Status:
COMPLETED
A Pharmacokinetic (PK) Study of NatrOVA Topical Creme (1%) in Pediatric Subjects 6 to 24 Months of Age
Lead Sponsor:
ParaPRO LLC
Conditions:
Pediculosis Capitis (Head Lice)
Eligibility:
All Genders
6-24 years
Phase:
PHASE1
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00410709
Start Date
December 1 2006
End Date
January 1 2007
Last Update
August 1 2008
Active Locations (1)
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1
Hill Top Research
St. Petersburg, Florida, United States, 33710