Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Mayne Pharma International Pty. The registered enrollment target is 140 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02978508
The ClinicalTrials.gov registry entry for NCT02978508 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayne Pharma International Pty, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Permethrin Cream, 5% is the first listed.
NCT02978508 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.