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

Pediculosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660321
• Other study ID #: SPN-109-11
• Status: Completed
• Phase: Phase 4
• First received: August 6, 2012
• Last updated: November 16, 2012
• Start date: September 2011
• Est. completion date: March 2012

Study information

• Verified date: November 2012
• Source: ParaPRO LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 4 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Lice Infestations
• Pediculosis

Intervention

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.

Locations

Country	Name	City	State
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Lice Solutions Resource Network, Inc.	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ParaPRO LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax for Spinosyn A	Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%	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.	No
Primary	Tmax for Spinosyn A	The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn A.	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.	No
Primary	AUC (0-12) for Spinosyn A	Area under the plasma concentration versus time curve (AUC) of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%.	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.	No
Primary	Cmax for Spinosyn D	Peak Plasma Concentration of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%	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.	No
Primary	Tmax for Spinosyn D	The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for Spinosyn D.	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.	No
Primary	AUC (0-12) for Spinosyn D	Area under the plasma concentration versus time curve (AUC) of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%.	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.	No
Primary	Cmax for Benzyl Alcohol	Peak Plasma Concentration of benzyl alcohol (above Limit of Quantitation (1.0 µg/mL) in Natroba (spinosad) Topical Suspension, 0.9%.	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.	No
Primary	Tmax for Benzyl Alcohol	The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached for benzyl alcohol.	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.	No
Primary	AUC (0-12) for Benzyl Alcohol	Area under the plasma concentration versus time curve (AUC) of benzyl alcohol in Natroba (spinosad) Topical Suspension, 0.9%.	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.	No