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

This study has been completed.

First Received: March 8, 2006 Last Updated: May 25, 2007 History of Changes

Sponsored by:	Summers Laboratories
Information provided by:	Summers Laboratories
ClinicalTrials.gov Identifier:	NCT00301340

Purpose

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).

Condition	Intervention	Phase
Head Lice	Drug: 5% Lice Asphyxiator lotion - Summers Laboratories, Inc.	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	An Open Trial to Evaluate the Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the Treatment of Head Lice

Further study details as provided by Summers Laboratories:

Estimated Enrollment:	200
Study Start Date:	March 2006

Eligibility

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

Criteria

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, or treatment failure with any live lice from Protocol SU-01-2005 or Protocol SU-02-2005.
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.

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Exclusion Criteria:

Participation in any clinical study, excluding protocols SU-01-2005 and SU-02-2005, within the past 30 days.
Known hypersensitivity to any ingredient in the product formulation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301340

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 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

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	SU-03-2005
Study First Received:	March 8, 2006
Last Updated:	May 25, 2007
ClinicalTrials.gov Identifier:	NCT00301340 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lice Infestations

ClinicalTrials.gov processed this record on May 07, 2009