PediculosisPhase 4NCT01660321

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

A Phase 4 study testing spinosad in people with Pediculosis, run by ParaPRO LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 6 months to 4 years
Conditions the study is for: Pediculosis
What is being tested?: spinosad
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 2 sitesUnited States
Study dates: Sep 2011to Mar 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 4 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Lice Solutions Resource Network, Inc.
West Palm Beach, Florida, 33407

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Pediculosis
Being tested: spinosad
Keywords: Pediculosis capitis, Head Lice
Medical subject headings: Lice Infestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

spinosadDrug
Also called Natroba (spinosad) Topical Suspension, 0.9%
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.

Study groups in NCT01660321
Study group	Role	What they receive
Natroba	Experimental	Natroba (Spinosad) Topical Suspension, 0.9% Receives: Drug: spinosad

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax for Spinosyn A
Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%
Measured: 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.
Measured: 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%.
Measured: 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%
Measured: 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.
Measured: 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%.
Measured: 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%.
Measured: 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.
Measured: 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%.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Mar 2012

First posted8 Aug 2012 (estimated)
Study startSep 2011
Primary completionOct 2011
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PediculosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01660321
Sponsor's protocol ID: SPN-109-11
Status last verified: Nov 2012
First submitted: 6 Aug 2012
Last updated: 22 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
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Recruiting
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All Pediculosis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01660321
Acronym / sponsor ID: SPN-109-11
Conditions: Pediculosis
Keywords: Pediculosis capitis, Head Lice
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: ParaPRO LLCIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Oct 2011 (actual)
Study completion: Mar 2012 (actual)
First posted: 8 Aug 2012 (estimated)
Results: Posted 19 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Natroba	Experimental	Drug: spinosadNatroba (Spinosad) Topical Suspension, 0.9%

Who may qualify

Ages: 6 months to 4 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
spinosadAlso: Natroba (spinosad) Topical Suspension, 0.9%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.	Drug	Natroba

Primary outcome

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%
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.
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%.
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%
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.
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%.
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%.
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.
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%.

Results and safety

Results posted to the registry on 19 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Natroba	26	26

Primary outcome: 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.. Number. Unit: ng/mL

Measure	Natroba n = 26
Value	NA

Population analysed: Per Protocol. For all but 1 subject (Subject 02-202), all spinosyn A and spinosyn D concentrations were Below Quantification Level (BQL) or \< 3.0 ng/mL for all samples. Therefore, Cmax, Tmax, and AUC 0-12 were not summarized.

Primary outcome: 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.. Number. Unit: hours

Measure	Natroba n = 26
Value	NA

Primary outcome: 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.. Number. Unit: ng*hr/mL

Measure	Natroba n = 26
Value	NA

Primary outcome: 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.. Number. Unit: ng/mL

Measure	Natroba n = 26
Value	NA

Adverse events

Time frame: Throughout the study.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Natroba	0 of 26 (0%)	9 of 26 (34.6%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dowling B Stough, M.D. principal investigator

Burke Pharmaceutical Research

Jeffrey C Seiler, M.D. principal investigator

Lice Solutions Resource Network, Inc.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing spinosad in people with Pediculosis, run by ParaPRO LLC at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01660321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2012.