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

This study has been completed.

First Received: May 25, 2007 No Changes Posted

Sponsored by:	Summers Laboratories
Information provided by:	Summers Laboratories
ClinicalTrials.gov Identifier:	NCT00479310

Purpose

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.

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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.

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:

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	SU-02-2005
Study First Received:	May 25, 2007
Last Updated:	May 25, 2007
ClinicalTrials.gov Identifier:	NCT00479310 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