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NCT01660321 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by ParaPRO.

Completed
Registry status
Phase 4
Development phase
26
Enrollment target

NCT01660321: Completed Phase 4 study, sponsored by ParaPRO.

NCT01660321 is a Phase 4 study that has completed, run by ParaPRO. The registered enrollment target is 26 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01660321, a Phase 4 study, has completed, sponsored by ParaPRO.

COMPLETED
Registry status
Phase 4
Development phase
26 participants
Enrollment target

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.

Primary Outcome

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

Interventions

  • DRUG spinosad

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2011-09
Est. Completion 2012-03
Phase Phase 4
ParaPRO

11 total trials

What the finished NCT01660321 record still lists

NCT01660321 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which spinosad is the first listed.

NCT01660321 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01660321 about?

NCT01660321 is a clinical study titled "Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics 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.

What is the current status of trial NCT01660321?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2011-09. Estimated completion is 2012-03.

What interventions are being tested in trial NCT01660321?

The interventions under investigation include: spinosad (DRUG).

Who is sponsoring clinical trial NCT01660321?

This trial is sponsored by ParaPRO, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01660321's enrollment target sits among peer trials

26 1655th of 2000 higher than 332 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01660321, the US trial registry maintained by the National Library of Medicine. NCT01660321 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.