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

NCT00994422 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2012-04-06

Study results available
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Summary

The purpose of this study is to compare the safety and efficacy of a 0.5% ivermectin cream to a placebo in subjects infested with head lice when used in an "at home" environment.

Conditions

  • Head Lice

Interventions

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

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
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2009-12-31
Completion
2009-12-31

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 NCT00994422 on ClinicalTrials.gov