CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 296 enrolled
Drug / intervention
Ivermectin 0.5% Topical Application Lotion +2 moredrug
Likely dose
Ivermectin 0.5% Topical Application Lotion 117gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03337490
NCT03337490Phase 3Completed
CompareCT.gov

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

Mayne Pharma International Pty Ltd·interventional·Posted Nov 9, 2017·Updated Sep 17, 2020

In Brief

A Phase 3 clinical trial evaluating Ivermectin 0.5% Topical Application Lotion, Ivermectin 0.5% Topical Application Lotion [SKLICE], and 1 other intervention for Head Lice. Completed, enrolled 296 participants across 6 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHead Lice
CountriesUnited States
CollaboratorsbioRASI, LLC

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 9, 2017
Enrollment StartOct 2, 2017
Primary CompletionDec 4, 2017
Study CompletionDec 18, 2017
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.6 years ago

Interventions

Ivermectin 0.5% Topical Application Lotiondrug

Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline.

Ivermectin 0.5% Topical Application Lotion [SKLICE]drug

Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline.

Placebo 0% Lotiondrug

Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline.