Completed
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
What is being tested
spinosad
Drug
Who is being recruted
Ectoparasitic Infestations+5
+ Infections
+ Parasitic Diseases
From 6 Months to 4 Years
+16 Eligibility Criteria
How is the trial designed
Services Research Study
Phase 4
Interventional
Study Start: September 2011
Summary
Principal SponsorParaPRO LLC
Last updated: November 22, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2011
Actual date on which the first participant was enrolled.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.
Principal SponsorParaPRO LLC
Last updated: November 22, 2012
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
26 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Services Research Study
These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 6 Months to 4 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Ectoparasitic InfestationsInfectionsParasitic DiseasesSkin DiseasesSkin Diseases, InfectiousSkin Diseases, ParasiticSkin and Connective Tissue DiseasesLice Infestations
Criteria
7 inclusion criteria required to participate
A parent (or guardian) must have signed an Informed Consent Form to allow any child to participate in the study
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
Male or female, 6 months to 4 years of age
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
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9 exclusion criteria prevent from participating
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
History of allergy or sensitivity to Heparin
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
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalNatroba (Spinosad) Topical Suspension, 0.9%
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Burke Pharmaceutical Research
Hot Springs, United StatesOpen Burke Pharmaceutical Research in Google MapsLice Solutions Resource Network, Inc.
West Palm Beach, United StatesCompleted2 Study Centers