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Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
South Florida Family Health and Research Centers
ClinicalTrials.gov Identifier:
NCT01514513
First received: January 11, 2012
Last updated: January 17, 2012
Last verified: January 2012

January 11, 2012
January 17, 2012
August 2011
November 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01514513 on ClinicalTrials.gov Archive Site
Adverse events [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
Number of participants with adverse events
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pediculosis Capitis
  • 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.
  • 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.
  • Experimental: Licefreee Spray
    Intervention: Drug: Licefreee Spray
  • Active Comparator: Nix Creme Rinse, 1% Permethrin
    Intervention: Drug: 1% permethrin creme rinse
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
December 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
4 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01514513
LF001-0011
Yes
South Florida Family Health and Research Centers
South Florida Family Health and Research Centers
Not Provided
Principal Investigator: Lidia Serrano South Florida Family Health and Research Centers
South Florida Family Health and Research Centers
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP