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Sponsored by: |
ParaPro Pharmacuticals |
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Information provided by: | ParaPro Pharmacuticals |
ClinicalTrials.gov Identifier: | NCT00410709 |
This is an open label, single center, single dose PK study of NatrOVA Creme Rinse (1%), an investigational treatment for head lice and nits, in normal, healthy infants.
Condition | Intervention | Phase |
---|---|---|
Pediculosis Capitis (Head Lice) |
Drug: NatrOVA Creme Rinse (1%) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
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 |
Enrollment: | 6 |
Study Start Date: | December 2006 |
Study Completion Date: | January 2007 |
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.
Ages Eligible for Study: | 6 Months to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | SPN-106-06 |
Study First Received: | December 12, 2006 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00410709 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pediculosis Capitis Head Lice Crawlers Ova Nits |
Lice Infestations Skin Diseases, Infectious Skin Diseases Parasitic Diseases |
Lice Infestations Ectoparasitic Infestations Skin Diseases, Infectious |
Skin Diseases Skin Diseases, Parasitic Parasitic Diseases |