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ivermectin

Phase 3

Lice Infestations | Small molecule | Infectious Disease |Johnson & Johnson|Last Updated: Oct 6, 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

ivermectin · 4 trials · 2 indications

Phase 3 1Phase 1 3
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
Pharmacokinetic parameters, including AUC0-t, AUC0-inf and Cmax
21 samples over 144 hours in each period, with 14-day washout
Pharmacokinetic parameters, including AUC0-t, AUC0-inf, and Cmax
21 samples over 144 hours in each period, with a 14-day washout

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)
Pharmacokinetic parameters, including t1/2, MRT=Mean residence time kel = Terminal Elimination Rate Constant, Tmax
21 samples over 144 hours in each period with a 14-day washout
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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 ivermectin

What is ivermectin used for?

Ivermectin is used for the treatment of head lice infestations. It is also studied in healthy volunteers for bioequivalence purposes. The drug is being developed by Johnson & Johnson (JNJ) and is currently in Phase 1 clinical development.

Who makes ivermectin?

Ivermectin is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is a small molecule currently in Phase 1 clinical development for the treatment of head lice infestations.

What phase is ivermectin in?

Ivermectin is in Phase 1 clinical development. While it has completed Phase 3 trials for head lice, the current development stage is Phase 1. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is ivermectin in?

Ivermectin has completed three clinical trials. NCT00819520 was a Phase 3 study in 812 patients with lice infestations in France, Ireland, Israel, and the United Kingdom. NCT00921154, NCT00921219, and NCT00921674 were Phase 1 bioequivalence studies in healthy volunteers.

Is ivermectin the same as Soolantra?

Ivermectin is also known by the brand name Soolantra. This alternative name is used in some contexts, and readers searching for Soolantra should be aware that it refers to the same drug compound.