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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00301327
Recruitment Status : Completed
First Posted : March 10, 2006
Last Update Posted : May 30, 2007
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Head Lice Drug: Summers 5% L.A. Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2006

Primary Outcome Measures :
  1. Treatment success is defined as the absence of live lice.

Secondary Outcome Measures :
  1. The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00301327

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00301327     History of Changes
Other Study ID Numbers: SU-01-2005
First Posted: March 10, 2006    Key Record Dates
Last Update Posted: May 30, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
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Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases