Clinical Endpoint Study of Ivermectin 0.5% Lotion

Status Completed

Clinical Trial 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.

Clinical Trial Description

Participants will be randomized by household in a 3:3:1 ratio to receive generic ivermectin lotion 0.5%, Sklice (ivermectin) lotion 0.5%, or vehicle lotion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03301649
Study type	Interventional
Source	Actavis Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	October 7, 2017
Completion date	March 12, 2018

View Details

See also
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