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Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice

NCT00545168 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2012-10-11

Study results available
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Summary

A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pediculosis capitis (Head lice).

Conditions

  • Pediculus Capitis Infestation

Interventions

DRUG

Spinosad

10 minute topical application of product, followed by a complete rinse off.

DRUG

Spinosad

10 minute topical application followed by a complete rinse off, followed by a nit combing regimen.

DRUG

Permethrin 1%

Topical application for 10 minutes, followed by a complete rinse off, followed by a nit combing regimen

Sponsors & Collaborators

  • ParaPRO LLC

    lead INDUSTRY

Principal Investigators

  • Bill Miller, MD · Concentrics Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-03-31
Completion
2008-05-31

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 NCT00545168 on ClinicalTrials.gov