Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pediculosis Capitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Licefreee Spray

Group Type EXPERIMENTAL

Licefreee Spray

Intervention Type DRUG

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.

Nix Creme Rinse, 1% Permethrin

Group Type ACTIVE_COMPARATOR

1% permethrin creme rinse

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes