A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age
Summary
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.
Description
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
Conditions
Pediculosis Capitis (Head Lice)
Intervention
NatrOVA Creme Rinse (1%)
Location
Hill Top Research
St. Petersburg
Florida
United States
33710
Status
Completed
Source
ParaPro Pharmacuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00410709
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Pediculus
Lice of the genus Pediculus, family Pediculidae. Pediculus humanus corporus is the human body louse and Pediculus humanus capitis is the human head louse.
Lice
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).
Phthiraptera
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).
Carbaryl
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.
Lice Infestations
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)
Clinical Trials
A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pedicul...
A comparative safety and efficacy study of NatrOVA Creme Rinse - 1% versus NIX Creme Rinse, under actual use conditions in subjects 6 months of age or greater who are infested with Pedicul...
A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse
A pilot study to compare the safety and efficacy of NatrOVA Creme Rinse 1% to NIX Creme Rinse in subjects with Pediculosis Capitis
Phototoxicity Potential of NatrOVA Creme Rinse - 1%
This study will evaluate the primary irritation potential of NatrOVA Creme Rinse - 1% in humans, after exposure to UV radiation.
NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers
Photoallergic reactions are assumed to be due to a delayed cell-mediated hypersensitivity response that requires the presence of ultraviolet irradiation. The predictive procedure is, ther...
PubMed Articles
Treatment of pediculosis capitis with topical albendazole.
Abstract Pediculosis capitis, or head lice infestation, caused by Pediculus humanus capitis, is a common and ubiquitous health concern. Increasing resistance and treatment failures are reported with a...
Circumscribed Alopecia: An Unusual Manifestation of Pediculosis Capitis.
A healthy 10-year-old girl was referred for evaluation of patchy hair loss on the scalp of longer than 6 months duration. She had been diagnosed and treated for head lice approximately 1 month...
Permethrin Treatment of Head Lice with Knockdown Resistance-like Gene.
To the Editor: Chosidow and colleagues (March 11, 2010, issue)(1) justify their study of oral ivermectin for the treatment of pediculosis capitis by the increasing resistance of head lice to pyrethroi...
What's bugging you? An update on the treatment of head lice infestation.
Head lice infestation (pediculosis capitis) is a common problem in paediatric practice. It can cause considerable distress to children and their families and may lead to bullying and social stigmatisa...
Prevalence of pediculosis capitis among Korean children.
Pediculus humanus capitis is an ectoparasite, which causes scalp pruritus particularly among children. A total of 15,373 children including 8,018 boys and 7,355 girls from 26 primary schools and 15 ki...
