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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00479310
First Posted: May 28, 2007
Last Update Posted: May 28, 2007
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.
Information provided by:
Summers Laboratories
May 25, 2007
May 28, 2007
May 28, 2007
January 2006
Not Provided
Treatment success is defined as the absence of live lice.
Same as current
No Changes Posted
The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Head Lice
Drug: Summers 5% L.A.
Not Provided
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
120
Not Provided
Not Provided

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.
Sexes Eligible for Study: All
6 Months and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00479310
SU-02-2005
Not Provided
Not Provided
Not Provided
Not Provided
Summers Laboratories
Not Provided
Not Provided
Summers Laboratories
May 2007

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