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

Pediculosis Clinical Trial

Official title:
A Multi-Center Phase III Study to Evaluate Malathion Gel 0.5% Formulation, for the Control of Head Lice in Pediatric Subjects and Adult Subjects With Pediculosis Capitis

Clinical Trial 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.

Clinical Trial 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 objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pharmaceuticals. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00963508
Study type Interventional
Source Taro Pharmaceuticals USA
Contact
Status Completed
Phase Phase 3
Start date August 2009
Completion date March 2010
View Details
See also
  Status Clinical Trial Phase
Completed NCT01660321 - Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation Phase 4
Completed NCT00752973 - Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice Phase 2/Phase 3
Completed NCT00545753 - Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice Phase 3
Completed NCT00381082 - A Randomised, Assessor-Blind, Comparative Efficacy Clinical Trial of 3 Pediculicides. Phase 2/Phase 3
Terminated NCT02499549 - Two Treatment Regimens of Cocamide DEA Lotion for Head Lice Phase 2/Phase 3
Completed NCT05643820 - Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis Phase 1
Completed NCT00731718 - Control of Head Lice Infestations in Children and Adults N/A
Not yet recruiting NCT01966965 - Efficacy and Safety Study for PIOLIN® Shampoo Phase 3
Completed NCT00927407 - Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice Phase 1
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Completed NCT00927472 - Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice Phase 3
Completed NCT01336647 - An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation Phase 2