NCT00988533

A Pharmacokinetics (PK) Study in Lice Infested Children 6 Months to 3 Years of Age

An Open-label Study to Assess the Bioavailability, Safety, Local Tolerance, and Efficacy of 0.5% Ivermectin Cream in Subjects 6 Months to 3 Years of Age With Pediculus Humanus Capitis (Head Lice) Infestation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Topaz Pharmaceuticals Inc · Industry
• Sex: All
• Age: 6 Months – 3 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the bioavailability of 0.5% ivermectin cream in a pediatric population aged 6 months to 3 years.

Conditions

• Head Lice

Interventions

Type	Name	Description
DRUG	0.5% Ivermectin Cream	Topical 0.5% ivermectin cream applied to scalp and hair on day 1

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-10-02
• Last updated: 2012-04-25
• Results posted: 2012-04-25

Locations

5 sites across 1 country: United States