Clinical Trial: Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 L

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 Summary: 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.
Sponsor: ParaPRO LLC

Current Primary Outcome:

• Cmax for Spinosyn A [ Time Frame: 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. ]
  Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%
• Tmax for Spinosyn A [ Time Frame: 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. ]
  The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn A.
• AUC (0-12) for Spinosyn A [ Time Frame: 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. ]
  Area under the plasma concentration versus time curve (AUC) of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%.
• Cmax for Spinosyn D [ Time Frame: 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. ]
  Peak Plasma Concentration of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%
• Tmax for Spinosyn D [ Time Frame: 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. ]
  The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn D.
• AUC (0-12) for Spinosyn D
  
  

  Original Primary Outcome: Spinosyn A, Spinosyn D and Benzyl Alcohol Plasma Concentrations [ Time Frame: Blood samples collected up to 12 hours post treatment ]

  Subjects were admitted into a clinical environment on the day of product application (Day 1) and stayed in the clinic until the 12-hour procedures were completed. On Day 1, all subjects were treated with a topical application of Natroba (spinosad) Topical Suspension, 0.9%. A sufficient amount of Natroba 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. Subjects had blood samples drawn at 0 (pre-treatment), 0.5, 1.0, 3.0, 6.0 and 12 hours post-treatment. A ±5 minute time window was allowed for all post-treatment blood samples. The relative times for the post treatment blood sample collection were based on the end of the time of the 10 minute application. Blood was collected by a qualified phlebotomist. Following the sample collections on Day 1, subjects were released from the clinic. Cmax, Tmax, and AUC 0-12 will be used to evaluate the blood samples.
  
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: ParaPRO LLC
  

  Dates:
  Date Received: August 6, 2012
  Date Started: September 2011
  Date Completion:
  Last Updated: November 16, 2012
  Last Verified: November 2012