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

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ClinicalTrials.gov Identifier: NCT01660321
Recruitment Status : Completed
First Posted : August 8, 2012
Results First Posted : November 19, 2012
Last Update Posted : November 22, 2012
Sponsor:
Information provided by (Responsible Party):
ParaPRO LLC

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Spinosad

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%




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%.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660321


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

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Responsible Party: ParaPRO LLC
ClinicalTrials.gov Identifier: NCT01660321     History of Changes
Other Study ID Numbers: SPN-109-11
First Posted: August 8, 2012    Key Record Dates
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:
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Lice Infestations
Parasitic Diseases
Ectoparasitic Infestations
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases