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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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
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Knoxville, TN
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Albuquerque, NM
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Boise, ID
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Cincinnati, OH
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Clinton TWP, MI
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Miami, FL
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Miramar, FL
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Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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Nashville, TN
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Newnan, GA
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Norfolk, VA
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Portland, OR
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Rochester, NY
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Spokane, WA
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