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malathion

Phase 3

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

malathion development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jan 2009

malathion target and mechanism

ModalitySmall molecule

Also known as Prioderm®

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

malathion clinical trials

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 InfestationsUnlock trial analytics

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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Frequently asked questions about malathion

What is malathion used for?

Malathion is a small molecule treatment for lice infestations. Johnson & Johnson has studied it in a Phase 3 clinical program for this infectious disease indication. It is applied as a topical therapy against head lice, a common parasitic condition affecting both children and adults.

Who makes malathion?

Malathion is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company has sponsored a Phase 3 trial of the drug in lice infestations, evaluating its use in a pediatric and adult population across several countries.

What phase is malathion in?

Malathion is in Phase 3 development for lice infestations. The program includes one completed Phase 3 trial with 812 participants. No active trials are currently listed, and the drug remains investigational for this indication rather than approved.

What clinical trials is malathion in?

Malathion has been evaluated in a single Phase 3 trial, NCT00819520, titled Ivermectin in the Treatment of Head Lice. The trial enrolled 812 participants, was randomized, double blind, and active controlled, and was conducted in France, Ireland, Israel, and the United Kingdom. It has completed.

Is malathion FDA approved for lice?

Malathion is an investigational therapy in Phase 3 development for lice infestations. The completed Phase 3 trial, NCT00819520, evaluated the drug in 812 participants. No approval has been granted for this indication based on the available development data.