Efficacy and Safety Study of ME1111 in Patients With Onychomycosis
NCT ID: NCT02022215
Last Updated: 2024-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
304 participants
INTERVENTIONAL
2013-12-19
2016-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ME1111 Solution, Low strength
ME1111 Solution, Low strength
ME1111 Solution, Low strength, applied once daily for 48 weeks
ME1111 Solution, High strength
ME1111 Solution, High strength
ME1111 Solution, High strength, applied once daily for 48 weeks
Matching Vehicle Solution
Matching Vehicle Solution
Matching Vehicle Solution, applied once daily for 48 weeks
Interventions
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ME1111 Solution, Low strength
ME1111 Solution, Low strength, applied once daily for 48 weeks
ME1111 Solution, High strength
ME1111 Solution, High strength, applied once daily for 48 weeks
Matching Vehicle Solution
Matching Vehicle Solution, applied once daily for 48 weeks
Eligibility Criteria
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Inclusion Criteria
* A positive potassium hydroxide (KOH) microscopy
* A positive fungal culture for a dermatophyte
* Good general health
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Meiji Seika Pharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Meiji Study Director
Role: STUDY_DIRECTOR
Meiji Seika Pharma Co., Ltd.
Locations
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Birmingham, Alabama, United States
Encinitas, California, United States
San Diego, California, United States
San Francisco, California, United States
Santa Rosa, California, United States
Denver, Colorado, United States
Miami, Florida, United States
Miramar, Florida, United States
Newnan, Georgia, United States
Boise, Idaho, United States
Evansville, Indiana, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Clinton Township, Michigan, United States
Fridley, Minnesota, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Rochester, New York, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Mt. Pleasant, South Carolina, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
College Station, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Lynchburg, Virginia, United States
Norfolk, Virginia, United States
Spokane, Washington, United States
Countries
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Other Identifiers
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ME1111-2
Identifier Type: -
Identifier Source: org_study_id
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