A Dose Ranging Study of Different Strengths of Spinosad Topical Creme in Subjects With Pediculosis Capitis
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|ClinicalTrials.gov Identifier: NCT00311779|
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : July 12, 2006
|Condition or disease||Intervention/treatment||Phase|
|Pediculosis Capitis (Head Lice)||Drug: Spinosad Creme Rinse||Phase 2|
There are millions of children and adults affected with head lice each year in the United States. It has become a major nuisance in school children resulting in many lost school days and frustrated parents. Lice and nit (ova) resistance to current OTC products has been reported. Compliance with product instructions is thought to be low. Therefore a safe and effective alternative to these products is desirable.
Spinosad and its formulations have been approved by the Environmental Protection Agency as crop protection products in the US, Canada and Australia, and has received provisional approval in the UK, Spain and several other European Union countries.
Spinosad is being formulated as a creme rinse using excipients that are widely used and are "generally regarded as safe" (GRAS).
This study is intended to show the safety and efficacy of Spinosad 0.5% and 1.0%, as compared to the vehicle control in subjects 2 years of age and older with at least a mild infestation of pediculosis capitis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Phase 2 Study of Efficacy and Safety of Different Strengths of Spinosad Topical Creme Rinse (0%, 0.5% or 1.0%) in Subjects 2 Years of Age or Older With Pediculosis Capitis - A Dose Ranging Study|
|Study Start Date :||March 2006|
|Estimated Study Completion Date :||July 2006|
- Efficacy variable: The presence/absence of live lice and/or nits at Day 7 and Day 14.
- Safety Analyses: The assessment of safety will be based on frequency of adverse events and on the scalp evaluations for irritation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311779
|United States, Arizona|
|Hill Top Resesarch|
|Scottsdale, Arizona, United States, 85251|
|United States, Florida|
|Hill Top Research|
|West Palm Beach, Florida, United States, 33409|
|United States, Ohio|
|Hill Top Research|
|Miamiville, Ohio, United States, 45147|
|Principal Investigator:||Dyal Garg, PhD||Hill Top Research|
|Principal Investigator:||Robert Lewine, MD||Hill Top Research|
|Principal Investigator:||Michael Noss, MD||Hill Top Research|