Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin

Not Applicable

Completed

• Conditions: Pediculosis Capitis
• Interventions: Drug: 1% permethrin creme rinse; Drug: Licefreee Spray

• Registration Number: NCT01514513
• Lead Sponsor: South Florida Family Health and Research Centers

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-17
• Study First Posted: 2012-01-23
• Status Verified: 2014-12
• Results First Submitted: 2014-12-03
• Results First Submitted QC: 2014-12-18
• Last Update Submitted: 2014-12-18
• Results First Posted: 2015-01-01
• Last Update Posted: 2015-01-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nix Creme Rinse, 1% Permethrin	1% permethrin creme rinse	-
Licefreee Spray	Licefreee Spray	-

Primary Outcome Measures

Name	Time	Method
The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice	15 days	No live lice 15 days following initial treatment

Secondary Outcome Measures

Name	Time	Method
Adverse Events	15 days	Number of participants with adverse events

Trial Locations

Locations (1)

Lice Source Services Inc.; 🇺🇸 Plantation, Florida, United States