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

This study has been completed.
Sponsor:
Information provided by:
Summers Laboratories
ClinicalTrials.gov Identifier:
NCT00301327
First received: March 8, 2006
Last updated: May 25, 2007
Last verified: May 2007
  Purpose

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 Intervention Phase
Head Lice
Drug: Summers 5% L.A.
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Summers Laboratories:

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

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

Estimated Enrollment: 120
Study Start Date: January 2006
  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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Exclusion Criteria:

  1. Participation in any clinical study within the past 30 days.
  2. Known hypersensitivity to any ingredient in the product formulation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301327

Locations
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
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
  More Information

Additional Information:
No publications provided by Summers Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00301327     History of Changes
Other Study ID Numbers: SU-01-2005
Study First Received: March 8, 2006
Last Updated: May 25, 2007
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 22, 2014