A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age
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|ClinicalTrials.gov Identifier: NCT00410709|
Recruitment Status : Completed
First Posted : December 13, 2006
Last Update Posted : August 1, 2008
|Condition or disease||Intervention/treatment||Phase|
|Pediculosis Capitis (Head Lice)||Drug: NatrOVA Creme Rinse (1%)||Phase 1|
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 resistance to current OTC products is being widely reported. Compliance with product instructions is thought to be low. Therefore a safe and effective alternative to these products is desirable.
Spinosad (the active ingredient in NatrOVA) and its formulations have been approved as agricultural insecticides 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 into a creme rinse product (NatrOVA) using excipients that are widely used and are "generally regarded as safe" (GRAS)
This study is intended to measure the absorption (or lack thereof) of Spinosad through the scalp of infants aged 6 to 24 months, as well as to observe any adverse events related to use of the study drug. A validated method for determining the levels of Spinosad in plasma will be utilized.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1B Single Treatment, Pharmacokinetic and Tolerance Study of NatroVA Topical Creme (1%) i Pediatric Subjects 6 to 24 Months of Age|
|Study Start Date :||December 2006|
|Actual Study Completion Date :||January 2007|
- Safety: Frequency of Adverse events and scalp evaluations for irritation [ Time Frame: 4 hours ]
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): NCT00410709
|United States, Florida|
|Hill Top Research|
|St. Petersburg, Florida, United States, 33710|
|Principal Investigator:||Michael Brown, MD||Hill Top Research|