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COMPLETED Phase 2

Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

NCT02022215 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 304 participants
Start Date 2013-12-19
Est. Completion 2016-03-01
Phase Phase 2

Sponsor

Meiji Seika Pharma Co.

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02022215

The ClinicalTrials.gov registry entry for NCT02022215 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Meiji Seika Pharma Co., which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02022215 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02022215?

This trial is sponsored by Meiji Seika Pharma Co., which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial