NCT01068158

A Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects

A Double-Blind Randomized Study to Compare the Efficacy, Safety, and Local Tolerability of a 0.5% Ivermectin Cream Compared to a Topical Vehicle Control in Subjects With Pediculus Humanus Capitis Infestation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 371 (actual)
• Sponsor: Topaz Pharmaceuticals Inc · Industry
• Sex: All
• Age: 5 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective treatment for head lice infestations.

Conditions

• Head Lice

Interventions

Type	Name	Description
DRUG	0.5% Ivermectin Cream	Up to 4 ounces of 0.5% Ivermectin Cream applied to hair and scalp on day 1.
DRUG	Placebo control	up to 4 ounces of topical vehicle control to head and scalp on day 1.

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2010-02-12
• Last updated: 2012-04-06
• Results posted: 2012-04-04

Locations

7 sites across 1 country: United States