A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age

2014-08-27 03:41:08 | BioPortfolio


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.


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 Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Pediculosis Capitis (Head Lice)


NatrOVA Creme Rinse (1%)


Hill Top Research
St. Petersburg
United States




ParaPro Pharmacuticals

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:41:08-0400

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Medical and Biotech [MESH] Definitions

Lice of the genus Pediculus, family Pediculidae. Pediculus humanus corporus is the human body louse and Pediculus humanus capitis is the human head louse.

A general name for small, wingless, parasitic insects, previously of the order Phthiraptera. Though exact taxonomy is still controversial, they can be grouped in the orders ANOPLURA (sucking lice), MALLOPHAGA (biting lice), and Rhynchophthirina (elephant-lice).

An order of small, wingless parasitic insects, commonly known as lice. The suborders include ANOPLURA (sucking lice); AMBLYCERA; ISCHNOCERA; and Rhynchophthirina (elephant and warthog lice).

A carbamate insecticide and parasiticide. It is a potent anticholinesterase agent belonging to the carbamate group of reversible cholinesterase inhibitors. It has a particularly low toxicity from dermal absorption and is used for control of head lice in some countries.

Parasitic attack or subsistence on the skin by members of the order Phthiraptera, especially on humans by Pediculus humanus of the family Pediculidae. The hair of the head, eyelashes, and pubis is a frequent site of infestation. (From Dorland, 28th ed; Stedman, 26th ed)

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