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

NCT01660321 | Completed Phase 4 Results

• 1 other identifier: SPN-109-11
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Pediculosis

Keywords

Pediculosis capitis; Head Lice

Outcome Measures

Primary Outcomes (9)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

Natroba

EXPERIMENTAL

Natroba (Spinosad) Topical Suspension, 0.9%

Drug: spinosad

Interventions

spinosad DRUG

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.

Also known as: Natroba (spinosad) Topical Suspension, 0.9%

Natroba

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female, 6 months to 4 years of age.
• Subjects must have had an active lice infestation including live lice.
• 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.
• A parent (or guardian) must have signed an Informed Consent Form to allow any child to participate in the study.
• 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.
• 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.
• 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.

You may not qualify if:

• History of irritation or sensitivity to pediculicide or hair care products or ingredients.
• History of known allergy or sensitivity to topical anesthetics including lidocaine and prilocaine.
• History of allergy or sensitivity to Heparin.
• Systemic diseases that could have interfered with the results of this study as determined by the Principal Investigator or designee.
• 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.
• 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.
• Participation in a previous drug study within the past 30 days.
• 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.
• 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.

Sponsors & Collaborators

• ParaPRO LLC: lead

Study Sites (2)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Lice Solutions Resource Network, Inc.

West Palm Beach, Florida, 33407, United States

Location

MeSH Terms

Conditions

Lice Infestations

Interventions

spinosad; Suspensions

Condition Hierarchy (Ancestors)

Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

It is suspected for Subject 02-202, at 0.5 hours, the sample to determine the spinosyn A and spinosyn D concentrations were possibly contaminated with Natroba.

Results Point of Contact

• Title: Director, Quality and Regulatory
• Organization: ParaPro

kerrym@parapro.com

317-810-6205

Study Officials

• Dowling B Stough, M.D.

  Burke Pharmaceutical Research

  PRINCIPAL INVESTIGATOR

• Jeffrey C Seiler, M.D.

  Lice Solutions Resource Network, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 8, 2012
• Study Start: September 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: March 1, 2012
• Last Updated: November 22, 2012
• Results First Posted: November 19, 2012

Record last verified: 2012-11

Locations

US (2)