Efficacy and Safety Study of ME1111 in Patients With Onychomycosis
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
1 other identifier
interventional
304
1 country
31
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2013
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2013
CompletedStudy Start
First participant enrolled
December 19, 2013
CompletedFirst Posted
Study publicly available on registry
December 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedMarch 18, 2024
March 1, 2024
1.9 years
December 15, 2013
March 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Complete cure rate at Week 52
complete cure :clear (zero %) clinical involvement of the target great toenail and mycologic cure.
Week 52
Secondary Outcomes (3)
Complete or almost complete cure rate at Week 52
Week 52
Number of Adverse events
Up to Week 48, Week 52, EOS
Local Tolerability Assessments
Up to Week 48, Week 52, EOS
Study Arms (3)
ME1111 Solution, Low strength
EXPERIMENTALME1111 Solution, High strength
EXPERIMENTALMatching Vehicle Solution
PLACEBO COMPARATORInterventions
ME1111 Solution, Low strength, applied once daily for 48 weeks
ME1111 Solution, High strength, applied once daily for 48 weeks
Matching Vehicle Solution, applied once daily for 48 weeks
Eligibility Criteria
You may qualify if:
- Mild to moderate distal lateral subungual onychomycosis
- A positive potassium hydroxide (KOH) microscopy
- A positive fungal culture for a dermatophyte
- Good general health
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Encinitas, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Santa Rosa, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Miramar, Florida, United States
Unknown Facility
Newnan, Georgia, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Clinton Township, Michigan, United States
Unknown Facility
Fridley, Minnesota, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Mt. Pleasant, South Carolina, United States
Unknown Facility
Knoxville, Tennessee, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
College Station, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Lynchburg, Virginia, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Spokane, Washington, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Meiji Study Director
Meiji Seika Pharma Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2013
First Posted
December 27, 2013
Study Start
December 19, 2013
Primary Completion
October 28, 2015
Study Completion
March 1, 2016
Last Updated
March 18, 2024
Record last verified: 2024-03