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NCT03337490 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Mayne Pharma International Pty.

Completed
Registry status
Phase 3
Development phase
296
Enrollment target

NCT03337490: Completed Phase 3 study, sponsored by Mayne Pharma International Pty.

NCT03337490 is a Phase 3 study that has completed, run by Mayne Pharma International Pty. The registered enrollment target is 296 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03337490, a Phase 3 study, has completed, sponsored by Mayne Pharma International Pty.

COMPLETED
Registry status
Phase 3
Development phase
296 participants
Enrollment target

Study Summary

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

Primary Outcome

The primary endpoint is the proportion of index subjects who are lice free at Day 15

Interventions

  • DRUG Ivermectin 0.5% Topical Application Lotion
  • DRUG Ivermectin 0.5% Topical Application Lotion [SKLICE]
  • DRUG Placebo 0% Lotion

Trial Details

FieldValue
Enrollment Target 296 participants
Start Date 2017-10-02
Est. Completion 2017-12-18
Phase Phase 3
Mayne Pharma International Pty

6 total trials

What the finished NCT03337490 record still lists

NCT03337490 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 3 interventions - of which Ivermectin 0.5% Topical Application Lotion is the first listed.

NCT03337490 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03337490 about?

NCT03337490 is a clinical study titled "A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice". This is a phase 3 randomized, multi-center, double-blind, placebo controlled, parallel group design study.

What is the current status of trial NCT03337490?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 296 participants. The study started on 2017-10-02. Estimated completion is 2017-12-18.

What interventions are being tested in trial NCT03337490?

The interventions under investigation include: Ivermectin 0.5% Topical Application Lotion (DRUG), Ivermectin 0.5% Topical Application Lotion [SKLICE] (DRUG), Placebo 0% Lotion (DRUG).

Who is sponsoring clinical trial NCT03337490?

This trial is sponsored by Mayne Pharma International Pty, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03337490's enrollment target sits among peer trials

296 1164th of 2000 higher than 835 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03337490, the US trial registry maintained by the National Library of Medicine. NCT03337490 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.