Back to resultsEfficacy and Safety of Licefreee Spray Against Nix 1% Permethrin
Primary Purpose
Pediculosis Capitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Licefreee Spray
1% permethrin creme rinse
Sponsored by
About this trial
This is an interventional treatment trial for Pediculosis Capitis
Eligibility 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
Sites / Locations
- Lice Source Services Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Licefreee Spray
Nix Creme Rinse, 1% Permethrin
Arm Description
Outcomes
Primary Outcome Measures
The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice
No live lice 15 days following initial treatment
Secondary Outcome Measures
Adverse Events
Number of participants with adverse events
Full Information
NCT ID
NCT01514513
First Posted
January 11, 2012
Last Updated
December 18, 2014
Sponsor
South Florida Family Health and Research Centers
1. Study Identification
Unique Protocol Identification Number
NCT01514513
Brief Title
Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin
Official Title
A Comparative Study to Demonstrate the Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin in Head Lice Infested Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
South Florida Family Health and Research Centers
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediculosis Capitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Licefreee Spray
Arm Type
Experimental
Arm Title
Nix Creme Rinse, 1% Permethrin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Licefreee Spray
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
1% permethrin creme rinse
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice
Description
No live lice 15 days following initial treatment
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Number of participants with adverse events
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lidia Serrano
Organizational Affiliation
South Florida Family Health and Research Centers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lice Source Services Inc.
City
Plantation
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin
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