NCT01066585

A Safety and Efficacy Study Comparing 0.5% Ivermectin Cream to a Vehicle Control in Subjects With Head Lice Infestation

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: 410 (actual)
• Sponsor: Topaz Pharmaceuticals Inc · Industry
• Sex: All
• Age: 6 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	Ivermectin Cream	Up to 4 ounces of topical 0.5% Ivermectin Cream applied to the hair and scalp on day 1
DRUG	vehicle control	Up to 4 ounces of vehicle control applied to the hair and scalp on day 1

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2010-02-10
• Last updated: 2012-04-06
• Results posted: 2012-04-04

Locations

8 sites across 1 country: United States