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Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01514513
Recruitment Status : Completed
First Posted : January 23, 2012
Results First Posted : January 1, 2015
Last Update Posted : January 1, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Pediculosis Capitis Drug: Licefreee Spray Drug: 1% permethrin creme rinse

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2011
Primary Completion Date : November 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lice
Drug Information available for: Permethrin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Adverse Events [ Time Frame: 15 days ]
    Number of participants with adverse events


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514513


Locations
United States, Florida
Lice Source Services Inc.
Plantation, Florida, United States, 33313
Sponsors and Collaborators
South Florida Family Health and Research Centers
Investigators
Principal Investigator: Lidia Serrano South Florida Family Health and Research Centers
More Information

Responsible Party: South Florida Family Health and Research Centers
ClinicalTrials.gov Identifier: NCT01514513     History of Changes
Other Study ID Numbers: LF001-0011
First Posted: January 23, 2012    Key Record Dates
Results First Posted: January 1, 2015
Last Update Posted: January 1, 2015
Last Verified: December 2014

Additional relevant MeSH terms:
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases
Permethrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action