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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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

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

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 ] [ Designated as safety issue: No ]
    No live lice 15 days following initial treatment


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: South Florida Family Health and Research Centers
ClinicalTrials.gov Identifier: NCT01514513     History of Changes
Other Study ID Numbers: LF001-0011
Study First Received: January 11, 2012
Last Updated: January 17, 2012
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013