Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation
Condition: Pediculosis
MeSH terms: Lice Infestations
Intervention: spinosad
Intervention description: A sufficient amount of Natroba Topical Suspension was applied to completely cover the scalp, worked out to the ends of the hair, and left in place for 10 minutes (±30 seconds), followed by a complete rinse and shampoo.
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 6 Months
Maximum age: 4 Years
Healthy volunteers: No
Keywords: Pediculosis capitis; Head Lice

Summary:

      A pharmacokinetic and tolerance study of Natroba (spinosad) Topical Suspension, 0.9% in
      pediatric subjects 6 months to 4 years of age with an active head lice infestation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, 6 months to 4 years of age.

          2. Subjects must have had an active lice infestation including live lice.

          3. Individuals in otherwise good general health, free of any systemic or dermatologic
             disorders which, in the opinion of the Principal Investigator or designee, would
             interfere with the study results or increase the risk of adverse events.

          4. A parent (or guardian) must have signed an Informed Consent Form to allow any child to
             participate in the study.

          5. Subjects must have been available to stay in the clinic for blood draws. Parents or
             guardians must have been available to stay in the clinic, with the subject, for the
             entire duration of the study.

          6. Subjects must have had veins capable of insertion of a Heplock catheter or
             withstanding multiple blood draws as determined by the Principal Investigator or
             qualified phlebotomist.

          7. Normal values (at screening) for serum chemistry and hematology for subjects, unless
             the principal Investigator or qualified medical designee determined that the abnormal
             value was not clinically significant.

        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. History of allergy or sensitivity to Heparin.

          4. Systemic diseases that could have interfered with the results of this study as
             determined by the Principal Investigator or designee.

          5. Any condition or illness that, in the opinion of the Investigator or designee, may
             have compromised the objective of the protocol or the safety of the subject.

          6. The use of antibiotics or other systemic medications within 2 weeks of the screening
             visit, which in the opinion of the Investigator or designee could have interfered with
             the outcome of the study.

          7. Participation in a previous drug study within the past 30 days.

          8. Individuals with any visible skin/scalp condition (other than from an active lice
             infestation) at the treatment site which would have interfered with the evaluations
             according to the opinion of the Investigator or designee.

          9. Parents or guardians who, in the opinion of the Investigator, did not understand their
             child's requirements for study participation and/or may be likely to exhibit poor
             compliance.