Back to resultsA Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age
Primary Purpose
Pediculosis Capitis (Head Lice)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NatrOVA Creme Rinse (1%)
Sponsored by
About this trial
This is an interventional treatment trial for Pediculosis Capitis (Head Lice) focused on measuring Pediculosis Capitis, Head Lice, Crawlers, Ova, Nits
Eligibility Criteria
Inclusion Criteria:
- Male or female, 6 to 24 months of age
- Individuals in good general health, free of any systemic or dermatologic disorders which will interfere with the study results.
- Completion of an appropriate Informed Consent Agreement.
- 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.
- Subjects must have veins capable of withstanding multiple blood draws.
- Normal values (at screening) for serum chemistry and hematology for subjects.
Exclusion Criteria:
- History of irritation or sensitivity to pediculicide or hair care products or ingredients.
- History of known allergy or sensitivity to topical anesthetics including lidocaine and prilocaine.
- Systemic diseases that could interfere with the results of this study.
- 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.
- 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.
- Participation in a previous drug study within the past 30 days.
- Individuals with any visible skin/scalp condition at the treatment site which will interfere with the evaluations according to the opinion of the Investigator.
- 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.
Sites / Locations
- Hill Top Research
Outcomes
Primary Outcome Measures
Safety: Frequency of Adverse events and scalp evaluations for irritation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00410709
Brief Title
A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
ParaPRO LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediculosis Capitis (Head Lice)
Keywords
Pediculosis Capitis, Head Lice, Crawlers, Ova, Nits
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
NatrOVA Creme Rinse (1%)
Primary Outcome Measure Information:
Title
Safety: Frequency of Adverse events and scalp evaluations for irritation
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female, 6 to 24 months of age
Individuals in good general health, free of any systemic or dermatologic disorders which will interfere with the study results.
Completion of an appropriate Informed Consent Agreement.
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.
Subjects must have veins capable of withstanding multiple blood draws.
Normal values (at screening) for serum chemistry and hematology for subjects.
Exclusion Criteria:
History of irritation or sensitivity to pediculicide or hair care products or ingredients.
History of known allergy or sensitivity to topical anesthetics including lidocaine and prilocaine.
Systemic diseases that could interfere with the results of this study.
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.
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.
Participation in a previous drug study within the past 30 days.
Individuals with any visible skin/scalp condition at the treatment site which will interfere with the evaluations according to the opinion of the Investigator.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Brown, MD
Organizational Affiliation
Hill Top Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hill Top Research
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
12. IPD Sharing Statement
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A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age
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