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

NCT01068158 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 371

Last updated 2012-04-06

Study results available
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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

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.

Sponsors & Collaborators

  • Topaz Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Topaz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-06-30
Completion
2010-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01068158 on ClinicalTrials.gov