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NCT02394340 · ClinicalTrials.gov registry record · Phase 4
Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris
A Phase 4 study, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT02394340: Completed Phase 4 study, sponsored by Bausch & Lomb Incorporated.
NCT02394340 is a Phase 4 study that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02394340, a Phase 4 study, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is an open-label, maximal use study to evaluate whether luliconazole in plasma acts as an inhibitor of cytochrome P2C19 (CYP2C19) as measured by circulating levels of omeprazole before and after treatment with a maximum dose of luliconazole cream 1% in participants with moderate to severe tinea pedis and tinea cruris.
Primary Outcome
Circulating plasma levels of omeprazole were measured using validated liquid chromatography with tandem mass spectrometry detection (LS/MS-MS) methods. The range for omeprazole determination was 4.64-9.27 nanograms/milliliter (ng/mL). Serial blood sampling occurred in each enrolled participant up to 24 hours post treatment (Day 1) with omeprazole (before the start of luliconazole cream 1% treatment on Day 2).
Interventions
- DRUG Omeprazole 40 mg
- DRUG Luliconazole Cream 1%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-02-03 |
| Est. Completion | 2015-04-01 |
| Phase | Phase 4 |
What the finished NCT02394340 record still lists
NCT02394340 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Omeprazole 40 mg is the first listed.
NCT02394340 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02394340 about?
NCT02394340 is a clinical study titled "Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris". This is an open-label, maximal use study to evaluate whether luliconazole in plasma acts as an inhibitor of cytochrome P2C19 (CYP2C19) as measured by circulating levels of omeprazole before and after treatment with a maximum dose of luliconazole cream 1% in participants with moderate to severe tinea...
What is the current status of trial NCT02394340?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2015-02-03. Estimated completion is 2015-04-01.
What interventions are being tested in trial NCT02394340?
The interventions under investigation include: Omeprazole 40 mg (DRUG), Luliconazole Cream 1% (DRUG).
Who is sponsoring clinical trial NCT02394340?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02394340's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 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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