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NCT02022215 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of ME1111 in Patients With Onychomycosis
A Phase 2 study of Onychomycosis, sponsored by Meiji Seika Pharma Co..
- Completed
- Registry status
- Phase 2
- Development phase
- 304
- Enrollment target
- 20
- Study locations
NCT02022215: Completed Phase 2 study of Onychomycosis, sponsored by Meiji Seika Pharma Co..
NCT02022215 is a Phase 2 study of Onychomycosis that has completed, run by Meiji Seika Pharma Co.. The registered enrollment target is 304 participants, above the 67-participant average among 11 other Onychomycosis trials with a reported enrollment target (354% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02022215, a Phase 2 study of Onychomycosis, has completed, sponsored by Meiji Seika Pharma Co..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 304 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to determine the safety and efficacy of high and low strength of ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.
Primary Outcome
complete cure :clear (zero %) clinical involvement of the target great toenail and mycologic cure.
Conditions Studied
Interventions
- DRUG ME1111 Solution, Low strength
- DRUG ME1111 Solution, High strength
- DRUG Matching Vehicle Solution
Study Locations (20)
California
- - Encinitas
- - San Diego
- - San Francisco
- - Santa Rosa
Florida
- - Miami
- - Miramar
Michigan
- - Ann Arbor
- - Clinton Township
New York
- - New York
- - Rochester
Alabama
- - Birmingham
Colorado
- - Denver
Georgia
- - Newnan
Idaho
- - Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2013-12-19 |
| Est. Completion | 2016-03-01 |
| Phase | Phase 2 |
What the finished NCT02022215 record still lists
NCT02022215 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, above the 67-participant average among 11 other Onychomycosis trials with a reported enrollment target (354% higher).
The record links to 1 condition, with Onychomycosis appearing as the primary indexed condition, and to 3 interventions - of which ME1111 Solution, Low strength is the first listed.
NCT02022215 names 20 study sites across 14 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT02022215 about?
NCT02022215 is a clinical study titled "Efficacy and Safety Study of ME1111 in Patients With Onychomycosis". The purpose of the study is to determine the safety and efficacy of high and low strength of ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.
What is the current status of trial NCT02022215?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 304 participants. The study started on 2013-12-19. Estimated completion is 2016-03-01.
What conditions does trial NCT02022215 study?
This clinical trial studies the following conditions: Onychomycosis.
What interventions are being tested in trial NCT02022215?
The interventions under investigation include: ME1111 Solution, Low strength (DRUG), ME1111 Solution, High strength (DRUG), Matching Vehicle Solution (DRUG).
Who is sponsoring clinical trial NCT02022215?
This trial is sponsored by Meiji Seika Pharma Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02022215 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Onychomycosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02022215's enrollment target sits among peer trials
304 2nd of 11 the highest of 11 other Onychomycosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Onychomycosis 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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