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
1 other identifier
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 11, 2012
CompletedFirst Posted
Study publicly available on registry
January 23, 2012
CompletedResults Posted
Study results publicly available
January 1, 2015
CompletedJanuary 1, 2015
December 1, 2014
3 months
January 11, 2012
December 3, 2014
December 18, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice
No live lice 15 days following initial treatment
15 days
Secondary Outcomes (1)
Adverse Events
15 days
Study Arms (2)
Licefreee Spray
EXPERIMENTALNix Creme Rinse, 1% Permethrin
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lice Source Services Inc.
Plantation, Florida, 33313, United States
Results Point of Contact
- Title
- Wendy Langley
- Organization
- Tec Laboratories, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Lidia Serrano
South Florida Family Health and Research Centers
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2012
First Posted
January 23, 2012
Study Start
August 1, 2011
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
January 1, 2015
Results First Posted
January 1, 2015
Record last verified: 2014-12