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

This study has been completed.
Sponsor:
Information provided by:
ParaPRO LLC
ClinicalTrials.gov Identifier:
NCT00410709
First received: December 12, 2006
Last updated: July 31, 2008
Last verified: July 2008
  Purpose

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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by ParaPRO LLC:

Primary Outcome Measures:
  • Safety: Frequency of Adverse events and scalp evaluations for irritation [ Time Frame: 4 hours ]

Enrollment: 6
Study Start Date: December 2006
Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   6 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410709

Locations
United States, Florida
Hill Top Research
St. Petersburg, Florida, United States, 33710
Sponsors and Collaborators
ParaPRO LLC
Investigators
Principal Investigator: Michael Brown, MD Hill Top Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00410709     History of Changes
Other Study ID Numbers: SPN-106-06
Study First Received: December 12, 2006
Last Updated: July 31, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by ParaPRO LLC:
Pediculosis Capitis
Head Lice
Crawlers
Ova
Nits

Additional relevant MeSH terms:
Lice Infestations
Ectoparasitic Infestations
Parasitic Diseases
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Parasitic

ClinicalTrials.gov processed this record on October 23, 2014