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:

NCT00479310

First received: May 25, 2007

Last updated: NA

Last verified: May 2007

History: No changes posted

Tracking Information
First Received Date ^ICMJE	May 25, 2007
Last Updated Date	May 25, 2007
Start Date ^ICMJE	January 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: May 25, 2007)	Treatment success is defined as the absence of live lice.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: May 25, 2007)	The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice
Official Title ^ICMJE	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.
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Head Lice
Intervention ^ICMJE	Drug: Summers 5% L.A.
Study Arm (s)	Not Provided
Publications *	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 1;27(1):19-24.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	120
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Males and females 6 months of age or older. Have an active infestation with Pediculus capitis, the human head louse, with at least three live lice at baseline. Agree not to use any other pediculicides or medicated hair-grooming products during the duration of the study. Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period. Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form. 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. Subject is willing to participate in the study, and abide by the protocol requirements. Exclusion Criteria: Participation in any clinical study within the past 30 days. Known hypersensitivity to any ingredient in the product formulation.
Gender	Both
Ages	6 Months and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00479310
Other Study ID Numbers ^ICMJE	SU-02-2005
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Summers Laboratories
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Summers Laboratories
Verification Date	May 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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