Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin

Pediculosis Capitis Clinical Trial

Official title:

A Comparative Study to Demonstrate the Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin in Head Lice Infested Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514513
• Other study ID #: LF001-0011
• Status: Completed
• Phase: N/A
• First received: January 11, 2012
• Last updated: December 18, 2014
• Start date: August 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2014
• Source: South Florida Family Health and Research Centers
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pediculosis Capitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Lice Source Services Inc.	Plantation	Florida

Sponsors (1)

Lead Sponsor	Collaborator
South Florida Family Health and Research Centers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice	No live lice 15 days following initial treatment	15 days	No
Secondary	Adverse Events	Number of participants with adverse events	15 days	Yes