Title
Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin
A Comparative Study to Demonstrate the Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin in Head Lice Infested Individuals
Phase
N/ALead Sponsor
South Florida Family Health and Research CentersStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Pediculosis CapitisIntervention/Treatment
permethrin ...Study Participants
42The 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.
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.
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.
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.
Inclusion Criteria: Must be 4 years of age or older Must have an active head lice infestation of at least 10 lice and viable nits Agree not used any other pediculicides or medicated products during the study Agree not to use a nit comb during the study Must have a single place of residence Exclusion Criteria: Used any form of head lice treatment, prescription, OTC or home remedy for at least four weeks prior to their visit Used topical medication of any kind on the hair for a period of 48 hours prior to visit Individuals receiving systemic, topical drugs or medications which may interfere with the study results Has a history of allergy or hypersensitivity to ragweed or any ingredient in either test products Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with the evaluation Females who are pregnant or nursing
| Event Type | Organ System | Event Term |
|---|
No live lice 15 days following initial treatment
Number of participants with adverse events
