Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin
The purpose of this study is to evaluate the safety and efficacy of Licefreee Spray in eradicating head lice as compared to Nix, both are available over-the-counter lice treatments.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Comparative Study to Demonstrate the Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin in Head Lice Infested Individuals|
- The proportion within each treatment group of subjects who have no live lice [ Time Frame: 15 days ] [ Designated as safety issue: No ]No live lice 15 days following initial treatment
- Adverse events [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]Number of participants with adverse events
|Study Start Date:||August 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
|Experimental: Licefreee Spray||
Drug: Licefreee Spray
Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
|Active Comparator: Nix Creme Rinse, 1% Permethrin||
Drug: 1% permethrin creme rinse
Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
Head lice is a worldwide problem. Many treatments for lice appear to be losing their effectiveness; therefore products are needed that safely and effectively eradicate lice.
|United States, Florida|
|Lice Source Services Inc.|
|Plantation, Florida, United States, 33313|
|Principal Investigator:||Lidia Serrano||South Florida Family Health and Research Centers|