- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00301340
Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice
An Open Trial to Evaluate the Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the Treatment of Head Lice
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Florida
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Miami, Florida, United States, 33143
- Global Health Associates of Miami 7800, SW 57 Avenue, Suite 219E
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Iowa
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Council Bluffs, Iowa, United States, 51503-3147
- Alegent Health, Harmony Street, 2nd Floor
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Ohio
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Cincinnati, Ohio, United States, 45230
- Dermatology Research Associates 7691 Five Mile Road, Suite 312
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Texas
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Longview, Texas, United States, 75605
- Diagnostic Clinic of Longview, TX 707 Hollybrook Drive
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Utah
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Layton, Utah, United States, 84041
- Wee Care Pediatrics, 1580 West Antelope Drive, Suite 100
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- 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
- Principal Investigator: Terri Meinking, Global Health Association of Miami
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-03-2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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