Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multi-Center Phase III Study to Evaluate Ovide Lotion 0.5% Formulation, for the Control of Head Lice in Pediatric Subjects and Adult Subjects With Pediculosis Capitis|
- Proportion of subjects free of any of lice [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
- Tolerability of treatment [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: Malathion Gel
Malathion gel 0.5% 30 minute application
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.
Active Comparator: Nix Creme Rinse
Nix applied to scalp for 10 minutes
Drug: Permethrin 1% rinse
Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.
Other Name: Nix Creme Rinse
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.
|United States, Arkansas|
|Children's Investigational Research Program, LLC (CHIRP)|
|Bentonville, Arkansas, United States, 72712|
|Harvey Pediatrics, PLLC|
|Jonesboro, Arkansas, United States, 72401|
|Principal Investigator:||Bryan Harvey, MD||Harvey Pediatrics|