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

A Phase 1B Single Treatment, Pharmacokinetic and Tolerance Study of NatroVA Topical Creme (1%) i Pediatric Subjects 6 to 24 Months of Age

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.

Study Overview

• Status: Completed
• Conditions: Pediculosis Capitis (Head Lice)
• Intervention / Treatment: Drug: NatrOVA Creme Rinse (1%)

Detailed 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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • St. Petersburg, Florida, United States, 33710
      • Hill Top Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, 6 to 24 months of age
2. Individuals in good general health, free of any systemic or dermatologic disorders which will interfere with the study results.
3. Completion of an appropriate Informed Consent Agreement.
4. Subjects must be available to stay in the clinic for blood draws. Parents or guardians must be available to stay in the clinic with the minor subject, for the duration of the study.
5. Subjects must have veins capable of withstanding multiple blood draws.
6. Normal values (at screening) for serum chemistry and hematology for subjects.

Exclusion Criteria:

1. History of irritation or sensitivity to pediculicide or hair care products or ingredients.
2. History of known allergy or sensitivity to topical anesthetics including lidocaine and prilocaine.
3. Systemic diseases that could interfere with the results of this study.
4. Any condition or illness that, in the opinion of the Principal Investigator or designee, may compromise the objectivity of the protocol or the safety of the subject.
5. The use of antibiotics or other systemic medications within two weeks of the screening visit, which in the opinion of the investigator, could interfere with the outcome of the study.
6. Participation in a previous drug study within the past 30 days.
7. Individuals with any visible skin/scalp condition at the treatment site which will interfere with the evaluations according to the opinion of the Investigator.
8. Parents or guardians who, in the opinion of the Investigator, do not understand their child's requirements for study participation and/or may be likely to exhibit poor compliance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: Frequency of Adverse events and scalp evaluations for irritation	4 hours

Collaborators and Investigators

• Sponsor: ParaPRO LLC
• Investigators: Principal Investigator: Michael Brown, MD, Hill Top Research

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: December 12, 2006
• First Submitted That Met QC Criteria: December 12, 2006
• First Posted (Estimate): December 13, 2006

Study Record Updates

• Last Update Posted (Estimate): August 1, 2008
• Last Update Submitted That Met QC Criteria: July 31, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Head Lice; Crawlers; Ova; Pediculosis Capitis; Nits
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations
• Other Study ID Numbers: SPN-106-06