Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation
NCT ID: NCT01660321
Last Updated: 2012-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
26 participants
INTERVENTIONAL
2011-09-30
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Natroba
Natroba (Spinosad) Topical Suspension, 0.9%
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
6 Months
4 Years
ALL
No
Sponsors
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ParaPRO LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Dowling B Stough, M.D.
Role: PRINCIPAL_INVESTIGATOR
Burke Pharmaceutical Research
Jeffrey C Seiler, M.D.
Role: PRINCIPAL_INVESTIGATOR
Lice Solutions Resource Network, Inc.
Locations
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Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Lice Solutions Resource Network, Inc.
West Palm Beach, Florida, United States
Countries
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Other Identifiers
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SPN-109-11
Identifier Type: -
Identifier Source: org_study_id