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

Head Lice Clinical Trial

Official title:
A Randomized, Multi-Center, Double-blind, Placebo Controlled, Parallel Group Trial to Evaluate Efficacy and Safety of Mayne Pharma's Ivermectin 0.5% Lotion Compared to Sklice® Ivermectin 0.5% Lotion in the Treatment of Head Lice

Clinical Trial Summary

This is a phase 3 randomized, multi-center, double-blind, placebo controlled, parallel group design study.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03337490
Study type Interventional
Source Mayne Pharma International Pty Ltd
Contact
Status Completed
Phase Phase 3
Start date October 2, 2017
Completion date December 18, 2017
View Details
See also
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