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

• Sponsor: ParaPRO LLC
• Information provided by (Responsible Party): ParaPRO LLC

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pediculosis	Drug: spinosad	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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 Start Date: September 2011
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Natroba; Natroba (Spinosad) Topical Suspension, 0.9%	Drug: spinosad; 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.; Other Name: Natroba (spinosad) Topical Suspension, 0.9%

Outcome Measures

Primary Outcome Measures :

1. 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%
2. 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.
3. 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%.
4. 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%
5. 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.
6. AUC (0-12) 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. ]
   Area under the plasma concentration versus time curve (AUC) of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%.
7. Cmax for Benzyl Alcohol [ 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 benzyl alcohol (above Limit of Quantitation (1.0 μg/mL) in Natroba (spinosad) Topical Suspension, 0.9%.
8. Tmax for Benzyl Alcohol [ 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 benzyl alcohol.
9. AUC (0-12) for Benzyl Alcohol [ 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 benzyl alcohol in Natroba (spinosad) Topical Suspension, 0.9%.

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 4 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Arkansas

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States, 71913

United States, Florida

Lice Solutions Resource Network, Inc.

West Palm Beach, Florida, United States, 33407

Sponsors and Collaborators

ParaPRO LLC

Investigators

• Principal Investigator: Dowling B Stough, M.D.; Burke Pharmaceutical Research
• Principal Investigator: Jeffrey C Seiler, M.D.; Lice Solutions Resource Network, Inc.

More Information

• Responsible Party: ParaPRO LLC
• ClinicalTrials.gov Identifier: NCT01660321 History of Changes
• Other Study ID Numbers: SPN-109-11
• First Posted: August 8, 2012
• Results First Posted: November 19, 2012
• Last Update Posted: November 22, 2012
• Last Verified: November 2012

Keywords provided by ParaPRO LLC:

Pediculosis capitis; Head Lice

Additional relevant MeSH terms:

Lice Infestations; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases