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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Summers 5% L.A. | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success is defined as the absence of live lice. |
| Measure | Description | Time Frame |
|---|---|---|
| The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit. |
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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.
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:
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| Name | Affiliation | Role |
|---|---|---|
| Terri Meinking | Global Health Associates of Miami | 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Health Associates of Miami 7800, SW 57 Avenue, Suite 219E | Miami | Florida | 33143 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20199404 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Alegent Health, Harmony Street, 2nd Floor |
| Council Bluffs |
| Iowa |
| 51503-3147 |
| United States |
| Dermatology Research Associates 7691 Five Mile Road, Suite 312 | Cincinnati | Ohio | 45230 | United States |
| Diagnostic Clinic of Longview, TX 707 Hollybrook Drive | Longview | Texas | 75605 | United States |
| Wee Care Pediatrics, 1580 West Antelope Drive, Suite 100 | Layton | Utah | 84041 | United States |