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
This is a multi-center, randomized, double blind, vehicle controlled, study designed to evaluate the pediculicidal activity of Summers 5% L.A. compared to a vehicle control.
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.
- 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 within the past 30 days.
- Known hypersensitivity to any ingredient in the product formulation.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00301327
Start Date
January 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