Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice.

Phase 3

Completed

• Conditions: Head Lice

• Registration Number: NCT00301327
• Lead Sponsor: Summers Laboratories

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-03-08
• Study First Submitted QC: 2006-03-08
• Study First Posted: 2006-03-10
• Status Verified: 2007-05
• Last Update Submitted: 2007-05-25
• Last Update Posted: 2007-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Males and females 6 months of age or older.

2. Have an active infestation with pediculus capitis, the human head louse, with at least three live lice at baseline.

3. Agree not to use any other pediculicides or medicated hair-grooming products during the duration of the study.

4. Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period.

5. Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form.

6. 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.

7. Subject is willing to participate in the study, and abide by the protocol requirements.

Exclusion Criteria

1. Participation in any clinical study within the past 30 days.
2. Known hypersensitivity to any ingredient in the product formulation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment success is defined as the absence of live lice.

Secondary Outcome Measures

Name	Time	Method
The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.

Trial Locations

Locations (5)

Alegent Health, Harmony Street, 2nd Floor; 🇺🇸 Council Bluffs, Iowa, United States

Global Health Associates of Miami 7800, SW 57 Avenue, Suite 219E; 🇺🇸 Miami, Florida, United States

Dermatology Research Associates 7691 Five Mile Road, Suite 312; 🇺🇸 Cincinnati, Ohio, United States

Wee Care Pediatrics, 1580 West Antelope Drive, Suite 100; 🇺🇸 Layton, Utah, United States

Diagnostic Clinic of Longview, TX 707 Hollybrook Drive; 🇺🇸 Longview, Texas, United States