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Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

NCT00927472 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2014-08-04

Study results available
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Summary

In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.

Conditions

  • Pediculosis

Interventions

DRUG

Malathion gel 0.5%

Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.

DRUG

Permethrin 1% rinse

Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-05-31
Completion
2010-06-30

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 NCT00927472 on ClinicalTrials.gov