Status:
COMPLETED
Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice
Lead Sponsor:
Summers Laboratories
Conditions:
Head Lice
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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.
- \-
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00301340
Start Date
March 1 2006
Last Update
May 30 2007
Active Locations (5)
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1
Global Health Associates of Miami 7800, SW 57 Avenue, Suite 219E
Miami, Florida, United States, 33143
2
Alegent Health, Harmony Street, 2nd Floor
Council Bluffs, Iowa, United States, 51503-3147
3
Dermatology Research Associates 7691 Five Mile Road, Suite 312
Cincinnati, Ohio, United States, 45230
4
Diagnostic Clinic of Longview, TX 707 Hollybrook Drive
Longview, Texas, United States, 75605