NCT03301649

Clinical Endpoint Study of Ivermectin 0.5% Lotion

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of Ivermectin Lotion 0.5% (Actavis Laboratories UT, Inc.) to SKLICE® (Ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC) in the Treatment of Human Head Lice Infestation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 905 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Head Lice

Interventions

Type	Name	Description
DRUG	Generic Ivermectin Lotion 0.5%	Topical lotion, generic formulation of the brand product.
DRUG	Sklice® (Ivermectin) Lotion 0.5%	Topical lotion, brand product.
DRUG	Vehicle Lotion	Topical lotion, placebo. Has no active ingredient.

Timeline

• Start date: 2017-10-07
• Primary completion: 2018-03-12
• Completion: 2018-03-12
• First posted: 2017-10-04
• Last updated: 2019-12-20
• Results posted: 2019-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study