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Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin

S

South Florida Family Health and Research Centers

Status

Completed

Conditions

Pediculosis Capitis

Treatments

Drug: Licefreee Spray
Drug: 1% permethrin creme rinse

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01514513
LF001-0011

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

4+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

42 participants in 2 patient groups

Licefreee Spray
Experimental group
Treatment:
Drug: Licefreee Spray
Nix Creme Rinse, 1% Permethrin
Active Comparator group
Treatment:
Drug: 1% permethrin creme rinse

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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