A Multi-Center, Randomized, Vehicle Controlled, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the Treatment of Head Lice.

Summers Laboratories5 sites in 1 country120 target enrollmentJanuary 2006

ConditionsHead Lice

DrugsSummers 5% L.A.

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Head Lice
Sponsor: Summers Laboratories
Enrollment: 120
Locations: 5
Primary Endpoint: Treatment success is defined as the absence of live lice.
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-center, randomized, double blind, vehicle controlled, study designed to evaluate the pediculicidal activity of Summers 5% L.A. compared to a vehicle control.

Registry

clinicaltrials.gov

Start Date

January 2006

End Date

TBD

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Summers Laboratories

Eligibility Criteria

Inclusion Criteria

•Males and females 6 months of age or older.
•Have an active infestation with pediculus capitis, the human head louse, with at least three live lice at baseline.
•Agree not to use any other pediculicides or medicated hair-grooming products during the duration of the study.
•Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period.
•Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form.
•Subject or guardian has read, understood, and signed appropriate informed consent in English. If English is not the primary language, the information about the study must be explained in their language and a copy of the informed consent must be in that language.
•Subject is willing to participate in the study, and abide by the protocol requirements.