Status:

COMPLETED

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

Lead Sponsor:

Sun Pharmaceutical Industries, Inc.

Conditions:

Pediculosis

Eligibility:

All Genders

2+ years

Phase:

PHASE3

Brief 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 h...

Detailed Description

This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The o...

Eligibility Criteria

Inclusion

  • Confirmed active head lice infestation

Exclusion

  • Allergy to pediculicides or hair care products
  • Scalp conditions other than head lice
  • Previous head lice treatment within the past 4 weeks
  • Current antibiotic treatment

Key Trial Info

Start Date :

August 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2010

Estimated Enrollment :

403 Patients enrolled

Trial Details

Trial ID

NCT00963508

Start Date

August 1 2009

End Date

March 1 2010

Last Update

June 13 2014

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Investigator Site

Hot Springs, Arkansas, United States

2

Investigator Site

Sacramento, California, United States

3

Investigator Site

Kissimmee, Florida, United States

4

Investigator Site

Miami, Florida, United States