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

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.
ClinicalTrials.gov Identifier: NCT00479310
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : May 28, 2007
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Head Lice Drug: Summers 5% L.A. Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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.
Study Start Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lice
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Treatment success is defined as the absence of live lice.

Secondary Outcome Measures :
  1. The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00479310     History of Changes
Other Study ID Numbers: SU-02-2005
First Posted: May 28, 2007    Key Record Dates
Last Update Posted: May 28, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases