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NCT02978508 · ClinicalTrials.gov registry record · Phase 3
Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.
A Phase 3 study, sponsored by Mayne Pharma International Pty.
- Completed
- Registry status
- Phase 3
- Development phase
- 140
- Enrollment target
NCT02978508: Completed Phase 3 study, sponsored by Mayne Pharma International Pty.
NCT02978508 is a Phase 3 study that has completed, run by Mayne Pharma International Pty. The registered enrollment target is 140 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02978508, a Phase 3 study, has completed, sponsored by Mayne Pharma International Pty.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 140 participants
- Enrollment target
Study Summary
This is a multi-center, double-blind, randomized, two arm parallel design study. This study is comprised of two phases: screening and treatment. The screening period will be up to 5 days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will be randomized to receive either test or reference treatments in a double-blind manner in an outpatient setting. Randomization of subjects will be in a 1:1 ratio for the test and reference drug arms and will be stratified by site. Screening will begin at visit 1, during which eligibility will be determined and prohibited treatments will be discontinued. Randomization will occur following the confirmation of the eligibility criteria at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The treatment phase will be 28±4 days in duration wherein subject will receive treatment with investigational product (either test or reference) on Day 1 or Baseline (visit 2). Safety and tolerability assessments will be performed on Day 7 (visit 3). Efficacy, safety and tolerability will be assessed on Day 14 (visit 4) followed by the End of study visit on Day 28 (visit 5). If positive identification of scabies is confirmed at Day 14 (visit 4), the subject will be retreated with the second application of the investigational product.
Primary Outcome
To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.
Interventions
- DRUG Permethrin Cream, 5%
- DRUG Elimite
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2016-11 |
| Est. Completion | 2017-05 |
| Phase | Phase 3 |
What the finished NCT02978508 record still lists
NCT02978508 is an interventional study that assigns participants to a tested intervention. The registered 140 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 (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Permethrin Cream, 5% is the first listed.
NCT02978508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02978508 about?
NCT02978508 is a clinical study titled "Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.". This is a multi-center, double-blind, randomized, two arm parallel design study. This study is comprised of two phases: screening and treatment. The screening period will be up to 5 days, followed by the treatment phase of 28±4 days. During the treatment phase subjects will be randomized to receive ...
What is the current status of trial NCT02978508?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 140 participants. The study started on 2016-11. Estimated completion is 2017-05.
What interventions are being tested in trial NCT02978508?
The interventions under investigation include: Permethrin Cream, 5% (DRUG), Elimite (DRUG).
Who is sponsoring clinical trial NCT02978508?
This trial is sponsored by Mayne Pharma International Pty, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02978508's enrollment target sits among peer trials
140 1565th of 2000 higher than 424 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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