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NCT01066585 · ClinicalTrials.gov registry record · Phase 3

A Safety and Efficacy Study Comparing 0.5% Ivermectin Cream to a Vehicle Control in Subjects With Head Lice Infestation

A Phase 3 study, sponsored by Topaz Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
410
Enrollment target

NCT01066585: Completed Phase 3 study, sponsored by Topaz Pharmaceuticals.

NCT01066585 is a Phase 3 study that has completed, run by Topaz Pharmaceuticals. The registered enrollment target is 410 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01066585, a Phase 3 study, has completed, sponsored by Topaz Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
410 participants
Enrollment target

Study Summary

The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective treatment for head lice infestations.

Primary Outcome

Treatment success defined as absence of live lice, was assessed in index participants, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.

Interventions

  • DRUG vehicle control
  • DRUG Ivermectin Cream

Trial Details

FieldValue
Enrollment Target 410 participants
Start Date 2010-03
Est. Completion 2010-07
Phase Phase 3
Topaz Pharmaceuticals

5 total trials

What the finished NCT01066585 record still lists

NCT01066585 is an interventional study that assigns participants to a tested intervention. The registered 410 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 (47% lower).

The record links to 0 conditions, and to 2 interventions - of which vehicle control is the first listed.

NCT01066585 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01066585 about?

NCT01066585 is a clinical study titled "A Safety and Efficacy Study Comparing 0.5% Ivermectin Cream to a Vehicle Control in Subjects With Head Lice Infestation". The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective treatment for head lice infestations.

What is the current status of trial NCT01066585?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 410 participants. The study started on 2010-03. Estimated completion is 2010-07.

What interventions are being tested in trial NCT01066585?

The interventions under investigation include: vehicle control (DRUG), Ivermectin Cream (DRUG).

Who is sponsoring clinical trial NCT01066585?

This trial is sponsored by Topaz Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01066585's enrollment target sits among peer trials

410 909th of 2000 higher than 1,090 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 NCT01066585, the US trial registry maintained by the National Library of Medicine. NCT01066585 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.