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

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.

Timeline

Start

2009-08

Primary completion

2010-05

Completion

2010-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); Malathion Gel vs Nix Creme Rinse; p = 0.0386; t-test, 2 sided NCT00927472 ↗

registry analysis (superiority or other test); Malathion Gel vs Nix Creme Rinse; p = 0.0490; t-test, 2 sided NCT00927472 ↗

registry analysis (superiority or other test); Malathion Gel vs Nix Creme Rinse; p = 0.0002; t-test, 2 sided NCT00927472 ↗

registry analysis (superiority or other test); Malathion Gel vs Nix Creme Rinse; p = 0.0003; t-test, 2 sided NCT00927472 ↗

registry analysis (superiority or other test); Malathion Gel vs Nix Creme Rinse; p = 0.0012; t-test, 2 sided NCT00927472 ↗

Publications

• Background Meinking TL, Vicaria M, Eyerdam DH, Villar ME, Reyna S, Suarez G. A randomized, investigator-blinded, time-ranging study of the comparative efficacy of 0.5% malathion gel versus Ovide Lotion (0.5% malathion) or Nix Creme Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol. 2007 Jul-Aug;24(4):405-11. doi: 10.1111/j.1525-1470.2007.00460.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Malathion	Small molecule	0.5 %	Topical
Comparator	Permethrin	Small molecule	1 %	Topical

Indications