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0.5% Ivermectin

Phase 2

Pediculosis Capitis | Small molecule | Other |United Therapeutics Corporation|Last Updated: Mar 7, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

0.5% Ivermectin · 1 trial · 1 indication

Phase 2 1
NCT03286101Efficacy and Safety of Topical 0.5% Ivermectin Lotion for the Treatment of Head Lice Infestation in FilipinosPediculosis Capitis
COMPLETED120 Analytics
PHASE2COMPLETED
Efficacy and Safety of Topical 0.5% Ivermectin Lotion for the Treatment of Head Lice Infestation in Filipinos
Pediculosis Capitis
NCT03286101120
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Study Endpoints

Primary Endpoints

Proportion of participants cured of head lice infestation from their assigned product on day 2, day 8 and day 15 after the first treatment.
Day 2 to day 15 after product application
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
0.5% Ivermectin LotionEXPERIMENTAL -
Vehicle controlPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
0.5% Ivermectin lotionDRUGThe intervention is composed of a single application of the 0.5% ivermectin lotion.
VehicleDRUGThe intervention is composed of a single application of the vehicle control.
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Eligibility Criteria

Age Range3 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Index subjects must have an active lice infestation defined as: At least 3 live lice (adult and/or nymphs) present on the scalp and/or hair as determined by a trained evaluator; After the index subject has been enrolled, additional infested household members will be enrolled. ...

Countries:Philippines
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Frequently asked questions about 0.5% Ivermectin

What is 0.5% Ivermectin used for?

0.5% Ivermectin is a topical lotion being investigated for the treatment of pediculosis capitis, commonly known as head lice infestation. It is a small molecule drug in Phase 2 clinical development, studied in a placebo-controlled trial in the Philippines.

Who makes 0.5% Ivermectin?

0.5% Ivermectin is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR. The drug is currently in Phase 2 clinical development for the treatment of head lice infestation.

What phase is 0.5% Ivermectin in?

0.5% Ivermectin is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. A Phase 2 clinical trial evaluating its efficacy and safety for head lice infestation has been completed.

What clinical trials is 0.5% Ivermectin in?

0.5% Ivermectin has one completed clinical trial, registered as NCT03286101. This Phase 2 study, titled 'Efficacy and Safety of Topical 0.5% Ivermectin Lotion for the Treatment of Head Lice Infestation in Filipinos,' enrolled 120 participants in the Philippines and was a randomized, double-blind, placebo-controlled trial.

Is 0.5% Ivermectin the same as ivermectin?

0.5% Ivermectin is a specific topical formulation of ivermectin, a small molecule drug. It is being developed as a 0.5% lotion for the treatment of head lice infestation. The drug is currently in Phase 2 clinical development and is not yet approved.