CompletedNCT01660321Updated Nov 22, 2012Results posted

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

A Phase 4 interventional study of spinosad in Pediculosis, sponsored by ParaPRO LLC. Completed at 2 sites in United States. Open to participants aged 6 Months to 4 Years. Per ClinicalTrials.gov, last updated 2012-11-22.

Sponsored by ParaPRO LLC · Phase 4, Interventional, and Health services research

Phase: Phase 4
Study type: Interventional
Enrollment: 26
Allocation: Not applicable
Ages: 6 Months to 4 Years
Sex: All

Study 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 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 studied

Pediculosis

Browse trials for

Lice Infestations 43

Keywords

Pediculosis capitis
Head Lice

In context

Lice Infestations

43 studies on the registry are indexed under Lice Infestations; 4 are open to participants now.

This study's enrollment of 26 is below the median of 105 across 42 interventional studies indexed under Lice Infestations.

Browse Lice Infestations studies →

Lead sponsor

ParaPRO LLC is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Months to 4 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 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 .

Exclusion criteria

Exclusion Criteria:

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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Study design

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

Study arms

Experimental
Natroba
Natroba (Spinosad) Topical Suspension, 0.9%
Drug: spinosad

Interventions

Drugspinosad
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%

What researchers measure

Primary outcomes

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

Results

Posted Nov 19, 2012

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.

Participant flow

Overall Study

Participant flow — Overall Study
Milestone	Natroba
Started	26
Completed	26
Not completed	0

Outcome measures

PrimaryCmax for Spinosyn A

Peak Plasma Concentration of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%

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.
Reported as:: Number · ng/mL

Cmax for Spinosyn A
ng/mL	Natroba
Cmax for Spinosyn A	NA

PrimaryTmax for Spinosyn A

The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached 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.
Reported as:: Number · hours

Tmax for Spinosyn A
hours	Natroba
Tmax for Spinosyn A	NA

PrimaryAUC (0-12) for Spinosyn A

Area under the plasma concentration versus time curve (AUC) of Spinosyn A in Natroba (spinosad) Topical Suspension, 0.9%.

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.
Reported as:: Number · ng*hr/mL

AUC (0-12) for Spinosyn A
ng*hr/mL	Natroba
AUC (0-12) for Spinosyn A	NA

PrimaryCmax for Spinosyn D

Peak Plasma Concentration of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%

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.
Reported as:: Number · ng/mL

Cmax for Spinosyn D
ng/mL	Natroba
Cmax for Spinosyn D	NA

PrimaryTmax for Spinosyn D

The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached 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.
Reported as:: Number · hours

Tmax for Spinosyn D
hours	Natroba
Tmax for Spinosyn D	NA

PrimaryAUC (0-12) for Spinosyn D

Area under the plasma concentration versus time curve (AUC) of Spinosyn D in Natroba (spinosad) Topical Suspension, 0.9%.

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.
Reported as:: Number · ng* hr/mL

AUC (0-12) for Spinosyn D
ng* hr/mL	Natroba
AUC (0-12) for Spinosyn D	NA

PrimaryCmax for Benzyl Alcohol

Peak Plasma Concentration of benzyl alcohol (above Limit of Quantitation (1.0 μg/mL) in Natroba (spinosad) Topical Suspension, 0.9%.

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.
Reported as:: Mean · μg/mL

Cmax for Benzyl Alcohol
μg/mL	Natroba
Cmax for Benzyl Alcohol	1.123 ± 0.3071

PrimaryTmax for Benzyl Alcohol

The time after administration of Natroba (spinosad) Topical Suspension, 0.9% when the maximum plasma concentration is reached 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.
Reported as:: Median · hours

Tmax for Benzyl Alcohol
hours	Natroba
Tmax for Benzyl Alcohol	0.5 ± 0.3071

PrimaryAUC (0-12) for Benzyl Alcohol

Area under the plasma concentration versus time curve (AUC) of benzyl alcohol in Natroba (spinosad) Topical Suspension, 0.9%.

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.
Reported as:: Number · μg*hr/mL

AUC (0-12) for Benzyl Alcohol
μg*hr/mL	Natroba
AUC (0-12) for Benzyl Alcohol	NA

Adverse events

Collected over Throughout the study.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Natroba	—	0/26 (0%)	9/26 (34.6%)

Most frequent other events

Most frequent other events
Event	Natroba
PyrexiaGeneral disorders	7/26
Application Site PruritusGeneral disorders	3/26
PruritusSkin and subcutaneous tissue disorders	2/26
ErythemaSkin and subcutaneous tissue disorders	1/26

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Natroba
<=18 years	26
Between 18 and 65 years	0
>=65 years	0

Age Continuous
Age Continuous(years)	Natroba
Mean	2 ± 0.9

Sex: Female, Male
Sex: Female, Male(Participants)	Natroba
Female	11
Male	15

Region of Enrollment
Region of Enrollment(participants)	Natroba
United States	26

Study locations

2 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01660321
Lead sponsor: ParaPRO LLC
Responsible party: Sponsor
First posted: Aug 8, 2012
Start date: Sep 2011
Primary completion: Oct 2011
Completion: Mar 2012
Results posted: Nov 19, 2012
Last update: Nov 22, 2012

Study contacts

Dowling B Stough, M.D.

principal investigator · Burke Pharmaceutical Research

Jeffrey C Seiler, M.D.

principal investigator · Lice Solutions Resource Network, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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