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

May 25, 2007 updated by: Summers Laboratories

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33143
        • Global Health Associates of Miami 7800, SW 57 Avenue, Suite 219E
    • Iowa
      • Council Bluffs, Iowa, United States, 51503-3147
        • Alegent Health, Harmony Street, 2nd Floor
    • Ohio
      • Cincinnati, Ohio, United States, 45230
        • Dermatology Research Associates 7691 Five Mile Road, Suite 312
    • Texas
      • Longview, Texas, United States, 75605
        • Diagnostic Clinic of Longview, TX 707 Hollybrook Drive
    • Utah
      • Layton, Utah, United States, 84041
        • Wee Care Pediatrics, 1580 West Antelope Drive, Suite 100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Treatment success is defined as the absence of live lice.

Secondary Outcome Measures

Outcome Measure
The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Summers Laboratories

Investigators

  • Principal Investigator: Terri Meinking, Global Health Associates of Miami
  • Principal Investigator: Anne Lucky, Dr., Dermatology Research Associates
  • Principal Investigator: Jon Thomas, Dr., Alegent Health
  • Principal Investigator: E.A. Clark, Dr., Diagnostic Clinic of Longview, Tx
  • Principal Investigator: Peter E Silas, Dr., Advanced Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Registration Dates

First Submitted

March 8, 2006

First Submitted That Met QC Criteria

March 8, 2006

First Posted (Estimate)

March 10, 2006

Study Record Updates

Last Update Posted (Estimate)

May 30, 2007

Last Update Submitted That Met QC Criteria

May 25, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-01-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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