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OpenTrials
Completed

NCT Number: NCT01514513

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.

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Key information

Conditions

Pediculosis Capitis

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lice Source Services Inc.

Plantation, Florida, 33313, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Licefreee Spray

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.

1% permethrin creme rinse

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.

Primary outcomes

  1. The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice

    Time frame: 15 days

    No live lice 15 days following initial treatment

Secondary outcomes

  1. Adverse Events

    Time frame: 15 days

    Number of participants with adverse events

Sponsors and collaborators

Lead sponsor

South Florida Family Health and Research Centers

Network

Registry information

Official study title

A Comparative Study to Demonstrate the Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin in Head Lice Infested Individuals

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 23, 2012
Registry last updated
Jan 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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