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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 is a Phase 3 study that has completed, run by Actavis. The registered enrollment target is 905 participants.

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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.

Interventions

  • DRUG Vehicle Lotion
  • DRUG Generic Ivermectin Lotion 0.5%
  • DRUG Sklice® (Ivermectin) Lotion 0.5%

Trial Details

FieldValue
Enrollment Target 905 participants
Start Date 2017-10-07
Est. Completion 2018-03-12
Phase Phase 3

Sponsor

Actavis

79 total trials

What the Registry Record Tells You About NCT03301649

The ClinicalTrials.gov registry entry for NCT03301649 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 905 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Actavis, which has 79 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Vehicle Lotion is the first listed.

NCT03301649 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.