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

Completed · Phase 1

Conditions studied: Pediculosis Capitis (Head Lice)

In brief

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.

Key facts

Study ID

NCT00410709

Run by

ParaPRO LLC

People needed

6

Starts

2006-12-01

Expected to finish

2007-01-01

Last updated by the study team

2008-08-01

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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