Efficacy and Safety Study of ME1111 in Patients With Onychomycosis

March 15, 2024 updated by: Meiji Seika Pharma Co., Ltd.

A Phase 2 Randomized, Double-Blind, Vehicle-Controlled, Dose-Ranging Study to Investigate the Efficacy and Safety of ME1111 in Patients With Mild to Moderate 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • Encinitas, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
      • Santa Rosa, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Miami, Florida, United States
      • Miramar, Florida, United States
    • Georgia
      • Newnan, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
    • Indiana
      • Evansville, Indiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Clinton Township, Michigan, United States
    • Minnesota
      • Fridley, Minnesota, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • New York, New York, United States
      • Rochester, New York, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Oregon
      • Portland, Oregon, United States
    • South Carolina
      • Mount Pleasant, South Carolina, United States
    • Tennessee
      • Knoxville, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • College Station, Texas, United States
      • Dallas, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Lynchburg, Virginia, United States
      • Norfolk, Virginia, United States
    • Washington
      • Spokane, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Mild to moderate distal lateral subungual onychomycosis
  • A positive potassium hydroxide (KOH) microscopy
  • A positive fungal culture for a dermatophyte
  • Good general health

Exclusion Criteria:

  • Uncontrolled diabetes
  • Onychomycosis of the fingernails
  • Prior use of antifungal drugs (Failure to complete the specified washout period)
  • History of HIV, Hepatitis B or Hepatitis C
  • Diagnosis of psoriasis or history of psoriasis
  • Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
  • Pregnancy/lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ME1111 Solution, Low strength
Drug: ME1111 Solution, Low strength
ME1111 Solution, Low strength, applied once daily for 48 weeks
Experimental: ME1111 Solution, High strength
Drug: ME1111 Solution, High strength
ME1111 Solution, High strength, applied once daily for 48 weeks
Placebo Comparator: Matching Vehicle Solution
Drug: Matching Vehicle Solution
Matching Vehicle Solution, applied once daily for 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete cure rate at Week 52
Time Frame: Week 52
complete cure :clear (zero %) clinical involvement of the target great toenail and mycologic cure.
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete or almost complete cure rate at Week 52
Time Frame: Week 52
complete or almost complete cure:5 % or less clinical involvement of the target great toenail and mycologic cure.
Week 52
Number of Adverse events
Time Frame: Up to Week 48, Week 52, EOS
Up to Week 48, Week 52, EOS
Local Tolerability Assessments
Time Frame: Up to Week 48, Week 52, EOS
Local Tolerability Assessments:Burning/Stinging, Pruritus, Dryness, Scaling, Erythema, General Irritation, Induration/Edema, Oozing/crusting.
Up to Week 48, Week 52, EOS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meiji Seika Pharma Co., Ltd.

Investigators

  • Study Director: Meiji Study Director, Meiji Seika Pharma Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2013

Primary Completion (Actual)

October 28, 2015

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

December 15, 2013

First Submitted That Met QC Criteria

December 20, 2013

First Posted (Estimated)

December 27, 2013

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ME1111-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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