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

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ParaPRO LLC

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.