Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice
NCT ID: NCT00301340
Last Updated: 2007-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
200 participants
INTERVENTIONAL
2006-03-31
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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5% Lice Asphyxiator lotion - Summers Laboratories, Inc.
Eligibility Criteria
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Inclusion Criteria
2. 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.
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.
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Exclusion Criteria
2. Known hypersensitivity to any ingredient in the product formulation.
6 Months
ALL
No
Sponsors
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Summers Laboratories
INDUSTRY
Principal Investigators
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Terri Meinking
Role: PRINCIPAL_INVESTIGATOR
Global Health Association of Miami
Anne Lucky, Dr.
Role: PRINCIPAL_INVESTIGATOR
Dermatology Research Associates
Jon Thomas, Dr.
Role: PRINCIPAL_INVESTIGATOR
Alegent Health
E.A. Clark, Dr.
Role: PRINCIPAL_INVESTIGATOR
Diagnostic Clinic of Longview, Tx
Peter E Silas, Dr.
Role: PRINCIPAL_INVESTIGATOR
Advanced Clinical Research Institute
Locations
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Global Health Associates of Miami 7800, SW 57 Avenue, Suite 219E
Miami, Florida, United States
Alegent Health, Harmony Street, 2nd Floor
Council Bluffs, Iowa, United States
Dermatology Research Associates 7691 Five Mile Road, Suite 312
Cincinnati, Ohio, United States
Diagnostic Clinic of Longview, TX 707 Hollybrook Drive
Longview, Texas, United States
Wee Care Pediatrics, 1580 West Antelope Drive, Suite 100
Layton, Utah, United States
Countries
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References
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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-Feb;27(1):19-24. doi: 10.1111/j.1525-1470.2009.01059.x.
Related Links
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Related Info
Other Identifiers
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SU-03-2005
Identifier Type: -
Identifier Source: org_study_id