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malathion

Phase 3

Lice Infestations | Small molecule | Infectious Disease |Johnson & Johnson|Last Updated: Aug 22, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment812

FDA Designations

No designations recorded

Clinical trial landscape

malathion · 1 trial · 1 indication

Phase 3 1
NCT00819520Ivermectin in the Treatment of Head LiceLice Infestations
COMPLETED812 Analytics
PHASE3COMPLETED
Ivermectin in the Treatment of Head Lice
Lice Infestations
NCT00819520812
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Study Endpoints

Primary Endpoints

Absence or presence of live head lice
Study Day 15

Secondary Endpoints

Absence or presence of live head lice at alternative Study Days.
Study Days 2, 8, 22, 29
Safety Assessments will consist of monitoring and recording all non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs), their frequency, severity, seriousness, and relationship to the investigational product.
throughout duration of the study (+ 30 days for spontaneously reported SAEs)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IvermectinEXPERIMENTALivermectin Stromectol®)
MalathionACTIVE_COMPARATORmalathion(Prioderm®)

Interventions

NameTypeDescription
ivermectinDRUGTwo single doses of oral ivermectin 400 mcg/kg (Days 1 and 8) plus 2 single applications of placebo lotion
malathionDRUGTwo single applications of malathion 0.5% lotion (Days 1 and 8) plus 2 single doses of placebo tablets
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Eligibility Criteria

Age Range2 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Head lice infestation confirmed by detection combing by study staff * previous (within 6 weeks) use of a topical insecticide product * minimum 15kg weight * providing informed consent Exclusion Criteria: * pregnant or nursing patients * households with 7 or more infested pat...

Countries:FranceIrelandIsraelUnited Kingdom
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