator Site
Bentonville, Arkansas, United States
Investigator Site
Jonesboro, Arkansas, United States
Countries
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References
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Meinking TL, Vicaria M, Eyerdam DH, Villar ME, Reyna S, Suarez G. A randomized, investigator-blinded, time-ranging study of the comparative efficacy of 0.5% malathion gel versus Ovide Lotion (0.5% malathion) or Nix Creme Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol. 2007 Jul-Aug;24(4):405-11. doi: 10.1111/j.1525-1470.2007.00460.x.
Other Identifiers
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MALG-0813
Identifier Type: -
Identifier Source: org_study_id
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