N/A
N=42
Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin
Pediculosis Capitis
Bottom Line
View on ClinicalTrials.gov: NCT01514513 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice — 17; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Licefreee Spray (Drug); 1% permethrin creme rinse (Drug)
- Age
- Pediatric, Adult, Older Adult · 4+ yrs
- Sex
- All
- Sponsor
- South Florida Family Health and Research Centers
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice |
17; 9 | — |
| SECONDARY Adverse Events |
0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01514513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.