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NCT03301649 · ClinicalTrials.gov registry record · Phase 3
Clinical Endpoint Study of Ivermectin 0.5% Lotion
A Phase 3 study, sponsored by Actavis.
- Completed
- Registry status
- Phase 3
- Development phase
- 905
- Enrollment target
NCT03301649: Completed Phase 3 study, sponsored by Actavis.
NCT03301649 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 905 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03301649, a Phase 3 study, has completed, sponsored by Actavis.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 905 participants
- Enrollment target
Study Summary
This clinical study is designed to evaluate the clinical (therapeutic) effect of a generic ivermectin lotion 0.5% (Actavis Laboratories UT, Inc.) relative to that of the Food and Drug Administration (FDA) Reference Listed Drug (RLD) SKLICE® (ivermectin) lotion, 0.5% (Arbor Pharmaceuticals, LLC) in participants with active head lice infestation. Additionally, both the test and reference (that is; the RLD) treatments were tested for superiority to a placebo.
Primary Outcome
Treatment success was defined as the absence of live lice. Index participant was defined as the youngest household member who was randomized into the study. Therapeutic equivalence evaluation between test (generic ivermectin lotion 0.5%) and reference groups (Sklice \[ivermectin\] lotion 0.5%) was done in this endpoint, hence placebo group was not included.
Interventions
- DRUG Vehicle Lotion
- DRUG Generic Ivermectin Lotion 0.5%
- DRUG Sklice® (Ivermectin) Lotion 0.5%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 905 participants |
| Start Date | 2017-10-07 |
| Est. Completion | 2018-03-12 |
| Phase | Phase 3 |
What the finished NCT03301649 record still lists
NCT03301649 is an interventional study that assigns participants to a tested intervention. The registered 905 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 3 interventions - of which Vehicle Lotion is the first listed.
NCT03301649 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03301649 about?
NCT03301649 is a clinical study titled "Clinical Endpoint Study of Ivermectin 0.5% Lotion". This clinical study is designed to evaluate the clinical (therapeutic) effect of a generic ivermectin lotion 0.5% (Actavis Laboratories UT, Inc.) relative to that of the Food and Drug Administration (FDA) Reference Listed Drug (RLD) SKLICE® (ivermectin) lotion, 0.5% (Arbor Pharmaceuticals, LLC) in p...
What is the current status of trial NCT03301649?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 905 participants. The study started on 2017-10-07. Estimated completion is 2018-03-12.
What interventions are being tested in trial NCT03301649?
The interventions under investigation include: Vehicle Lotion (DRUG), Generic Ivermectin Lotion 0.5% (DRUG), Sklice® (Ivermectin) Lotion 0.5% (DRUG).
Who is sponsoring clinical trial NCT03301649?
This trial is sponsored by Actavis, which has 79 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03301649's enrollment target sits among peer trials
905 347th of 2000 higher than 1,653 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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