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.

Study Overview

• Status: Completed
• Conditions: Pediculosis Capitis
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Plantation, Florida, United States, 33313
      • Lice Source Services Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice	No live lice 15 days following initial treatment	15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Number of participants with adverse events	15 days

Collaborators and Investigators

• Sponsor: South Florida Family Health and Research Centers
• Investigators: Principal Investigator: Lidia Serrano, South Florida Family Health and Research Centers

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: January 11, 2012
• First Submitted That Met QC Criteria: January 17, 2012
• First Posted (Estimate): January 23, 2012

Study Record Updates

• Last Update Posted (Estimate): January 1, 2015
• Last Update Submitted That Met QC Criteria: December 18, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Permethrin
• Other Study ID Numbers: LF001-0011