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NCT01068158 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects
A Phase 3 study, sponsored by Topaz Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 371
- Enrollment target
NCT01068158: Completed Phase 3 study, sponsored by Topaz Pharmaceuticals.
NCT01068158 is a Phase 3 study that has completed, run by Topaz Pharmaceuticals. The registered enrollment target is 371 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01068158, a Phase 3 study, has completed, sponsored by Topaz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 371 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 subjects, 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 Placebo control
- DRUG 0.5% Ivermectin Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 371 participants |
| Start Date | 2010-03 |
| Est. Completion | 2010-07 |
| Phase | Phase 3 |
What the finished NCT01068158 record still lists
NCT01068158 is an interventional study that assigns participants to a tested intervention. The registered 371 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 (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo control is the first listed.
NCT01068158 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01068158 about?
NCT01068158 is a clinical study titled "A Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects". 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 NCT01068158?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 371 participants. The study started on 2010-03. Estimated completion is 2010-07.
What interventions are being tested in trial NCT01068158?
The interventions under investigation include: Placebo control (DRUG), 0.5% Ivermectin Cream (DRUG).
Who is sponsoring clinical trial NCT01068158?
This trial is sponsored by Topaz Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01068158's enrollment target sits among peer trials
371 992nd of 2000 higher than 1,008 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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