Efficacy and Safety Study of ME1111 in Patients With Onychomycosis



Status:Completed
Conditions:Podiatry
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 70
Updated:3/24/2017
Start Date:December 19, 2013
End Date:March 1, 2016

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
33
sites
Clinical Trial Facility in Denver Colorado
Denver, Colorado
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Clinical Trial Facility in Albuquerque New Mexico
Albuquerque, New Mexico
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Albuquerque, NM
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Clinical Trial Facility in Ann Arbor Michigan
Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Clinical Trial Facility in Austin Texas
Austin, Texas 78744
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Austin, TX
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Clinical Trial Facility in Baltimore Maryland
Baltimore, Maryland
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Baltimore, MD
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Clinical Trial Facility in Birmingham Alabama
Birmingham, Alabama
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Birmingham, AL
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Clinical Trial Facility in Boise Idaho
Boise, Idaho 83712
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Boise, ID
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Clinical Trial Facility in Cincinnati Ohio
Cincinnati, Ohio
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Cincinnati, OH
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Clinical Trial Facility in Clinton TWP Michigan
Clinton TWP, Michigan 48035
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Clinton TWP, MI
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Clinical Trial Facility in College Station Texas
College Station, Texas 77845
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College Station, TX
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Clinical Trial Facility in Dallas Texas
Dallas, Texas 75390
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Dallas, TX
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Clinical Trial Facility in Encinitas California
Encinitas, California 92024
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Encinitas, CA
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Clinical Trial Facility in Evansville Indiana
Evansville, Indiana 47713
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Evansville, IN
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Clinical Trial Facility in Fridley Minnesota
Fridley, Minnesota 55432
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Fridley, MN
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Clinical Trial Facility in Knoxville Tennessee
Knoxville, Tennessee 37920
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Knoxville, TN
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Clinical Trial Facility in Lynchburg Virginia
Lynchburg, Virginia 24501
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Lynchburg, VA
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Clinical Trial Facility in Miami Florida
Miami, Florida 33136
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Miami, FL
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Clinical Trial Facility in Miramar Florida
Miramar, Florida 33027
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Miramar, FL
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Clinical Trial Facility in Mount Pleasant South Carolina
Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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Clinical Trial Facility in Nashville Tennessee
Nashville, Tennessee 37232
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Nashville, TN
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Clinical Trial Facility in New York New York
New York, New York 10032
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New York, NY
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Clinical Trial Facility in Newnan Georgia
Newnan, Georgia 30263
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Newnan, GA
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Clinical Trial Facility in Norfolk Virginia
Norfolk, Virginia 23507
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Norfolk, VA
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Clinical Trial Facility in Portland Oregon
Portland, Oregon
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Portland, OR
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Clinical Trial Facility in Portland Oregon
Portland, Oregon
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Portland, OR
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Clinical Trial Facility in Rochester New York
Rochester, New York
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Rochester, NY
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Clinical Trial Facility in Salt Lake City Utah
Salt Lake City, Utah
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Salt Lake City, UT
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Clinical Trial Facility in San Antonio Texas
San Antonio, Texas 78224
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San Antonio, TX
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Clinical Trial Facility in San Diego California
San Diego, California
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San Diego, CA
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Clinical Trial Facility in San Diego California
San Diego, California
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San Diego, CA
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Clinical Trial Facility in San Francisco California
San Francisco, California
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San Francisco, CA
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Clinical Trial Facility in Santa Rosa California
Santa Rosa, California 95405
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Santa Rosa, CA
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Clinical Trial Facility in Spokane Washington
Spokane, Washington
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Spokane, WA
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