Last updated on February 2018

A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice


Brief description of study

This is a phase 3 randomized, multi-center, double-blind, placebo controlled, parallel group design study. This study is comprised of two phases: screening and treatment. The screening period is 24 hours, followed by the treatment phase of 15 3 days. During the treatment phase, subjects will be randomized to either test, reference of placebo treatments (3:3:1) in a double-blind manner in an outpatient setting. Once eligibility is confirmed, randomization will occur at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The treatment phase will be 15 3 days in duration wherein subject will receive treatment with investigational product (either test, reference or placebo) on Day 1 or baseline (visit 2). Efficacy will be evaluated at Day 15. Safety and tolerability will be evaluated based upon AEs and patient self-assessments and self-assessments collected during follow-up visits.

Clinical Study Identifier: NCT03337490

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Sumit Bajracharya

Site 105
Dinuba, CA United States
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Sumit Bajracharya

Site 104
Miami, FL United States
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Sumit Bajracharya

Site 101
Plantation, FL United States
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Sumit Bajracharya

Site 102
West Palm Beach, FL United States
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Sumit Bajracharya

Site 106
Nashville, TN United States
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Sumit Bajracharya

Site 103
Richland, WA United States
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