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Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin

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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):
South Florida Family Health and Research Centers

Tracking Information
First Submitted Date  ICMJE January 11, 2012
First Posted Date  ICMJE January 23, 2012
Results First Submitted Date  ICMJE December 3, 2014
Results First Posted Date  ICMJE January 1, 2015
Last Update Posted Date January 1, 2015
Study Start Date  ICMJE August 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01514513 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2012)
Adverse Events [ Time Frame: 15 days ]
Number of participants with adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin
Official Title  ICMJE A Comparative Study to Demonstrate the Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin in Head Lice Infested Individuals
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pediculosis Capitis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Licefreee Spray
    Intervention: Drug: Licefreee Spray
  • Active Comparator: Nix Creme Rinse, 1% Permethrin
    Intervention: Drug: 1% permethrin creme rinse
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2012)
42
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01514513
Other Study ID Numbers  ICMJE LF001-0011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party South Florida Family Health and Research Centers
Study Sponsor  ICMJE South Florida Family Health and Research Centers
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lidia Serrano South Florida Family Health and Research Centers
PRS Account South Florida Family Health and Research Centers
Verification Date December 2014

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