Clinical trial NCT01660321: Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation
Official title: A Single Treatment, Pharmacokinetic (PK) 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pediculosis
Keywords: Pediculosis capitis
Head Lice
Lead sponsor: ParaPRO LLC
Sponsor class: INDUSTRY
First posted: 2012-08-08
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: A Postmarketing Requirement Protocol, multicenter, open-label study in pediatric subjects 6 months to 4 years of age with an active head lice infestation designed to determine the topical absorption and safety of Natroba (spinosad) Topical Suspension, 0.9% for a single, 10 minute treatment for spinosad (Spinosyn A and Spinosyn D) and benzyl alcohol.

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.

Primary outcomes:
measure: Cmax for Spinosyn A
timeFrame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
measure: Tmax for Spinosyn A
timeFrame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
measure: AUC (0-12) for Spinosyn A
timeFrame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
measure: Cmax for Spinosyn D
timeFrame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
measure: Tmax for Spinosyn D
timeFrame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
measure: AUC (0-12) for Spinosyn D
timeFrame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
measure: Cmax for Benzyl Alcohol
timeFrame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
measure: Tmax for Benzyl Alcohol
timeFrame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
measure: AUC (0-12) for Benzyl Alcohol
timeFrame: Blood samples collected up to 12 hours post treatment - 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: West Palm Beach
country: United States
facility: Lice Solutions Resource Network, Inc.
state: Florida
Study officials:
affiliation: Burke Pharmaceutical Research
name: Dowling B Stough, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Lice Solutions Resource Network, Inc.
name: Jeffrey C Seiler, M.D.
role: PRINCIPAL_INVESTIGATOR
References: