NCT03257943

A Bioequivalence Study, Comparing Two Formulations of Ivermectin Lotion, 0.5%

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Ivermectin Lotion, 0.5% in the Treatment of Subjects With Active Infestation With Head Lice and Their Ova

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5%

Detailed description

A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5% to Sklice (Ivermectin) Lotion, 0.5% and both active treatment to a placebo control in the treatment of subjects with active infestation with head lice and their Ova

Conditions

• Lice; Head Lice

Interventions

Type	Name	Description
DRUG	Ivermectin Lotion, 0.5%	Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)
DRUG	SKLICE (ivermectin) Lotion, 0.5%	SKLICE (ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC)
DRUG	Vehicle of the Test product	Vehicle for Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)

Timeline

• Start date: 2017-03-20
• Primary completion: 2017-06-27
• Completion: 2017-08-18
• First posted: 2017-08-22
• Last updated: 2018-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study