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:
NCT00301340
First received: March 8, 2006
Last updated: May 25, 2007
Last verified: May 2007

March 8, 2006
May 25, 2007
March 2006
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Complete list of historical versions of study NCT00301340 on ClinicalTrials.gov Archive Site
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Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice
An Open Trial to Evaluate the Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the Treatment of Head Lice

Summers Laboratories has developed a non-pesticide treatment for head lice. Lice Asphyxiator (L.A.) works by mechanically blocking the respiratory spiracles of the head lice, therefore causing a quick-acting suffocation that will not result in the development of resistance.

The objectives of this open label study are to evaluate the efficacy and safety of home use of two 10-minute treatments of 5% L.A. (applied one week apart).

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Interventional
Phase 3
Primary Purpose: Treatment
Head Lice
Drug: 5% Lice Asphyxiator lotion - Summers Laboratories, Inc.
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Meinking TL, Villar ME, Vicaria M, Eyerdam DH, Paquet D, Mertz-Rivera K, Rivera HF, Hiriart J, Reyna S. The clinical trials supporting benzyl alcohol lotion 5% (Ulesfia): a safe and effective topical treatment for head lice (pediculosis humanus capitis). Pediatr Dermatol. 2010 Jan-Feb;27(1):19-24. doi: 10.1111/j.1525-1470.2009.01059.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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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, or treatment failure with any live lice from Protocol SU-01-2005 or Protocol SU-02-2005.
  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, excluding protocols SU-01-2005 and SU-02-2005, within the past 30 days.
  2. Known hypersensitivity to any ingredient in the product formulation.
Both
6 Months and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00301340
SU-03-2005
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Summers Laboratories
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Principal Investigator: Terri Meinking Global Health Association 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
Summers Laboratories
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP