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Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin

This study has been completed.
Information provided by (Responsible Party):
South Florida Family Health and Research Centers Identifier:
First received: January 11, 2012
Last updated: December 18, 2014
Last verified: December 2014
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 Intervention
Pediculosis Capitis
Drug: Licefreee Spray
Drug: 1% permethrin creme rinse

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by South Florida Family Health and Research Centers:

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

Enrollment: 42
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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

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
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Please refer to this study by its identifier: NCT01514513

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

Responsible Party: South Florida Family Health and Research Centers Identifier: NCT01514513     History of Changes
Other Study ID Numbers: LF001-0011
Study First Received: January 11, 2012
Results First Received: December 3, 2014
Last Updated: December 18, 2014

Additional relevant MeSH terms:
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017