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NCT02485717 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
A Phase 3 study, sponsored by ParaPRO.
- Completed
- Registry status
- Phase 3
- Development phase
- 291
- Enrollment target
NCT02485717: Completed Phase 3 study, sponsored by ParaPRO.
NCT02485717 is a Phase 3 study that has completed, run by ParaPRO. The registered enrollment target is 291 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02485717, a Phase 3 study, has completed, sponsored by ParaPRO.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 291 participants
- Enrollment target
Study Summary
To assess the safety and efficacy of Natroba (spinosad) topical suspension versus placebo for the clinical cure of scabies after a single treatment. The trial will also assess the pharmacokinetics (PK) of spinosad and benzyl alcohol following a single dose of Natroba™ in pediatric subjects 4-16 years of age. These subjects will be a separate population of pediatric subjects.
Primary Outcome
The primary efficacy assessment is the proportion of index subjects completely cured of scabies by Day 28. Complete cure is defined as a demonstration of both clinical cure (all signs and symptoms have completely resolved, including burrows, inflammatory/non-inflammatory lesions and pruritus) and microscopic or dermatoscopic cure demonstrating the absence of mites, eggs, and/or scybala, and a negative dermatoscopy for burrows.
Interventions
- OTHER Placebo
- DRUG spinosad topical suspension, 0.9%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2017-05-02 |
| Est. Completion | 2018-06-25 |
| Phase | Phase 3 |
What the finished NCT02485717 record still lists
NCT02485717 is an interventional study that assigns participants to a tested intervention. The registered 291 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02485717 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02485717 about?
NCT02485717 is a clinical study titled "Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies". To assess the safety and efficacy of Natroba (spinosad) topical suspension versus placebo for the clinical cure of scabies after a single treatment. The trial will also assess the pharmacokinetics (PK) of spinosad and benzyl alcohol following a single dose of Natroba™ in pediatric subjects 4-16 year...
What is the current status of trial NCT02485717?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 291 participants. The study started on 2017-05-02. Estimated completion is 2018-06-25.
What interventions are being tested in trial NCT02485717?
The interventions under investigation include: Placebo (OTHER), spinosad topical suspension, 0.9% (DRUG).
Who is sponsoring clinical trial NCT02485717?
This trial is sponsored by ParaPRO, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02485717's enrollment target sits among peer trials
291 1168th of 2000 higher than 830 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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