Advertisement

Topics

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

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)

View Results

Links

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

Clinical Trials [996 Associated Clinical Trials listed on BioPortfolio]

A Comparative Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Pediculosis Capitis

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...

Safety and Efficacy Study of NatrOVA - 1% Creme Rinse and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice

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 [2267 Associated PubMed Articles listed on BioPortfolio]

Effect of a health education program on reduction of pediculosis in school girls at Amphoe Muang, Khon Kaen Province, Thailand.

Pediculosis caused by head lice (Pediculus humanus capitis) infestation is still an important health problem in schoolchildren, especially girls, worldwide, including in Thailand. Although pediculicid...

Impact of ivermectin administered for scabies treatment on the prevalence of head lice in Atoifi, Solomon Islands.

Scabies and head lice are ubiquitous ectoparasitic infestations that are common across the Pacific Islands. Ivermectin is an effective treatment for both conditions, although the doses used vary. At a...

Mutations in GluCl associated with ivermectin Field-Resistant Head lice from Senegal.

Through its unique mode of action, ivermectin represents a relatively new and very promising tool to fight against human lice, especially in cases of resistance to commonly used pediculicides. However...

Muscle Activity, Timing and Head Kinematics Differ Between Male and Female Ice Hockey Players During Sudden Head Perturbations.

This study examined sex differences in head kinematics and neck muscle activity during sudden head perturbations. Sixteen competitive ice hockey players participated. Three muscles were monitored bila...

Acute prurigo simplex in humans caused by pigeon lice.

Pigeon lice are insects that feed on feathers of these birds; their life cycle includes egg, nymph and adult and they may cause dermatoses in humans. Four persons of the same family, living in an urba...

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)

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

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


Searches Linking to this Trial